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Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
August 2012
Now That Obesity Is A Disease …
81 min reading time

… what is the implication to the medical device industry? To the economics of healthcare?

From TIME: “Treating obesity as a disease implies … moving from a body-mass index (BMI) of 29 to a BMI of 30, is equivalent to contracting a disease. But that is simply not the case.”

The Washington Post: “We should hope that labeling obesity a disease can at least change how America trains doctors to treat it.”

Forbes: “The American Medical Association’s announcement … terrible news for food companies, public health advocates, and … obese Americans.” And “calling obesity a disease gives a hall pass to many who either don’t care or who struggle with their food and lifestyle choices.”

Also from Forbes: “Obesity IS a disease, a chronic, frequently progressive, and rarely remitting disorder that triggers an additional 65 or more other conditions….”

The New York Times: “There is not even a universally agreed upon definition of what constitutes a disease. And the A.M.A.’s decision has no legal authority.”

Will “obesity as disease” have any impact on your business? How?

++++++++++

As an experiment, let’s see if we can’t help some members connect with a hiring company.
If it works, maybe we’ll do it again.

Irvine, California-based Kareo (medical office software and services) needs a Director of Marketing Communication with success at a technology company, most likely B2B SaaS. They need a CTO and another half dozen roles filled.

It would be great to fill these roles with Medical Devices Group members, don’t you think?

Good luck! http://medgroup.biz/Kareo

++++++++++

Discussions To Discover:

Device Tax: Is 3M being audited?
http://linkd.in/3M-audit

The Reasons Why Medical Startups Fail
http://linkd.in/startup-failure

How to find distributors in Latin America?
http://linkd.in/LatAm-dtn

++++++++++

Happy Independence Day to the 59% of the Group that celebrates it!

Joe Hage
Medical Devices Group Leader

On the blog: The dominant meddev marketing tool http://medgroup.biz/marketing-tool


Bernadette Silva
Sr. Director, Business Development & Marketing at Life Science Intelligence, Inc.
This new Market Report addresses both of Joe’s questions well:
http://www.lifescienceintelligence.com/market-reports-page.php?id=HRI-071|leo://plh/http%3A*3*3www%2Elifescienceintelligence%2Ecom*3market-reports-page%2Ephp%3Fid%3DHRI-071/Y6HF?_t=tracking_disc]

Nadine Lepick
VP Business Development at CTX, Inc.
A couple of things have been introduced to me recently:
1)The lead article in the August edition of National Geographic is all about sugar. I learned that because of an evolutionary development, all fructose is processed by the liver ONLY and glucose is processed by a number of organs in your body. Read it and see if this opens your eyes about a problem you may be having. I found it enlightening.
2)In a recent visit to a mission at an Indian reservation while on vacation in Arizona, the lecturer told us that a particular tribe has lived on this piece of property for hundreds, if not thousands of years. Historically,they were always big meat eaters.Only when a missionary from Spain came there, built the mission and taught them how to grow wheat did these people gain enormous amounts of weight from adding bread to their diets. (Now, all of the wheat they harvest is sent to Italy for processing into macaroni products and then shipped back to us). Carbs turn into sugars, right?
3)I’ve recently learned that extremely obese people may have developed metabolic syndrome. Essentially, this means that their leptin processes don’t work, (the natural process of burning fat to lose weight either through eating less or exercising more). In this group of people, their whole metabolisms have been altered in some way. They definitely need help and will get it either through surgery or a medication.

I agree with Mark Hollingworth that there are many different reasons for gaining weight. Sometimes, one only needs to look at what is specific to the things they’ve been doing to find the root cause.

Of course, we in any medical field are going to look at this as a problem and try to provide help. That is what we do.

Erica Heath, CIP
Retired – available for small human subject protection, informed consent consulting jobs
From Gigaom via LinkedIn (MAGI) this morning…

“Summary:
According to a new report, Apple has been bringing on board experts in sensors that monitor the human body. Here’s how that could play into the company’s “iWatch” effort…”

Guy Hibbins
Medical Officer
Well actually I have written several thousand clinical evaluation reports on medical devices since 2005 and it is surprising just how few of them are innovative. However, innovation is what the device companies want and this is especially true of the cardiovascular, neurological and orthopaedic sectors as they can then claim that their device has something which their competitors do not have and which fulfils an unmet clinical need. The most successful devices I have seen have been highly innovative.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Guy, the most innovative will get the most buzz. The most successful will get the most reward. Still, however, with a $102B market waiting to be tapped, even those that work only fairly well will be hugely rewarded. Try to make a statement like that in the cardiovascular, neurological, or orthopedic sectors and you’d be laughed out of the room.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
If you want to see what is coming down the ACO runway, take a look here:

http://mobihealthnews.com/24057/orlando-health-explores-telemonitoring-as-an-alternative-to-hospital-admissions/%7Cleo://plh/http%3A*3*3mobihealthnews.com*324057*3orlando-health-explores-telemonitoring-as-an-alternative-to-hospital-admissions*3/E38l?_t=tracking_disc]

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
Sorry, I inadvertently added my last comment before I was finished. One of the problems with using a touch pad on a laptop instead of a mouse. Lets try it again.

I think the medical device and healthcare industries are already benefiting financially due to the increased need of treatment for diseases and conditions brought on by obesity. It is hard to say what the effect of reducing the prevalence of obesity will have on them in the future. It may just shift healthcare needs in a different direction.

There will probably be no magic solution. Obviously, it will take a multifaceted approach including changes in society, the food industry, farming, biological science, healthcare, fitness programs etc. Since it developed over a long period of time, it will take a long time to change, therefore the medical device industry and hospitals will continue deal with and profit on the effects of the obesity for quite some time. If we are successful at reducing obesity, it should have the effect of reducing the cost of healthcare in the long run. There may be some opportunities in the medical device industry to produce devices to help with reduction of weight, or weight, diet and exercise management. I also think healthcare organizations, employers and health insurance companies must take a proactive approach in the promotion and management of weight loss, diet and fitness initiatives.

If the cost of medical care keeps rising with the issues of aging baby boomers, obesity and it’s collateral health effects along with all the other current healthcare concerns and issues, it could become cost prohibitive and unsustainable. I think it is imperative to devise a public health initiative to aggressively promote healthy weight, including measures to make restaurants and the food industry become more responsible in providing disclosure and more healthy ingredients and offerings and communities, employers, health insurance companies, fitness professionals and health providers teaming together to help promote health conscious habits and guidance.

Patrick Kullmann
CEO, Co-Founder and Board Member at SubioMed
Obesity is an outstanding area for the contributions by the medical technology industry. This is a complex disease with very significant implications to general health. Solutions in the future will extend well beyond the current gastric bypass surgical techniques and tools of the day.

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
I think the medical device and healthcare industries is already benefiting finatially due to the increased need of treatment for diseases and conditions brought on by obesity

Clara Chung
clerk at Richmond Public Library
Knowledge is power. Educate our generation is a must. Diet and lifestyle should be emphasized.

Guy Hibbins
Medical Officer
The fact is that obesity is increasing exponentially across the world.
See
http://ndt.oxfordjournals.org/content/26/1/28.long%7Cleo://plh/http%3A*3*3ndt.oxfordjournals.org*3content*326*31*328.long/dtJP?_t=tracking_disc]

http://www.ncbi.nlm.nih.gov/pubmed/20335585%7Cleo://plh/http%3A*3*3www.ncbi.nlm.nih.gov*3pubmed*320335585/1Er9?_t=tracking_disc]

This is especially true in rapidly transitioning economies like India and China. The cost in terms of health dollars and in human terms is enormous. The so called diabesity tsunami is doing a lot of damage already.

I think that the most innovative solutions will be the best rewarded. How about a treadmill with its own inbuilt TV/WiFi internet/DVD capability.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Folks, I think that recently we have really drifted away from the main discussion point of how the new definition of obesity will be impacting your medical devices businesses.

Clara Chung
clerk at Richmond Public Library
Here is some information regarding obesity prevention from Harvard Education http://www.hsph.harvard.edu/obesity-prevention-source/obesity-prevention/%7Cleo://plh/http%3A*3*3www.hsph.harvard.edu*3obesity-prevention-source*3obesity-prevention*3/gB09?_t=tracking_disc].

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Pete: you picked the most efficient modes of locomotion which apparently don’t nudge your weight in the right direction. Per my personal observations, people can walk for a long time, without much improvement: every day I see overweight people walking 40 minutes-1 hour on a treadmill, and after several months of watching them, I don’t see much change. I think the trick is not the total energy spent, but the power (as in energy per unit time) attained.
The common denominator for the (slow) walking people is that they don’t sweat (and most probably don’t increase their heart rate appreciably).
I think getting your metabolism up (by increasing your heart rate and sweating as a result/signal) is the key to really burning calories.
I don’t subscribe to the notion that a 5-mile walk is equivalent to a 5-mile run: it’s the power output, again.
Also, a leisurely bike ride (esp. over a flat terrain) is not the same as a high intensity (read, power output) spinning class: just an example, I don’t know whether you live in Colorado or the Netherlands:).
Biking, in particular, perplexes me: here, in San Diego, lots of people bike year round, and a sizable (and surprising to me) number of them are not slim (borderline heavy). You’d think with all the miles biked to/from work and on weekends most of them would look like Lance Armstrong. Far from it: lots of pot bellies.
The only explanation I came up with is that biking is an extremely efficient form of motion (duh!), and people do not realize just how efficient it really is.

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Leanna: didn’t mean to, but there are a lot of dubious (at least to me) exercises that put people at risk. This, BTW, includes cattle bells and even some yoga poses (!). Also, qualifications for personal trainers vary widely and there’s a whole slew of internet courses one can take to quickly become a trainer. So, caveat emptor.
As I mentioned, I personally know several people who got seriously injured by ‘fashionable’ routines.
A doctor may not predict all the crazy routines one’s trainer/class instructor may come up with, so sanity and listening to your body are the best approaches. Unfortunately, peer pressure works against it, but what else is new :). Speaking from experience :).

Pete Bobb
Sterile Processing Professional
I’ll take any suggestions.
First, it was cut calories.
Then, it was cut carbohydrates.
Next it was walk.
Next it was walk 5-6 miles every single day.
Then walking wasn’t aerobic enough, so I’m riding my bike 17 miles every single day, and twice a week walking the 6 mile round trip to the grocery store, carrying the groceries home in my backpack.

Leanna Levine
President & CEO, ALine, Inc.
@Gary: your comment effectively scared anyone unfamiliar with strength training into staying away from personal trainers and weights. To balance the picture, I have seen a dozen women ranging from age 85 to 50 see tremendous improvements in balance, with weight loss, an improvement in general strength and aerobic capacity by engaging with a certified trainer, who herself is 60 years old. None of them were hurt, all of them have been working with her for well over a year. It is possible to find appropriate training. For anyone just starting out, a focus on resistance bands, and body weight exercises are most appropriate, no weight machines!

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Leanna: Interesting calculation, thank you.
Also, I cringe every time I see a 20-something personal trainer at my gym pushing an obviously out-of-shape client in his/hers 50’s: I think this is why my gym has an AED at every location :).
I also think one has to be extremely careful with coach/exercise selection after the age of 40 (when we start to slowly break down). I know of several 60-ish people who got seriously injured (almost permanently, some requiring joint surgeries) by doing things designed for 20 year olds.
Also,one’s (mine including) weight will go up as muscle mass builds up, so going by pure weight is misleading.
Now I’m going to go away and invent a new over-exertion detector, to satisfy this thread requirements for a medical device :).

Leanna Levine
President & CEO, ALine, Inc.
@Pete, though this isn’t really the right forum for a discussion on weight loss and diet posting an entire menu suggests you are really looking for some answers. The one thing I haven’t heard anyone really talk about in this whole discussion is the role of muscle in the metabolism of food. There is a lot of focus on what the fat is doing, but not much on the muscle. Which leads to my suggestion that anyone who is having difficulty losing weight with diet and aerobic exercise is not working to increase muscle mass. I think of muscle as the engine in the body that burns fuel…more muscle more fuel burning. For people with a sedentary lifestyle, which I am going to guess 90% of us on this forum are, you are losing muscle more rapidly the older you get, therefore, less engine to burn calories. The only solution is to engage in strength training; weight bearing exercise that taxes the muscles and forces them to grow. The benefits are multiple: improved balance, reduced back pain, increased mobility, less joint pain. Based on my experience, the only way to build muscle is by working with a professional trainer who will provide the right exercises for each person’s level of fitness. There are plenty of personal trainers in our age bracket who understand our goals and the changes in the body with age. More than counting calories (which often has about 30% error), its better to build muscle and increase the calorie burning capacity of the body. It seems to me a simple system approach (fat accumulates fat, muscles burns whatever fuel you put in your body; no more calorie counting required). The cost: $120 -$150 /week; 2 sessions/wk (+/- ). It is the best investment in health (and quality of life as we age) I can think of, far more effective than plunking down more for a health insurance policy.

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Pete: what about your secret ‘no-holds-barred’ beer&burger bash Tuesday and the visit to ‘all-you-can-eat’ buffet Wednesday? 🙂 Just kidding, just kidding. I’m just extremely surprised by your results (or lack thereof). I wish you all the best in your quest.
Like Gary Abramov’s comment
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1 Like 1 Like on Gary Abramov’s comment

6y
Pete Bobb
Pete Bobb 2nd degree connection2nd
Sterile Processing Professional

Weight Maintenance diet
Sunday

Zucchini
Amount Per 1 medium (196 g)
Calories 33, carb 6 grams

Peppers, green
Amount Per 1 large (2-1/4 per lb, approx 3-3/4″ long, 3″ dia) (164 g)
Calories 33, carb 6 grams

1 med. raw red onion
40 Calories

calories in 3 ounces squid
78 Calorie
2.6 grams carb

calories in garlic 2 teaspoons
8 Calories
1.8 g Carbs

Tomato Pasta Sauce, 1 cup
120 Calories, 20grams carbohydrate

5 small strawberries
Strawberries
Amount Per 1 medium (1-1/4″ dia) (12 g)
Calories 4, carb 0.9 grams
Total 20 calories
Carbs 4.5

Olive Oil
1 Tablespoon
119 calories

Unsweetened tea
Calories zero

Total for Sunday Brunch meal

343 Calories
40 grams carbohydrates

Diner
Smoked salmon
110 grams 120 calories
2 grams carbohydrate

Tomato, large
Calories 30
6.6 grams carbohydrates

Olive Oil
1 Tablespoon
119 calories

Total for Sunday diner

269 Calories
8.6 grams carbohydrates

Snack
6 Blackberries
15 calories
4 grams carbohydrates

1/4 cup macadamia nuts
241 calories
4.6 grams carbohydrate

Sunday total:
868 calories
57.2 carbohydrates

Monday

Brunch
Smoked salmon
110 grams 120 calories
2 grams carbohydrate

Tomato, large
Calories 30
6.6 grams carbohydrates

Olive Oil
1 Tablespoon
119 calories

Total for Monday brunch
269 Calories
8.6 grams carbohydrates

Monday Snack
Peppers, green
Amount Per 1 large (2-1/4 per lb, approx 3-3/4″ long, 3″ dia) (164 g)
Calories 33, carb 6 grams

9 Blackberries
22 calories
6 grams carbohydrates

Olive Oil
1 Tablespoon
119 calories

1/4 cup macadamia nuts
241 calories
4.6 grams carbohydrate

Snack total
413 calories
16.6 carbs

Monday dinner

Tomato, large
Calories 30
6.6 grams carbohydrates

Peppers, green
Amount Per 1 large (2-1/4 per lb, approx 3-3/4″ long, 3″ dia) (164 g)
Calories 33, carb 6 grams

Smoked salmon
110 grams 120 calories
2 grams carbohydrate

Olive Oil
1 Tablespoon
119 calories

Total for Monday diner
302 Calories
14.6 grams carbohydrates

Monday total:
984 calories
39.8 grams carbohydrates

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Basal Metabolic Rate for humans (Basal Energy Expenditure): 5 foot 10 inches, 170 lbs @ age 30 = 1700 calories/day.

BMR measurements are typically taken in a darkened room upon waking after 8 hours of sleep; 12 hours of fasting to ensure that the digestive system is inactive; and with the subject resting in a reclining position.

I just don’t believe anyone can gain on 800 calories a day, except a young child. That is like 2 muffins a day. I had a friend who said he had a very low caloric intake, but then he noted he went through a six pack a day plus his chips, so there was another nearly 1000 calories.

Pete Bobb
Sterile Processing Professional
Less food works is a very popular myth.
I can gain weight on 1500 calories a day while burning over 700 calories a day in aerobic exercise.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Uts, indeed, though individual’s predispositions can promote obesity, there were no heavy people in the WWII concentration & work camps, unless it was the guards. Less food works.

Urs Mattes
Healthcare Executive in Life Science and experienced Board Member
There is more and more evidence from basic research that overweight and obesity are caused by food addiction. If you have treated other addictions such as nicotin, alcohol, cocain and others, you know to well how hard it is to treat them. The success rate is very low for most of them. That is why most diet programs won’t work. That is why education is the key, not a magical pill or surgery. We all have to realise that there is not always a solution for a health problem which actually could be prevented.

David Pennington, PE
Senior Project Manager at Commissioning Agents, Inc | CAI Consulting
In all of this discussion about causes, it is worth noting that two centuries ago, obesity was almost unknown in this country. Bankers were notorious among the 97% of the populous that farmed, for having “bankers’ hours”, not doing any “real work”, and for being plump. An 1826 cartoon that lampooned the rag-tag troops being sent to Florida to fight the Seminole Indians showed disheveled men of various heights, none wearing a uniform…but all of them thin. No doubt it did not even occur to the political cartoonist to depict any of them as portly, although any cartoonist in modern times would be remiss to leave that out.

Guy Hibbins
Medical Officer
Members might be interested to see this report which just came out which looks at obesity and life expectancy by county region in the US.
See http://inplainsight.nbcnews.com/_news/2013/07/10/19397882-almost-death-by-zip-code-study-suggests-link-between-health-and-wealth?lite|leo://plh/http%3A*3*3inplainsight%2Enbcnews%2Ecom*3_news*32013*307*310*319397882-almost-death-by-zip-code-study-suggests-link-between-health-and-wealth%3Flite/LkKV?_t=tracking_disc]
This certainly suggests some underlying trends for obesity by region.

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
All of these devices are interesting and may be helpful in achieving weight loss but I don’t believe any one of them alone will be the total answer for anyone, although some of them may provide a big push in the right direction. Every individual who is overweight has a different set of circumstances which has contributed to their condition. There is very often physical problems such as back pain, Knee pain, hernia or possibly a physical injury that has also contributed. Anything that contributes to a reduction of physical activity, including employment commitments that reduce the amount of time spent in physical activity can contribute. If you top that with continuing the same diet from before the reduction of activity, weight gain will happen. It usually happens over a long period of time so you must accept that and make a lifelong commitment to reduction and weight management.

Everyone’s circumstances are different, therefore their approach to weight reduction will depend on their physical limitations, biological circumstances and mental commitment. It will require a tailored and flexible plan (which may include progressive diet changes, physical therapy, medical procedures and exercise) as well as a long term commitment. There will be stumbling blocks along the way. The other underlying problems will have to be dealt with appropriately and with each progression, or if there is a setback, a reevaluation should be done to determine further action. Some people will progress faster than others and some will probably be faced with failure along the way which may or may not be overcome.

I think it is time for the medical community to step up and develop a team approach with doctors, nutritionists, physical therapists, and fitness coaches to tackle this issue by providing an individualized approach. Hopefully the medical device, pharmaceutical and clinical laboratory sectors will come up with the tools that will aid in managing this type of program. This is a very important (I would say Number one) issue since it is a catalyst for so many other medical issues. I think the device industry would be wise in making sure their developments are poised to become one of the tools rather than the total answer.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Fred, I greatly appreciate your educating this group with the truly wide-ranging potential of the myriad of medical devices in development. Many of the outcomes with each are still TBD at this point, but with each partial success, or even raw failure, lessons will be learned. It’s really an exciting time to be in the field.

Fred Voss
President/CEO at PlenSat, Inc.
Paul and Paul,

While I agree that the current intragastric balloons do have a number of issues and are certainly limited to short term use, they do however assist some patients and have had some good success. Other transoral esophageal approaches such as GI Dynamics endo sleve, Enteromedics Neuroblocking, as well as a host of endoscopically delivered space altering and surgical assist devices will all have a place to treat the great numbers of individuals that are most at risk for complications as defined by their clinical condition.

There are a few companies that are developing and/or have entered the market recently with ingestible devices and approaches that can be delivered without endoscopic assist. These approaches may allow bariatric space feeling therapies to be made available to the 10’s of millions of individuals who are obese or overweight and clearly pre-diabetic by objective testing criteria. These approaches have the hope of being pill-like in delivery without the potential issues of pharmaceutical risk.

We are developing one such device as has Obalon, Gelesis and a Canadian Academic under the name of Eat Little.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Paul and Fred, I don’t know if balloons are a long-term way to go. The stomach is one of those organs that hypertrophies pretty well. So, while in the short-term, one might feel full, after a while the stomach will stretch to accommodate the “spacer”. Stretching of the stomach to accommodate food with a vertical sleeve gastrectomy also occurs in time (years), requiring a second removal of the reservoir portion of the stomach.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Fred,

Interesting points. I also wondered myself, after writing that comment, if the recent AMA announcement might alter Allergan’s thinking. Will be interesting to see what happens.

I have heard that intragastic balloons have been having some challenges or questions about the approach, but could not recall the details.

Also I am aware of an early stage endoscopically-placed technology that seemed quite promising to me when I looked at it a year ago. They secured some funding from one of the F500 device companies, but things have been put into hibernation since there has been a restructuring at the F500. I wonder if with the recent developments, some technologies might be dusted off and re-invigorated.
Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Fred, great points. I think Allergan’s letting the LapBand go was a pure business decision, however. It’s use has been waning quite a bit due to the rapid rise of the equally minimally-invasive vertical sleeve gastrectomy procedure. Yes, as with any surgical procedure, and with most medical devices, there are potential issues with its use, such as esophageal dilation, gastric erosion, and band slippage. But, the weight loss success in most, overall, cannot be denied. Allergan is just getting out while the getting is good. Whoever buys it will have lots of income for years to come.

ReShape is just one of many interesting products in the obesity space. Keep looking, and you’ll find much, much more out there besides balloons.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Fred, great points. I think Allergan’s letting the LapBand go was a pure business decision, however. It’s use has been waning quite a bit due to the rapid rise of the equally minimally-invasive vertical sleeve gastrectomy procedure. Yes, as with any surgical procedure, and with most medical devices, there are potential issues with its use, such as esophageal dilation, gastric erosion, and band slippage. But, the weight loss success in most, overall, cannot be denied. Allergan is just getting out while the getting is good. Whoever buys it will have lots of income for years to come.

ReShape is just one of many interesting products in the obesity space. Keep looking, and you’ll find much, much more out there besides balloons.

Fred Voss
President/CEO at PlenSat, Inc.
Paul,

Unfortunately Allergan has been now looking for a buyer for the Obesity product area for the last six months or so.

http://articles.latimes.com/2013/feb/05/business/la-fi-mo-allergan-earns-20130205%7Cleo://plh/http%3A*3*3articles.latimes.com*32013*3feb*305*3business*3la-fi-mo-allergan-earns-20130205/MOTV?_t=tracking_disc]
The reasons for this lack of interest in continuing this promising technology are many fold. One of the issues is apparently the recent finding in Europe of potential long term adverse effects of the LabBand based on one writers review.

“It is very odd, if not concerning, when a company wants to unload its once prized product,” said Dr. Amir Mehran, board certified bariatric surgeon and Medical Director for the Bariatric Surgery Center of Excellence. “It makes one wonder if they are concerned over long term side effects of the device (as is now being seen overseas), and they don’t want to be owning it once that happens in the U.S.” http://bariatricsurgerymd.com/examining-pending-allergan-lap-band-sale%7Cleo://plh/http%3A*3*3bariatricsurgerymd.com*3examining-pending-allergan-lap-band-sale/SDOa?_t=tracking_disc]

However, even this should not dissuade the medical device industry from moving forward to develop improved devices for the diagnosis, primarily of risk factors, and therapies for those who need to control their weight. One such company ReShape is currently in clinical trials for an improved Intragastric Balloon system. If successful ReShape will have the first FDA approved gastric balloon in the US since the early 80’s.

The ReShape system, as well as other Intragastric Balloons, are approved and marketed outside the United States.

It will be interesting to see if Allergan reverses course on the divestiture of the obesity product area with the recent AMA decision to classify Obesity as a disease.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Bo, look no further than the LapBand. That little piece of molded silicone rubber goes for $4,000 wholesale. Many of those who have gotten it paid out-of-pocket, as is the case for a good portion of those undergoing other, much more complex, bariatric surgeries involving costly stapler systems. Allergan didn’t worry about “getting profitable” when it purchased the technology from tiny InnoMed for $1.2B. Again, that’s a B. (Here is where I wish LinkedIn had the possibility of larger fonts and bolding.)

In addition, 14M people classified as obese are Medicare-Medicaid eligible. With the AMA declaring obesity as a “disease requiring treatment”, legislation and insurers will move more rapidly to approve various treatments, as it is in the best interest of everybody. For anyone with a successful design, I am personally not worried one bit about profits immediately or tremendous reimbursement in the future.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
To look at Joe Hage’s statement at the beginning, an important distinction was NOT MADE: “Now That Obesity Is A Disease … what is the implication to the medical device industry?”

There is a difference from what is defined by Joe’s references and Medicare & Insurer’s decisions as to what they will cover & what CPT code, if any, would apply.

If we design a new, much better product, there is no guarantee we can get a reimbursement allowed, much less allowed at the price we want to sell the product.

We can do our best work in product design and still have one heck of a time getting profitable.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Maurice is right on. Laugh or point fingers all you want, but the problem is everywhere, it is getting worse by the day, and the issues affecting obesity are multifactorial; nutritional, psychological, physiological, cultural, medical, etc. Medical devices are now and should be part of the solution. For those who are serious enough to research and look to tackle the issue of obesity, which is most likely the biggest medical problem worldwide, you will reap the rewards of your efforts…as you would for any other unmet medical need.

David Arndt
Software Development Consultant
I suppose this will require manufacturers to follow FDA rules for validating the development process of *scales*, since they are now taking measurements used in diagnosis of a “disease”. Look for prices of scales to increase dramatically… 😉

Maurice Coates
https://www.linkedin.com/in/coatesi/?lipi=urn%3Ali%3Apage%3Ad_flagship3_detail_base%3Bpazp9vnKSsW8kmP7U9aU5A%3D%3D&licu=urn%3Ali%3Acontrol%3Ad_flagship3_detail_base-comment_actor
I must say that all of the comments are interesting reading. Sitting here in Europe and being confronted with Europe®s favorit past time “Watching America” it is interesting to see a normal news cast where people in America are commenting on an incident. The percentage of over weight people is alarming. Worst than that is the percentage of over weight police officers. It appears that there is no stopping or concern for the problems being created in the American society. Of course one begins to look closer to home and finds out that we are having a similar trend here in Europe. The problems and answers were discussed in the various comments. We have multi national food companies selling the same unhealthy food products and drinks and the general public has no control over the content or identification of the products. More interesting is to see the damage being created in China with fast food and the weight gains of the Chinese population. Interesting comments, but no real solutions.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Unfortunately, my observation of kids who grow up is that those with parents who don’t instill discipline and values related to how you keep healthy and learn at your best are the ones who wind up being overly heavy by high school.

If you don’t get the young, you don’t instill values. We see it throughout society.

Richard Jeffery
Managing Director
We are now installing hoist systems with ceiling track in homes for this issue as home care is now the big push in Australia as in Europe. The cost is cheaper than hospital care an we have home care professionals to do the visits… So the technology and equipment is available.

In a lot of northern European countries they are building homes and apartments with ceiling hoist track already installed as standard part of homes and with universal adapters available on hoist systems so you can install a hoist for wide range of solutions and provide a true home care solution for a variety issues.

Jagu Barot
Design & Development Engineer, Quality Engineer, Manufacturing/Project Engineer

Nadine and Rochelle, Imagine Home Health Care nurse going on a visit of a 300 lb patient trying to move him or her in the bed. Need a hydraulic lift which is not issued by any medical agency. In the hospital you can at least summon a crew. But Home Health care Nurse? Heavens help.

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
Rochelle Froloff,R.N. In my position as a Consultant for a company that produces an Operating Room product that addresses decubitus ulcers, this is a huge problem. The Morbidly Obese patient creates a multitude of problems for the staff working them. There has to be adequate padding while they are on the Operating Room Table and in some cases the width of the O.R. Table is not wide enough even with the tables that accommodate those patients.

Nadine Lepick
VP Business Development at CTX, Inc.
This situation not only makes it difficult for the patient. The doctors and nurses, all care givers have problems. There are no efficient ways to lift really overweight patients onto tables. There are no tables strong enough to hold patients who require surgery-pannicular fat needs to hang off the table!
In terms of trauma surgery, there are no retractors that can be used during surgery to restrain the adipose tissue to give the surgeon a clear field in which to work.
Read this for some idea of the difficulty that hospitals and clinicians are having in treating obese individuals:
http://www.aaos.org/news/aaosnow/jul13/clinical1.asp%7Cleo://plh/http%3A*3*3www.aaos.org*3news*3aaosnow*3jul13*3clinical1.asp/5wDJ?_t=tracking_disc]
The current obesity situation affects nearly every medical specialty.

Louis DePaul
Formerly with B Braun Medical
This is a very interesting read. To answer the original question, the Medical Device Industry is by definition reactionary – find a problem and find the solution. Defining obesity as a disease changes little, the industry will still build the devices needed to serve the need. The side affect might be that insurance companies will charge more for those at risk – a slippery slope. Think camel’s nose theory.

The cause of obesity might be argued, but unless someone has developed the equivalent of a perpetual motion machine that generates calories, at some point, reducing calories consumed or increasing calories burned should work.

My observation is that much of medicine is about treating symptoms and not the cause, and certainly not the cure.

Ken Kasper
Adviser – Quality and Regulatory Affairs at ARK Diagnostics, Inc.
The discussion has been an education. To respond to some of the original questions: The USA will devote huge economic resources without doing enough to inform our citizens with objective information. Naturally business will take advantage, and this applies to medical device companies and pharma and nutrition and agriculture and medicine and so on. The foregoing discussions highlight that multiple factors can contribute to a weight condition or metabolic condition(s) that are costly to the payment systems that underwrite healthcare. If persons were informed accurately as to which factors apply to them individually, they would have an objective basis to make choices on the next course of action for their healthful living (or not). So for example, if a drug could usefully modulate the complex metabolism of fat cells, that could be a targeted approach and money well spent for applicable individuals. Exercise and a balanced diet is good for everybody. I agree that the decision to call obesity a disease is a political and economic gambit. Its usefulness may be primarily to focus attention. Teach children that they are valued. Provide them sufficient information about healthful living and provide the means for enactment and encourage. Stop picking on the fat kid. The plus size is not a disorder. Chubby people are good huggers. When I was a kid, President Kennedy initiated a physical fitness requirement for grade schoolers. It is OK for having a national consciousness that celebrates personal fitness without calling half the class a bunch of sickies to start with. How objective is that?

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
Good call on the anti-microbials, Bo (well, the whole comment, really). Gut microbes are essential to life and heath and may even become a diagnostic modality — this just came to my inbox while reading your comment:

http://www.the-scientist.com//?articles.view/articleNo/36332/title/Gut-Microbes-for-Life/|leo://plh/http%3A*3*3www%2Ethe-scientist%2Ecom*3*3%3Farticles%2Eview*3articleNo*336332*3title*3Gut-Microbes-for-Life*3/6keS?_t=tracking_disc]

Diets influence the microbial balance, with and without anti-microbials.

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
I agree with Marc as there are so many aspects to this problem and prevention has to be addressed in Healthcare. Hospitals are trying to implement programs but Physicians need to be pro-active with their patients as well.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Jean, we are up against a quadruple whammy of human nature in modern societies.

1. People “work” less when given the choice: less exertion = less fit–low burn rate.
2. People tend to eat more and “sneak a bite” even when they know they shouldn’t:
3. People “take” more of something that is “free”: so much for low taxes.
4. Government & their workers never reduce anything even in a depression, so they “add” new rules & staff to “help” people, whether they do good or not. The way you get ahead in in GS scale is to have more people under you: they never downsize.

The large issues of human nature pervade the entire society we are in.

Madison Avenue then found they could use human nature to sell us things we otherwise wouldn’t buy. Canned vegetables rather than the better ones we can grow or buy fresh much of the year.

Science “comes to the rescue” with many good solutions, but also leads to things that can harm as we have seen. We need some mineral “elements” (aluminum, strontium) in micrograms per day and they are critical to human health in the right amounts.

On the opposite side of Science are “preservatives” and “anti-microbials” that are added to foods & condiments of all types to keep them fresh for months rather than refrigerated. Micrograms of these “anti-microbials” must also affect the (guess what) microbes in our own digestive tract. That means we might be altering the balance of microbes into ones which cause adverse effects on people.

Evidence is building that upsets in the digestive tract (the engine that powers you) may be behind many medical conditions including the rise of undesirable bacteria & viruses that lead to diseases including obesity if you want to call it that. Some bacteria break down food into more easily digested different components than normal.

Human nature being what it is, including denial, even though the bathroom scale says otherwise, means we have a very tough “row to hoe”, because no one is doing any “hoeing” anymore.

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
I have been collecting information about these studies because I work with
a product that has been in research for about eight years that normalizes
the bacteria so that you can lose weight if you need to lose weight. Very
interesting discussion. Rochelle

Sent from my iPhone

Fred Voss
President/CEO at PlenSat, Inc.
Marc,

An excellent summary and a fitting close. I had similar thoughts for a final statement but you have stated the points that need to be said.

Fred

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Rochelle, it’s interesting that you brought this topic up. There has been quite a bit of research associated with what happens following bariatric surgery. Bacterial transferring studies in mice to create similar populations in non-surgically treated animals produce similar weight losses as in surgically-treated animals. What exactly the changes in biota mean and do are open to question and much further research. My own opinion is that the bacteria simply follow the food. Following bariatric surgery, food is processed in very different manners compared to beforehand, and the bacterial populations simply response to what is given them, increasing and decreasing in their populations. Hence, all the surgery may just simply alter the bacterial colonies to our own advantage.

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
There is alot of studies going on in Major Universities concerning the Microbiota in the Gut which has an effect on weight loss. This is also being studied by Genecists.

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
This will probably be my last comment as it is apparent that the lines have been drawn and those that feel that obesity is a choice will never step back and see the facts. Before the semantics police start I am not saying that some obesity is not a result of laziness or poor choices, however that is, without a doubt, not the norm. So to summarize my thoughts as Amanda feels this has diverted to emotional discussion, which it has, here goes:
1. The medical device industry will do what it always does. Capitalize on a problem, create products to cure the symptoms and not contribute to the solution. Again, I am not saying that all companies don’t have social values but few really get involved in the causes other than the big corporations and they need the tax right off’s anyway.
2. Whether obesity is a disease or not is irrelevant. It is a serious problem here and needs to be addresses.
3. There is no one cause of obesity and it is certainly not as simple as mass gluttony. There are socio-economic, cultural, genetic, physiological and dare I say psychological causes, including addiction to food.
So we can shoot our wounded or put into place a comprehensive program to treat those who want help and educate those that don’t know they need help. That should leave us with the one’s who apparently don’t care which include a portion that have some serious psychological issues, so there is still hope. Finally for those who feel that conditions like this are purely an aspect of poor self-control or a lack of desire to get better I sincerely hope that you are never personally faced with or have someone you care about be faced with the challenges of obesity or any other addiction.

Pete Bobb
Sterile Processing Professional
Thanks Gary.
I do lose weight if I limit my food intake to one avocado with two spoonfuls of cream cheese for my total daily consumption….
Avocado 235 calories and cream cheese 150 calories, meaning less than 500 calories consumed per day while I walk or bike ride two hours a day.

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Pete: I tip my hat to you: 700 cals every day is huge. I’m jealous, since I don’t have the time to do it: I can only burn about 350-400 max in my gym classes and only 2x/week (not nearly enough). I, however, do watch what I do and don’t eat (I don’t eat much on Sundays, for example). And, (I think it’s also important) I don’t eat when I’m not hungry. But, (again, I think it’s important) what works for me may not work for anyone else: I’ve been blessed with a very responsive body: I gain and lose weight (read ‘fat’, since I gain weight after exercise, esp. weightlifting) relatively fast and I can normally notice the difference (flab vs muscle).
Being an intelligent person that you are, you have to analyze your situation:
1. your present doctor is of no help to you since he can’t explain what’s happening. You may want to consider finding another doctor.
2. your body chemistry may be (probably is) so unique, that ‘common’ approaches (carbs, no carbs, ‘common diets’ etc.) do not/will not work for you.
3. the energy is not created or dissipated: it just changes forms. So, if you consume 1,800 cals, and spend 700, where do the rest go? You are most probably a very efficient, metabolically-speaking, system (no puns whatsoever intended): this is just (bio)physics. So your approach to your system maintenance should be ultra-specific. (This is an engineer in me talking).
4. If the current specialists could not explain/alleviate my condition, I probably would start trying things on my own: try, very gently (not to worsen things) and very precisely: small, controlled input (one at a time) while measuring the results, to see if things move in the right direction. If they don’t, change the input, if they do, continue with this type of input but play with its level. This is, btw, how professional athletes maintain and tune their ‘systems’. I myself eliminated several foods from my diet, because I noticed they were not good for me (they were fine for everybody else). There are no guarantees, of course, because our bodies are very complex and will try to compensate for whatever they think they lack. But, the bottom line is: all science notwithstanding, you know your own body better than anyone else.
Good luck!
@group: this is diverging from the original question, for which I apologize, but Pete’s apparent desperation prompted me to respond. Hey, there maybe, like, one in a million chance I helped him just a little. Worth it, in my book. Hope you don’t mind, terribly 🙂

Pete Bobb
Sterile Processing Professional
My doctor can’t explain why when I eat a low carbohydrate diet of 1800 calories a day and perform daily aerobic exercise burning 500-700 calories each day, that I have high blood sugar and can’t lose weight.
I think people who think weight loss is simple are just plain ignorant.
Blame me for eating 1,800 calories and tell me to get a spoon with a hole in it while they lose weight on 2,500 calories a day!
Tell me that two hours of aerobic exercise each day is me being just lazy!
Yet, I bet these people calling me names sit on their butts and feel proud of themselves if they actually exercise for 20 minutes three times a week!

Mike Rauch
North East Regional Manager at ALLTEC GmbH (FOBA Laser Marking + Engraving)
Not a medical professional (we just sell equipment to the industry), but in personal view only I think that this allows for one more excuse for the people who could improve their health, not to. Obviously there are many, many reasons for people to be overweight but certainly one of them is lack of personal responsibility. Access to proper education on nutrition is part of it but also, one must WANT to eat better. Calling it a “disease” across the board allows some people to simply play the “woe is me” card and give up trying. On a side note, not a 100% believer in the BMI either.

Lindsay Webster
Quality Assurance Specialist at Quest Diagnostics
I agree with Glenn that education is key. I frequently find real life applications for what I learned about nutrition and physiology in a nutrition class that I took at a junior college years ago. I am often perplexed when I observe that people (many with advanced scientific degrees) do not seem to understand the basics of nutrition, such as what is the difference between fat, carbohydrate and protein, how is glucose metabolized, what role the liver plays in glycogen storage and other key functions, etc. etc. I wish there was a way to make a class like the one I took a requirement for all high school students. It would certainly help people to make better choices and not be so swayed by all of the nonsense and psuedoscience out there.

John Abbott
Consultant, Medical Devices & Regulatory Affairs
I am all for compassionate, comprehensive and customized healthcare approaches to weight management. Package it in whatever way you must in order to be effective. However weight control IS a simple equation: Burn off more than you take in. Or “eat less and exercise more”. How you convince people to do that is the social science part – and the most difficult part of course.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.

Jagu, it would be a winner for the doctors, except that the government winds up both defining the disease under Medicare rules and then defining how little the doctor will get paid to treat the disease.

Medicare has inherent conflict of interest positions that make it unviable as a sustainable organization and yet WDC politicians want nothing to do with changing it.

If you are on a 10 mile road heading for the edge of the Grand Canyon traveling at 60 mph and the throttle sticks and you can’t shut the engine off, everything is still fine until …

Well, the politicians say to themselves, “I’ll be dead by the time Medicare reaches the edge, so I’m not going to stand in front of the train and get run over.”

Meanwhile everyone wants to pretend they &their families are going to be riding the Orient Express with luxury service forever … right?

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
Angelique; I absolutely agree with you. Also even well meaning studies and science can fall short of providing good solutions for various reasons. Becoming overweight is something that slowly sneaks up on a person over a long period of time. It has become more prevalent over time for many reasons.

Over the years we have acquired more devices and gadgets that help us to get things done with less physical labor in an effort to accomplish more in a shorter period of time In factory jobs, there are computers and machines that do the physical aspects of the work. Even farming has evolved to the point where much of the work is done with computers and machines. Now, on the horizon, there is the possibility that our brain will be connected to a computer so we only have to use out thoughts to perform a task. There are things like the Segway to move from place to place without walking. Will it eventually get to the point where our brain will control them too? Our bodies are part of who we are as a species and we cannot physically evolve as fast as these things becoming available. We need to continue to use our bodies because it is a part of who we are. We cannot survive as a species by exercising our brain alone. We need to maintain our bodies in order to maintain the health of our brain.

This is a very complex issue and there are many other contributing factors that have been brought up here. I hope that in regard to medical devices that will be developed to address various aspects this issue, that they first and foremost provide real solutions without costing an arm and a leg. This problem (pardon the puns) is so massive that if it isn’t addressed practically, it could be the straw breaks the back of the healthcare system.

Jagu Barot
Design & Development Engineer, Quality Engineer, Manufacturing/Project Engineer
Anything in excess is poison——-Ancient wisdom passed on to us from our Grandmaa.

So, now the doctors and the taxpayers are responsible for individual personal excesses. It is understandable if there is a genetic abnormality or a thyroid abnormality beyond the individual’s control. Otherwise, the individuals must take the responsibility for their weight control. Hammer it down the heads of the kids in their formative years.

I see doctors as the winners with obesity promoted to a disease–one more way to make more money.
Like Jagu Barot’s comment

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
In the near term — I’m wondering if the bathroom scale will now become a medical device…

Realistically, where’s the role of education? And physical education — I had it every day in school — every day. Now, kids don’t have it at all. They work out their thumbs on the gaming console and their cell phones. Corrective action looks insurmountable, but preventive action is education, and that we can do, for the long term.

Angelique Lynch
Healthcare Consultant, Client Relationship Manager, Pharmaceutical Sales, Population Health, and Health IT Leader
Gary: I absolutely believe in the necessity of pristine independent scientific studies. Again, many issues obtaining but they are essential and there is no substitute. It is not science per say that is failing but the potential to manipulate/bias studies that confounds the issues. I am not suggesting that this fixes everything because science is always evolving but it is a good place to start.

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
Angelique: I totally agree with you that we NEED a compassionate, etc. healthcare, but the reality is vastly different.
Science, up until now, has provided, at best, a great confusion for the masses, with its ‘compass needle’ (borrowing your imagery) turning by 180 degrees seemingly with every new ‘study’. At their worst, the ‘scientific’ studies confirmed and supported the stances of the people paying for them (insert your faves here: tobacco companies, Big Pharma, insurers, etc..).
Ethical medical/pharma R&D and marketing is an oxymoron for me, sorry: there are just too many examples to the contrary and no present real incentives for these guys to change their ways: they are all about money and money only.
Healthcare providers may want to be the voice of reason, but the reality often is, they just can’t afford it: it’s too expensive to offer a very individualized, patient-centric care when one’s patient load is huge in order to make ends meet. Again, I don’t see any incentives on the horizon, only tighter financial squeeze on the providers,
It will take a very ugly crisis to change things, and probably not for the better, at least short-term.
BTW, I am being blunt basically because I’m as frustrated as just about everyone on this thread.

Angelique Lynch
Healthcare Consultant, Client Relationship Manager, Pharmaceutical Sales, Population Health, and Health IT Leader
We need compassionate, comprehensive and customized healthcare approaches to weight management because obviously one size does not fit all. Simply recommending controlled intake and increased exercise doesn’t cut it. Instead of waiting until we are in a crisis investment in prevention will improve the quality of life, care and ultimately the bottom line. Science will provide the true North including medical/pharmaceutical innovations although ethical R&D and marketing by these entities is pivotal. Finally, people need hope. I am willing to guess that most of us on this panel do and know individuals who have worked very hard at weight management. Many with limited success. Although I personally am not a big fan of mandating and regulating I would like to see accountability of companies who promote products and diet plans that make false promises that are not based on science. I think it contributes to a sense of helplessness and the belief that nothing can work. Healthcare providers have to be the voice of reason.

Fred Voss
President/CEO at PlenSat, Inc.
It is Saturday afternoon and the group is obviously off enjoying their 4th of July weekend. The follow up to my post regarding the 89 workers is an example of several things regarding obesity. My thanks to Bo, Erica, Aaron and Pete for your responses. Peter you were very astute and Aaron you are correct that unfortunately this type of distribution can occur in many workplaces.

The 89 individuals are on the pre-season starting roster of the San Francisco 49ers football team. The men are extremely fit and have great stamina in order to play in the NFL. The results of the obesity in this case are minimal during their playing years due to this work regimen. The NFL and the teams are very serious regarding the procedures that they have put in place to prevent obesity complications. In May of this year a player on the New England Patriots was released because he was diagnosed with type 2 diabetes. Now that is serious workplace discipline.

The team and the league have not disclosed the regimen that is undertaken in order to allow these excellent results. I would suggest that the players, besides being on strict dietary regimens and exercise (obviously), have a number of guidelines that including periodic screenings. In these screenings is most likely:

Quarterly or semi-annual HbA1c
Post prandial glucose following oral glucose challenge
Cardiovascular marker tests, including possibly C-Reactive Protein.

In addition, a test for non-alcoholic fatty liver disease (NAFLD) is warranted in the most severely obese players. Fatty liver represents an inappropriate fat storage by the liver and is a marker for more serious complications. The presence of NAFLD is currently best determined by MRI scans. There are no IVD tests but some visualization is possible with ultrasound. I am not well versed in scanning technology, however, if an innovative company can come up with a device, presumably ultrasound that is tuned to detect NAFLD it would be a significant advance. The ability to screen millions of obese individuals and alert them to this issue could be most lucrative and life-saving.

A final note, the NFL has a workplace program they call Q5 that is for retired players. Q5 stands for quarter five and represents the time after active playing. This program, among a long list of other non- obesity related assistance, is intended to ensure that the obesity required for the job is well controlled and that players manage their health and lose the weight necessary to avoid complications. Apparently this works well and could be emulated by companies and health insurers.

Pete Bobb
Sterile Processing Professional
Amen Guy!

Guy Hibbins
Medical Officer
I think that there are some misconceptions here. The AMA did not classify obesity as a mental illness but as a physical disease, which it is in the same way that hyperthyroidism or hyperadrenalism is a disease. Abdominal fat is highly metabolically active and secretes pro-inflammatory hormones called adipokines which directly cause the metabolic syndrome along with cardiovascular disease, diabetes, gout and hypertension. The main epidemiological risk factor for Alzheimer’s disease is obesity in middle age and we now know that this is mediated via the adipokine TNF-alpha.

I was surprised to see comments that obesity was not an appropriate topic in a business forum. Well medical devices are part of the healthcare industry, which treats diseases, including obesity, however they might be classified.
I think that we do need innovation here. I doubt that the companies which contribute and benefit most here will simply be designing the latest me-too devices like titanium alloy walking frames. Real innovation might be represented a smart glucose meter which suggested healthy dietary choices.

Erica Heath, CIP
Retired – available for small human subject protection, informed consent consulting jobs
BTW – the eating at the desk ban is because lots of weight eating is nibbling or noshing. If there is something there to be eaten… it will be. If there is work and no food, it won’t be.

Pete Bobb
Sterile Processing Professional
Re: BMI distribution for 89 individuals
I will hope this is is a group of weight-lifting athletes who have an average body fat percentage of under 10%.
Otherwise, Houston, we have got a problem!

Fred Voss
President/CEO at PlenSat, Inc.
Thanks for the comments,

I will wait until later this evening to see if we get other comments and then describe the work environment and situation.

Erica Heath, CIP
Retired – available for small human subject protection, informed consent consulting jobs
My first impression was similar to Bo’s: there are no anorexics or too skinny or sick employees. The distribution is quite skewed.

What would I do? I would ban any eating at their desk or on the job and, if possible, I would require that they leave their work area for the duration of their lunch period.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Fred, my opinion is that the definition of obesity was set by someone partial to anorexia.

Fred Voss
President/CEO at PlenSat, Inc.
Here is a small exercise for the group.

The following represents the BMI distribution for 89 individuals that work for a company.
What do you think about this company?
What would you say about this distribution?
What would you suggest the employer should do regarding the workers?

These are real numbers and real people.

Classification Number
Normal (BMI=< 25) 2 Overweight (BMI>25 =<30) 35 Moderately Obese (BMI>30 =<35) 28 Severely Obese(BMI>35 =<40) 21 Very Severely Obese (BMI>40) 3

Fred Voss
President/CEO at PlenSat, Inc.
Pete Bobb

I am not a physician and this advice is offered only due to your obvious concern regarding your situation. I would suggest that you discuss this with your physician and if he/she is not receptive to the discussion find one that will discuss this with you.

Joe, this is way off topic however it may serve to illustrate a point.

Unfortunately the condition in which you find yourself is not unknown. You have not given us your BMI but it could be anywhere from 20 to 45 with the same situation. Yes folks there are normal BMI individuals with prediabetes or full blown type 2 diabetes.

Here is a suggestion determine your post prandial (after eating) blood glucose levels. Measure your glucose one hour after a meal. If it is above 130 or so you have an issue with response to carbohydrates in meals. These high post prandial spikes can and do result in elevated HbA1c levels and are signs of insulin resistance or poor beta cell (insulin producing cells) response to glucose. Try different carbohydrate sources and determine your post prandial glucose, you may see a pattern.

I would also suggest that, whatever your current BMI may be, you begin a more strenuous exercise regimen and attempt to lose some weight.

The problem we are seeing in the world, sorry for those who like to point to the indulgent US population, this is not restricted to the US but is a worldwide issue. The human species has a complex and diverse genetic makeup. One of the features of this make up is the processing of food and the metabolic response to ingested food.

There are some in this thread who out of ignorance and/or spite believe that because they have no problem with weight or diabetes then others are simply indulgent, gluttonous, sloth or any other derogatory term you can find. While this is perhaps true in some cases it does not represent the majority of the tens/hundreds of millions of people worldwide who find their bodies responding inappropriately to our modern food supply. Like it or not humans have developed modern methods of producing great quantities of food at reasonable prices that has fed the world. This is in contrast to the dire scenarios of my youth that suggested we would be faced with world wide starvation as the population continued to increase.

Unfortunately for human biology this abundance has come at a price. The easiest and cheapest food that can be produced are grains containing high concentrations of carbohydrates and these are used in almost all of our foods. Combine that with food processors who have learned how to make processed foods more appetizing and we have an epidemic.

One last comment, within the genetic makeup of the species in which we all find ourselves is great variation. One of those variants are individuals who do not process food well and have to eat larger quantities to obtain the energy for life. These individuals in our current situation seem to be able to remain thin without concern for their diet and are often admired for their thin bodies. Fortunately we will never have famine and world wide starvation, however, if we did you would be the first to go. People could say how lazy you were to not go out and work harder to find food for yourself.

Interesting discussions.

Pete Bobb
Sterile Processing Professional
Leanna Levine: Yes, many people’s ignorance about the causes of obesity and weight reduction are exactly like witchcraft,. based on ignorance instead of science.
I can imagine some people whining that just because you have a broken leg, you should still go on a five mile walk anyway.
It is so simple, just put one foot in front of another and repeat.
Some, thinking they are compassionate may make exceptions for the person with a genuine medical condition such as the unreduced femur fracture which has not been casted and suggest that maybe they should be permitted to crawl.
Explain to me, if you will, why I can’t lose weight eating an average of 1800 calories a day while performing 500-700 calories of aerobic exercise a day.
I consume ZERO refined sugars. Zero grains, potatoes or any food with a high glycemic score. I eat an anti-inflammatory diet with little red meat and focusing primarily on fish such as wild caught salmon for protein. Cruciform vegetables such as broccoli or Bok Choy and nuts provide over half my carbohydrates. Tomatoes, zucchini, strawberries, blueberries, celery, cucumbers, peppers, spinach, collard greens, lettuce and a few other foods are only eaten if organic and completely pesticide and herbicide free.
BTW, my fasting blood glucose is 99 when my diet includes only 30-60 grams of carbohydrates a day, and my A1c Hemoglobin Levels are also elevated following a severely restricted carbohydrate diet. Can you explain where all this blood sugar comes from since it does NOT come from dietary carbohydrates or sugars?
Don’t feel shy about discussing this using advanced biochemistry terms as my 20 Semester Hours of Chemistry included metabolism/Biochemistry. If I don’t know the word used, I will research it.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Interesting ideas. I’ve voiced a few similar ones myself – coverage stops, premiums go up, surcharges, lack of discounts or incentive payments others get for being healthy weight, airline surcharges, mass transit fares higher. Pay by the pound. Or by number of points above 25 BMI. Transit fare machines could have built in scale and camera to check your height and calciulate your BMI in 1 second. Exit turnstyles in subways could have a scale and height measurement in them and send you to the Add Fare machine to let you exit. But have to figure out a way to not discriminate against people who’s obesity is not their fault (doc can give a hyperthyroid obese patient a bar coded letter or card that is scanned and the penalty is waived). In the US though, many people fear invasion of privacy, “Big Brother” and other issues and lobby for their own best Interests. There’s been a lot or talk and concern lately about the NSA and what the govt is looking at. But let me just say one thing – if we have come to accept certain activities in this country to protect our national security – obesity IS a serious threat to our national security. So somehow, and I’m not professing how, we need to figure out ways to get it under control.

John Minarovich
Field Account Executive – West Coast at D-Link
I have often said that this is a topic of which there is very little knowledge and understanding. I am excited that this forum has firmly underscored that belief. This is the last great bastion of prejudice, one where you can still make comments based on someone’s physical characteristics in order to assuage your own shortcomings. One of the few examples left that has not been legislated into submission. Shame on all of us. The suggestion that this is simply an “eat less and exercise more” issue assumes that fat people want to be that way. That is simply irresponsible and inane.

This is a multi-faceted issue that crosses the boundaries of psychology, physiology, culture, agricultural abundance, genetically altered foods and I would argue evolution at a slower pace than our technological advancements

With regard to the original question, obesity being designated as a disease, perhaps now the medical community will put some thoughtful and intelligent assets to work on a comprehensive method of addressing the situation – hopefully more curative than treatment oriented. Perhaps this is an opportunity for the genomic experts to shine.

Jennifer Ahlstrom
Document Specialist at Forever Nutraceutical
@ Clark’s comment ” the bottom line is that we all understand the harm we do to our bodies by smoking, eating poorly and the bad lifestyle choices we make,etc.”

In my opinion, this is absolutely NOT true in all cases; maybe not very many cases, at all. I am a reasonably intelligent (in my opinion, anyway) professional with a degree in biology, and by the age of 43 had had gallstones, a stroke, high cholesterol, thyroid issues, and ovarian cancer. I NEVER understood (and my Dr. never explained to me) just how my poor eating habits and being overweight most likely contributed directly to the various disease conditions I had until I started doing some of my OWN research and found information about how fat cells, inflammation, stress, hormones, etc. all interact (as Pete Bobb has been talking about up-thread).

Now that I DO know more (which still isn’t very much) about this, I understand just how much of a part I may have played in contributing to my own poor health and am working- on my own- to hopefully reverse those years of neglecting my health. But my Dr. never explained it- they only said (and just once or twice in the 5+ years I was going to them) ‘you might think about losing some weight.’ Never WHY, or WHAT the connection actually WAS. Not all that helpful, in my opinion!

To address the problem long-term, I think doctors will have to become more nutrition and behavior focused and actually spend some time TALKING to their patients (gasp, the horror!) about what specific lifestyle issues they face that could be contributing to their diseases, and how to overcome them, instead of spending 10 minutes with them and tossing a Rx at them now and then. (And I do agree that agri-business and their $$ play a very large role in putting all those tasty, unhealthy foods front and center, too.)

I understand that this group is business-focused and that this ruling could open the door to companies capitalizing on the obesity ‘epidemic’ but as a human being, I do hope medical device and pharmaceutical companies work to truly HELP people in addition to just making money from them.

Leanna Levine
President & CEO, ALine, Inc.
Seriously, Pete Bobb, you would compare obesity to witch hunts in colonial America? Perhaps we can petition to have witchcraft listed as a disease and people with a nose twitching problem can get specific help. We can develop prosthetics and drugs and even diagnostic tools to monitor and treat the condition.

Everyone here who understands something about the biochemistry of obesity, seems to suggest that it controls the body, is irreversible, and we should pity people who can’t help but consume 5000 -10,000 calories or more a day. The biochemistry seems to suggest that obesity is actually a more natural state. Given vast quantities of readily available food, we can’t help but become obese. The genetics drive us to eat more than we need. The ill effects of overeating can’t be helped except with drugs, diagnostic devices, and surgical procedures. People who are obese shouldn’t be expected to know how to make better choices for themselves, they are driven by their biochemistry.

As many people have commented here, the medical industry has been offered many new opportunities for making money by leveraging the need for a myriad of new products required to manage everything from simply moving these patients from one place to another, to developing new drugs to combat the altered biochemistry of obesity, creating products we didn’t need 30 years ago. We are busy building hospitals with larger doors, beds, rooms. Obesity is great for business. Let’s applaud this new opportunity and get busy writing business plans.

After all the social issues that underpin the national pastime of eating are far too complex to tackle, its much easier to find ways to invest in a new pill and a new gadget to monitor it and control it in an objective way that decouples personal choices from medical consequences.

Clark Celmayster
Evaluation Engineering / West Coast Sales & Publisher
Clara, You are correct that some may have hereditary reasons as to why they are obese, so I do apologize to any of those who would fall into that category, which I would surmise the exception not the rule.

That being said “Harmony” may be a reason as to why so many do not take their conditions (whatever they may be) seriously enough to do something about them! Self prevention (and preservation) would alleviate many of the healthcare problems we face and reduce the rising costs we all face.

“Zen” will not fix the problem and it takes more than being coddled to make people realize they need to address their self created afflictions and addictions. For some the end result of being, feeling and looking healthy may be enough of a reward, others may find that some other kind of reward might work, but many more may need stronger methods to force them into a healthy life style.

If I had the real solution I would be sitting on a yacht right now, however there is obviously no silver bullet, other than people taking responsibility for their actions and if they don’t, be willing to suffer the consequences without asking others to suffer along with them.

This is the malaise of not just health and healthcare but of society and our changing culture in general that needs to be realigned before it is too late. Obesity is just one issue of many…

Mark McCarty
Regulatory Editor at Clarivate Analytics
To those who want to see penalties of some sort applied to those who are overweight: Be careful what you wish for because once that mechanism is deployed, it will not be readily put away. What you think is a great idea now might turn into something you loathe later. I strongly urge everyone to step back and think about that. The law of unintended consequences is certain, absolutely certain, to make itself felt should this concept be put into play.

Clara Chung
clerk at Richmond Public Library
Harmony should be placed on earth. Medication comes out only after the health issues such as obesity. Some people might have the heredity from the obese cells. Would there be solution other than penalties?

Clark Celmayster
Evaluation Engineering / West Coast Sales & Publisher
Absolutely! Perhaps the best incentive would be one that has heavy penalties (excuse the pun) where those whose doctors have put them on notice would not get coverage unless it came all out of their own pockets rather than weighing down (another pun) our healthcare system or suffer the real consequences on their own dimes.

This may seem cruel but for those whose issues are due to their own fault, just like committing a crime, there need to be consequences that are significant enough to make them change their lifestyles, since how they (and often by example their children) look and feel aren’t seemingly enough.

Airlines are starting to charge people for 2 seats if they are too obese to fit into a normal seat. We do not (YET) have the government underwriting that additional expense, so why should the tax payers who are fit pay the price for those who are not? Bottom line is it is time for people to stop looking for excuses and think about how their actions impact not only themselves but everyone else!

Stephen Glassic
Available: Biomedical Equipment Technician, Field Service Engineer, Electronic/Electromechanical Technician
Joe, here are my thoughts in regard to your original question.

In many ways, medical devices are already being implemented in hospitals, medical centers and emergency response to deal with overweight people but it seems reasonable that with the declaration of obesity as a disease there will be a need to come up with a tailored approach to weight management which could pave the way for new methods to monitor the progress of patients at an individual level in a day to day approach. I think the door is opening for devices with Aps that have the ability to monitor a variety of biological indicators and patient activity in an ongoing basis with the capability of being tailored to the individual, including a reasonable diet, activities etc. based on the capabilities of the person. Of course this should all be monitored by specialists who work closely to tailor and tweak the program in order to produce results. If these devices could also be used for other purposes and eventually become an overall health monitor that can be tailored to all the individual health concerns of the individual and connected to the appropriate data systems and health management teams with a timeline of individualized data. They could also be used to manage various implanted devices.

Many people who are overweight do not believe it is a problem at first or don’t think there is a solution to the problem and/or they are unwilling and sometimes unable to make the changes in their lifestyle in order to achieve results.

There are many diet plans, exercise plans and pills on the market but most of them fall short of achieving lasting results or in many cases no results at all. Therefore it is not uncommon for people to jump from one approach to another and then to another looking for something that will magically produce results in a short period of time. It is possible some of these things, in combination with a managed program, could achieve good results. But it must be understood that it has to involve a long term and lifelong commitment from the individual and results will be gradual. It usually takes a long period of time for someone to become overweight and it will undoubtedly take a long time to reverse it. The changes in diet and lifestyle must be tailored to the individual and gradually changed over a period based on what the person is willing to commit to and able to achieve.

Very often there is also other physical and biological limitations that will also have to be taken into account, especially in older individuals. Anything that can be done to address other limitations must be done.

I think it is time for hospitals and medical clinics to set up departments that specialize in physical health and weight management. Maybe they can also partner with health clubs to produce prescribed and monitored programs for each individual. But it will take a lot more than that to get our population in better shape. There has to be a multifaceted cultural drive to incorporate healthy choices in our lifestyle and diet. Many of us don’t get enough physical activity in our workplace or our daily lives and we don’t have the time or ability to prepare healthy meals and choose quick (often unhealthy) alternatives. Our culture must be reorganized to include time for healthy activities, healthy (and more importantly) properly proportioned meals at the right time of the day. How about a program where employees get paid to exercise (based on their abilities) and the insurance company provides a discount or credit to the employer to cover a certain portion of the cost. If it is managed well, the employer will probably see a certain amount of increased productivity and less employee downtime. The FDA must also become more diligent about what is allowed (or not allowed) in our processed foods based on scientific studies performed by truly independent sources.

Sorry Joe, that I got off on some tangents but this topic is very conducive to that.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Interesting point. But remember – diseases can be self-inflicted. AMA not saying it’s not the obese person’s fault. They want to raise awareness and have people’s doctors increasingly coach and prescribe to their patients that they must lose weight, and to treat it. You are right that it may have some unintended consequences though. But what the AMA and others need to do is to put forth “treatment” guidelines that start with change in lifestyle and eating habits. Maybe patients who are obese but have normal hormones and thyroid should only get bariatric surgery once they have shown that after a 30-60 day period that they have changed their diet and maybe lowered their weight by X pounds, or that their liver enzymes have started to improve or glucose levels lowered on a subsequent blood test. Also checks and balances and financial incentives need to be put in place to push people that are obese because of life choices to take control of their health and so they don’t get the easy fixes and/or so that they pay penalties and higher premiums. It’s all in the enforcement and implementation. And people who get Bariatric surgery need to be warned that if they don’t change their lifestyle, they can still regain weight and that they will still suffer serious consequences like diabetes or a destroyed liver. Also, there need to be other employer, payor and other checks put in place that don’t allow obese people to abuse the system – being treated as disabled, getting extra benefits, etc. I am an asthmatic. But I do not get any special Hall Passes for anything. There are other people with other types of diseases that don’t either. But you’re right – people need to speak out to ensure that people with obesity caused by lifestyle do not get any extra perks and must work hard to keep themselves healthy even if they get surgery.

Clark Celmayster
Evaluation Engineering / West Coast Sales & Publisher
The AMA should be ashamed of themselves! This is just another example in the long line of issues, conditions etc. that Americans no longer need to take personal responsibility for by an “authority” (lol) developing a Free Pass to blame something or someone else for America’s growing health problems.

There are those that will blame our endocrine system, society, fast food companies etc. for obesity, cigarette companies for cancer etc. however though they play a large role as the providers of our addictions, the bottom line is that we all understand the harm we do to our bodies by smoking, eating poorly and the bad lifestyle choices we make,etc.

Granted, eating a more healthy diet is not the only way to overcome obesity. We need to exercise more, get off the couch, get outside and become more active. Instead we take pills, purchase vibrating belts, get liposuction or stomach reductions, etc., i.e. taking the laziest and least effort generating means to address the root causes of many of our health problems.

Until we change the growing mentality of people blaming others for their poor lifestyles and take responsibility for our own actions, we will continue on this downward slide of personal health, increased costs of healthcare and more opportunities for our government to feel like they need to take control of our lives at every level, through the creation of a nanny state, because we are increasingly proving them right, that many of us are unable govern our own lives.

The definition of insanity is doing the same thing over and over again, expecting a different result and based on that statement It would seem that we have a growing % of our population that need to be committed! HOWEVER, then the AMA would classify all of our bad lifestyle choices as a Mental Disease!!

OOOPS.. I may have opened another can of worms..Can You Deep Fry Them Please?

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Yes. We’ve been working on it. Probably a few days – ok?

There are not many that are approved and currently marketed in the US – it might only be the Lap Band by Allergan, which is actually pondering selling the business. But there are a number in development and we are compiling that.

Can you pass this on to him and have him ping me?

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
My mother always said – everything in moderation. Best advice. It is actually bad to completely devoid yourself of some things – snacks once in a while, all carbs, all fats, etc. Because then you create cravings and swing to an opposite extreme. It’s all about healthy balance and giving yourself treats a couple/few times a week or once a day, and portion control.

Clara Chung
clerk at Richmond Public Library
Should education be reinforced in schools? Educate the next generation in order to minimize the heavy health cost in future.

Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„

David Lim just started a related conversation at http://bit.ly/obesity-product-list%7Cleo://plh/http%3A*3*3bit.ly*3obesity-product-list/x1lg?_t=tracking_disc].

He’s hoping we, as a group, can list the medical devices currently addressing the obesity market.

Can you help?

Pete Bobb
Sterile Processing Professional
Witches used to be blamed and murdered for causing measles in children.
No one knew about those invisible viruses that cause disease.
Now we know better.
Obesity used to be blamed on a lack of self control, gluttony and self destructive wishes.
No one knew about insulin-resistance or leptin resistance, and fat cells were thought of being mere storage bins.
Now we know that fat is an active part of the endocrine system which, among other things, releases hormones to protect its own existence.
Leptin can let normal weight people know they have eaten enough and should stop eating. Lepton resistance can result in people NEVER getting a signal that they have eaten enough. Distention on the stomach may be the first sign that you have eaten anything at all.
And our fast food culture completely by-passes normal leptin signals. Even in a normal weight person with a normal Leptin response, a thirty minute meal break when you must gulp down food and get back to work immediately does not allow enough time for your body to get signals saying you have eaten enough.
You must guess correctly regarding how much food you need.
With insulin resistance, blood sugar can’t get into cells to be burned. The blood sugar gets converted to triglycerides and is laid down as fat at the very same time that the brain cells and muscles cells are sending out signals saying they are literally starving and need more glucose.
Combine Insulin Resistance where the system is being flooded with signals that cells are starving, with Leptin Resistance where the signals that you have eaten enough go unheard, you have a recipe for weight disaster.
If you are fortunate enough to have a proper insulin response and a proper leptin response, you may not have any empathy for someone who has these medical problems. You don’t have a body flooded with signals reporting you are starving at the same time you lay down layers of fat, and you have a shut-off switch that tells you when it is time to stop eating.
A triple whammy is that in some people, calorie reduction results in the basal metabolism rate slowing. They burn fewer calories just sitting or sleeping than a normal weight person. Even if you consciously reduce calorie intake, you don’t lose weight.
As you eat less, your body adjusts to store fat at the lower calorie levels. So an overweight person may actually be eating fewer calories than their normal weight peer, but still be gaining weight.
The old saw that to lose weight, you should just eat less and exercise more is too simplistic, and it doesn’t work for many overweight people.

Fred Voss
President/CEO at PlenSat, Inc.

Joe

A meeting would be interesting. The medical device industry has been steadily supplying the needs of the increasing obese and overweight populations of the world for the last 40 years and this is certainly going to continue.

With the classification of obesity as a disease we will see more attention to the direct treatment of obese and overweight individuals instead of the treatment of the longer term complications. Both the medical community in terms of physicians, nurses and other care-givers will be more likely to put aside the many biases and begin honest discussions with patients regarding their conditions and potential treatments.

We have two issues, prevention and treatment. Both of these need significant effort and the medical device industry needs to play a role in both.

On the prevention side better tools to monitor food intake and project weight gain in terms of both smart device apps and IVD’s will be important. Unfortunately many individuals do have different metabolic and social situations that make these types of tools important.

On the treatment side we need to find ways to assist the 10’s of millions of individuals who can be staged as having or developing serious complications. This effort requires more than simple diet, exercise and social engineering approaches. Better diagnostic tools to identify those most at risk as well as better devices to assist in weight loss that recognize the inherent metabolic and psychological fight to prevent starvation even when one is obese are needed. The treatments will come from a variety of existing, developing and hopefully novel medical devices. The medical device industry has been working on less invasive bariatric surgical therapies for the more severely affected super obese individuals where the condition is life threatening. For others in the overweight/obese categories less invasive technologies are being developed and the funding for some of these efforts may be more available.

There are plenty of opportunities and in my honest opinion the recent classification of obesity as a disease makes these opportunities even more compelling.

Ronel Jessen
Jessen Pty Ltd
Frightening but true also for south Africa

Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
We have a passionate discussion. Few have answered the original question.

Now that obesity is a disease, what is the implication to the medical device industry? To the economics of healthcare?

And Paul Teitelbaum wrote me and suggested we have a meeting/conference as a medical device industry on obesity. Would that be of interest for you? If the stars aligned (cost, timing, location, availability), would you attend?

John Abbott
Consultant, Medical Devices & Regulatory Affairs
Interesting conversation and surprising how those with clearly different political leanings all seem to have the same general view. Who said we can’t all get along? That said, if obesity is a disease shouldn’t driving fast also be a disease? The AMA has simply expanded the scope of the term “disease” in this case. Yes, there are commercial benefits to this, but there will also be societal benefits. Regardless of how they got that way, PEOPLE ARE FAT! The simple solution for most cases is “eat less and exercise more”. It does not mean don’t eat chips or go to your favorite burger joint. And, by the way, more warning labels will do nothing. Cigarette use declined not because of labels on the package but more because of legislation like cigarette taxes, no-smoking in public places and no-smoking within 25′ of an entrance. These and societal pressures (education) have ostracized the smoker making it less of a social pleasure. Perhaps we need to begin implementing similar requirements for obesity: pay for two seats to fly, make obese people sit in special sections, make obese people eat outside in the rain 25′ from the door…. Al little silly, perhaps, but you get the idea.

My problem is that I just don’t get it. I am 6 feet 178 pounds and over 60. If I gain 5 pounds I feel bad. I exercise regularly and I eat less. I occasionally stop by my favorite burger joint and I (gasp!) eat ice cream and potato chips. So maybe I am not qualified to comment…

Guy Hibbins
Medical Officer
Members might be interested to see the trailer of the Obesity documentary at http://www.killeratlarge.com/%7Cleo://plh/http%3A*3*3www.killeratlarge.com*3/lWin?_t=tracking_disc] where the US Surgeon General states that obesity is the biggest threat to the US at the present time. (Go to the site and click on “Watch the trailer”)
Dean Ornish’s TED Talk on “The World’s Killer Diet” is also worth watching at http://www.youtube.com/watch?v=I1E-D37URTY|leo://plh/http%3A*3*3www%2Eyoutube%2Ecom*3watch%3Fv%3DI1E-D37URTY/yCrH?_t=tracking_disc]

Gary Abramov
General Manager – Product Development Manager at Pacific Blue Innovations, LLC
@Mark H: Re: “it is also apparent that there is not one cause of the disease as it can be attributed to genetics, upbringing, economic conditions, easy access to poor food, psychological issues and for some just plain laziness.”
I disagree. I think, outside of hypothyroidism, the real cause of obesity (read gluttony, in my book), is the LOVE OF FOOD. I have never seen a fat person (yes, I’m not Politically Correct) who ate like a hummingbird. On the contrary, ALL of them were consuming VAST quantities of stuff: 2-, 3x the normal person’s intake. Now, did they physically train themselves to do it (i.e. stretched their stomachs), or got there by training their endocrine system via insulin/blood sugar crushes, the fact remains: they eat a lot and really enjoy doing it. It is apparent even at a fairly young age: a child’s eyes light up when he sees food: you can always tell when a child just LOVES to eat. A simple extrapolation for 10-20 years forward results in an obese adult with multiple health problems.

So, here’s a ‘radical’ (not really) idea, to answer some of the questions raised here regarding treatment/sessation: just like an alcohol-sessation program, make food unpalatable for these people. This can be done via the food itself (poi-only diet, anyone?): a very temporary solution, since the people will go on a Twinkie binge right out of the ‘bland’ therapy, or by disabling reward/pleasure pathways to/in the brain, starting with the taste receptors (probably the easiest to anesthetize anyway): the action can be extended/reversible or even made permanent (for ‘repeat offenders’).
This is definitely doable, although it can (and will) be perceived as cruel and too radical (and depriving all the pharma, med devices industry, hospitals, bariatric surgeons, diet counselors, etc., of their just profits).

The efficacy of this approach is, unfortunately, proven and is right in front of us: geriatrics with diminished/lost sense of taste are rarely (never?) fat (uh, sorry, overweight, in our aseptically paranoid PC lingo): for them food lost its sensory attractiveness, and they eat for its energy content only. Very sad indeed, but, in this context, effective. The same goes, again, very sadly, for cancer victims: frequently they stop eating and lose (a lot of ) weight.

I’m convinced that anything less will fail sooner or later, since for the obese people the love of food has often replaced all other pleasures in life, including sex. Since very few people will give up the pleasure of sex (last time I checked:), the same goes for the love of food: abstinence/surrogates (go hungry/”eat your veggies” instead of sweet/fatty/salty instant pleasure stuff), don’t/won’t work either. It may work for a while, but people will revert to the ‘real’ (for them) thing. This very dynamic is a rule rather than exception for a majority of ‘weight-loss’ programs, including some surgical procedures.People make lots of money even by merely discussing these ‘yo-yo’ effects: just look at the mags in the checkout line at the supermarket.
With a radical therapy, IMO, there’s a chance that the patients will re-gain the old pleasures (or pleasures they’ve never experienced before) to replace the one (of eating vast amounts of food) lost.
Now that I painted a big fat target on myself, fire away :).

Urs Mattes
Healthcare Executive in Life Science and experienced Board Member
Overweight and obesity are first world diseases which spread fast to countries that take over western food habits. We eat too much and we move too little. Except for some metabolic conditions, overweight and obesity did not exist in the past. I saw this first hand in China where parallel with the development of the fast food chains overweight and obesity developed with children being one of the victims. Bicycles were rapidly replaced by cars and motorbikes.
Overweight and obesity are associated with a number of chronic diseases which will bankrupt our healthcare systems sooner or later. That is why the decision to declare obesity a disease is a wake-up call to act sooner than later. Beside taxes on harmful foods, insurance companies could incentive’s normal weight.
There are plenty of diets available to reduce weight and most do NOT work. There is no magical pill in sight and bariatric surgery is restricted to a few cases which qualify.
I am surprised that only a few talk about prevention of overweight. Overweight does not develop in one day, it takes quite some time to gain weight. France and Japan are good examples. In these countries children are taught at schools healthy lifestyle choices which is usually embraced by most children. Education is the key to solve the overweight and obesity problem. I have treated dozens of people who were moving from the higher percentiles of normal weight in the direction of overweight with simple measures. It is much easier to treat this kind of people and motivate them for retaining a normal weight. The Romans already knew: “Mens sano in corpore sano!”
To come back to the original topic raised, we as manufacturer of artificial joints benefit from the overweight and obesity pandemic because joints degenerate earlier as compared to people with a normal weight. We also found out that overweight and obesity causes more postoperative problems. The earlier you get an artificial joint, the more likely you need a revision surgery which is much more complicated and much more expensive.

Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
@David, assuming you meant 41% …

59% of the Medical Devices Group resides in the United States.
41% resides outside the US.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Yes, but what is the prevalence in all these countries? Is it possible our rate of increase is slower because our prevalence is already very high and they are starting from a smaller base of diabetics? America has been eating poorly for the last 30-40 years so we’re already saturated with diabetics. Over the more recent past decade, these other countries, as they have been developing, have been becoming more Americanized, embracing our fast food and adopting our bad habits. We can thank ourselves and the globalization of American food companies and restaurant chains and cultural influences for a lot of that. Sad.

Fred Voss
President/CEO at PlenSat, Inc.
A quick response to Pett Bobb..

“Philip, it may be a chicken or egg issue, but I suspect that most overweight people also have hyperinsulinaemia as well as elevated levels of neoglucogenesis.”

The data for metabolic syndrome indicates that the combined overweight/obesity category has greater than 60% of the individuals without hyperinsulinaemia, 50 Percent of Overweight and 1/3 of obese are free of metabolic syndrome issues. With 1/3 of ‘normal’ weight individuals having metabolic syndrome it clearly is not a simple correlation.

With regard to the comments regarding obesity as a US issue the current information suggests that the fastest increase in obesity is occurring in China. In part due to better living conditions and in part due to the one child per family situation that has resulted in a generation of very pampered children and young adults. Is this becoming more US like, the question exists!

Finally the rise in type 2 diabetes around the world as reflected in projections from the year 2000 to 2030 show that it is not only the US diet as one commenter suggested.

Projected increases are: (number in millions base year 2000 – projected year 2030)
North America 72% 19.7 to 33.9
Middle East 263 20.1 to 52.8
Latin America 248 % 13.2 to 33.0
India 251 % 31.7 to 79.4
China 204 % 20.8 to 42.3

The reference and graphic is posted on by facebook page..

I will echo Mark’s comment above. What are we going to do tomorrow to make a difference?

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
That’s the right attitude.

Angela D. Hollen
Experienced medical device sales professional
@ Marc: What am I going to do tomorrow to make a difference? What I’ve been doing for years! Make healthy choices, set good examples, talk about it, educate, inspire, and share important health AND social impacts to oneself and others. It’s small. But it’s effective…one brick at a time.

Angela D. Hollen
Experienced medical device sales professional
There are countless numbers of blogs, books, articles, compendiums, conferences, etc. on the “why’s” and emotional opinions, which I, too, have. I try to keep those in the appropriate forum, not the business forum because that becomes rhetorical and, again, that is literally EVERYWHERE around us to access. Just like education. There is plenty of education. In fact, an overwhelming amount, which only confuses people seeking help. It’s a very complex issue – as someone mentioned earlier: psychological, physical, physiological, social, and 1st world issue. It is affecting every one of our pockets, even those who are super-fit. We all know this. With regard to the original question, I find some comments very related and thought-provoking, and others just more of the same emotional rhetoric for personal, not professional, opinions.

David Pennington, PE
Senior Project Manager at Commissioning Agents, Inc | CAI Consulting
Joe: Who are the 31%?

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Completely agree. As I said in one of my comments about “Supersize Me”, like the movie that was out close to a decade ago. One disease is obesity. Another disease is a pervasive mentality about wanting everything, now and big, and without regard to cost – it’s all about consumption and it’s all about me. The third disease is lack of education and common sense. Fourth disease is a food industry bent on maximizing craving and profit and restaurants and movie theatres tyring to outsize each other to win your business and supermarkets putting the cheap unhealthy crap that makes the most profit at eye level. We need to work on these problems. They just do not exist in some European countries, Canada, etc. to the same extent they exist here.

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
What is interesting about this discussion is how many different opinions can exist with few solutions. At the end of the day whether obesity is defined as a disease or not is irrelevant…..it thrives in the US. it is also apparent that there is not one cause of the disease as it can be attributed to genetics, upbringing, economic conditions, easy access to poor food, psychological issues and for some just plain laziness. This further indicates that there is not one single cure or solution to the problem and we will never eliminate it completely. The most important thing that has come out of this discussion is that a small group of supposedly intelligent people have become more aware of how serious this problem has become. So to everyone, including myself, now that we have expressed our valued opinions what are we going to do tomorrow to make a difference?

C. Angelique Steccato
VP Business Development, Client Services and Marketing at USDTL
If you can categorize it as a disease then there are billing codes for surgical intervention, lots of money for pharmaceutical drugs to flood the market, and of course every new diet book, website etc. designed to sell something.

ACO stands for Accountable Care Organization, but what about Accountable Care Organism “human beings”.

Think McDonalds in the early days, there were no “Value Meals” “SuperSize” or “Designer Drinks”, how many Americans eat more processed foods laden with fat, salt and preservatives this generations over last and last over prior. Add to that refrigerators for keeping our wine chilled, our vodka in the freezer, etc.

The fact is that Americans want a “Pop a Pill” “Cut and Remove” solution, weight is not put on overnight and is not removed overnight with long lasting results, unless a true behavior modification plan is put in place post procedure.

I feel for those whose weight issue is due to genetics but take a look around, HPB, Diabetes, Heart Disease are not the norm in countries where the “Mediterranean” or other type of diet is prevalent.

Angela D. Hollen
Experienced medical device sales professional
I am a medical device rep in the minimally-invasive surgical space. Our instrumentation shafts are standard length: ~36cm, and our bariatric length: 45cm. We sell these instruments (miniature scissors, graspers, clamps, and dissectors at the tip of a shaft with the aforementioned shaft lengths, for moving/cutting/clamping tissue) to nearly all surgical specialties, including general surgeons and the sub-specialty of bariatric surgeons. 45cm length is selling more frequently, not in a sudden rush, but it is requested more often for surgeries that AREN’T necessarily a bariatric procedure (not limited to Lap-Band, which I will only comment to say has the most marketing but is NOT a favored long-term solution such as a bypass or gastric sleeve, which have more literature support related to metabolic changes). Point is: more patients for surgeries such as a gall-bladder removal (also, by the way, associated with overweight patients) or laparoscopic hysterectomy, need a longer-than-standard instrument length to do the procedure. There is also a demand in certain areas of the country for even LONGER than the 45cm “bariatric length”, such as 50cm or 55cm length. That creates concerns with how to make and keep the integrity of devices that work with tiny moving parts and long levers…maybe fewer MORBIDLY obese (highest BMI category) will be able to have the minimally-invasive option, and revert to more invasive (i.e., “open” procedures – the big, long incisions that leave more risk for infection, longer healing times, and many other risks that minimally-invasive moved medical procedures AWAY from.

Last point: in general, hospitals must have a special approval for caring for obese patients. Everything from larger beds, devices to move larger patients (to decrease risk of employee injury), larger commode chairs, larger rooms and restrooms, specially-trained staff to manage all of these during patient use, etc. It is not at ALL surprising to me the cost of obesity, and where it is heading.

Pete Bobb
Sterile Processing Professional
Sharon, if we can have a cigarette tax and an alcohol tax, we can surely have a soda pop tax, cookie tax, and potato chip tax.
How many people will eat a whole bag of potato chips or a whole bag of Oreos in a single sitting?
And how many of them would eat a dozen boiled eggs or even 6 apples in a single sitting?
How many Americans will eat the value meal of the ‘Big Catch’ at Long John Silvers with 1,320 calories, 19 grams of saturated fat, 33 grams of trans fats and 3,700 milligrams of sodium because it is an inexpensive, quick, filling fish meal they can afford?
I read somewhere that the average American has been on 12 different weight reduction diets, and as you note, spend billions every year in failed attempts to lose weight.
People try to lose weight and fail for a variety of reasons.
How many people would be helped if offered the inexpensive drug Metformin under a doctor’s supervision? How many doctors even offer it to their overweight patients with metabolic syndrome?
I think many overweight (1/3 of Americans) and obese (another 1/3 of Americans) would gladly accept help from their doctors to help them lose weight. (edited)

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
I agree with everyone here as there is no right or wrong answer. We all have our personal views. What I would suggest is those that are commenting on psychological disorders or being accountable for having an addictive disorder do their homework and research. Being 20 or 30 pounds overweight is probably just poor eating habits and lack of exercise. Being obese is more than just that. Someone who does not care enough to take care of themselves has a psychological problem. I don’t condone government activity in anything quite frankly that has to do with public conscience. But if history proves itself correctly we will just let these people flounder if it’s not brought to this kind of level. If the fire is not in our house we don’t feel a need to fight it. And, I will reiterate by not addressing this issue it is costing the healthcare system billions in unnecessary disease as a result of the obesity.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
I would add that there needs to be tort reform as well and monitoring of malpractice, litigation and legal costs. Another item that will probably be very difficult to get passed and implement. We are also a society that is hyper-focused on freedoms, having the very best, having full equality, maximizing votes to get elected and wanting to make money by suing each other. Other countries that temper these things a bit with common sense seem to have much lower healhcare costs (except yes – they do have longer wait times). The cost of delivering a baby in the US (by natural means or Caesarian) is at least 2x – 3x what it costs in Europe and most other countries (and the amounts billed to insurance companies by the hospitals, nurses, anesthesiologists, etc., etc., etc., all separately, are about 8x what the costs are in other countries). And despite the highly “intensive” level of prenatal, obstetric and post-partum care in the US, the rates of fetal and maternal complications are higher than in the other countries and outcomes are worse.

Sharon Kohanna (prev. Murray)
Staff Electrical Engineer at Abbott
Follow the money trail. Obesity is now labeled as a disease because it is all about reimbursement. Realistically, what is a doctor going to fix? The 2012 annual Weight Loss Market in the US was $20 BILLION with108 million participants and obviously not effective as it is estimated to grow to $66 BILLION in 2013. This represents people who are incentivized enough to spend their own money and time without insurance reimbursement for their “disease”. To effectively treat the bulk of obesity you would have to force people to eat less and exercise more, remove the appetite stimulating chemicals from our foods, and get rid of junk food advertising for starters. That sounds like a job for newly created governmental food police employees! Then how do we address the food-related psychological contributors? Perhaps the AMA will next address man’s search for individual meaning and significance in today’s world, which is probably getting closer to the root cause of the obesity issue.

This is on par with the recent update to the DSM IV [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition]. It contained a Bereavement Exclusion which allowed people a period of six months after the loss of someone meaningful in their life to have feelings or behaviors associated with grief be regarded as normal and not diagnosed as a mental disorder. The new DSM5 has changed that and now allows that within two weeks of a death of someone important to them, patients who mention having feelings of sadness, confusion, etc, relative to that death, can be diagnosed as Major Depressive Episode [MDE] and be given prescriptions for psycho-pharmaceutical drugs.
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Jim Carr
Strategic Account Manager
well put Leanna….

Leanna Levine
President & CEO, ALine, Inc.
Obesity has become a major health problem since the advent of the availability of cheap, processed foods that contain lots of carbohydrates from wheat, corn and potatoes. Let’s see, what are the government subsidies to agra-business for the cheap production of these staple crops? HUGE. Who pays for that, we do. We are paying to make ourselves sick.

What would happen if the price of a bag of potato chips were the same as the cost of a healthier choice that was vegetable-derived and fresh? The balance is tipped way in favor of grabbing a bag of chips than a bag of veggies just from economics that is driven by subsidies for production. But if government got out of agra-business and the real cost of grain production were realized, perhaps people will make different choices based purely on economics, both from the viewpoint of what the grocer puts on the shelf, who can afford to offer more veggie products because the price differential is less, and for the consumer.

I wish conservatives would focus on eliminating all the government welfare that goes to business which contributes much more to screwing up our economy and our health than any program that serves the ‘little guy’. The problem is, the big ag producing states are represented largely by republicans, who would get run out of office if the touched any of these issues.

We’ve only gotten fat since the advent of government subsidized agra business.

The big issue I see with calling obesity a disease is the cost to business because now people can claim disability due to the disease obesity that somehow limits their ability to perform a job. That worries me as a business owner.

As a citizen, it seems that once you call something a disease, a person is now able to forfeit any personal responsibility for their health. Its a disease, its out of their hands.

The lack of personal responsibility and accountability seems to me to be the biggest disease affecting our country.

Regarding Obamacare or the alternative of our current extremely expensive and broken system; until we all wake up and demand accountability from hospitals and other institutions providing healthcare for the cost of healthcare delivery, we will continue to swirl in this quagmire.

As a society we seem to have lost the concept of personal responsibility and accountability. What if we all knew what the cost of having a by-pass surgery BEFORE we needed it? Couldn’t we shop around for the best deal? What if we all knew what was included in the cost of a one day hospital stay? There isn’t any other service that we pay for where we are not provided costs upfront.

Why is everybody so content to let someone else negotiate these prices? Do you really need an insurance company to do that? Why can’t the consumer do that? No one can navigate the current system as an individual, and that is WRONG and has created the non-competitive marketplace we have.

I wish we were truly a republic that was run by citizens for citizens.

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
If you read my full post you would note that I stated that is probably psychological or emotional in nature. I believe that is the same as mental. The same can be said for any addiction which in essence this is. We can blame everyone until we put the programs in place to combat these issues. If you don’t like the advertising than speak up against that but not against programs that may have at least a chance to affect even one person. I was in a similar discussion regarding illicit use of prescription drugs. It focused on blame and not solution. Until someone presents a better idea I will support anyone who endorses helping others. BTW before you say not everyone wants help and we will not get to them before its very late. But one human at a time is good enough for me.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Marc, you noted “Obesity may be a result of poor diet which is often a result of economic conditions.”

I know some upper income families that never have a home cooked meal unless it is chili from the crockpot, so it is NOT economic in some families. It is mental.

Maybe the effect of very highly specialized psychologically studied & oriented marketing from the bowels of focus groups and other very professional Madison Avenue advertising programs has figured out how to push the high fat, high calorie food items to become “the norm” for many people because it is easy to make lemmings out of them with things they find that taste good.

It is all done for the sake of profit on legitimate products. Then we have to get back to how do parents and schools teach and train kids. The ads start teaching kids what to eat almost or sometimes before their parents do it, if they do it at all. Then we have to ask should TV even be allowed for early years of life.

The nanny state can then fight with Madison Avenue over who gets the bucks.

Marc Hollingworth
Proven Business Leader in Medical Devices and Healthcare
These discussions seem to revolve more around the industry and potential financial implications than treating the disease. Obesity may be a result of poor diet which is often a result of economic conditions. Or it may be a result of psychological issues similar to addiction, which by the way we choose to ignore nicely as a society where it is now an epidemic. People are not obese because they choose to for the fun of it. There is some physiological, emotional, neurological or economic reason. It is also the tip of the iceberg for more serious diseases, so if we treat it first we may actually avoid more treatment for diabetes, kidney disease and many more associated conditions. There is never a perfect answer but at least the AMA had the guts to start the ball rolling.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Even intensive bariatric surgery is no magic wand, and the bariatric surgeons are the first to admit this. For every patient, there is a medical and psychological team to help each specific person get through to health. Medical devices hold great promise to be a very important cog in this wheel.

Jean Bigoney, PhD, RAC, CQE
Regulatory Affairs Specialist.
Pete, if the person with the broken arm broke it by jumping out of a second story window, I’d blame him AND help him. And without seeing you I do not know how you come to the conclusion that you are 25-30 lbs overweight. You certainly do not sound as though you fit the category of “obese.” Unless of course the criteria as designed to include as many millions of pigeons oops I mean patients for the pharma industry to get paying for new meds.

Just FYI, I am considered “overweight” according to most weight tables for women. Evidently whoever publishes these tables don’t consider the possibility of a middle aged woman lifting weights and having a much higher percentage of muscle than average. I don’t let it bother me in the least.

Again I realize that there are people who are overweight, even seriously overweight through no fault of their own. However, I see people leading a sedentary lifestyle. I see them driving their kids 1/2 mile to a school bus stop so the kids don’t have to walk. I see peoepl consuming insane amounts of soda. I see on TV the mothers feeding their obese children homemade chocolate covered donuts for breakfast (Jaime Oliver’s food revolution). Pills are not going to help those people

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Agreed that it would be tough.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Paul, from what I see it is going to take Solomon’s magical mind to convince any substantial portion of the population to change their lifelong habits because we don’t have enough medical types to go around shepherding people like flocks of goats.

I think Obamacare is going to be the biggest albatross around the neck of this country we have ever seen. I don’t know what is going to happen to it, but it will fail, but in WDC, that means it just gets “changed.”

Cost is ultimately what causes individual people to change habits. When they run out of money, they are forced to change. That could mean they are taxed out of available funds.

All in all on a business side, though, I have to agree this will create a boon in both products and services. Some of them will be very good and help people, but ONLY if they adopt new healthier lifestyles. That is tough. How tough? Well, the last number I saw said we have 120 million or so people with STDs in the U.S. Alcohol and “recreational” (debilitating) drugs are another biggy.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Reigning in healthcare costs would involve attacking the root causes and incentivizing the right behaviors on the part of individuals and providers that have more favorable clinical outcomes and reduced short and long term costs. Ensuring that everyone has coverage and goes to see a physician to help start pointing people in the right direction so they end up in the ER less frequently is an important start. But the ACA is not complete and more work will be needed to add and fix things so that utilization is optimized and the right behaviors are incentivized.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Paul is absolutely correct in the numbers and the urgency, and it is just as bad or worse all around the world, as Richard states. That one-child policy in China has created the most coddled, fat group of kids in the world where every relative, from great-grandparents on down, feeds them. Just do a little research, and one will quickly see that the market is monstrous, no pun intended, and we have an amazing opportunity to address it. I’m working with one start-up medical device company, Onciomed, that is working on just such solutions. There is enough room right now for many, many others to join in.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Paul, in addition per the CDC report about 120 million live with chronic illness and 32 million are severely chronically ill to the point of having a tough time with simple tasks every day. Those same people have about 30 million on anticoagulants and another 70 million on regular aspirin.

About 40-50%, depending on how you count it, have illness conditions caused by personal choices and actions. Hence the other 50-60% are going to pay the price of healthcare for the other people who don’t want to minimize or eliminate their bad personal choices.

An example, the obese people I’ve known myself that fall down because they don’t have the strength and balance to manage normal walking. One person I saw was so far gone that when he fell down, he could not get up by himself.

When the government offers to do everything for everyone, the people who do a normal working life are going to get the shaft in taxes to support those, about half who do not choose live a healthy life. Eventually this will create a crisis.

Insurance was to always from the beginning of Lloyds of London meant to assess risk and charge appropriate freight insurance. If you had a new ship, you paid less premiums than an old tub.

Today “health insurance” has become corrupted as it is now just a form of give-away from the government when premiums have little to nothing to do with risk. Without incentives to stay healthy we get what we have and where we are going…toward a collapsed system eventually. You can’t bleed society at ever growing rates of taxation before one form or another of collapse occurs.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
Correction – 32% of Americans are obese. Look at the person on your left, look at the person on your right – one of the 3 of you is obese. And this drives much of the above – 32 million with diabetes, etc. Obesity is at the root of what could cause the bankruptcy of our nation, and it needs to be attacked now and aggressively.

Paul Teitelbaum
Experienced Strategic Advisor in Medical Technology
10% of Americans (32 million) have diabetes. That is absolutely staggering and unacceptable. Probably the highest prevalence in the world. It truly is a disease, along with the lack of understanding of the average American about diet and staying healthy. It leads to diabetes, sleep apnea, heart disease and other complications. Poor diet also drives autoimmune diseases and other problems. These issues in turn drive a large part of the costs of our healthcare system. Instead of just playing around with health insurance reform and taxes, the ACA and others need to focus on strong financial incentives on individuals, providers, hospitals, etc. to drive people to lose weight and watch their diet (in addition to bundling reimbursement for hospital procedures, cracking down on crazy end of life care, cutting out excess utilization, waste and inefficiencies). Studies show that higher premiums and other financial penalties, if big enough, are effective at driving behavior. In terms of med devices, I think overall it’s an opportunity – studies have shown that bariatric surgery procedures work, but we need better devices and there are a few interesting companies that finally seem to be on the right track (although a few are having problems). Issue will be cost of procedures and will the government and private health plans pay for the procedures? “An ounce of prevention worth a pound of cure” – key is to lower incidence of obesity. This may seem a bit radical, but maybe people with a BMI over 27/28 who, during a calendar year, get below that level and can show that they ended the year below the level, get a tax credit of a few % or a few thousand $. Or the other way – penalize everyone who let their BMI rise above the level (hard and costly to enforce).

Pete Bobb
Sterile Processing Professional
Jean, I think that you would blame the person with a broken arm rather than help them.
I favor treating with neutraceuticals over pharmaceuticals whenever possible.
I exercise daily, either 30 minutes on a cyclic machine, walking 6 miles or bike riding 12.5 miles, burning between 500 and 700 calories per day in the daily exercise segment.
I eat between 1800 and 2000 calories per day, with over 50% of my carbohydrates coming from cruciform vegetables and nuts.
I normally fast every Sunday, consuming only vitamin pills, water and unsweetened tea.
Tell me again how my unhealthy lifestyle and overeating causes me to remain 25-30 pounds overweight without being able to shed the excess pounds.
Tell me more about how I need a spoon with a hole because the 1800 calories a day I eat is too much food….

Jean Bigoney, PhD, RAC, CQE
Regulatory Affairs Specialist.
Paul you are right. We are not talking about public health, we are not talking about saving lives, we are talking about the medical device and pharmaceutical industry seeing an opportunity to make MONEY by labeling a BMI of 30 as a “disease.”

I don’t remember where I saw it, or perhaps I was talking to a friend in the device industry abotu some pill that big pharma has come up with. They weren’t targeting seriously obese, even though morbid obesity can be life threatening; instead they were targeting the borderline obese because the market is bigger.

I was not kidding about the stunt big pharma pulled with “pre-hypertension” by the way. In 2003 they labeled it a “disease,” big pharma profited to the tune of about $16 bil a year, and in 2012 a Cochrane study on nearly 9000 patients showed NO benefit of “treating” these patients in terms of reduced risk for stroke or cardiovascular events. It would seem that the panel of 11 “experts” (nine of whom were consultants to big pharma) slipped up on that little distinction between correlation and *causal* correlation. Looks like they get to play the same game now with patients who can not or will not make lifestyle choices to reduce their weight.

And I understand that not everyone who is obese is themselves the cause of it. But I am convinced that if it were a matter of treating only those patients who are obese through no fault of their own, the market is not big enough to make big pharma sit up and take notice.

Want ideas for a medical device for treating obesity? How about a spoon with a big hole in it? Or substitute a pair of cross-country skis for that snowmobile, or hiking shoes for
that four-wheeler?

Pete Bobb
Sterile Processing Professional
There are multiple hormonal imbalances which can cause sugars to be converted to fats, leaving no sugar in the blood to feed the brain or muscles.
Although a person is consuming enough calories, their brains and muscles are literally starving.at the same time their body is laying down additional layers of fat.
Insulin Resistance and Hyperinflation are just two of the better known and more common causes of this.
Addressing obesity and metabolic syndrome BEFORE they cause full-blown diabetes and coronary disease saves money!

Guy Hibbins
Medical Officer
Abdominal obesity is the basis of the metabolic syndrome which is the basis of a whole range of diseases through the mechanism of adipokines which are pro-inflammatory hormones secreted by the abdominal fat cells.
This in turn leads to diabetes and cardiovascular diseases such as atherosclerosis and hypertension. In Australia we will triple our number of diabetics to three million people out a population of 23 million in just 12 years by 2025 according to projections.
This is more than just a business opportunity for the medical device industry – it is a genuine public health crisis and we need to do something about it now. The Australian Government recognizes this and has recently legislated for the introduction of traffic light labelling on food in 2014.
I recently read “Food Politics” by former FDA Advisor Marion Nestle, where she describes how sections of the food industry have worked against public health education campaigns on obesity as they do not want people to eat less of their type of unhealthy food.
Former FDA Head and dean of Yale and UCSF medical schools describes in his book The End of Overeating how the US National Institutes of Health in Washington have used regression analysis to link virtually the entire rise in obesity to increased consumption of food unnaturally high in fat, sugar and salt – junk food. The same food which is promoted in multibillion dollar advertising campaigns. He describes the current obesity crisis as the perfect storm, and one which will never get better by itself.

Fredrik Kaestner
Ingenjör med inriktning pÄ sÀkerhet.
From a hospitals point of view it’s a challenge to provide care with the same level of quality. Lots of equipment is only rated to about 150 kg… this is a daily problem in ICU / surgery / MRI / CT… Should the “normal” equipment be upgraded and adjusted to the new patient category ?
Obesity is connected to a great led of problems and cost for the hospitals.
And lets not forget the people, they are still having the same rights to good care. It’s not OK to use a truck scale in the hospital kitchen simply because it’s the only scale that works over 250 kg.

Mark McCarty
Regulatory Editor at Clarivate Analytics
And the connection between emotional problems and obesity is…???

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
Tom, I totally agree with you, we do not have enough resources to provide help to people who obviously have emotional problems.

Mark McCarty
Regulatory Editor at Clarivate Analytics
America has created this dilemma? Mesmerize the public? Another underlying disturbance? Oooooookay. If we could only get government ban some foods and some advertising, and pay for a check-up from the neck up, all would be well, is that it?

You act like obesity doesn’t happen without Madison Avenue and modern food processing. Care to back that up with studies of other populations across place and time?

Tom M.
Manufacturers Representative at Designs for Vision
America has created this dilemma whereupon public media and corporations mesmerize the public with lifestyles and food that offer immediate gratification.Obesity often like alchohol and gambling are symptomatic of another underlying disturbance that interferes with normal daily functioning. Maybe resources should be focused on the psychological element of obesity rather than addressing medical treatments.

Richard Jeffery
Managing Director
Obesity is a world wide disease and not restricted to the US here in Australia we have caught up to the US with this as a major epidemic. We can argue all we like what is the correct measurement but here we are trying to mandate a traffic light system on food …

Red is no, yellow is a some times food and Green is go for it but we have fast food and soft drink manufactures saying no way with lots of money and clout. The cost to society is huge and health budgets are stretched and often they do not have enough money for bariatric beds and products let alone address work place safety issues eg a standard toilet can only support 180kg. So these are problems but they are also opportunities from room fit outs, through to equipment and treatment. Will this go the same way as tobacco and we now have plain packet for all tobacco products with extreme graphic of what happens if you smoke that we have here, probably.

Talking to Prof Paul O’Brien from the Monash Obesity Centre states there are no magic pills on the horizon that FDA are likely to approve in the near future and since the US is the driver of these products and he has been working both here in Australia and the US for the last 20 years.I think he is some one that is great reference point.

So I see is opportunities as peoples health, lifestyle and age decrease and we are in the perfect position to assist.

Bonnie Trefny-Scilingo
CEO, President, Service Medical Equipment
If obesity is a disease, than it should be included as a acceptable DX code for billing all orthotics. With Medicare currently, a patient needs to be post-op or some major deformity or instability to be covered. As I know from fitting orthotics for patients for more than 20 years, a TLSO style lumbar corset, with core support could help many. Obesity is the cause of the problem to begin with.

Andrea Robles
Owner – Senior Consultant en RARS – Regulatory Affairs & Related Services
Obesity was perceived as an esthetic issue for a very long time, at least in Latin America, with the pertinent implications (the products to treat this condition were not recognized by medical insurances neither government programs, all costs in charge of the particulars and so on). As I see it, the fact that obesity is seen as a disease has a great impact in all the health industry, from drug products to medical devices.

Erica Heath, CIP
Retired – available for small human subject protection, informed consent consulting jobs
Thank you, Joe. That was an excellent video recommendation. Unfortunately I watched that excellent talk and then the next and the next and the color coded surgery. There is so much there.

I understand that this is not a political discussion but, just fyi, I took greater offense at the dig about contraceptives being free under Obamacare. For a long time with many insurers Viagra was covered and contraceptives weren’t. How fair was that? I wasn’t going to comment on it but it seems that the idea in that talk about being open to other points of view might apply to this as well.

Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
That “useless pre-hypertension racket!” Ha!

Professor Jean is back!

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
For us in the medical devices industry, we need to look at this as a tremendous opportunity to create the next generation of medical devices. Criticize the AMA’s decision or the use of BMI all you want, but we are talking MONEY here. The current set of drugs, along with their toxicities, do very little. And, the one marketed medical device, the Lap Band, has proven its worth in treating obesity. But, the most important fact that needs to be soberly understood is that the little medical device company that invented that device was paid $1.2B by Allergan for it. Yes, that’s a B.

One of the other very popular treatments for obesity, the vertical sleeve gastrectomy, uses several thousands of dollars of linear staples (Covidien, J&J) per procedure. Performed over a million times per year, you do the math.

So, be blind and criticize away at anyone and everyone, but in this $65+B market, the promise of medical devices will provide untold riches for some very sharp inventors and those investors who see an opportunity when it slaps them in the face.

Jean Bigoney, PhD, RAC, CQE
Regulatory Affairs Specialist.
Looks like big pharma has found another segment of the population to throw pills at and make billions of dollars off of. Just in time for them too, after they got outed for that useless “pre-hypertension” racket.

Hanna MĂ€hlen
Portfolio Marketing Manager at Omnicell
Here is a very thought-provoking TED talk on the topic: http://www.ted.com/talks/peter_attia_what_if_we_re_wrong_about_diabetes.html%7Cleo://plh/http%3A*3*3www.ted.com*3talks*3peter_attia_what_if_we_re_wrong_about_diabetes.html/KeCM?_t=tracking_disc]

Mark McCarty
Regulatory Editor at Clarivate Analytics
The problem with the obesity debate is that it has a zillion moving parts, including what appears to be a serious definitional issue. Are BMI measurements enough? Obviously not, but where does the science go next to come up with a rubric for determining whether someone’s obese? Measurements of lipids and triglycerides? At some point, a lot of biomarkers will creep into the debate, and it seems as though it’ll take time to sort them all out.

If I had to guess, I’d guess the AMA announcement does little more than add fuel to the debate. There’s still a need to define obesity, and a need to factor in interaction with co-morbidities. Then there’s the issue of evidence of effectiveness of interventions, which CMS and private payers are going to eye very carefully. Anyone care to take a stab at how “reasonable and necessary” will play out here?

Up next are registries and coverage with evidence development. At the risk of seeming to pretend there are no FDA-approved treatments (and I hate to sound like a doubting Thomas), but this whole discussion has a long, long way to go if you ask me.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
BMI has been shown recently to be a less than reliable indicator of obesity than Waist to height index.

Just for reference, my legs are 3 inches shorter than my brother and that alone puts me over the edge on the BMI index, just because my legs are shorter. Don’t know that WTH index is better.

Jennifer Ahlstrom
Document Specialist at Forever Nutraceutical
I’m not commenting on the AMA’s decision, but I have to comment on what Rochelle said:

There absolutely ARE reasons- outside of poor lifestyle choices and people being in ‘denial’ about their condition- that people ‘end up’ obese. Debilitating health conditions that do not allow them to exercise and metabolic disorders that affect their weight negatively are just a couple of them. People who live in ‘food deserts’ with NO available choices for unprocessed, healthy food is another, as is living in conditions lacking the equipment necessary to cook healthy foods even if they DID have access to them.

Obesity is a very complex social AND medical problem, without a simple answer. I do agree that the ‘standard’ BMI measurement isn’t very good, and hope that isn’t what the medical industry ends up choosing to use as a basis for whatever they do propose.

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc. Contact 954-895-7216
I will watch this, but I based on my thoughts on working with people in my
capacity as a healthcare professional.

Rochelle

In a message dated 7/2/2013 2:41:25 P.M. Eastern Daylight Time,

Joe Hage
đŸ”„ Find me at MedicalDevicesGroup.net đŸ”„
Rochelle, I invite you to watch this heartfelt and thought-provoking video.

http://www.ted.com/talks/peter_attia_what_if_we_re_wrong_about_diabetes.html%7Cleo://plh/http%3A*3*3www.ted.com*3talks*3peter_attia_what_if_we_re_wrong_about_diabetes.html/KeCM?_t=tracking_disc]

Maybe it’s not as easy as (your words) “the problem [lying] with the person who is obese and is in denial and continually makes poor choices in their lifestyle.”

David Branscum
National Sales And Marketing Director at Cleanint, LLC
Although it won’t have a direct effect on my company, it will have a devastating effect on American Healthcare. Not to mention one more excuse people can use to shirk their responsibilities and moral obligations to themselves and fellow human beings. But this is not a forum for personal beliefs, so I digress.

The BMI has a lot of holes for diagnosis of obesity.

For example: I am obese. I am also 6’1″, 215 lbs, at 14% body fat. I can also dead lift twice my body weight 3 reps at the gym. I am not obese.

Depending on the doctors definition, maybe I need pills? Maybe I don’t, but I know someone who wants them for recreational purposes?

Obviously I would never do this, but it contributes to the higher cost of healthcare which affects my personal bottom line.

I would love to hear the perspective of a member that provides devices for lap band, etc. Anyone?

Rochelle Froloff, R.N.
Medical Products Specialist and Clinician, Action Products, Inc.
Contact 954-895-7216
Obesity is a challenge for every healthcare provider because the problem lies with the person who is Obese and is in denial and continually makes poor choices in their lifestyle. The information is out there as to how to maintain a healthy lifestyle. There are clinically validated products that will assist them. I believe healthcare providers are going to have to implement wellness programs for their patients and try to work with them.

Joerg Schulze-Clewing
Electronics Design Consultant
Who knows. With this Obamacare law that even provides contraceptives free of charge we may get weight loss pills free of charge. “Free” as in “your rates will go up”, as usual.

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