- The American Society for Metabolic & Bariatric Surgery states surgery is the best solution for morbid obesity.
- Adoption is less than one percent of candidates for surgery. By the numbers: 119 million (US addressable market), 228,000 surgeries between 2011 and 2017.
- Therefore, patients don't want, can't afford, or can't access the surgery.
- This: "Reoperation after Bariatric Surgery: Still a Devastating Complication," J. Amer. College of Surgeons. October 2015
- And this: Medicare paid $470 million for laparoscopic gastric band associated procedures, of which $224 million [1/4 Billion] (47.6%) of the payments were for reoperations. JAMA Surg. 2017 Sep 1;152(9):835-842
- Peter says today's common procedures (laparoscopic sleeve gastrectomy, bypass obesity surgery, esophageal sleeve gastroplasty) require high surgical skill and represent higher patient risk.
- Peter's Laparoscopic Gastric Plication (LAGP) surgical method was invented by him and, concurrently and separately, by an Iranian doctor, M. Talebpour, MD. (Talebpour has since performed thousands of these surgeries, manually plicating (stapling) tissue.)
- "In 92% of patients, LAGP resulted in remission of Type II Diabetes, and significantly decreased fasting blood sugar." Journal of Diabetes and Metabolic Disorders 14(1) – July 2015
- Peter's LapProx device simply substitutes the time-consuming plication process with an easy-to-use device.
Now if only someone would fund and make it.I'm no expert, but this seems like a good idea to me. The invention is protected by nine patents. Do you know a company or investor who would help realize its potential? If so, check out Peter's LinkedIn profile and this 19-page presentation. (It contains his contact information.) And last, here's a 85-second video of the concept. It's not for the queasy: It shows proof-of-feasibility in a live pig surgery at the 35-second mark. If you contact Peter, tell him, "Joe sent me." 😊 +++
Hey, what're you doing on Thursday?If you have anything to do with regulatory submissions, I sure hope your answer is "attending your free webinar with Rob Packard." Free webinar: How to prepare a 510(k) submission. Thursday, October 25, noon EDT. Yes, sign me up! As always, if you can't make the live event, I'll email you the recordings and slides afterward. +++
Hey, what're you doing on January 29?If you have anything to do with marketing, sales, or business development, I sure hope your answer is "attending 10x for Sales and Marketing in Orlando with you, Joe." I hope to complete the agenda by this time next week but you can still apply to speak or sponsor it. For that matter, you can apply to speak for our May event, the 10x Medical Device Conference, and/or our October event, 10x for Design and Manufacturing, too. We record and professionally edit the sessions. You can use the footage however you see fit. I can promise: Your marketing team will love you for it. +++
Jobs for Hire: Click for details.
And this one, just in: Project Manager, Medical Laser Product Development for Aerolase in Tarrytown, NY. I met their Director of Strategy at an investment conference a few years back; I was very impressed with the concept. (I would have invested, but Beth said no.)
Hiring managers, one more week! List your opportunities for just $39 at https://medgroup.biz/jobs before month's end (promo code OCTOBER). Prices go up November 1.
Candidates, search medical device jobs and sign up for job alerts at https://medgroup.biz/jobs.
Discussions You May Have Missed
Ask your question at medicaldevicesgroup.net/question/add.
Juan Ángel Gracia, García has a question about European regulations when active ingredients are highly concentrated.
Clément Vallois, Project leader at Fresenius Kabi, asks, "Finished good article codes"
Tanguy Van Regemorter, General Manager at Manetco - Materials and New Technologies Company, has a question about, "Importance of anti-adherence or hydrophobicity for medical device applications?"
Christian Costantini, Regional Sales Manager Americas at Redax Spa/Maclin Power, Inc, asks you "Who provides market intelligence services for the medical device industry?"
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
P.S. A call for speakers (apply here): Our 10x for SALES and MARKETING will be January 29-30 in Orlando, FL. Medical device marketing is my turf so I can guarantee robust, interactive learning. I'm teaching a 6-hour workshop there on January 28th. Learn more.
Discussions You May Have MissedAsk your question at medicaldevicesgroup.net/question/add. Juan Ángel Gracia, García has a question about European regulations when active ingredients are highly concentrated. Clément Vallois, Project leader at Fresenius Kabi, asks, "Finished good article codes" Tanguy Van Regemorter, General Manager at Manetco - Materials and New Technologies Company, has a question about, "Importance of anti-adherence or hydrophobicity for medical device applications?" Christian Costantini, Regional Sales Manager Americas at Redax Spa/Maclin Power, Inc, asks you "Who provides market intelligence services for the medical device industry?" +++
Thank you for being part of our Medical Devices Group community!Make it a great week. Joe Hage Medical Devices Group Leader P.S. A call for speakers (apply here): Our 10x for SALES and MARKETING will be January 29-30 in Orlando, FL. Medical device marketing is my turf so I can guarantee robust, interactive learning. I'm teaching a 6-hour workshop there on January 28th. Learn more.
Group member Amy Baxter, MD, is furious.
"I just got back from #PAINWeek where supposedly doctors are learning about what works for their patients to manage pain. We brought our new DuoTherm low back pain thermal/vibration prototypes – almost all the doctors cared about was drugs!
Let me tell you a little about Dr. Baxter.
Amy Baxter MD is an inventor, innovator, and pediatric emergency physician. She made Buzzy, which, to date, has blocked pain from 31 million needle procedures.
And she's serious about drug-free pain relief. After Buzzy, she made VibraCool.
Then, in response to the repeated question, "When are you making one for the back?" she and her colleagues at PainCareLabs developed DuoTherm, now in the concept/prototyping stage and featured in an Indiegogo campaign through November 2018.
Why won't you believe me?
The history of devices is paved with skepticism. For your entertainment, a 1930 video entitled, "Fat Men Use Mueller Exerciser Belt." And, well, Theranos.
So you probably won't be shocked to learn, of the $60 billion spent on U.S. pain management each year, only two of it is on devices.
Devices are at such a disadvantage versus medication that – get this – the family behind OxyCotin is now looking to market a milder opioids to help wean addicts off, well, opioids.
Yet primary pain physicians aren't won over yet. "Only two of 126 #PAINWeek presentations were about consumer devices," Amy reported.
Turning the tide
"The first difficulty in turning the tide from pharma to device is, of course, reimbursement. Any prescription medication is fast tracked for coverage.
On the other hand, devices that work may not get paid for. Just last week, FDA announced a plan to give manufacturers clear guidance on what studies need to be done for payor reimbursement. This is extremely helpful, but underlies the huge hurdle of high quality studies."
"In general," Amy continued, "device research (especially for consumer devices) isn’t as rigorous as in pharma.
• Pharma has more cash to get top researchers;
• Evaluating drug studies is familiar to most physicians; and,
• Even "real-world" case studies can undermine the device industry."
Just one example, a device company study compared 800 compliant patients to 100 who self-selected out. They concluded those who stuck with the program, did better, evidence "the device works." Uh huh. 🙄
Audaciously, the QR code accompanying their "scientific poster" took you to a "Buy a Device" page. 😠
Fighting the good fight
Check out the IndieGogo campaign and, if you (or someone you love) is a back-pain sufferer, maybe get a unit at half price.
Thanks for reading and tell me what you think of this article, her concept, and the imbalance between device and pharma solutions in today's comments.
Jobs, Jobs, Medical Device Jobs!
Thank you for your warm response to the new Medical Devices Group Job Board last week.
Candidates can upload their resume and fill out a profile with links to sites of your choosing. And due to popular demand, medical device hiring managers can post a job for free through Thursday, September 13. Use code BETATEST at checkout.
I think it's gonna be big.
Also, we added a slick "Sharing" icon for each discussion. Use it to easily share items of interest over LinkedIn, Twitter, or email. I'm thrilled with the functionality.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Four weeks to go, and the group rate at the beautiful Hyatt Regency Mission Bay Spa and Marina expires next week. So if you're flying in to San Diego for our 10x for ENGINEERS event, act today!
"HeartSciences’ MyoVista® Wavelet ECG Device is breakthrough technology in electrocardiography designed to assist in the early detection of heart disease*. MyoVista wavECG Technology is focused on closing the diagnostic gap related to identifying patients having an elevated risk of a cardiac adverse event. Patented signal processing methods using wavelet mathematics provide new information related to energy in the acquired ECG signal.
As for me and my family, I don't want to waste my -or taxpayer money. But a simple, inexpensive ECG or EKG that provides early diagnosis makes sense.
Doctors Told Not to Order ECG's for Low-Risk Patients
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"Why don't we see a more widespread use of virtual doctors? We see some here and there, but with the technology already available, why don't we see more?"
I put myself in the physicians shoes.
-Would I ADD computer screen virtual meetings with patients to my existing patient load? Where would I get the time to do that?
-Would I have to cut my existing patient load to add time for virtual meetings? If so, would I charge the same? Can I justify the same charge? Would the quality be the same?
Researchers have told us that over 90% of communication is non-verbal. This is why Webex meetings take longer than face to face meetings. It takes longer to understand something. in face to face encounters we capture feelings, perhaps see expressions that the camera would not catch, hear and feel things the microphone may not hear. We can sense despair, fear, and anxiety, which could lead us to better suited treatment paths.
Will quality of care go down with more virtual doctor visits, or up as some say? Or is it just about cost?
I would like to hear your thoughts.
His father askes if I had any ideas - stem cell are the only thought I had or an external body robot that could be strapped on.
I wonder, do you know of any researchers who are in that area of research. If you do, I would appreciate their names so I can help him.
If any group of professionals can, I know they will be in this group who have dedicated their careers to alleviating human and animal suffering.
Eager to know, if there exist vendors/platform to connect multiple health parameters (BP, TP, Glucose, ECG & much more) from monitoring devices of the patient.
This is basically to monitor the patients remotely.
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