Can you explain what Article 22: System and procedure packs of EU MDR means?
What, exactly, do we do to comply with this article?
You know that nice, little Medical Device Directive (the MDD) you've been using for 20 years to get a CE mark?
You know it's going away, right? Zero MDD certificates will be issued after May 25, 2020.
And since CE marks need renewing every five years, by May 2025, everyone doing business in the European Union will have transitioned to the new way of getting their CE mark.
The new sheriff in town. 🤠
The Medical Device Regulation (MDR) is the new sheriff in town. He may be new, but he's bigger and badder than his predecessor.
You're going to have to jump through some serious hoops to get your coveted CE mark.
Or should I say, your notified body is going to have serious hoops to help you get your CE mark. Is your notified body (NB) up to the task?
Are you in bed with the right partner?
Mark schmark – How hard can it be? 🤷
I ignorantly thought, "Any NB worth its salt should be able to give a CE mark. Under this Directive, under that Regulation, whatever."
A CE mark is the basic requirement for marketing and selling medical devices in Europe.
I mean, if a notified body can't even give a CE mark for someone, how could they even be in business?
Then I read Michelle Lott, RAC's article.
Get your notified body on the phone. Like, now. 📞
Michelle helped me understand these issues. Internalize them.
1. Are they designated? You don't get to "just do MDRs." Every notified body has to apply to become an MDR designee.
Okay, that sounds pretty basic, right? If you're in the NB business and you need one, you go get one, right?
With a hat-tip to NSAI's Colm O’Rourke for this data, 68 notified bodies have Withdrawn/Expired/Suspended Notifications to issue MDD certificates (so MDRs are terribly unlikely). Only 55 notified bodies even remain (see list) and, anecdotally, I hear fewer than half have even applied yet. 😲
2. Have they been audited yet? Your NB has to weather a "Joint Assessment audit." If they haven't even scheduled one yet, get nervous. And if they had it – and it didn't go well – get very nervous.
3. What did they apply for? Designations aren't one-size-fits-all. Did your NB ask to cover your category of products?
4. Did they add staff? Michelle suggests – and a former TUV employee agrees – if your NB hasn't added 20-30 percent to its payroll in the past three years, they won't have the talent necessary to cover all the extra work.
5. How do they define "significant change?" This one's a bit more nuanced. Basically, and whenever possible, you want your proposed product change to be considered "insignificant" by your NB. Because otherwise, you'll need to apply for a new CE mark right away – and under the more burdensome MDR.
Since each NB has its own interpretation of "significance," you may find another NB has a looser definition, one that lets you squeak by without the added disruption.
In sum, you may have the wrong notified body if...
- They haven't applied for an MDR designation.
- They haven't scheduled a Join Assessment audit. Or they had one, and it went badly.
- They didn't apply to cover all your products, current and future.
- They haven't done some serious hiring in the past few years.
- Their definition of "significance" is too strict.
I think Michelle's article was super helpful in understanding this thorny issue. If you visit her site, you can download a copy of her Regulatory Pathways Assessment. It can help you work through project feasibility and requirements.
Coda: Can you afford to switch notified bodies?
I talked with Michelle afterward and pressed her. "Aren't medical device manufacturers even lucky to have a notified body in the first place? I understand NBs are so busy and so under-staffed, they're not even calling back new-business prospects in a timely way."
She quipped, "And if they can't get you a CE mark, what's the point of having them at all?"
And drove home her point, "That's why I'm telling all my clients to ask these questions. Because if your notified body is out of business, YOU'RE out of business."
Are you hiring?
Then you should be on this email for thousands of medical device professional eyeballs. I know quite a few folks who are in transition. Ask me!
Do You Know The Answer?
Robin Shepherd could sure use your marketing ideas for "a ‘tricky’ innovative product in a vertical market.
Emily Saba is looking for ER Vital Wristband Input.
Amy DeWinter needs Advice on hardware maintenance pricing.
Good karma for you in advance for helping a fellow group member.
Thank you for being part of our Medical Devices Group community.
Make it a great week.
Medical Devices Group Leader
P.S. If you missed last week's email, click here for the Exponential Medicine videos.
Hi, I'm an ex-medical osteopath who has 'invented' a modern-day chamber pot for use in the home by everyone (not just the invalided or elderly).
Night-time urination is the biggest cause of sleep disturbance in all adult age ranges.
My product encourages users to pee by the bedside. They can sit or stand (versus taking a trip to the loo; thereby risking injury and/or having to wake up fully.
I need help marketing it. The potential market is enormous, the story and statistics compelling, and the product does what it says it can. Testimonials are hugely encouraging.
How can I break into a vertical market, and educate the public so they see the benefits and adopt the concept.
Design and attributes:
• It looks pleasing so doesn't have to be hidden away
• It's always open so no fiddling
• It baffles sound and captures odour
• It won't spill its contents if dropped (over two full bladders)
• It holds up to five average voids and remains incredibly stable.
• Its even got a glow-in-the-dark band for ease of location and is dish washable!
The product is called the Handi-P. Please take a look at handi-p.com and let me know your thoughts. Many thanks, Robin.
I wish there were a way to adequately convey what's going on right now at Singularity University's annual event Exponential Medicine.
I know. It sounds like a commercial. Like I'm being paid to say this.
I'm not. Event founder and chairperson Daniel Kraft doesn't even know I'm writing this.
His sold-out event is "an intensive four-day experience that gathers world-class faculty, innovators and organizations from across the biomedical and technology spectrum to explore and leverage the convergence of fast moving technologies in the reinvention of health and medicine.
It was live-streamed and available for you right now.
Here's the four-day agenda. Look it over and decide which presentations you want to watch.
Each video is roughly 10 hours long. You'll have to be selective.
Thank you, Singularity University!
For the inspiration, the leadership, and so much more to improve the world's healthcare.
Your biggest fan
HORIBA Instruments: Regulatory Manager - Medical
Encision: Director/VP RA/QA
GeneCoda: Regulatory and Quality Consultant
Hiring managers, promote your jobs for only $49 at https://medgroup.biz/jobs (promo code NOVEMBER) and candidates, search medical device jobs and sign up for job alerts!
Discussions You May Have Missed
Emily Saba, Research and Development Intern at NCGrowth, asks for input on an "ER Vital Wristband"
Tom Bowen, President at Bowen Medical, asks if you need to "sacrifice accuracy of blood pressure cuffs to low cost disposables?"
Thank you for being part of our Medical Devices Group community.
Make it a great week.
Medical Devices Group Leader
P.S. Check out those Exponential Medicine videos when you have a chance.
Hello, MedDevice Group!
I am helping a client with all-things-marketing and finalizing their launch plans for a US launch. They have a hardware/disposable model and the hardware will be priced upwards of $60K to cardiac centers. The units will come with a 2-year warranty but will require an annual tune-up; how have you typically seen this done before?
Options as we see them:
1) Create two item codes, one for warranty period maintenance + one at a higher price for post-warranty maintenance; or,
2) Build the tune-up cost into the price of the hardware, which does increase the hardware pricing by around $12-15K.
Thoughts? Have you seen this done in other creative ways?
We'd like customer compliance in using our maintenance plan, as we don't want system downtime. Thank you in advance!
YAY! I finally figured out how to conduct polls for you here on MedicalDevicesGroup.net!
To create your own poll for our community, ask your question here.
YAY! Let's do this thing!
I’m currently a student at the University of North Carolina at Chapel Hill, studying economics. I am taking an Entrepreneurship class, where we must create a venture in relation to health care.
My group has come up with an idea to create wristbands that monitor the four major vital signs – blood pressure, body temperature, pulse, and respiration rate – while patients are waiting to receive care in the emergency room.
The band would send the measurements to an accessible system, allowing physicians and nurses to have access to the health information of waiting patients.
Please let us know what you think about the product, including its usefulness, practicality, problems, etc. Thanks in advance for the input!!!
I've been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – sang on stage.
You likely recognize Bob's name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief.
I cite the lyrics below. But you'll want to hear it for yourself. While you're there, pick up his FDA guidance slides and the transcript.
Some key takeawaysOr should I say, "on key takeaways." Get it? On key? Because he sang? 🙄 Oh, forget it. 🙄
- Patient population splits. "For a long time in clinical trials, we’ve not done a good job covering gender, ethnicity, and other issues in having a good population to represent the end users." FDA gives us guidance on that now.
- Is it a device? FDA realized some previous guidance was going to be problematic, specifically related to things around chemical action. They initially said, “There can’t be any chemical action or it’s not a device.” In this guidance, they've backed off. Now they ask, "Is the chemical action coincidental or is it the main part of how the results are achieved?"
- Submissions involving cybersecurity. They've given us guidance. They want to know your 'updates over time' plan because software changes all the time. You need to tell them how you're planning for it.
- Medical device accessories. FDA is looking at them differently now. This post is getting long so click through for more information, including what Bob calls "Coming Distractions."
That Packard webinarRob knocked it out of the park in our "How to prepare a 510(k) submission" presentation last week. As promised, here are the slides.
Discussions You May Have MissedAsk your question at medicaldevicesgroup.net/question/add. Juan Ángel Gracia García, Technical Director Medical Device Department, asks, "Chemical peels: cosmetic, medical device, drug... or what?" Kasper Friis, Head of UX & Design for Technolution A/S, seeks your feedback: "How do you make sure that people will love your product?" Ruth Clark, wonders "Which medical products are made from fabric/textiles?"
Thank you for being part of our Medical Devices Group community!Make it a great week.
Medical Devices Group Leader
- 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.
Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).
Active ingredients in higher concentrations (such as in the case of chemical peels, where concentrations are as high as 10-15%) are not allowed under the European regulations of cosmetics.
How to proceed in these cases?
In Spain, there's a special category as "Hygienic Products" where chemical peels are included, but how to proceed in other European countries?
Should it be regulated under the medical device directive or new medical device regulation? Should it be considered a drug?
I can not found any official document where the classification of chemical peels was stated.
Thanks in advance and best regards, Juan Angel
Then how about Carsten Horn, the business development manager for maxon precision motors? Carsten gave a 10x Medical Device talk on product design and manufacturing considerations when you miniaturize your medical device.
I made the replay, slides, and transcript available for you: Click here.Of course, miniaturization is one of the major trends in medical devices. Miniaturization, along with digitization, is a central theme ResMed's go-to-market strategy. (See ResMed CEO Mick Farrell's 10x keynote presentation.)
Why is miniaturization so big?
You see what I did there? 😄
Because, as Carsten notes, "The major driver is the patient. Smaller devices, especially ambulatory devices (drug pumps, patches, etc.), shouldn't bother you to wear."
"To make them comfortable, you need to make them extremely small," he continued. "We are working on micro robots and miniature robots that work within the body and doing the surgery, not from the outside anymore. That will be the future, and you need to miniaturize for that."
So if you might miniaturize, or just wish to stay current on this hot trend, give our summary a look.
#HumbleBraggingExample: It was an honor to host so many thought-provoking speakers and guests at last week's 10x for Design and Manufacturing event. Another: I don't know what it is about 10x Medical Device Conferences. Alumni come again and again, saying 10x delivers so much value in terms of content and connections. In other words... First up: 10x for SALES and MARKETING (call for speakers) on January 29 and 30 in Florida. (Early bird pricing now available.) Then: The 10x Medical Device Conference (call for speakers) on May 15-16 in San Diego. Then: 10x for Design and Manufacturing (call for speakers) in October in Minneapolis. So, possible? I'm giving you a whole year of notice – and before you've set your annual budget. Please, join us. You'll see why I guarantee your satisfaction and offer the industry's most generous return policy. +++
Two Free Webinars!Since I already know who you are, all you have to do to register for these webinars is click the links. Easy! 😊 • Live FDA announcement. Thursday, October 18, 11:45 Eastern Daylight time (EDT). FDA will discuss new draft guidance, entitled "Computer Software Assurance for Manufacturing, Operations, and Quality System Software." Yes, sign me up for that. • Workshop: How to prepare a 510(k) submission. Thursday, October 25, noon EDT. Yes, we do FDA submissions. I'm interested. As always, if you can't make the live events, we'll send you the recordings and slides afterward.
+++Project Manager, Medical Device Product Development, Mansfield, MA • Entry Level Medical Device Sales Representative, Fort Dix, NJ • Director of R&D, Natick, MA Hiring managers, list your opportunities for just $39 at https://medgroup.biz/jobs anytime this month (promo code OCTOBER). Candidates, search medical device jobs and sign up for job alerts at https://medgroup.biz/jobs. +++
Discussions You May Have MissedAsk your question at medicaldevicesgroup.net/question/add.
- Barbara Duffy, Chief Operations Officer for Healthcare Innovations Institute, has a question about "How else to use medical models?"
- Jackie Jaskula, Regulatory Manager at OrthoPediatrics , asks, "Why is FDA accepting 510(k) for implants with no usability or biocompatibility?"
Thank you for being part of our Medical Devices Group community!
Make it a great week.
Medical Devices Group Leader
My group is making realistic, full-sized, medical models that provide a high-fidelity surgical experience.
Used for medical schools' education and training, these durable, soft, silicone models can mimic nearly any organ or system (including normal, diseased, or patient specific) with tumors, bleed when incised, be scoped, sutured, etc.
I can’t help but think there may be potential for use or interactivity with some medical device items – but the students don’t know to ask, and both this group and I have little experience with what is available and where there may be opportunity to augment student learning.
Any ideas? Thanks so much! Barbara Duffy, email@example.com. P.S. We need more awesome groups like this!
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility beyond materials standards, and predicate comparison.
That was not the case in my previous company (external communicating devices, short-term).
Can you help me understand why these devices are being treated differently?
We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons of these products. Also, are there any others that you'd recommend?
Dear colleagues, what are your "tips and tricks" to limit the number of article codes for your finished products?
How do you manage the different power cords, languages for software interface, languages for IFU, duration for authorization time, labeling differences, and more?
Thanks in advance, and best regards.
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.
Let’s say I am designing a PCB and have to write a protocol to test it. I would include measuring voltages and current at different stages.
But there is much more to consider, even before I plug in the device (like shorts and loose solder connections). Many companies have a team to take care of this, but in a start-up that may not be practical.
My question: What's a good approach when just starting out in protocol design?
I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.
I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certification for their QMS. That is, as long as their QMS is in accordance to recognized harmonised standards, and subject to an NB assessment/audit.
Do you arrive at the same conclusion, that they'd be able to get CE certified in this situation?
It wasn't until I transcribed Dr. Howard Levin's presentation from our last 10x for ENGINEERS event did I realize how much his past 15 years he packed into 25 minutes.
It was fantastic presentation for anyone who ever works in bringing a medical device concept to market.The video, slides, and transcript are immediately available for you now at https://medgroup.biz/Howard-Levin.
For credentials, Howard's company Coridea issued 120 US patents, raised $100 million, and returned more than 1.4 billion to investors.
Have I got your attention? Some key takeaways but srsly, download it:
• A university gets a patent on a concept constructed with "academic engineering" (different than "real engineering"). When they find the idea, as written, is unworkable, they've effectively shut everyone else out from expediting the innovation to market.
• A device may be good for mankind but not for business. You, as a medical device design engineer, get pitched more ideas than you can execute. How do you choose?
• If you consider taking equity as a form of payment, how do you minimize the risk there's no payout at all?
• "Breakthrough therapies tend to start in academics; better tools developed by industry or clinicians."
• Determine if the physician wants help developing clinical data and generating
IP for acquisition versus help manufacturing the device you'll make money on selling.
Then Howard took us through a dozen questions to ask, ranging from clinical need to regulatory risk to sales and marketing.
As I said, a really worthwhile presentation. Replay, slides, and transcript athttps://medgroup.biz/Howard-Levin
+++Featured Medical Devices Group Job Board opportunities
See something you like? Click away!
Hiring managers and recruiters, let's get these nice people some jobs!
Please list your opportunities at https://medgroup.biz/jobs anytime this month for just $29 using code 29dollars.
Candidates, make yourselves at home. You can:
• Create a profile;
• Upload your resume;
• Run searches by keyword and location (city/state or ZIP); and,
• Sign up for job alerts (available at this time only in the US, Canada, UK, and Australia).
Good luck, and if there's additional functionality – like this resume review tool – you'd like to see on the job board, just reply to this email with your suggestions!
How familiar are you with risk analysis according to ISO 14971?If you have a few moments, would you take this short Jama Software survey? They basically wanna know how medical device manufacturers perform risk analysis. It's, like, six questions, the first of which is your level of familiarity: None | Somewhat | Mostly | Expert. So if you have the time, I'd appreciate it.
Discussions You May Have Missed
Yay! 🥂 I've wanted to restore this feature for three years now!
In this section, I highlight some of the recent contributions from group members because, hey, this is a community we have here! Please, add your questions right here.Kyle Vlasak, VP Sales and Marketing at Vonco Products, asks, "Why is PVC the go-to when developing liquid tight medical fluid bags in the US?" Saurabh Dubey, Junior Regulatory Affairs Manager at Syngene, asks for "Help with 510(k), GTIN, and GUDID." Christian Costantini, Regional Sales Manager Americas for Redax Spa/Maclin Power, asks, "Who provides market intelligence services for the medical device industry?"
Hello, is there a need to submit an annual safety reporting in medical devices, informing the progress of the investigation, in the pre-marketing phase?
If so, what´s it´s name? To whom should be submitted?
Polyolefins have been shown to be safe alternatives to PVC's widely reported risks.
However Polyolefin films make up only a small percentage of liquid tight medical bags in the US with shapes and fitments.
Is it because of the sizable investments already made, or not knowing how to make with Polyolefins in scale?
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!
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market?
I've started on our 510(k). Do I need to have GTIN and GUDID as well? How do I go about it?
Your assistance appreciated!
IS BLOOD PRESSURE READING JUST A NUMBER?
One of the most critical factors in patient assessment is the blood pressure reading. If the accuracy of the blood pressure reading is compromised then the ability for accurate assessment of the patient is also compromised.
For many years we were exposed to cross contamination due to microbe laden blood pressure cuffs. The medical industry has solved this dilemma through the use of cheap disposable blood pressure cuffs. New research questioning the accuracy of these cuffs is now available.
A major teaching hospital was concerned about the cross-contamination of their manufacturer-validated cuffs. They substituted a washable cuff. In their hypertensive unit they documented that 33% of their patients with poorly controlled hypertension were wrongly diagnosed as normotensive due to lack of accuracy of the washable cuffs. One third of the entire patients in this hypertensive unit would not be given the proper medication to control their hypertension had they not discovered the compromise in accuracy.1
The most comprehensive research to date on accuracy of various types of cuffs compared eight different types of cuffs made of coated woven and non-woven fabrics. There were variations of up to 27mmHg for systolic readings and 17mmHg for diastolic reading.2
Using the American Heart standards for blood pressure- a person with an accurate blood pressure reading of 113 systolic that had an erroneous 27mmHg systolic cuff could be diagnosed as Stage 2 hypertensive at 140.
This lack of accuracy should alarm every health care worker. The blood pressure measurement should be focused on accuracy, not the lowest cost of a cuff.
There is remedy for the compromise of accuracy by using a reliable well-made reusable cuff such as the W.A.Baum company makes and a low cost cover to protect the cuff, like Bowen Medical Cuff-Guard to prevent cross -contamination. Cleaning of the reusable cuffs between each patient is also an option-if it is thorough and documented.
The most basic of healthcare are the accurate evaluations of vital signs. The blood pressure reading should always be the most accurate we can strive to obtain.
“Since hypertension is a major world-wide problem affecting millions of people, its accurate estimation is imperative and needs further attention. The methods of measurement, equipment and the size of the cuffs have already been standardized but the cuff fabric construction and the material of the cuffs which are the cornerstone of accurate BP measurement have been neglected.”2.
1. Unsafe health and safety: sphygmomanometer cuffs are not interchangeable. By Shaw KC, McEniery CM, Wilkinson and Brown. Published in Journal of Hypertension 2013 July,27(7):434-36 2. Variation in BP values for different cuff types by Naqvi, Potluri, Mandal and Lewis published in Journal of Industrial Textiles 2018, Vol.47(7) 1478-1495.
Designing delightful and robust user experiences is not an art. It is science. And it is business.
These are the questions you should ask yourself - and the tools to get you started: http://bit.ly/product-love
Do you ask yourself these questions? If not, why? (I am genuinely interested in your perspective, so please comment)
All the best, Kasper
I've said for years, "The Medical Devices Group is the world's largest medical device community and the industry's only spam-free, curated forum for intelligent conversations with medical device thought leaders."
It was nice. But we've outgrown it.
We have an even bigger vision now.
and specifically MedicalDevicesGroup.net,
will be the world's most useful website
serving the medical device industry.
What do you think of our big, hairy, audacious goal?
I think we can do it. And it starts today!
Introducing the Medical Devices Group Job Board
I could tell you all about it. Or you could check it out now!
As of today, the job board lets:
- Candidates can post a resume.
- Candidates can create a profile.
- Candidates can search by keyword and location.
- Candidates can get job alerts.
- Employers can post jobs. (Today it's FREE! Ask me how.)
- Employers can highlight "urgent need" jobs and raise visibility with a "featured" job.
- Employers can sponsor a "featured employer" spot on the job portal.
I'm figuring it out as I go – today's job board is the minimally viable product – but I was too excited to wait another week to show you.
Please, try it out, and slam my inbox with feedback - good and bad (I can take it). I want to build the single most robust career platform available anywhere for the medical devices industry.
The Most Useful Medical Device Website:
What does that mean?
I know this is ambitious – it wouldn't be fun if it weren't. I'm setting a five-year horizon to build "every useful tool you can think of" to further your career and company success.
We have a strong head start, with:
• Years of completely searchable, archived questions and answers on the Community tab.
• 40+ archived webinars with replays, slides, and transcripts, all ready for your immediate download.
• The most comprehensive medical device events calendar available anywhere (also minimally viable, improvements underway).
• Legacy resources (we will build heavily here) and a blog (soon to be open for your contributions).
And with today's job board launch, we have the foundational elements in place.
SO WHAT ELSE?
My late mother-in-law would prompt me, “So what else?” right after I told her about something great that just happened.
So what else?
These are in the concept stage:
- Member reviews for events, books, content, etc.
- E-learning courses (for credit)
- Access to the Medical Devices Group Advisory Board
- Supplier directory
- Resources for distribution and inmport/export
- Research and tools you tell me you need
- Survey tools
And some nice-to-haves: Communication preferences (opt out of "this" but not "that"), a calendar of upcoming online events (webinars, etc.), nested comments, and more.
So what else? Well, that's up to you! What's on your wish list?
What do you wish "someone would just make because it would make your life so much easier?"
I may be that someone! Let's talk about it.
You can start by hitting the contact page today.
Big Things Ahead
I've never been more bullish on what our community can do together. Won't you tell your friends and colleagues about this site and our new job board?
I hope you will – and thank you in advance.
We're going to make something great together.
Thank you all so much!
Make it a great week.
Medical Devices Group Leader
P.S. Please come to 10x for ENGINEERS in San Diego if the agenda is remotely interesting for you. I want to meet (and serve) as many of you as I can. https://medgroup.biz/10x
We are an Italian medical device company promoting its products in the USA. Our products are related to post-op drain, chest tubes, and chest catheters. We seek an up-to-date information about prices, competitors' market share, SKUs and so on.
Which research companies provide that information? Recommendations welcomed.
PS: We seek local distributors too.
I'm trying to put together a very high level view of medical device development for novice (meaning no prior experience in the industry, not just this is their first invention) inventors.
I am interested to hear from others what (if any) role they have seen research play in the process of developing a new medical device, including at what point in the process the research occurred. Did most of the research occur pre-IP? Pre-POC? Did any occur after the design process (user requirements, design inputs, V&V plan, etc.) got underway?
P.S. Does anyone here has been involved in medical device development at a medical device company think that a data collection activity (bench testing, clinical trial) done to verify or validate the design could appropriately be described as "research?"
Group member Alma Denisse Martinez submitted a discussion that warrants a larger audience. She posted an article, "Mexico's new President-Elect Lopez Obrador and the future of NAFTA and Mexican Manufacturing."
Some excerpts (paraphrased for brevity):
- Leftist Andres Manuel Lopez Obrador (AMLO) won in a massive landslide... [in a] mandate to change the country. What does this mean for manufacturing in Mexico and the future of NAFTA?
- Rivals' propaganda and memes said AMLO would be disastrous for Mexican business.
- In his post-victory, AMLO said he'd sign NAFTA, affirmed practical economic policies, and the independence of the Bank of Mexico. (As former mayor, he had been a stauch NAFTA critic and has since adjusted his views, championing better wages and working conditions within existing trade agreements.)
- The US will resume NAFTA negotiations after the November elections, giving AMLO some time.
- Commentators suggest AMLO wants to put money into infrastructure, to be fiscally responsible, to gain investor confidence. They saw possible public-private investments, particularly in energy and power.
The unabridged article at https://medgroup.biz/AMLO.
For the group:
- Do you have experience manufacturing in Mexico?
- Do you believe NAFTA and/or the election will impact conditions materially?
- If you produce outside your country, was Mexico ever in your consideration set and rejected for some reason?
Agnitio’s take on an interesting BCG study at https://medgroup.biz/medtech-commercial-model. “Clinician-focused models generate revenues per sales rep 35% to 50% of those generated by companies targeting administrative decision makers.”
The demise of our LinkedIn group
The inside scuttlebutt among owners of big LinkedIn groups like mine say today (Tuesday, August 28, 2018) is the day LinkedIn starts the conversion to new groups.
This is the content of my last announcement to the group: "I SEE DEAD GROUPS."
And yes, I am quite pleased with my little meme here.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader
P.S. So you know how I say my 10x events are fun?
This is one of the between-session clips I played. Still makes me laugh.
I am doing a market study for a high performance coating and I seek your expert advice.
The technology allows the deposition of a very thin coating (between 200nm and 1,5 micron) on glass, stainless or ceramic. It brings anti-sticking, anti-corrosion, and hydrophobic properties to the surface. It can be deposited on and inside complex parts.
How often this type of problems are found in medical devices? Are they critical?
If they are, how are they generally solved?
I'm really interested by your feedback and advice on this topic. Many thanks in advance for your help.
Tanguy Van Regemorter
I am interested to learn about the fabric/textile products people are using in their medical-related work.
I am particularly interested to learn what problems could be helped with new or improved fabric/textile products. Thanks!
I am working with Live Life Personal Mobile Alarms in Canada to set up sales agents. Live life is a unique cell phone-based fall prevention alarm designed for seniors. Outstanding and innovative product with no monthly monitoring fees, extensive out of home coverage and a real benefit for seniors and their families. check it our and email me if you are interested. https://www.livelifealarms.ca
How gone are we?We're so gone that I changed the name of the LinkedIn group, From: Medical Devices Group To: MedicalDevicesGroup.net (we moved!)
Our progress so farI'm delighted with our first month of progress. We already have:
Full question-and-answer functionality along with the ability to be notified(!) when someone leaves a comment;
793 archived questions and 18,302 answers;
40 accessible webinars (replays, slides, transcripts);
Weekly announcements (opt-in required at https://medgroup.biz/stay); and,
NEW TODAY! A full calendar of 89 upcoming medical device events!
Coming attractionsVery soon, you'll also be able to:
Access our jobs board;
Search the entire database for questions and answers;
Share posts on LinkedIn, Twitter, and email;
Ask questions directly to our Medical Devices Group Advisors;
Consult a "promotions" tab for member offers;
Conduct a poll; and,
This is where you come inI grew up in Bay Ridge, Brooklyn, New York, where my 1978-1989 mayor Ed Koch asked his tagline, "How'm I doin'? If you have the time and inclination, tell me how I'm doin' with this group transition. I'm hosting an online "town hall" next week, Wednesday, August 29, where I can hear your real-time feedback and requests so we can build our new home into something really great. Here's the link to join us: Join the Town Hall.
Special Two-Day Offer: $250 offIn a cheeky farewell to the LinkedIn group, I'm running a 48-hour special on admission to 10x for ENGINEERS this October. Use promo code ByeLinkedIn to save $250 before Friday. It's the only time I'll have a promotion with this deep a discount. Take advantage of it today.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Tick tock goes the clock! Just 48 hours to save $250 on your 10x for ENGINEERS admission.
- The rise of wearables and EHRs make precision medicine concepts possible.
- If medical device manufacturers are going to be successful with precision medicine, they’ll need to figure out how to navigate outcome-based compensation models for these therapies.
- Pharmaceutical companies work alongside medical device manufacturers for precision medicine. Pharma creates the targeted therapeutic; manufacturers design the diagnostics. There are 40,000+ different in vitro diagnostics (IVDs). The 2022 IVD market projection is $81.3 billion (a CAGR of 4.9%).
- 93% of drugs currently in phase III clinical trials are diagnostic-dependent.
- Multiple studies have shown that most traditional therapies in the US today are effective in fewer than 60 percent of treated patients, costing the healthcare system billions of unnecessary dollars.
- According to a National Academy of Medicine report, a precision-medicine innovation – one that more accurately identifies people who are at risk for a disease and is coupled to an intervention that reduces incidence even by as little as 10% – could generate hundreds of billions of dollars in value in the form of longer, healthier lives enjoyed by the US population.
FDA webinar in two days.Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru. They will cover: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. And you'll get access to the first FDA in the series where they covered what CfQ is and how FDA is engaging; summary detail on CDRH pilot programs; and, how FDA is rethinking regulations.
Members with questionsIf you've got the answers, please share with our community. Tautvydas Kazlauskas has a question on how to classify a fibrin-glue like medical device. Antonia Trevisan asks, "Are custom-made devices exempt from CE marking?" And I could really use help on Irina's question. So far no one has answered, "How to estimate safety BSE requirements?"
A whole new worldAs you can see, with our new home here in WordPress, I can add images and video each week. But even better, I have enough room to express myself and to highlight questions and contributions from group members like you! So here's your chance to ask a question and get a crowd-sourced answer from our members. Just go to https://medicaldevicesgroup.net/question/add/ to ask it. The page will look like this and there's even a way for you to get notified with each comment (just like the very old days):: I look forward to your participation!
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. Meet me at ConX (Sep 17, South Carolina), the MedTech Regulatory Awards at RAPS (Oct 2, Vancouver, BC), and our group's 10x for Engineers (Oct 10-12, San Diego) – especially that last one! 😊
How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?
According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking.
Are there any conflicting interpretations or guidelines?
Kessler's RegretI was going to discuss the much-discussed Netflix documentary, "The Bleeding Edge" today. (Here is a direct link to the documentary for Netflix subscribers.) But the group could not wait until Tuesday! Three submitted discussions this week about it. I finally published Amy DeWinter's commentary and it racked up two dozen comments in no time. There is so much to unpack in "The Bleeding Edge." I'll likely return to it in the future. But they covered something so interesting about our 510(k) path to FDA clearance in the first 20 minutes, I couldn't get past it.
Direct excerpts from "The Bleeding Edge"These are intended for context for our discussion. Dr. Michael Carome, Director, Public Citizen Health Research Group [Carome]: Most people probably believe, when they get a medical device implanted, be it a pacemaker or a joint, that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that is not the case. William K. Hubbard, Former FDA Associate Commissioner: Originally, Congress intended that almost all new devices go through pre-market approval (PMA). A PMA is similar to a new drug application, in that a manufacturer must test it first in humans, compile all this data, and then present that to FDA scientists, who will approve the device if in fact it is safe and effective. Industry argues, "We're innovating, we're changing products every year and that costs a lot of money, to test each of those iterations in humans.” So Congress established the 510(K) process. Carome: For the 510(k) pathway, all the manufacturer needs to demonstrate is that their device is substantially equivalent, is the regulatory term, to another device that's already on the market. Dr. David Kessler, FDA Commissioner, 1990-1997: Dr. Adriane Fugh-Berman, Professor of Pharmacology & Physiology, Georgetown University: This really can cause problems when one medical device is approved on the basis of being substantially equivalent to a previous medical device that was approved because it was substantially equivalent to an earlier medical device than that. Dr. Deborah Cohen, Associate Editor, British Medical Journal: You end up with what we call a daisy chain. And then, quite often what you found is that some of these predicate devices, as they call them... have been recalled from the market because they've been failing. Jeanne Lenzer, Author, The Danger Within Us: I called the FDA and asked them, "How can you clear something based on a predicate device that's already been shown to be dangerous? And they said, "We don't judge what the prior device is." Dr. Rita Redberg, Editor, JAMA Internal Medicine: So even if the device was recalled because it was dangerous, you can still use it as a predicate and get your device cleared 'cause it's substantially equivalent. So there's a lot of problems with that 510(k) system.
Your TurnSo there we are, folks. The current state of the 510(k) pathway. Does it make you feel safe... especially that part about basing your device on a failed predicate?! Yikes! "The Bleeding Edge" documents a number of devices gone terribly, terribly wrong. What say you? Is 510(k) a pathway to close? Markedly reform? Leave alone? I can't wait to read your robust comments – which(!) – you can receive as alerts(!!) – when subsequent members leave their comments.
Access to the first two of four FDA’s Case for Quality webinars.Part 1 covered: • What CfQ is and how FDA is engaging; • Summary detail on CDRH pilot programs; and, • How FDA is rethinking regulations. Part 2 will cover the: • 'Critical To Quality' pilot program; • 'Manufacturing and Product Quality' pilot program; and, • Issues and concerns FDA is hearing from constituents. Guys, it doesn't get much better than this. Cisco Vicenty works at FDA right now as the FDA Case for Quality program manager. And you can ask direct questions during the live event, August 16 at 11:45 New York time. Come if you do QA, RA, Clinical Affairs, R&D, or any kind of medical device engineering. Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru.
Want to meet in person?As leader of our Medical Devices Group, I host a few events annually to meet and help members in person. Here are my upcoming events:
- September 17-18, 2018 for ConX, the 31st operational excellence event hosted by the Institute for Process Excellence, in South Carolina (as keynote speaker).
- October 2, 2018 at RAPS; I'll participate in the MedTech Regulatory Awards (as master of ceremonies).
- October 10-12, 2018 for the 10x Medical Device Conference event, "10x for Engineers," in San Diego (as host).
Fast RoundAnother new feature, I'll close most weeks with short stories, links of interest, sponsored ads, and more. Is there something our community should know about? Contact me and tell me all about it. I'll reply as quickly as I can.
- Your Feedback. I'm acutely interested in your feedback about this email and the new site.If you have the time and inclination, I'd be ever so grateful if you hit "reply" to this email. It will come directly to me.
Thank you for being part of our Medical Devices Group community.Make it a great week. Joe Hage Medical Devices Group Leader P.S. 10x for ENGINEERS is two months away. We have a "Buy Two, Get Three" promotion: Send any two employees at regular price and send the third one, free!
I'm curious to hear what other industry professionals feel about the Netflix documentary "The Bleeding Edge" that recently debuted offering a scathing exposé of our industry. My thoughts: For sure there are companies that have not always held patients' best interests, as illustrated by the alarming number of adverse events reported with the Essure device in the film. That said, we rely on FDA to initiate investigations and recalls as a result of such reporting, and regulatory agencies SHOULD employ what is necessary to keep patients safe. Lastly, the argument that clinical trials are too short is unrealistic. For implants, post-market surveillance is key, and it appears FDA needs to do a better job.
It is extremely important for those involved to review and comment on the text, as this is the last chance for technical modifications to the project - if draft is accepted, technical requirements can no longer be modified until publication.
For each country, the availability of the document (which is copyrighted and not for open circulation) and means to comment depends on how the country deals with mirror groups to ISO TC 210 or ISO TC 210 JWG 1. Usually, there's a national mirror group that deals with the international work. Please inquiry at your National Committee organization.
In Brazil, the document is handled by WG 2 - Risk Management - from EC 26: 150.01 of ABNT CB 26. WG 2 members will receive and review the document.
The WG will also hold an open meeting for those interested to take note of the text and assist in creating the Brazilian comments. This meeting will be scheduled shortly.
Having no references to similar devices, I find it difficult to find the way to be able to license it when it is in the prototype phase.
First, where are other Healthcare Technology industry related discussions occurring in your life? I know some professional organizations may have forums on their websites, or during conferences, but I am asking to make sure I am aware of all resources.
Second, do you have any recommendations for transitioning into this industry? (medical device OEMs, contract medical device engineering firms, medical device consulting firms, etc.)
I have a Biomedical Engineering degree and an MBA, with much of my experience in clinical engineering within hospitals. While I have enjoyed my hospital time and may continue in that direction, I am exploring transitioning from the clinical setting towards industry to expand my experiences. There are many areas that peak my interest such as R&D, Quality, Manufacturing, Testing, Consulting, Auditing, Regulatory, etc., and I may be looking for a technical / hands-on role as an individual contributor. I’m pretty flexible on U.S. locations, and whether the roles are temporary or permanent, etc. (I have thought of performing or managing service for an OEM as a way to get my foot in the door, but I haven’t pursued that yet because it seems pretty close to what I’ve been involved in already.)
Difficulty seems to be convincing people my transferable skills allow me to take on new types of roles, kind of a chicken and egg scenario. I understand it is easiest in hiring to match jobs with candidates who perfectly match the stated position requirements. Have you ever had success in pivoting to new types of roles in this industry? If you have hired employees in this industry, have you been able to effectively source candidates with highly transferrable skills?
Thank you in advance for your insight!
Anyone here have answers for, or maybe just some thoughts on, any of these questions?
FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’
New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the agency is starting to bump up against difficult legal and regulatory...