There are rumours of potential changes to the FDA approval process particularly geared at devices processed through the 510(k) pathway. Will these changes affect reimbursement strategies?
If so, how?
A company is interested in getting a private label agreement with an OEM to sell a Class II medical device in the USA. The OEM has 510(k) clearance and the only product change will be the company's name on the label. There will be no change for the indications for use.
- What is the process to get this private label for the class II device?
- What is the impact on UDI? Will the company need a different UDI?
Many thanks for your help,
Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.
Recently, I have come across a manufacturer of IIa MD who claims that they launch their products without prior NB approval provided that the given MD is within the scope of the Full Quality Assurance certificate already issued, i.e., if the certificate was issued, let’s say, for catheters and they have developed a new catheter model, they can CE-mark the product and freely market it.
Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity, and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls, and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.
I went through the MDD several times and it seems that it depends on the interpretation of your NB. Do you agree?
Thanks in advance for the discussion.
Hello everyone, what are the requirements for selling first aid kits in USA?
The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.
What needs to be done to get clearance of the first aid kits?
Thank you in advance for your help!
Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download.
Four slides that stood out to me
It was hard to narrow down the four hours from four presentations to four slides. But here goes, from me to you. 😊
Above: FDA Case for Quality Program Manager Francisco Vicenty explained why they're leading the Initiative, saying, "We are in this together: The Agency, the medical device manufacturers, the providers, the hospitals [to] drive the best public health outcomes... We need to change from a compliance mindset to a drive on quality."
The slide shows the present economic impact of today's FDA processes. "People stopped submitting ideas or change activity."
Above: This is a slide Francisco "stole" from Boston Scientific, how they see the difference between an FDA inspection and the new approach, using Capability Maturity Model Integration (CMMI).
Above: A medical device manufacturer proposed this slide. Francisco found it "exceedingly helpful," giving FDA areas where the manufacturer felt their metrics aligned with the Case for Quality Initiative: How they monitor the safety, effectiveness, reliability, and availability of their product.
Above: The main obstacle for medical device manufacturers to justify technology investments? The computer system validation effort: The regulatory and compliance risk associated with implementing that system. Sometimes the cost was 1.5 to 2 times the base system cost, a "huge eye-opening moment for the FDA."
Download the slides, listen to the recordings.
I'll close this section as I began it. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download.
And thanks to Greenlight Guru, the only Quality Management Software designed speciﬁcally for the medical device industry, for sponsoring the presentations.
An easier way to use FDA's databases
I'm hosting a webinar next week on how to dramatically simplify extracting data out of FDA databases. You can click the yellow button below to join me.
This is interesting. So, among 64 people who took the survey, this is what they said about their FDA data use. I wonder how you compare.
I hope you'll join us for the live event on December 11 at 2 p.m. Eastern Daylight Time. Click here to register: The slides and replay will be available to all who register.
Leave a penny, take a penny
I had a live chat with Maggie Holland from Sweden this morning. She was following up on her question about transitioning to MDR.
I told her I'd raise it here today, then asked her for a favor. I realize now it's a favor I should ask of every reader.
Please tell your friends about the site and get them registered and involved. This only works if the whole medical device ecosystem comes together and participates in the resource. I don't know the answers all by myself!
It's like the old "leave-a-penny, take-a-penny" containers you'd see at checkouts.
I can now see how many subscribers take pennies. I'm hoping you'll give some pennies back, in the form of expanding our community (for example, share this email with your department), or contributing questions and answers to our community page.
Plus, it makes a lovely holiday gift 🎄 for Joe Hage!
So thank you in advance.
Inquiring Minds Want to Know!
• Maggie's question about transitioning to MDR and avoiding clinical equivalence.
• Whitney's question about investigational use labels.
• Lena's question about the impact of Netflix on our industry.
• Robyn's fears about the CRISPR twins!
Thank you for being part of our Medical Devices Group community!
If you're looking for work, check out the newly posted jobs here!
Make it a great week.
Medical Devices Group Leader
P.S. I'm excited about our upcoming 10x keynote presentation. Former Proove Biosciences CEO Brian Meshkin will answer the question he gets so often, "What the F**k Happened at Proove Biosciences?!* I really hope you'll come! See the agenda in progress!
I know a guy who got a $500,000 grant to make FDA data easier to search. As it neared completion, it was scuttled by two employees whose jobs would be jeopardized.
So the answer to "which is the most frustrating FDA database" is probably:
"whichever one you're using today."
I think I found a solution and I'm inviting you along to discover it with me.
If my understanding of the product is right, compiling and analyzing FDA data will be so much easier.
Navigator from Reed Tech
I signed up for a product demo and set it up so you could join me on the call. Please join me for the live demonstration.
It will be on December 11 at 2 p.m. Eastern Daylight Time, recorded for later viewing.
Navigator saves search time and effort
Again, as I understand it, Reed Tech built a platform to make using FDA data much easier. They pull in data from:
They also use data from the GUDID and device listings databases behind the scenes.
What's the big deal?
If you routinely access FDA databases, you know it’s a hassle searching multiple sites and matching the data up get a holistic view of the issue.
Navigator lets you look up by product to get everything you need: Adverse events, recalls, approvals and clearance information associated with that product. You can also compare to the industry for all those data points.
If you don't use FDA databases, here's how that data can help you:
- Risk management. See if there are recalls for your or your competitors products. If a competitor's product failed, your product might also, depending how similar they are. So you need to plan for that. Or if you're in the design stage, you might invent a way to avoid that failure.
You can also set up alerts and get notified by email for adverse events, new recalls, and new device problems.
Post-market surveillance. Similar to risk management but focuses more on your product (versus competitors'). See industry trends.
Regulatory intelligence. Search directly for 510(k)s. You can search by intended use and indications for use. That's helpful for predicate searching. You can discover successors to predicates as well.
FDA data is more than regulatory and quality
Other uses for FDA data:
Legal and Insurance. For product liability and product lawsuit research. Is this a product they want to insure?
Medical device investors. For due diligence. Anything lurking there in product quality? Industry trends?
Healthcare providers. For due diligence. Anything you should know before you approve that capital investment? Are you sure the product has been cleared by FDA? Are there any active recalls in that category? Any usability issues?
That registration link again
If you'd like an easy way to use FDA data, click here to join our call.
Special thanks to Rachel Benway for the education.I'm looking forward to the demo and I believe Reed Tech will be at the 10x Medical Device Conference in May.
Three FDA Safety Stories
Updates to Medical Device Safety Action Plan to enhance post-market safety. Click for the Nov 20 press release. Of note, new funding for the National Evaluation System for Health Technology (NEST), and an emphasis on women's health.
From the release, "In particular, we’re focusing on addressing clinical questions on device therapies that are unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception."
Breast Implant Cancer Risk. As reported by NBC Nightly News, "A cancer of the immune system linked to breast implants called a ALCL, was only first identified by the FDA in 2011, who now new fears it's an emerging risk."
Steps to Modernize the 510(k) Program for Safety and Effectiveness. Click for the Nov 26 press release. Of note, FDA believes manufacturers will gravitate toward de novo applications.
From the release, "To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market.
However, we believe encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device.
It would promote greater competition to adopt modern features that improve safety and performance, and help make sure newer devices reflect more modern technology and standards that can improve patient care and outcomes."
In Other News: Crispr Babies!
After regular IVF (after sperm inseminated eggs), an embryologist sent in CRISPR/Cas9 protein and instructions to perform a gene surgery intended to protect the girls from future HIV infection.
As I understand it, it's the first reported case of gene surgery in embryos intended for pregnancy.
Thank you for being part of our Medical Devices Group community!
If you're looking for work, check out the newly posted jobs here!
Make it a great week.
Medical Devices Group Leader
P.S. I probably spent more time on this post (eight hours?) than any in my seven-year history with the Group. If you appreciate it, email me or – better yet – spread the word! Tell colleagues to join our community. Invite them to the December 11 webinar, perhaps!
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.
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
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
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?
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?
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!
Question for discussin: There is no doubt that the manufacturer has breached the local act and should be punished for that. But what about validity of the clinical evidence?
a) Do you think that the original clinical data (assuming that scientifically and ethically correct) is not valid?
b) Do you think that other clinical data obtained during PMCF is also not valid?
c) Is there any precedent in EU, how competent authorities are solving such issues?
Thanks for your ideas. I believe that someone may have experience with such manufacturer`s fault to share for interesting discussion within the group :-)
COMPANY ON $4B SPENDING SPREE
Every business morning, Medical Device Daily provides a balanced daily report on med-tech to executives, analysts, investors and legal professionals. Medical Device Daily covers companies, deals, court reports, financings, conferences, and more.
Chinese FDA to Update the Medical Device Classification Catalogue
Late last month, the CFDA released a draft document updating their Classification Catalogue for medical devices. The currently used classification catalogue for medical device was published in 2002 and in the time since its issue, the CFDA has...
On August 1, the FDA released the new MDUFMA fees for FY 2017–which begins October 1, 2016. Any companies that have not already filed an application for FY 2016 will now be applying for FY 2017 small business status instead. The criterion for qualification is annual gross income of less than $100 million. This income threshold includes any subsidiaries in the US or abroad. If you have subsidiaries, you have to submit tax returns for each subsidiary. If you don’t subsidiaries, you only need to submit one of the following documents for your business:
Form 1040, Schedule C
Form 1040, Schedule C-EZ
Form 990 (for non-profits)
You only have to submit the most recent tax return. Therefore, your 2015 tax return should be your most recent tax return on October 1, 2016 (in 12 days). If you have a copy of your 2015 tax return, then you can fill out the application form and submit the tax return and the application form to the FDA for review and approval. This process takes 60 days, and many clients wait until they are just weeks away from a submission to apply.
If you think you might submit a 510(k) before October 1, 2016--submit your application on October 1. By December 1, 2016 you will receive your small business qualification identification number. This is all you need to take advantage of the fee reduction and save $2,345 on your next submission.
The form, and all the requirements for this application, are included in the free FDA guidance document:
If you just don’t understand the guidance document, or you don’t have time to read all 36 pages, you can also purchase my webinar on the topic. It’s only $29 and it’s only 18 minutes long. In just 18 minutes you will know exactly what documents you need, what steps to follow, what forms to fill out and where to send your application. Every single question I have ever been asked about the process is answered in the 36 pages, but you could listen to my webinar on your cell phone while you drive your car home this evening--instead of reading the 36 pages. Just download it to your mobile device and play it.
If you have suggestions for a new blog, webinar or weekly announcement, please visit my suggestion box:
I’m always looking for new ideas.
Brexit and the CE Mark - implications for European regulation of medical devices
The questions are coming thick and fast about the implications of the UK’s decision to exit the European Union for the CE marking of medical devices a
Premarket submissions are not posted to FDA’s website until the review is complete, so the information provided here reflects only those De novo requests that were submitted after the draft guidance was published and had been granted as of last Friday.
Industry has made moderate use of the new De novo classification path in the two years since the draft guidance was published. It appears that some 40 De novo classification requests were submitted post-guidance. Of these, 25 had been granted by August 14, 2016. The Reclassification Orders and Decision Summaries have been posted for most, but not all, of these 25 De novo classifications.
The class of one recently classified cardiovascular device has not yet been posted. Of the other 24 classified devices, FDA determined that all but one was Class II; the remaining device was determined to be Class I.
The sample size is still too small and variability too high to draw any firm conclusions about "typical” timeframes and data requirements for De novo requests. For the 25 De novo requests that were submitted and granted in the two years after the guidance was finalized, the time between submission and reclassification ranged from 40 to 587 days, with an average of 282 days. By comparison, the average timeframe from receipt to decision for an approximately matched set of 39 510(k)s and for the 74 original PMAs approved during the same time period was 150 and 465 days, respectively.
I’m now working on a summary of the clinical data that were included in these requests and will post it soon….
This video provides definitive evidence that it works for Alzheimer's and TBI: https://youtu.be/46oBjzW5OJM
Adding neurofeedback will rapidly help improve some degree of cognition from the Alzheimer's patient, but on its own will not stop degeneration.
The combination is the optimal therapy, a company called Lumineu (www.lumineu.com) has a home or in-clinic combination device and has acquired pending patents that cover these combinations. They are seeking investors.
I am a co-inventor of the patents they acquired, which we had help from the former Chief Patent Counsel of Medtronic, and the former patent attorney for J&J medical devices, helping us prosecute. I am helping Lumineu get the word out and generate funding.
The former head of neuroscience for DOD, who led over $800 million in R&D into traumatic brain injury (TBI), which studies show benefits from the identical therapy, is Lumineu's CEO.
The company is seeking impact investors who wish to disrupt the industry with a new paradigm that can be minimally invasive, or non-invasive. Non-invasive is dramatically less expensive to get through FDA approvals, and with the new PET Scan markers for early Alzheimer's detection, have a huge market potential.
Infrared penetrates transcranially, and effectively, in spite of folklore to the contrary. See the video evidence and the published literature.
Evidence in clinical trials shows that mesenchymal stem cells can be generated with light therapy and are regrowing cardiac tissue, in situ, in human clinical trials. We are collaborating with the core patent holders, to bring a new paradigm to the clinic, better than the biggest companies in outcomes and without morbidity, if done non-invasively.
This has the potential to be the next revolution in medicine.
As an example, just over 1 million pacemakers are implanted annually, generating well over $10 billion in high margin sales, and over a $100 billion market cap.
40 million patients have Alzheimer's, and 20 million more TBI and other forms of dementia. Our automated home therapy device can drop the cost of treatment for 1 million patients from $50 billion to $10 billion, per year.
But, like hand washing after the discovery of the germ, it may take a long time to adaptation and use. The money is in minimally invasive, and we have that, as well.
The purpose of this post is to get the word out on one of the most tragic failures of the healthcare system to care about patient health.
Revenue and profits should have some semblance to effectiveness and quality, including patient health and lifestyle. Until they do, the industry will not live up to its potential, and millions will continue to die, needlessly.
This footnote is not appreciated or spoken in the device, community.
It should be a topic of discussion. Backing Lumineu and others like it, including Vielight, Thor Laser, Lite-Cure, and others who sell the devices (in the 800 to 830 nanometer range), but cannot claim their utility, because they cannot raise the cash to pursue the Alzheimer's proven solution, are a sign of what is wrong with the healthcare system.
I post this so those with a concern for the devastation of Alzheimer's can help us get the evidence needed to get FDA approval and make the solution available. All that is needed is capital to run the trials.
Mike Weiner - 239-603-6446 - firstname.lastname@example.org
my bio: www.lifeboat.com/ex/bios.michael.l.weiner
SCIENTISTS SHOW A WORKING SOLUTION FOR ALZHEIMER'S AND TBI IN VIDEO
This video provides definitive evidence that it works. https://youtu.be/46oBjzW5OJM This video link above, by Lew Lim, Ph.D., working with the leading
Transparency under the new MDR and IVDR
Presentation about transparency under the new MDR and IVDR at Informa Medtech Summit in Clinical evaluations and investigations for medical devices track
FDA Biocompatibility – New Risk Based Guidance on ISO 10993
The long awaited refresh of US FDA’s biocompatibility guidance has finally arrived. This is a quantum leap from the old G95-1 Blue Book Memo. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects...
And if some wording is necessary, what is appropriate? Is a simple “Dispose of properly” sufficient if the product is intended only for use by medical professionals?
I am having a really hard time getting the "leadership" and engineers to come on board with doing things in a structured manner.
I have discussed, made presentations, given examples, people agree, but when it comes to first steps towards ISO 13485 and ISo 14971 compliance, they are not responsive.
I have simplified the set up, given out easy to fill questionnaires, but even the leadership is lackadaisical about it.
What I believe is their perception: they have never taken a product to market. And like most fresh out of college bachelor degree graduates feel they know everything. And the general perception is: since we do not need FDA clearance, we do not really need to pay attention to detail or have an organized approach.
I really want the company to succeed. I want to help, but I need help on how to motivate them, or even scare them in to following procedure.
Your advise would be helpful. Maybe some examples about what happens to companies with similar products, when there is a failure and a fatality, or government ordered re-call, etc would help these guys understand this is not a college project. Parents are going to use their product with some level of trust and expectations!