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Question
4 days ago
Joe Hage
ᴍᴇᴅɪᴄᴀʟ ᴅᴇᴠɪᴄᴇ ᴍᴀʀᴋᴇᴛɪɴɢ ᴇxᴘᴇʀᴛ 🍨 🅼edical 🅳evices 🅶roup Leader
Did you know the market for precision medicine is projected to more than triple by 2026? I'm not surprised by the growth rate given everything we're reading about personalized medicine. So I got to thinking: How would you regulate something like that? Taken to extremes, if every device were customized to every single patient, how could the clearance for use be comprehensive enough? How will you position yourself to ride this wave? This piece is a good thought starter: "Companion Diagnostics, Biomarkers, and Novel Innovations for Oncology and Beyond." You know this isn't my personal area of expertise so you may want to download it. I pulled some of these lines for you:
  • 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.
For more information, download the paper, a courtesy of our friends at ICON, plc.

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 questions

If 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 world

As 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)::

Image

I look forward to your participation!

Thank you for being part of our Medical Devices Group community.

Make it a great week.

Joe Hage signature

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! 😊

2 weeks ago
Joe Hage
ᴍᴇᴅɪᴄᴀʟ ᴅᴇᴠɪᴄᴇ ᴍᴀʀᴋᴇᴛɪɴɢ ᴇxᴘᴇʀᴛ 🍨 🅼edical 🅳evices 🅶roup Leader
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't support. Oh! What will follow: Bolding! Color! Images! Video! Hyperlinks! I should have done this a long time ago – and if you haven't registered for this specific site yet, please take a moment and do so now, so I can continue to communicate Medical Devices Group messages to you. (Your LinkedIn group membership does not automatically extend to this WordPress-based website.)

Kessler's Regret

I 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: That 510(k) pathway provision, which was meant as an exception, in essence, a little loophole... That exception became the rule. So the vast majority of devices today, regrettably, are regulated under this framework. 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 Turn

So 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 10-12, 2018 for the 10x Medical Device Conference event, "10x for Engineers," in San Diego (as host).

Fast Round

Another 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 signature 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!

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