From The Editor | January 16, 2018

Get Involved In The FDA Process…Or Else!


By Bob Marshall, Chief Editor, Med Device Online

Get Involved In The FDA Process…Or Else!

As a child and student, I was mostly an academic. I got report cards with lots of “A’s” on them, but they didn’t hand out trophies for that. I did earn two small trophies for being on the first place team in kickball tournaments (it would have been way cooler if that was dodgeball instead). I did win a “Louie” as the guitar-player in the high school jazz band. I still have the little trophy for my Louis Armstrong Jazz Award and every time I lay eyes upon it – I think to myself, what a wonderful world!

But, for every other unsuccessful endeavor I participated in, there was no trophy; I was a loser, and I’m okay with that. Losing as a kid didn’t break me. On the contrary, it motivated me to learn from my mistakes, to try harder to win, or to accept that I will not be good at certain things, and move on.

If I extrapolate the current paradigm to the medical device industry, one might expect that FDA will soon be awarding participation trophies to medical device companies alongside their not-substantially-equivalent (NSE) letters: “We can’t clear your device because it’s not safe or effective for people to use, but hey – you really tried hard.”

In other recent, crazy news, some schools want to ban best friends in an attempt to protect students’ feelings, driven by concern that certain students will feel left out. What?!! Will schools start expelling students for having a BFF? Maybe every time you “like” something on social media (e.g., one of my articles, posted on my Linkedin page), every other similar piece of content gets a computer-generated “like” so that other writers don’t feel left out. This makes me think the FDA might soon have to stop the preSub (or Q-Sub) process, because it involves an exclusive meeting with only one medical device company. Won’t the others feel left out? Instead, the agency might have to create a new process called “GroupSubs” (or G-Subs), so the entire industry could dial in or log in for the discussion. These sessions will end in e-group-hugs.

Finally, much attention has been paid to leadership in recent years. Lots of books have become “classics,” including Good To Great, by Jim Collins, The 7 Habits Of Highly Effective People, by Stephen R. Covey, Developing The Leader Within You, by John C. Maxwell, and The One Minute Manager, by Ken Blanchard and Spencer Johnson — to mention just a few. I have studied leadership extensively, especially servant leadership, but I wonder how long it will be until a counter-movement is started by someone who thinks that no one should be called a leader, because that might make others feel like followers. As chief editor of Med Device Online (a part of Life Science Connect), I even suspect that we could be asked to change the name of our flagship magazine – Life Science Leader – into something more inclusive, like Life Science Followers and Leaders.

Okay, I know what you’re thinking: why the silly rant, Marshall? Well, quite honestly, I wished to make a point: stand up and get involved in what you believe in! Within the medical device industry, there are a couple of great opportunities to do just that right now. If you sit back and let others take the lead and shape the future, you will have no one else but yourself to blame. You’ll have no recourse if future regulatory changes don’t go the way you might want them to. Dare I say it? You need to PARTICIPATE! [Editor’s note: no participation trophies will be awarded].

Premarket Approval (PMA) Critical-To-Quality Pilot Program

The FDA Center for Devices and Radiological Health (CDRH) has initiated a program aimed at streamlining the PMA while still assuring safety and effectiveness of approved devices. In this pilot program, third-party teams certified by the Capability Maturity Model Integration (CMMI) Institute will conduct quality system maturity appraisals using a maturity appraisal model developed by CMMI. The goal of these appraisals is to drive continuous improvement and organizational excellence among participating medical device manufacturing sites. The pilot program is open to nine participants, but the FDA will look for ways to engage in discussions with firms that request participation, but are not officially selected.

Through this program, the FDA intends to forego conducting surveillance and preapproval inspections for participating manufacturing sites, reducing the burden and disruption such inspections may cause, and allowing participants to shift resources to innovation and improvement efforts.

The pilot program runs from Jan. 2, 2018, to Dec. 28, 2018. Interested manufacturers can refer to the official notice in the Federal Register to find more information, including participation criteria and instructions for requesting to participate.

Digital Health Software Precertification (Pre-Cert) Program

The FDA has embraced digital health technology’s capacity to empower consumers to make better-informed decisions about their health. Accordingly, the FDA is evaluating its oversight of digital health technology with the goal of providing patients with timely access to high-quality, safe, and effective digital health products.

One important piece of this plan is a new pilot program for software developers, the Software Precertification (Pre-Cert) Pilot Program. With this pilot, FDA is acknowledging that its traditional approach to moderate- and higher-risk, hardware-based medical devices is not well-suited to the faster and iterative design, development, and validation used for software products.

The FDA selected nine companies for the Software Precertification (Pre-Cert) pilot program, representing the breadth of the digital health community and its range of products: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

The FDA will continue to engage all stakeholders through its website, public meetings, and the public docket created specifically for this pilot. Stakeholders are encouraged to provide input by posting comments to the docket.

If You Are Not Part Of The Solution, You Are Part Of The Precipitate – Scott Trahan

As controversial Civil Rights figure Eldridge Cleaver is credited with saying, “You either have to be part of the solution, or you are going to be part of the problem.” I sincerely encourage all medical device companies and professionals to get involved in the FDA process. The future of healthcare and the quality of life for those who need our devices depends on you!

— Bob Marshall – loser, BFF, servant leader