Regarding attendance at the FDA meeting back on February 18,  Zuckerman made the erroneous claim, “I think it was all industry, one patient and me, and on the discussion panel it was industry plus FDA people and me.”  Looking at the record of speakers, it is clear that the group ranged from physicians, to university professors, private citizens, consultants, and yes…the “industry”.  The other point to make clear is that this was a public meeting, with no limits on who could attend or register as a speaker.  This was not a case of the odds being in favor of the medical device industry.  Quite the contrary, the meeting finally gave companies a small opportunity to answer their critics in the media and public sector that want to depict the 510(k) as a “fast track” process.  

As discussed in the meeting, anyone who has filed a 510(k) application knows that it is accompanied by rigorous testing to show safety and efficacy.  This was brought up by industry representatives and confirmed Dr. Donna-Bea Tillman, director of the FDA’s office of device evaluation who said, “It doesn’t mean FDA just sort of rubber stamps the 510(k).  In order to demonstrate that [substantial equivalence] we require the submission of testing… a lot of it.”  These companies document their testing in literally hundreds (sometimes thousands) of pages within their 510(k) applications.     

Ms. Zuckerman also said she felt that public health concerns were not even addressed at the meeting.  In another hyperbole stated by Ms. Zuckerman during the interview she stated, “I did not see one word expressed in terms of concern about public health, not one word,”  The truth from reviewing the archives and transcripts, is that statements of concern for the patient were brought up over 50 separate times by at least 10 speakers in addition to Zuckerman.  The reality is that medical device makers are in business of improving the health and well-being of their patients.  They invest hundreds of millions of dollars into research and development to provide the latest technology to improve patient care.  This does not mean that problems do not arise, and device makers employ entire departments to work on improving design controls, production QC, and supplier quality management.

If you missed it, you can watch the meeting again for yourself, and feel free to comment on your take.  While I do share her concerns for the patients on these devices, there is little if any basis for Dr. Zuckerman’s allegations about the industry’s attitudes.  The 510(k) process will need to be addressed, but is not a catch-all or “magic pill” solution, nor was it ever intended to be this.  I think that Medtronic CRO Susan Alpert put it best during the meeting in suggesting, “I think we need to be careful as we think through how we’re going to change the program that we change it in ways that don’t get rid of the good things about the program, but allow the program to evolve.”