Innovation Exasperation


In a recent LinkedIn Medical Device Group posting, it was noted that DuVal & Associates, P.A. filed a Citizen Petition and Petition for Stay of Action with the FDA, on behalf of the Minnesota Medical Device Alliance (MMDA). See:

The petition challenges the FDA's practices and interpretations for reviewing 510(k)s and asks the Commissioner to stay the implementation of “Draft Guidance: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” dated December 27, 2011. It seeks reversion to older guidance until FDA addresses:

  • Its practice of “stage-gating” reviews (because it leads to an inevitable FDA request to pursue the de novo path);
  • Its interpretation of “general versus specific intended use,” now applied so narrowly that FDA considers almost every new indication for a 510(k) device to be a new intended use;
  • Its interpretation of clinical utility/benefit as part of the substantial equivalence (SE) criteria (because it essentially allows FDA to determine which devices practitioners should use);
  • Its inappropriate use of statutes and regulatory matters extraneous to the SE decision (e.g., cGMP/Quality Systems, MDR, FD&C Act advertising and promotion, and OSHA regulations or CDC guidance);
  • Its application of risk mitigation and “assurance case” principles to 510(k) clearance criteria;
  • Its interpretation when a device has a new technological characteristic which raises new questions of safety and effectiveness;
  • Its failure in stage-gated reviews to review performance data to determine same intended use / technological characteristics and if new safety and effectiveness questions need to be asked;
  • Its practice of dictating the non-clinical and clinical performance data an applicant must generate (instead of reviewing submitted data at face value for an SE decision); and,
  • Its approach to “whistleblowing,” which can lead to risk-averseness for political, not safety, reasons.


The petition seems on the mark. Medical device companies are under enormous financial pressures with difficult economies both domestically and abroad. Add to this the 2.3% medical device tax on gross revenues and a highly bureaucratic, overbearing (if you agree with this petition) FDA and you can’t help but envision difficult times ahead for our industry. Innovative small and midsize companies are struggling, and the government and the FDA aren’t helping matters by treating innovation as the problem. Many on the device side seem unable or unwilling to challenge the FDA bureaucracy.  Win the battle but lose the war, perhaps? As one CEO recently shared, "Challenging [the FDA] might make me feel better but it won't resolve the problem." A real shame as, according to this petition, the FDA and some of its policies need to be challenged.

I agree with this petition that the United States may fall behind other countries in having access to state-of-the-art medical devices while they still are state-of-the-art. That ship may have already sailed, in fact. I also agree that innovation – something we have always embraced and encouraged as a great nation – is being thwarted rather than supported. Healthcare consumers and innovative device companies are suffering and will continue to do so if changes aren’t made. 

Despite said doom and gloom, some innovative, well-managed companies will blast through the aforementioned roadblocks and become stronger, particularly as competition drops off. But I’m concerned that it's going to be mostly the largest companies that survive, and innovation might not always be their strongest suit. I’m also concerned that, as competition disappears, medical device prices will increase – not good for consumers or our Healthcare System.

There is a symbiotic relationship between healthcare providers, healthcare consumers, device manufacturers, our government and the FDA. Sadly, the later have too much power and our system, as this petition suggests, is out of balance and in need of correction. If you agree, beat the drums!

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I think we are mixing our metaphors

The FDA was created to ensure safety and efficacy of drugs and food.  Medical devices were added in later.  Nowhere in their charter does it talk about making this process enjoyable for commercial entities.  Complaining to the FDA or any regulatory agency that what they are doing will hurt growth, jobs and profits is anathema to those working at the agency.  

Whenever I read an article about the FDA or attend a seminar about their apparent disregard for the impact of their decision on industry I'm reminded of the movie the Fugitive.  Specifically I think of the scene where Richard Kimble (Harrison Ford) is at the end of the outlet pipe over the spillway and he looks back at Sam Gerald (Tommy Lee Jones the Federal Marshall) and says, "But I didn't kill my wife."  And Sam Gerald, with a gun pointed at Kimble says, "I don't care."  As Kimble goes over the edge and down the spillway I think, what a perfect metaphor for the FDA and private industry.  

Addressing FDA rules and proposed rules by demonstrating how these changes will affect industry is like Richard Kimble, after proclaiming his innocence expecting Sam Gerald to do something other than want to apprhend him.  To change the FDA process industry must help them to see how their changes are less efficient for FDA, increase the potential for dangerous devices, drugs and food to slip through and in general how the changes are not meeting their charge to make certain that all items approved are safe and efficacious.  

We as a group continue to make pleadings to an agency that each time we plead for our best interest, says, "We don't care."  I think when translated it should say, "We are not in a position to care."

I tell my clients trying to solve business problems this; describe the problem and then develop a solution you find acceptable that works for your opponent.

Wayne Webster


Proactics Consulting

 Sean, this is probably one

Sean, this is probably one of the most urgent and thorniest issues we'll see in the group this year. Thanks for amplifying for your audience and I look forward to more collaborations.

My best, Joe

Thanks for amplifying!

Sean, this is probably one of the most urgent and thorniest issues we'll see in the group this year. Thanks for amplifying for your audience and I look forward to more collaborations.

My best, Joe