Sean Reilly, ITN Publisher
Sean Reilly, ITN Publisher

Sean Reilly is healthcare brands group publisher (Imaging Technology News and Diagnostic and Interventional Cardiology) at Scranton Gillette Communications.
 

Blog | Sean Reilly, ITN Publisher | January 09, 2013

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: http://medgroup.biz/FDA-petition

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the FDA's practices and interpretations for reviewing 510(k)s and asks the Commissioner to stay the implementation of “Draft Guidance: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” dated December 27, 2011.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!

Related Content

Sponsored Content | Videos | Enterprise Imaging | February 20, 2019
At RSNA 2018, Philips Healthcare introduced Performance Bridge as an integral part of its IntelliSpace Enterprise Edi
Amazon Comprehend Medical Brings Medical Language Processing to Healthcare
News | Artificial Intelligence | February 15, 2019
Amazon recently announced Amazon Comprehend Medical, a new HIPAA-eligible machine learning service that allows...
Fujifilm Exhibits Enterprise Imaging Solutions and Artificial Intelligence Initiative at HIMSS 2019
News | Enterprise Imaging | February 15, 2019
Fujifilm Medical Systems U.S.A. Inc. and Fujifilm SonoSite Inc. showcased their enterprise imaging and informatics...
IBM Watson Health Announces New AI Collaborations With Leading Medical Centers
News | Artificial Intelligence | February 14, 2019
IBM Watson Health announced plans to make a 10-year, $50 million investment in research collaborations with two...
Medivis Launches SurgicalAR Augmented Reality Platform
Technology | Advanced Visualization | February 14, 2019
Medical imaging and visualization company Medivis officially unveiled SurgicalAR, its augmented reality (AR) technology...
Office of the National Coordinator Releases Proposed Rule on Healthcare Data Interoperability
News | Information Technology | February 14, 2019
The U.S. Department of Health and Human Services (HHS) has proposed a new rule to support seamless and secure access,...
Siemens Healthineers Demonstrates Artificial Intelligence, Healthcare Digitalization at HIMSS19
News | Artificial Intelligence | February 13, 2019
February 13, 2019 — At the 2019 Healthcare Information and Management Systems Society (HIMSS) global conference and e
PaxeraHealth Launching Universal Image Sharing Platform at ECR 2019
News | PACS Accessories | February 13, 2019
PaxeraHealth will launch the PaxeraShare image sharing platform at the 2019 European Congress of Radiology (ECR) annual...
NVIDIA Explores Role of AI, Analytics and Virtualization in Healthcare at HIMSS19
News | Artificial Intelligence | February 13, 2019
Digital technology company NVIDIA will highlight its newest partnerships to advance the digital transformation of...
Patients and surgeons at Hoag Memorial Hospital are looking at virtual reality reconstructions (right) over conventional 2D images

Slice v 3D: Patients and surgeons at Hoag Memorial Hospital are looking at virtual reality reconstructions (right) over conventional 2D images. Images courtesy of Hoag Memorial Hospital

Feature | Information Technology | February 13, 2019 | By Greg Freiherr
The same virtual reality (VR) reconstructions that surgeons use to plan and rehearse brain surgeries at Hoag Memorial