Weighing Market Needs Against Regulatory Risks


ID-10059010Working in collaboration with my esteemed partner Joe Kalinowski of Trilogy Associates, I recently had the opportunity to organize and moderate a series of key opinion leader panels to assess the clinical viability of a promising IVD product concept. Our client had hinged their commercialization strategy to a 510k regulatory pathway. To the contrary, the physician experts who signed on to advise them arrived eager for the promise of breakthrough innovation in a clinical application for which current technology is seen as woefully lacking. The panelists pushed for more ambitious claims and cautioned against coming to market with a new and improved “me too” that simply replicates the status quo without providing any real clinical validation. This was clearly not the message our client wanted to hear.

The PMA pathway was deemed unattractive for myriad reasons (time commitment and expense topping the list) and the necessity to go down that road threatened to derail the entire initiative. In effect, the chosen regulatory path had become so deeply embedded in product design and development that to change course dictated a fundamental revision of what the product is and does and would basically send the scientific team back to the drawing board. My conclusion? Regulatory decisions matter – a lot! Read on for some basics on PMA versus 510k pathways, as well as a peak at (and a link-to, of course) a landmark study examining the impact of the current FDA climate on medtech innovation.

Regulatory Strategy 101

Perhaps you’ve been there too. Medical device companies strive to streamline and reduce risk, while physicians demand breakthrough technology with evidence to back it up. Although PMA approval confers significant market advantage in terms of competitive positioning, managing the enormous time commitment, expense and uncertainty of a PMA submission is a burden many companies simply cannot afford to bear.

In a recent conversation with Ellen O’Malley, an associate consultant who specializes in clinical study documentation and has experience navigating the FDA submission process, I asked whether she could provide any insight on how to calibrate market needs against regulatory risks. “There is a regulatory risk/benefit assessment that needs to be done with each product,” says O’Malley, “and I don’t always see that being done to the level that I think would benefit the companies in the long-term. Many companies are hesitant to push back with the FDA. But as trials get more expensive and more complex, companies will need to be creative in finding a least burdensome approach that will also ensure product safety.”

Establishing that “least burdensome approach” remains a significant challenge. What’s critical, in my view, is that everyone within an organization, from engineering to marketing and sales, understand comprehensively the implications of the designated pathway. In a video interview, First Steps in the Regulatory Process, for BioDesign’s Regulatory Video Briefs series, Su-Mien Chong, a regulatory consultant, stresses the need to consider multiple regulatory scenarios early on and even recommends applying this pathway assessment as a filter for concept generation. This brief interview (less than 12 minutes in duration) provides a comprehensive overview of issues that need to be considered at the outset of product development, touching on a range of topics including multiple predicates, de novo 510k, substantial equivalence and marketing of products based on multiple submissions.

Another useful installation in the BioDesign Regulatory Video Briefs series is Howard Holstein’s detailed summary of the advantages and disadvantages of 510k versus PMA. Holstein, former deputy chief counsel at FDA and now an independent medical device attorney, advocates a stepwise approach, starting with a basic application and subsequently building on that by seeking additional clearance or approval.

Unpredictable, inefficient and expensive . . .

To state the obvious, the appropriate role of regulation for medical products (or anything for that matter) is a subject of much debate. On-going scrutiny of this role both within the FDA and within the medtech community at large attests to the fact that many believe the current US regulatory climate is unsustainable. In a landmark study published in November of 2010, BioDesign Institute co-founder Josh Makower and colleagues set out to objectively measure whether FDA is fulfilling its mandate of “promoting the public health through new innovations.” The study surveyed more than 200 medical device companies and inquired about experiences working with both FDA and EU regulatory authorities. Key metrics include time from first communication to approval/clearance, and average costs associated with submission. Much of the analysis draws on contrasts between the US and EU experiences. As one might guess, the FDA did not compare favorably. The authors conclude, “Unpredictable, inefficient and expensive regulatory processes are jeopardizing America’s leadership position in medtech innovation.” I’d love to know whether you agree!