In early December 2011, CDRH director Jeffrey Shuren, MD, while giving a keynote presentation at the LifeScience Alley Conference in Minneapolis titled "Regulatory Science—Reducing the Cost and Time to Market Through Scientific Innovations." Bill Betten, senior technical advisor of UBM TechInsights shares his notes from the presentation here:
- In addition to acknowledging Minnesota’s long history of medical device development and large number of medical companies located in the state, one of Shuren’s purposes in attending the conference was to announce that a Memo of Understanding (MOU) had been signed between CDRH and Life Science Alley. The MOU formalizes interactions that had been occurring between LifeScience Alley and CDRH for more than a year regarding the advancement of regulatory science. The MOU recognizes that CDRH and LifeScience Alley, which represents the industrial and academic medical technology community sectors, have shared interests in further developing regulatory science for medical devices and in enhancing the understanding of the safety, effectiveness, quality, and performance of medical devices. It also forms the basis for the development of scientific and intellectual collaborations, outreach, and educational initiatives among the FDA, LifeScience Alley, the University of Minnesota, the medical device community and eventually other partners across the country.
- This MOU was focused around regulatory science. An interesting definition of it was provided and provides a stark contrast to the criticism that the FDA has been under. The definition said that regulatory science provides the tools, standards, and approaches needed to evaluate the safety, effectiveness, performance, and quality of medical products. It was also suggested that this benefits patients by speeding the rate of important technologies reaching market and reducing time and resources needed for device development, assessment, and review. The definition is hard to argue with. However, the impact of the FDA on these issues was the subject of much of the rest of the talk.
- Much of Shuren’s presentation related to the issues related to the FDA’s pace of regulatory approvals, a topic about which much has been written recently so I won’t dwell on it at this time. However, as a former VP of Engineering for a medical device company, I can say that even relatively routine 30-day submissions were frustrating, often with questions coming back from the FDA examiner on day 29. In addition, training and knowledge of the examiners with regard to the subjects they were being asked to review were often an issue as many of the questions were not representative of someone with a knowledge of the particular space. Shuren has been on the defensive on these issues for some time.
- Shuren did discuss relative funding issues, contrasting spending on basic R&D by the government and industry with that on basic regulatory and engineering issues. He pointed out that, from 1990–2008, federal spending for applied R&D had dropped from about 40% to 20% of the total, with industry basically filling in by growing to almost 80% of the total during that time. He also commented that the U.S. government contribution to R&D had stayed relatively flat as a percentage of economic output while a number of countries (notably Japan, South Korea, and China) are increasing theirs. However, percentages can be deceiving as the U.S. economic output is larger than those countries so total overall spend is more. Finally, from a financial investment perspective, he pointed out that in fiscal year 2011 NIH invested $30 billion in research, while the FDA investment in regulatory science was $15 million, accentuating a previous call made for additional resources to address some of the issues associated with device reviews and approvals.
- Shuren did have recommendations for addressing some of the concerns, most of which tie back to the MOU. These included establishing a public-private partnership between industry, the FDA, and academia; working on projects where there is shared interest; implementing a governance structure; sharing human and financial resources; and validating tools, standards, approaches developed. There was substantial focus on the issues associated with the last point on validation and development of tools, with a suggestion that by standardizing and defining approaches to product development and testing, that perhaps time to market could be accelerated. There was also some brief suggestion of perhaps a set of tests that could be passed (perhaps a certification?) that could be used as a basis for decision making by the FDA.
General Reaction to the Presentation
I first met Shuren a couple of years ago at an FDA-sponsored meeting on device interoperability shortly after he was appointed to the Director’s role. He seemed to say all of the right things. However, it has now been a couple of years since then and the FDA is under even more fire from industry with regard to product approvals. Perhaps it is a case of good vision with poor operational execution, which plays to the resource issue. However, many device companies have been vocal about these issues and we are now seeing products introduced overseas well before the United States, in some cases years before introduction here. While product safety is indeed important, it is clear that the system today is not working well. When a product development team worries more about the two R’s (regulatory and reimbursement) than the technical issues, it isn’t a healthy product development environment and threatens our competitiveness. Perhaps Shuren’s call for greater engagement with industry will work. At the very least it may be an attempt to quiet the FDA’s harshest critics by engaging them as part of the solution. Only time will tell, but it can’t be allowed to get worse if U.S. medical device companies expect to continue to be world leaders. Finally, one challenge that I will watch with interest, particularly with regard to presentation from Leslie Saxon, MD earlier [during the conference] on mobile devices and health care, will be how the FDA addresses the rapid proliferation of mobile devices and the convergence between consumer and medical. This was not explicitly addressed during his talk nor during the Q&A.