Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) recently had some alarming words of warning for medical device manufacturers operating in the United States. According to Dr. Shuren, a number of different factors have come together to place unprecedented pressure and strain on the medical device industry, with no clear indicators as to when the situation might improve.
Using the dramatic phrase “perfect storm” to sum up the issues currently facing medical device companies and regulators, Dr. Shuren outlined a number of different market problems which have no easy answers. First and foremost amongst the Director’s concerns was the effect that the global recession, which has hit particularly hard in the United States and parts of Europe, has had on medial device industry investment. In particular, early-stage research has taken a hit in terms of attracting dollars, which in turn delays innovation and development across the board.
The remainder of Dr. Shuren’s comments, which were made at the Food and Drug Law Institute’s annual meeting this spring, addressed regulatory problems that are coming to a head at the CDRH. Some of these issues are procedural, such as the common sentiment in the medical device industry that CDRH reviews have become unpredictable in nature, making it more costly and time-consuming for manufacturers to bring products to market. Obstructionist institutional review board policies that send clinical trials outside of American borders, as well as the conclusion by many medical device companies that current regulatory practices are incapable of properly evaluating advanced technological products have also played a large role in the deterioration of the CDRH’s ability to keep pace with the realities of the industry.
The Center has attempted to at least in part deal with these complaints through the development of the Innovation Pathway, which is still in its early stages of deployment. The Innovation Pathway could also provide an answer for another major problem faced by the CDRH, which is the fact that medical device applications are growing more complex with each passing year. Dr. Shuren stated that his organization is now forced to evaluate technologies that have only appeared on its radar in recent years, especially with regards to the software, nanotech and personalized medicine product categories. Combined with the trend towards globalization in the medical device industry, Dr. Shuren feels that the CDRH simply does not have the resources to stay ahead of the rising tide of medical innovation.
Much of what Dr. Shuren had to say this spring comes as no surprise to medical device companies frustrated by a perceived lack of funding and regulatory willpower at the CDRH to accelerate plans to meet the needs of the modern marketplace. The Director’s call to improve transparency and application processing speed, as well as invest in experts and make regulatory pathways more predictable are all excellent and vital steps that must be taken by the FDA in order to foster innovation in the U.S. medical device sector. It remains to be seen how the CDRH will move forward in addressing each of these concerns.
repurposed and adapted with permission from the MDCI Blog