“Innovation” has become something of a buzzword of late—especially in the medical device industry. The belief that there is a dearth of innovative new products is widespread among medical device professionals. And FDA is commonly blamed for impeding creativity and making it difficult for medtech firms to introduce breakthrough products. Unpredictable review cycles are often cited as one of a principle reason for this as is the unclear criteria used to clear devices.

The agency seems to be sensitive to this negative sentiment. Earlier this year, FDA launched the Innovation Pathway to prioritize the review of breakthrough devices.

Today, FDA commissioner Margaret A. Hamburg, MD announced a plan to further address the issue. Naming the effort “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” FDA hopes to “addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development,” acknowledges a press release from FDA.

The blueprint was designed with several goals in mind. Chief among them, according to the aforementioned press release, are rebuilding the agency's small business outreach program, creating infrastructure to support personalized medicine, increased use of data mining, and improved consistency and clarity in the medical device review process. In addition, the agency seeks to help "[train] the next-generation of innovators" and streamline regulations. 

More information on the effort is available from www.fda.gov/innovation.

A copy of the document is available in PDF format.

—Brian Buntz