At an estimated $105.8 billion, the U.S. medical device market may be the world's largest, but it could do with a healthy boost of innovation.* According to a recent White House blog post, "In trying to understand why the country’s pharmaceutical, biotech and medical device sectors seem to be facing a slowdown in terms of innovation, there is no single cause." Some critics, however, find cause in the lengthy FDA approval process. A recent Wall Street Journal opinion piece points to the example of a tiny catheter that was approved for sale in the U.S. last July — more than four years after it first hit the market in Europe.
Meanwhile, the FDA is not sitting idly by; in fact, it has been doing some brainstorming of its own. This week, the agency released a document called "Blueprint to Drive Biomedical Innovation," which analyzes its role in facilitating and promoting innovation in the U.S. medical industry. Some highlights from the report follow.
As medical device makers may already know (and as an article in the June issue of MDB explains), simulation can be a cost-effective, invaluable tool in the development process. The FDA recognizes this and is developing a Virtual Physiological Patient — a collection of functional computer models including both normal human anatomy and diseased tissues — that it will make publicly available to medical device companies.
In the report, the FDA admits that the vast majority of its de-identified clinical trial data has gone un-mined and unorganized, but no longer. It pledges to devote resources to developing a scientific computing model — an environment where communities of scientists can come together to analyze large, integrated data sets and address important questions confronting clinical medicine. The scientific computing environment will also serve as a dedicated infrastructure for application development and software testing for FDA scientists and reviewers. It will also be used to evaluate innovative software developed outside of the FDA that may be incorporated in support of FDA regulatory reviews. (Read this case study about the FDA's collaboration with GrammaTech to use static analysis software to identify infusion pump defects.)
The agency is setting up a partnership with the Small Business Administration to find "innovative, strategic ways to strengthen and support the diverse needs of small businesses." The program includes an exchange program for SBA and FDA employees to provide cross-educational training.
A new expedited review program has been developed. This "Innovation Pathway" is designed to provide a more streamlined path to market for important technologies. The agency will employ experts to identify which technologies demonstrate the potential to revolutionize unmet medical needs.
The agency is also encouraging innovation within its own doors, and will invest in key scientific areas while also working with other agencies such as NIH.
*INSEAD's 2011 Global Innovation Index ranked the U.S. 7th (Switzerland, Sweden, and Singapore took 1st, 2nd, and 3rd), while a report from PwC predicted that the U.S. would lose ground to other countries during the next decade, and determined that "innovators are going outside the United States to seek clinical data, new-product registration, and first revenue."