Originally Published MPMNJune 2004

EDITOR'S PAGE

Finding a Shortcut on theCritical Path 

Bringing a new medical device to market is not easy.
 
Or fast. 

To produce a commercially available medical product, companies must negotiate a "critical path" to determine whether it is safe and effective. Each of the three steps of the path--assessment of safety testing, proof of efficacy, and industrialization--presents its own set of scientific challenges. These are often unrelated to the science behind the development of the product itself. 

Increasingly, there is a disconnect between the science that is used to discover new products and that which is used to measure their safety and efficacy. Today's scientific advances hold great promise for breakthrough products. But according to FDA, not enough applied scientific work has been done to create new tools to determine their safety and effectiveness. The agency says that in many cases, developers use outdated tools and concepts to assess new devices. Thishinders the process.

"Who knows what medical innovations we are missing out on because they are stuck somewhere in the research or approval pipeline?" says secretary of Health and Human Services Tommy Thompson. "Or worse, who knows what new products aren't making it into the pipeline in the first place because innovative companies find the entire process too daunting or not worth their efforts?"

FDA is trying to rectify this by creating its Critical Path Initiative. "This initiative will help us identify the areas along the critical path that provide the greatest opportunity for rapid improvement and public health benefits and allow FDA and its partners to bring exciting research developments to the patient's bedside," says Thompson.

The initiative will focus on the most pressing development problems, the areas that provide the greatest opportunities for rapid improvement, and public health benefits. The agency recognizes three key areas of product development--safety assessment, evaluation of medical utility, and product industrialization. 

According to FDA, because of its unique vantage point, it can work with experts in companies and academia. Together they can develop and disseminate solutions to critical path problems.

FDA is establishing a public docket for comments. This is a perfect opportunity for medical device manufacturers to be heard. The agency is interested in identifying hurdles and solutions from industry and academia. They also want to hear your opinion on what FDA's role should be. Comments will be accepted through July 30, 2004. Information on how to submit materials can be found atwww.fda.gov/OHRMS/DOCKETS/98fr/04-9147.htm. 

"Ultimately, the solution to this problem will depend on many more forces besides the federal government," says Thompson. "In fact, you in the private sector will probably do more to drive this change than we in the government will. But it's my job as HHS Secretary to push all of you to make this a reality."

Susan Wallace, Managing Editor

Copyright ©2004 Medical Product Manufacturing News