what it means if a genetic diagnostic test result indicates, for example, a 10 percent risk of diabetes. In other words, what does a given diagnostic result mean? And at what point does the data become relevant and useful?
In an FDA blog last month, Shuren outlined some of the agency’s accomplishments so far. But now comes the hard part. In discussing his quest to bring clarity, efficiency, and consistency to the process of ensuring that medical products are safe and effective, Shuren says agency officials need better scientific tools to carry out their regulatory duties. “If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science,” he says.
The improved regulatory tools Shuren has in mind include improved computer modeling, which could be used to more accurately predict the safety and effectiveness of devices under different conditions. He also wants the industry to help pool its resources by creating what he calls a “Switzerland” for medical devices—a public-private biomedical research partnership like the pharmaceutical industry’s Biomarkers Consortium,that could be used to safely share proprietary information without fear of having trade secrets leaked to competitors. Establishing a similar entity for medical devices is more of a challenge, Shuren says, because the universe of device makers includes consumer electronics, wireless, and other non-traditional biomedical companies and product life cycles are short and fiercely competitive.
Shuren and Biocom’s Panetta also talked about the necessity of engaging FDA regulators much earlier in the development process for medical devices. “The more than we can do to engage the agency early on, the better off we’re going to be down the road,” Panetta says. With genetic diagnostics, for example, he says, “We don’t want to be caught off guard in the future because we haven’t engaged at the level that Jeff is talking about with some of this personal genomics technology. We want to avoid those types of situations in the future. We hope by developing this public-private partnership, we can be getting answers to those types of questions at a much earlier stage and we hope to create a much more expeditious and smoother review process.”
Or as Shuren put it, “It’s a little bit of Dorothy and the red slippers. You can get back to Kansas, but you have to be willing to use the tools you’ve been given.”
