Wow! We’re excited to welcome not one, but three senior FDA officers as joint guest posters here at the ‘Mine today. All three of these individuals attended and participated in the recent 2012 DiabetesMine Innovation Summit, which we hosted at Stanford University on Nov. 16.

Dr. Alberto Gutierrez gave an opening talk titled “How Different Constituencies Can Work Together to Improve Technology Tools for Diabetes Care ” (slides here); Stayce Beck participated in our “Data and Device Interoperability” panel, and Arleen Pinkos in the panel on “Breaking Out of the Clinical Silo into Lifestyle Thinking.”

As you can imagine, FDA was somewhat under the gun, as attendees rattled off questions about their “sluggish processes.” I asked these FDA folks to kindly share some of their takeaways from the event, and this is what they had to say:


A Guest Post by FDA’s Arleen Pinkos, Stayce Beck and Alberto Gutierrez

We had the privilege two weeks ago to attend the 2012 DiabetesMine Innovation Summit, which gave us the opportunity to discuss medical device-related experiences, challenges and solutions with members of the diabetes community.  While we were able to share the Food and Drug Administration’s regulatory perspective on diabetes-related medical devices and to update attendees on FDA’s recent actions in this arena, the true value for us was listening first-hand to patients perspectives on their diabetes and understanding how medical device innovation and regulation can improve their lives.

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for assuring that medical devices are safe and effective.  Diabetes-related devices that come to CDRH for review include glucose meters, continuous glucose monitors, insulin pumps and software associated with managing diabetes. Artificial pancreas systems also fall under CDRH’s purview.

We understand the kind of burden that diabetes management presents to patients and we weren’t completely surprised to hear the community voice concern over the length of time it takes us to review and approve new, innovative diabetes technology. Central to this conversation was the need for researchers, manufacturers and the FDA to work closely and collaboratively in the earliest possible stages of device development. For it is in the early stages that we can all best think creatively about what kind of studies and data will be necessary to support the successful approval of new technology in the shortest timeframe.

FDA has explored other ways to expedite the development of new and innovative devices.  By defining the type of studies needed for investigational artificial pancreas devices through guidance for industry and communication with FDA reviewers, we have provided clear expectations that researchers, manufacturers and investors can use to plan and develop artificial pancreas studies. Furthermore, FDA has consolidated the artificial pancreas review under a single management chain reducing internal inconsistencies and providing clearer priorities for that team.

FDA’s recent quick approval of a new continuous glucose monitor sensor, the Dexcom G4 sensor, and approval of the first outpatient studies of an artificial pancreas device are both positive examples of FDA’s efforts to expedite the device development process.

The FDA is also tackling broader issues with medical devices, some of which will have a particular impact on diabetes management. For example, the development of new mobile medical apps for smartphones and tablets has great potential to enhance the management of diabetes. By working with a wide range of groups, the FDA is developing a policy for mobile medical apps that will assure that those apps that present the greatest patient risk receive the appropriate agency review. We want to make sure that our regulation is as smart and as nimble as the technology it is designed to cover.

We also heard your desire to connect with us more often. And we agree.

Directly connecting to the patient community—and not just those with diabetes—helps us better accomplish our public health mission. To that end, you will be hearing from us and hopefully see us more often.

We are working directly with the public to more thoroughly incorporate the patient perspective into the review of medical devices.  The FDA recently published guidance for FDA reviewers and industry describing what factors the FDA considers when making benefit-risk determinations about new devices. This outlines an approach that takes into account patients’ tolerance for risks and perspectives on benefits.  In May 2012 the FDA held a meeting specifically to discuss how patients define and perceive benefits and risks related to medical products and to discuss ways of collecting patient input.

We look forward to the next time we are able to talk with the DiabetesMine community at the next Innovation Summit. In the meantime, we are looking for new ways to connect with and communicate with the diabetes community. Please remember that you can stay up to date with FDA’s work in this area by visiting our Diabetes Information web site.

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Special thanks to Alberto, Stayce and Arleen. Wow again — to think the patient community could be on first-name basis with these folks …  They seem to be making some great progress, but there’s still a long way to go, starting with the fact that the FDA’s Diabetes Info pages are nearly impossible to find from the agency’s home page. How are patients to even know where to begin?

If you’ve got specific ideas about helping the FDA communicate more closely with the D-community, and especially if you live nearby Washington, D.C., please give some thought to applying as an FDA patient representative. The more active involvement, the better!

** NOTE to Readers: Don’t miss feedback on the Summit from the American Diabetes Association’s CEO Larry Hausner and Chief Medical Officer Dr. Robert Ratner posted last week on the ADA blog. **