When We’re In the Know, So Are You

One of the most gratifying aspects of my job here at The O&P EDGE is keeping pace with emerging O&P technologies. Reporting on these technologies, though, is a double-edged sword. While it’s exciting to learn about robotic orthoses and advancements that are making prosthetic devices more powerful and feel more like a person’s natural limb, making those technologies accessible to the general public can be a long, drawn-out process that often results in promising devices going no further than the user trial. For products that make it onto the manufacturing line, obtaining L-Codes is an uphill battle and presents another obstacle to consumer accessibility. What if there was a way to streamline the process?

Last month, we reported on the U.S. Food and Drug Administration (FDA) Innovation Pathway, a priority review program for new, breakthrough medical devices. One of the overarching goals of the program is to streamline the premarket review of these transformational products—cutting the review time nearly in half while still adhering to the regulatory standards for new applications. The pilot device for the program is the Modular Prosthetic Limb (MPL), the brain-controlled, upper-limb prosthesis that has been in development over the last several years as part of the Defense Advanced Research Projects Agency (DARPA) Revolutionizing Prosthetics Program.

The O&P EDGE recently learned that another agency has become a collaborator on the FDA’s Innovation Pathway Program—the Centers for Medicare & Medicaid Services (CMS). When EDGE writer Judith Philipps Otto asked Col. Geoffrey Ling, MD, PHD, manager of DARPA’s Revolutionizing Prosthetics Program, about the FDA’s new program, he revealed that he had just come out of a meeting with the FDA. “And not just the FDA,” he said. Representatives from CMS were also at the meeting. “The Centers for Medicare Services is also…a collaborator…,” he said. “They’re trying to…see how they can coordinate their efforts as well.” Ling described such broad agency cooperation as “unprecedented. Seriously, to have both FDA and Medicare/Medicaid…. Think about that. That is unprecedented.”

For those who are waiting anxiously to see what commercially viable products emerge from DARPA’s aggressive upper-limb prosthetics program, this is indeed an encouraging development. As we learn more about what this means in terms of bringing these products to market, you can be sure that The O&P EDGE will keep you informed.

Thanks for reading.

Karen Henry