FDA Commits to Facilitating Medtech Innovation

It took a good bit of cajoling and dire forecasting, but U.S. Food and Drug Administration (FDA) officials are beginning to realize the importance of preserving America’s leadership role in medical technology innovation.

On Tuesday, the agency unveiled a plan to expedite the approval of innovative medical devices that potentially can dramatically improve patients’ lives. The program, dubbed “Innovation Pathway,” would review first-of-its-kind devices in five months, or about half the time the FDA currently spends reviewing most new products. A white paper released with the Innovation Pathway initiative defines innovative devices as those that:

• Significantly improve upon currently available treatments or diagnostics for life-threatening or irreversibly debilitating diseases or conditions;
• Treat or diagnose a life-threatening or irreversibly debilitating disease or condition for which there is no approved or cleared alternative treatment or means of diagnosis;
• Address an unmet public health need as identified by the Council on Medical Device Innovation; and
• Address an issue relevant to national security such as vaccine development and medical counter measures.

Once an innovative device is identified, the FDA would work with device scientists and designers early in the development process to help them devise studies that prove the safety and effectiveness of their products. According to the details of the program, the FDA would choose and monitor qualified projects through its newly-created Center Science Council (comprised of senior managers and experienced staff). Those with projects that show promise will be assigned a “case manager” to help them navigate the Pathway and establish a primary review team earlier in the development process. Within 120 days from being accepted into the “Pathway,” the review team and product sponsor will devise a proposed roadmap and timeline for device development, assessment and regulatory review.

“This isn’t an ordinary initiative and it’s not the kind of proposal you’re used to hearing from a regulatory health agency,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), said in unveiling the Innovation Pathway. “Today’s Innovation initiative is our response to requests to address unmet medical needs by proposing solutions for truly innovative technologies. Encouraging and facilitating innovation isn’t just about faster product review times, although expediency is key. It’s about smarter regulation and sharing our experience and knowledge with industry and users to make devices better for patients and practitioners.”

By front-loading resources to reduce delays and expedite the review of medical devices, the FDA hopes to pacify device executives who have complained for years about the agency’s slothful review and approval times. The proverbial foot-dragging has become so bad over the last few years that many U.S.-based medical device manufacturers now release new products overseas before introducing them at home. Such a strategy is not surprising, considering that countries in Europe and places such as Israel approve new technology in half the time it takes the FDA to make such an endorsement. And while CDRH leaders are fully aware of the sluggish nature of FDA approvals (clearly admitting so in the white paper), they nonetheless defend the current system, claiming the need to balance patient safety with new or unproven medical technology.

“Expedited review times are typically longer than standard review times and have not reliably met the targets FDA agreed to as part of the Medical Device User Fee Act negotiations, primarily due to the unique regulatory and scientific challenges presented by devices that are granted expedited review status,” the white paper stated.

Though the agency is holding a public meeting on Innovation Pathway initiative on March 15, it already has identified its first candidate: a prosthetic arm remotely linked to a microchip in the brain that gives patients near-normal coordination of a prosthetic hand and fingers. Funded by the Defense Advanced Research Projects Agency within the U.S. Department of Defense, the device is designed for patients who have suffered a stroke, a spinal cord injury or have had an amputation.

The FDA’s announcement of the Innovation Pathway occurs as the agency forges ahead with a sweeping, multi-year effort to overhaul its 35-year-old system for approving medical devices. Last month, the FDA unveiled 25 changes to its highly-criticized 510(k) program; officials said the changes would transform the procedure into a more transparent, efficient process.

Though it deferred some of the more radical reforms, the FDA is still planning some major alterations to the 510(k) process, including streamlining the “de novo” process (typically reserved for innovative, lower-risk products) and publishing guidance on product modifications and clinical trial data. In addition, the agency is hoping to deliver by September a 510(k) “paradigm” guidance that would include information on ways in which companies could use multiple predicates, the types of applications that would require clinical trial data, and a clear definition of “intended use.”

The FDA also plans to develop a network of external experts to help the agency address scientific issues about new medical device technologies.

Between the changes released last month and its Innovation Pathway initiative, the FDA clearly is at ease with revamping its product approval process. Advocates for the changes claim the overhaul is necessary if the nation is to keep its world leadership position in medtech innovation.

“We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to unacceptable delays and inconsistencies which needlessly delay patient access to life-saving, life-enhancing medical technology,” said Stephen J. Ubl, president and CEO of the Washington, D.C.-based Advanced Medical Technology Association.

The Medical Device Manufacturers Association, which represents smaller medical device companies, similarly commended the FDA’s innovation plan and urged the agency to continue addressing delays in device approval.

“Unnecessary and unreasonable delays for safe and effective products not only hurt innovation, they unfairly punish patients who are relying on America’s med-tech entrepreneurs for help,” said Mark Leahey, the group’s president.