Speaking at the recent International Conference on Medical Standards and Regulation in Washington, D.C., Sheldon explained that early feasibility studies, designed to find ways to allow projects to go forward more expeditiously, indicate it may be possible to permit evaluation of some products as IDEs.
He noted that preclinical studies typically involve the use of animal models but also that “Some animal studies clearly don’t apply to humans.” CDRH is conducting small feasibility studies, each involving less than 10 subjects, to provide insight on whether less nonhuman data can prove safety.
Sheldon said this project is part of a, larger Innovation Pathway Program, a CDRH-wide effort intended to shorten the time from product concept to commercialization, transform the user’s (i.e., the sponsor’s) experience, and make decisions that create forward momentum.
In his opening remarks, Sheldon minced no words: “The current state of medical device development in the United States is not good. Innovation in this area has largely moved overseas. Americans are not getting access to useful devices on a timely basis. And FDA itself is often seen as a roadblock to turning this situation around,” he said.
A cardiac surgeon by training, Sheldon explained that he brings personal insight to problems facing CDRH. Prior to joining the agency he served for several years as a consultant to device manufacturers that chose to develop products in Europe and South America rather than in the U.S. He said that his immediate focus is to help find answers to the following questions:
- How can FDA innovate itself?
- How can FDA spur innovation in the regulated industry?
- What is FDA’s role in shaping the medical device ecosystem?
“FDA now makes 10,000 premarket decisions each year, and it’s clear that we need a process improvement—we need to change to a more innovative mindset,” Sheldon said. “We will need to learn when it’s possible to take a chance and not continue to follow customary cut-and-dried procedures.”
As a critical aspect of the innovative mindset, Sheldon said, “When goals are understood, the methods to achieve them can be improvised. We must learn to value improvisation, experimentation, risk-taking, and problem-solving over process-following or uniformity of approach to problems.” He further noted that it’s “okay to fail,” as failure along the way is always a part of innovation.
The initial approach to implementing the Innovation Pathway involves practicing new review concepts without dismantling CDRH’s core review procedures, including the 510(k), IDE and PMA, Sheldon said.
If proven successful, new review concepts applied to the more innovative products will be expanded to other existing review programs. Sheldon noted that experimentation is now underway with innovative reviews of three products intended to treat end-stage renal disease, chosen from among 32 device applicants.
Other Innovation Pathway projects for 2013 include studying ways to streamline clinical trials, ways to streamline approval to reimbursement (in collaboration with Medicare and the Centers for Medicare and Medicaid Services), and ways to strike the right balance between pre- and post-market evidentiary requirements.
According to Sheldon, an essential aspect of the Innovation Pathway will be to create a “shared view” of what constitutes Innovation Program—and product—success. He indicated that reviewers must begin to understand the time-cost of different regulatory choices and work with sponsors to create a more collaborative environment. The use of FDA’s IT Conference Center, which allows conference participants, including sponsors and CDRH staff to meet via Skype for exchange of views will help foster and maintain “forward momentum” on innovative projects as they move through the development process, he said.
Jim Dickinson writes the Washington Wrap-Up Column for MD+DI.
