There is most certainly a better way to handle medical device approvals in the US. That was the consensus of testimony to the US House of Representatives Committee on Oversight and Government Reform hearing June 2. The hearing, titled ‘FDA Medical Device Approval: Is There A Better Way?’ elicited some new suggestions and reiterated many of the findings of recent studies. Even CDRH’s Jeffrey Shuren acknowledged the need for change, highlighting the agency’s recent steps to make improvements. Shuren, however, had his own harsh criticisms of industry and its role in the agency’s problems. Industry and VC representatives presented some concrete steps the agency should take to restore the balance of risk versus benefit when assessing medical devices for approval.

“There are a limited number of areas in which we are not meeting the goals agreed to with the industry, although our performance in those areas is generally improving,” said Shuren. “This is the result of several factors, including increasing workload, turnover of key staff, growing device complexity, and poor-quality submissions by industry that require significant time and attention to address. The number of applications for premarket approval for breakthrough devices has increased by 56% over the past two years.”

Shuren said that FDA recognizes that it could do a better job at managing its premarket review programs. “We know that medical device development is expensive. And we agree that, in many areas, insufficient clarity, consistency, and predictability on our part contributes to those expenses. This is why we’ve undertaken a number of initiatives to improve our review processes.

But the focus of the hearing was to continue to examine new ways to improve the process. Jack W. Lasersohn, general partner of the Vertical Group, Summit, NJ, provided some insights from the venture capital perspective. He pointed out the crucial fact that venture capital has provided the fuel for US medical innovation for decades, noting that virtually every major new medical device from the last 30 years was developed by a US start-up company and funded by venture capital.

“Unfortunately, the environment that allowed these innovations to flourish has changed significantly over the last decade. Today, America’s medical innovation ecosystem has come under intense strain. Although revolutionary research is ongoing, fewer groundbreaking medical devices are making it to the marketplace, and those that do make it are taking longer and costing significantly more to get there. As a result, investment in medical devices is beginning to dwindle,” he said.

“In addition, there is a small but vocal minority in the community, the press, and in Congress who are beginning to question the value of medical technology innovation in general.” Lasersohn said that this attack on innovation fosters an atmosphere that is increasingly hostile to entrepreneurial risk taking and may contribute to increased FDA risk aversion.

“At the same time, other countries have emulated our model–from financing methods to clinical research infrastructure–and have begun to draw innovators and capital away from the US. As a result, we are starting to see stagnation within the US innovation ecosystem. The US is losing its competitive lead in medical innovation, and will continue to do so unless lawmakers, regulators, and the private sector work together to bring the FDA’s risk-benefit analysis back into balance.”

“The research suggests that FDA’s risk-benefit analysis for novel medical devices has grown out of balance relative to its past practices and relative to current practices in other countries–especially in Europe.”

Lasersohn said that there are two major steps that the FDA can take to bring its risk-benefit analysis back into balance. In the cases of Class I and Class II 510(k) devices, he said FDA should significantly expand its use of certified third-party entities for reviews. Such a shift would significantly reduce the resource burden on FDA because the agency could redirect its efforts to reviews of PMAs and higher-risk 510(k) devices.

He also suggested that FDA should establish, as a general principle, that reviewers employ a much more flexible risk-benefit analysis than what is currently in use. “This means that while the general requirement that benefit exceed risk will always apply, the specific threshold for each of the elements within that analysis will change depending on the clinical context for the specific device. The review should take into account the incidence and severity of the disease at issue, whether there is an urgent and unmet need in the marketplace, and any potential safety issues,” he said. He emphasized that FDA should make clear to its reviewers that this calculus is explicitly adjustable.

“The US has led the world in developing and marketing innovative medical devices for decades. If we act now to implement policies and regulatory reforms that bring the risks and benefits of novel technologies back into balance, we can revive the US medical innovation ecosystem and ensure that seriously ill patients continue to have access to breakthrough therapies and technologies in a timely fashion” said Lasersohn.

FDA’s shift in culture also came under fire, and David L. Gollaher, PhD, president and CEO of the California Healthcare Institute (CHI) in La Jolla, CA, suggested that the elimination of “moving goalposts” and fixing other internal issues must be at the heart of change.

“Faced with accusations from the press, consumer groups, and some in Congress that its reviews were too lax and failed to protect the public from safety problems with devices and drugs, FDA has shifted emphasis in product reviews from the benefits of new devices to an increasing weight on their possible risks,” said Gollaher. “When broken down, industry anecdotes about agency uncertainty, unpredictability, moving goalposts, and the like all seemingly revolve around ever-increasing demands that are not justified by science or by any increased risk profile of the devices to which those demands are associated.” Gollaher said that from the perspective of an FDA device reviewer, this may be understandable. “After all, an individual reviewer has nothing to gain by approving a product, but much to lose by approving a device that has a problem in the future.”

Among Gollaher’s suggestions for “how to do it better” was that the agency focus on core principles: safety and efficacy. “Instead of creating expansive new authorities and responsibilities requiring ever increasing user fee levels, Congress and FDA should focus on recentering the agency to its primary mission and core competencies, addressing the serious inefficiencies and performance breakdowns of recent years. He also said that while increased funding might not always be the best solution, “in this case, cutting the agency’s budget would be damaging. “What is needed–to support medical technology innovation, job creation and patient and public health–is a steady and sustained congressional commitment to FDA funding, even in today’s difficult budget environment.” Other changes must center on improved training for reviewers and managers, he said.

Gollaher also said that FDA needs to look at the European model of device review and approval. Although it differs significantly from that of FDA, he said, there still may be lessons in terms of process and managerial improvements to address the numerous a consistency, predictability, and efficiency concerns industry has experienced.

“Finally, and perhaps critical,” he said, “is the need to address, including through constructive congressional oversight such as today, an improved, more appropriate balance between benefit and risk.”