Regulatory Hurdles Pose Challenges for Device Approvals in US, Europe

San Francisco, CA—The current approval process for new medical devices in both the United States and Europe has posed challenges for manufacturers. A multi-faceted approach is needed to improve the process with an overall focus on providing the patient with access to the newest devices while maintaining patient safety, according to presenters at TCT 2013.

Regaining device leadership in US

The two main US goals for improving the device process are to provide the earliest and broadest patient access to beneficial medical devices and focusing on regaining leadership in the worldwide market, according to Andrew Farb, MD, of the division of cardiovascular devices in the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA).

However, the United States faces several challenges. Devices are currently being developed specifically for non-US markets and therefore innovation is likely to follow overseas, Farb said.

Farb added that there is a need for a new framework — the application of benefit/risk principles throughout regulatory decision-making. In turn, he said, FDA regulators are able to consider the risk/benefit profile for the device. On Oct. 1, the FDA’s early feasibility study guidance was published, requiring a small number of patients in a trial to test a device that is in early development. 

Current efforts will include the development of intra- and extramural training programs. Moving forward, several sponsors have committed to “test the waters” of conducting early feasibility studies in the United States, Farb said.

“There are clear and positive opportunities for bringing feasibility studies back to the United States. We can enhance contact between inventors, developers, investigators and regulators moving them geographically closer where the intellectual property and the engineers and designers are,” he said. “We also have to remember to keep the patient in focus. By bringing these studies back to the United States, it allows access to the new technologies sooner for patients, and after approval this will allow for a smoother and more effective transition to these beneficial devices.” 

Challenges mounting in Europe

Despite the demand for greater clinical and economic evidence for new devices in Europe, there is a need to reduce the costs of clinical trials, and challenges to bringing new devices to the market in Europe are growing.

“The general sense is that it’s easier to say ‘no’ than to find the money to fund testing,” said Keith Dawkins, MD, of Boston Scientific. “Bringing new medical devices to Europe is becoming a challenge, particularly in the last few months — despite the increase in regulatory requirements, the European financial industry is driving the changing approval environment,” he said. “Randomized data supporting safety and efficacy now need to be reinforced by cost effectiveness.”

Funding is only one impediment to clinical research in Europe. There is a “downward pressure” on procedural volumes and comparative effectiveness considerations when choosing therapies, according to Dawkins. Although Europe requires a single CE mark, there are different country-specific rules required for device approval and reimbursement.

More recently, a set of proposed changes have been suggested for the Medical Device Directive, which regulates how devices are approved and enter in the European Union. If adopted, the vote — expected in the middle of 2014 — may shorten the lag between European and FDA approval. A significant increase in evidence and surveillance for adverse events will be required for device approval.

“If adopted, a company like Boston Scientific could face up to an additional $20 million in costs per year and an additional 3 to 5 years or more to bring new devices to the market. This could actually create parity between Europe and the United States from the regulation point-of-view,” Dawkins said.

Disclosures:

Dawkins reports a financial relationship with Boston Scientific.

Farb reports no relevant conflicts of interest.