Shifting Global Regulations to Hit Home for Medical Device Manufacturers

Posted April 10, 2017

Federal regulators in the United States and the European Union are gearing up for a big shift in the way they approve and monitor medical devices. Representatives from both sides of the Atlantic detailed the potential ramifications of these changes during a symposium hosted by AAMI, the Food and Drug Administration (FDA), and BSI, April 4–5.

One of the main areas of focus during the Symposium on the Evolving Standards and Regulatory Structure for Medical Devices was the generation and use of evidence to support the safety and effectiveness of new devices—and the valuable role that standards can play in navigating the altered regulatory landscape.

The U.S. Perspective

Industry has long argued that the costs associated with conducting clinical trials and fulfilling other requirements associated with the regulatory process have created disincentives for companies to launch their devices in the United States, driving innovation to Europe and other parts of the world. They contend this is especially true for small companies (less than 20 employees), which make up approximately 80% of medical device manufacturers in this country.

Jeffrey Shuren, director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), has acknowledged the fine line the agency must walk in order to balance safety with innovation.

“The U.S. regulatory standard for market approval protects patients by setting a high public health bar but imposes costs that make the U.S. marketplace less attractive for innovators, thereby delaying patient access to important technologies,” Shuren said during a 2016 presentation. “The solution is to reduce the time and cost of the total product life cycle … without compromising the reasonable assurance of safety and effectiveness standard.”

For small medical device manufacturers, time really is money, according to William Maisel, deputy center director for science and chief scientist at CDRH. During his keynote presentation at the April symposium, Maisel showed that when the FDA requires a 30-employee company to conduct an additional 20-animal study, it costs about $5.5 million. An additional 100-patient study with a one-year follow up will rack up a bill of more than $24 million.

“A really great product can die if we’re not thinking about time and not striking the right balance in our evaluation,” Maisel said.

Establishing a national device evaluation system is one way the FDA is hoping to strike this balance between patient safety and regulatory efficiency, with a goal of shifting the focus to the postmarket. In other words, the premarket requirements could be eased a little because there would be stronger postmarket surveillance, allowing regulators and companies to react more quickly to any issues that arose with products already being sold. Such a system would also allow manufacturers to compile data about the safety and effectiveness of devices being used under "real-world" conditions, which could be used to support a label extension.

This change in mindset, coupled with the increased resources provided by the Medical Device User Fee Agreement, have set the stage for “very substantial improvements in overall performance” for the agency, Maisel said.

Changes in Europe

Meanwhile, following safety concerns over breast and metal-on-metal hip implants, the European Union has decided to go in a different direction, implementing stricter premarket requirements for high-risk devices and strengthening designation criteria for notified bodies―changes presenter Ibim Tariah, technical director for BSI Healthcare, described as a “tsunami on steroids.”

Fittingly, the new regulations for medical devices, or MDR, cleared their final legislative hurdle during the symposium, with the E.U. Parliament voting overwhelmingly in favor of their adoption.

“As of today, they’re real,” said Gary Slack, senior vice president of global medical devices and healthcare at BSI Group. “From now on, we’ll be living it rather than talking about what if, when, and where.”

During a debate in Brussels last Tuesday, Glenis Willmott, the parliament's lead negotiator on the MDR and Labour's European spokesperson on health, said that the new regulations would improve patient safety.

"The metal-on-metal hip scandal highlighted weaknesses in the current system. So we've introduced much stricter requirements for the bodies that authorize medical devices and will insist that particularly high-risk devices, such as implants, joint replacements, or insulin pumps, be subject to additional expert assessments before they can be authorized," Willmott was quoted as saying by the Regulatory Affairs Professional Society.

However, for some experts, like Ronald Rakos, BSI’s global head of vascular medical devices, an unintended effect might be that small start-up companies might “opt out” of the European market. The new rules on clinical evidence—especially the ones requiring manufacturers of equivalent devices to have “full access to the technical documentation on an ongoing basis”―are going to be a “very difficult hurdle to get through,” he said during his presentation at the AAMI/FDA/BSI symposium.

Although the MDR has been finalized, it remains unclear how many of the provisions will be implemented, which will make a big difference for how manufacturers plan to comply, according to John Wilkinson, director of devices of the U.K.’s Medicines and Healthcare products Regulatory Agency. There is a need to “ensure the interpretation is sensible,” he said.

Importance of Standards

With so many changes underway, regulatory affairs professionals are still trying to wrap their heads around the new expectations and plan for the future. Standards, according to symposium presenters, are going to become even more important.

“Voluntary consensus standards are important for regulatory purposes because they assist in demonstrating compliance to some of the expectations of device regulators in a consistent and predictable way,” said Jeff Eggleston, corporate standards advisor for Medtronic.

Standards can be seen as a constant in the evolving global regulatory landscape, Joe Lewelling, vice president of emerging technology and health IT standards at AAMI, added.

“Regulators cannot possibly have the expertise and bandwidth to determine what is safe for the broad range and every-changing variety of medical devices and healthcare technologies being utilized,” Lewelling said. “Consensus standards are created by a diverse community of industry representatives, clinicians, regulators, patient safety advocates, and technology experts. Using these documents as voluntary adjuncts to regulations enables regulatory authorities to utilize this knowledge and expertise in their efforts to promote the safety and effectiveness of healthcare technology.”