Study emphasizes importance of trials for changes to medical devices

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Robust clinical trials are the cornerstone of medical technology development. Makers of healthcare products are deeply familiar with the extensive processes of testing and modification that must come before submitting a new device to the U.S. Food and Drug Administration for clearance or approval. However, a new study published in JAMA suggests that firms may need to take a fresh look at how they handle the research that goes into making changes to high-risk devices.

As manufacturers strive to deliver improvements in products and explore the possibilities of human factors engineering, scrupulous testing remains an essential part of their work. Advancing technology offers opportunities to boost treatment effectiveness and streamline medical user experience design, but firms must plan for the long term by working to ensure optimal safety. The research raises important questions about whether firms are doing enough to check that changes to their products are safe for patients.

Regulatory compliance and making changes to devices

"A manufacturer must compare a new version of product to the last one cleared."

According to FDA guidelines, manufacturers must submit a new 510(k) notification for premarket approval when making an alteration to an existing device if the changes have the potential for significant effects on safety, effectiveness or the way that device is used. For incremental or cosmetic changes, it is often unnecessary to resubmit the product. However, if the time comes for a bigger upgrade after the design already underwent shifts over the years, the manufacturer must compare the new version to the last one cleared by the FDA.

When many changes in a design happen at once, firms have to consider each one individually for its possible impact on the safety and use of the device and determine whether it calls for a difference in labeling. Medical device makers should consider questions such as:

  • Does the change make a difference in the indications for use?
  • Is there a new control mechanism for the device, such as a shift from analog to digital?
  • Does the latest version of the product run on a different energy source?
  • For an implanted device, will the changes result in a new type of material coming into contact with bodily fluids or tissues?

Any of these possibilities, among others, suggest a 510(k) notification needs to be submitted for premarket approval of the altered product. Regulatory compliance calls for clinical testing of the device, much like when submitting a new one, but now questions have been raised about the rigor of these procedures.

Researchers have said changes to medical devices should go through more robust trials.Researchers said changes to medical devices should go through more robust trials.

Study may show limitations of current research

New findings suggest that when it comes to seeking FDA approval for alterations in high-risk devices, some manufacturers may not be conducting adequate trials. Researchers at the University of California-San Francisco and Yale School of Medicine reviewed 83 clinical studies for devices that had their modifications approved between 2006 and 2015. They determined that too few of these submissions were based in high-quality clinical tests.

In a press release, senior investigator and UCSF professor of medicine Rita Redberg explained why the report offers a vital caution for manufacturers and regulators alike.

"There's a lot of pressure on the FDA to speed things up, to let innovative or life-changing treatments go to market, but you don't know if they're innovative or life-changing until you've done a careful study," she said.

The researchers called for more double-blind studies with randomized subjects and controls to provide better data on device modifications. They also suggested longer trials, including follow-ups to determine the effects of change to a product over time. However, that approach could also have disadvantages for firms and patients alike, since it slows down the time to market for potentially life-saving products and, especially in the case of implanted devices, a double-blind trial may be inappropriate or unethical.

A spokesman for AdvaMed, an international trade organization representing medical device companies, told TCTMD that existing regulations lay out a clear path for the FDA to request additional data on any device changes, and there's more to this process than what is included in a supplemental premarket submission.

"Device innovation is an iterative process and the information included in a PMA supplement does not stand alone, but is built on the comprehensive data that FDA reviewed favorably to approve the original PMA application," the AdvaMed spokesman said.

Medical device design and development is a long, complex process, and firms must always balance the advantages of speeding the time to market with the need for careful trials. This new study shows the importance of tracking any alterations to a device that could have consequences for its proper labeling, uses or effects. Quality trials and close attention to long-term results have the potential to make a new version of a product better and safer for everyone.

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