How do patient preferences influence medical device regulations?
Federal regulations for medical devices are designed to minimize risks, requiring manufacturers to provide evidence of a product's safety and effectiveness before bringing it to market. In some cases, however, the people who actually rely on those devices can affect the U.S. Food and Drug Administration's oversight. In September 2013, the launch of the Patient Preference Initiative established guidelines for taking their voices into account.
For organizations involved in medical device design and development, it's important to be aware of the ramifications that patient preference could have on the path to regulatory clearance. The FDA's Center for Devices and Radiological Health set up the PPI as part of a larger push toward increased emphasis on the patient in the way new products are created, evaluated and put to clinical use. As firms strive to achieve consistent results and develop innovations for human factors engineering, the user experience is a vital consideration.
How the Patient Preference Initiative changes premarket submissions
" These steps put a spotlight on the everyday implications for users' lives."
The FDA issued its guidance on patient preferences in August 2016, presenting manufacturers with detailed information on how user feedback would influence the agency's decisions going forward. The CRDH gathers its insights into relevant perspectives from a variety of sources, including patient groups, industry representatives and studies. In addition, the agency organized the Patient Engagement Advisory Committee to gain detailed input from individuals, advisory groups and experts in areas like primary care experience and clinical research.
While clinical findings on safety and effectiveness remain the primary criteria for clearing or approving a device, these steps put a spotlight on the everyday implications for users' lives. In their premarket submissions, manufacturers are invited to convey information on how patients manage a particular condition or disease. That context can guide the agency's consideration of the trade-offs in benefits and risks presented by a new product.
The guidelines pointed out that the feelings of patients can have a more pronounced influence in cases that are considered preference sensitive. These are situations where:
Multiple treatment options exist and one is not categorically better for everyone.
The evidence showing that one of those choices is superior is not fully conclusive.
Patients have opinions on the benefits and risks are very different from one another or from the assessment of healthcare experts.
Patient preferences in actions
These guidelines have made a notable impact on how regulations are administered for medical devices, as outlined in a blog post on the FDA website. Jeffrey Shuren, the director of the CRDH, along with Director of External Expertise and Partnerships Anindita Saha and Associate Director for Quantitative Innovation Martin Ho, offered examples of how patient preference has come into play since the initiative's launch.
One such case involved altering the indications for use of a home hemodialysis machine. The indications required that the patient have a care partner to address the risks that go along with home dialysis. Patient representatives told the FDA that this requirement made home care impossible for many individuals who live alone. A medical device maker then produced a study on patients' tolerance for the risks involved in administering the treatment by themselves, leading to an expansion in the indications.
Patient feedback also led to added safety features for a continuous glucose monitoring system with an insulin pump. Patient groups were concerned about the possibility that young children might misuse the pump. The FDA collaborated with the manufacturer to add a lockout feature, making the product safer.
With the FDA taking a greater interest in viewpoints of patients, medical device manufacturers can seize the opportunity to focus on the experience of using their products. Prioritizing the needs of the patient can lead to advances in medical user interface design and more appealing visual brand language. By learning more about patients' feelings about various aspects of their treatment and conducting studies, firms can find exciting ways to innovate and evidence to bolster their premarket submissions.