There is much interest in engaging patients in the medical device development process, at all stages of development. In 2016, FDA released a guidance for the use of patient preference information (PPI) in device marketing submissions. Since then groups such as Clinical Trials Transformation Initiative, Medical Device Innovation Consortium, and Patient Centered Outcomes Research Institute have worked to identify best practices for engaging patients and conducting studies to collect patient preferences. It is important to design such patient preference studies that target the appropriate patient population(s), communicate effectively with the patients, and successfully characterize patients’ true priorities. Patient preference studies should identify patients’ desired health outcomes of course, but also risk tolerance, device usability concerns, and the level of potential benefit that patients would consider significant.
Each stakeholder benefits by incorporating PPI into the medical device development process:
- Patient interest: Patients are not a monolithic group. Patients with different diseases and severity of disease may have a much different outlook on what improvements they would consider significant, and how much risk they would be willing to undertake for that chance at improvement. Simple quality of life is an important motivator that often gets overshadowed by the more technical (and quantifiable) metrics of device performance. By engaging in the device development and research process, patients can help steer industry toward products that meet the priorities of specific patient populations and can help create products that address those priorities in ways that are meaningful to them.
- Regulatory interest: Regulators recognize that they can better meet patient needs by encouraging industry to incorporate PPI in their device development. They have indicated a willingness to consider PPI in marketing submissions for medical devices. If PPI is collected through a well-designed patient preference study and shows that patients will accept a lower than expected level of benefit as a meaningful improvement, it may indicate a lower threshold of effectiveness is needed to consider the device successful in its clinical trials.
- Industry interest: By investing the time and resources into collecting PPI, medical device companies can tailor products to better meet patient needs. But they can also use PPI to identify unmet needs for new products, learn about the market and patients’ decision-making, identify concerns with product usability, and identify other reasons for patient non-adherence in the use of commercial products. By using PPI to inform clinical trial design, sponsors may be able to adjust trial endpoints and success thresholds, as long as those still indicate a meaningful difference for patients. Trials designed with patient preferences in mind can also have reduced barriers to enrollment and improved patient compliance. This could potentially lead to smaller sample sizes and reduced study timelines, thus lowering trial costs.
- Investigator/trial site interest: Clinical trials that have been designed in accordance with PPI can be more attractive to patients, in terms of wanting to participate and being able to comply with follow-up instructions. This will help sites enroll more patients and reduce the instances of non-compliance for the trial sites. PPI can also be used to design patient-friendly trial materials such as informed consent documents, informational brochures, posters, and newsletters.
We can help design and conduct patient preference studies to identify patient priorities specific to your target patient population. We translate the results into actionable intelligence that can be applied throughout the device development process.
Visit medinstitute.com or contact us at 855.463.1633 to learn more about how we can partner with you.