Patient Preferences for Device Development

Patients and care partners live with their device every day. Yet, as new medical devices are being designed or tested, patients and care partners are often not consulted regarding their preferences or requirements. To address this issue, the U.S. Food and Drug Administration (FDA) began the Patient Preference Initiative.

In August 2015, KHI convened a workshop where the FDA, clinicians, the device industry, and patients, care partners and patient advocacy groups to discuss the barriers and solutions to device development. At the time, there were few tools available to incorporate patient preferences into product development. Additionally, the FDA was interested in hearing patients' ideas to help their regulatory decision making for medical devices in kidney disease, including – but not necessarily limited to – dialysis, vascular access, and transplantation.

Workshop Results: Understanding Patients' Preferences: Stimulating Medical Device Development in Kidney Disease

Executive Summary Summary Slide Deck AJKD Special Report

In August 2015, the workgroup hosted a workshop with more than 110 individuals, including 70 patients, care partners and family members. This diverse group of stakeholders listened to what patients considered important and how those ideas can be measured and used by companies that are developing new medical devices. The workshop combined education and teaching with small group discussion. Click here to view the workshop agenda and slides.

Webinar: Patients and Families Lending Their Voices to Improve Medical Devices

This webinar educates patients on the product lifecycle and the role of the FDA, specifically the Center for Device and Radiological Health, to increase patients' interest and knowledge before participating in the device development process.

The workgroup developed and launched this short, animated video to engage patients and encourage them to get involved in the device development process.