The Kidney Health Initiative, a partnership between the American Society of Nephrology, the U.S. Food and Drug Administration, and more than 70 other organizations, will be sponsoring a workshop that brings together kidney patients, care partners, scientists, doctors, nurses, technicians, and companies to hear what is important to patients, and to think about how those ideas can be measured and used by the companies that are developing new medical devices. According to ASN, the workshop will balance education and teaching with small group discussion.
“Patients and care partners experience life with their device every day or nearly every day. Yet, as new medical devices are being designed or tested, patients and care partners are often not involved in communicating what they like or will work best for them,” reads an ASN description of the workshop. “A new program at the U.S. Food and Drug Administration called the ‘Patient Preference Initiative’ is interested in finding ways to match patients’ choices with the approval of new medical devices.”
According to a post on the blog “FDA Voice,” the agency hopes to answer some of the following questions:
- How much of a risk is acceptable to a patient in the context of the potential benefits of the device?
- If patients enter a clinical trial, how much of a chance are they willing to take on an unproven treatment?
- If a device could greatly improve a patient’s health, but is not portable or cannot be used at home, would a patient find this too limiting?
- If a device has new-found risks but is the only one of its kind on the market, should it be recalled?
About the workshop
Understanding Patients’ Preferences: Stimulating Medical Device Development in Kidney Disease
Wednesday, August 12 – Thursday, August 13, 2015
Hilton Baltimore BWI Airport
1739 West Nursery Road
Linthicum Heights, MD, 21090