This sounds like another one of those types of studies to “find out how people work” from reading the article. It sounds very strange and all these folks, advocates, industry representatives, and regulators have to be involved in the process. I don’t know about you but the average patient I don’t think is too concerned here or want to be other than being educated on the device they are using or have implanted. That part is very important and we do it now.
What is the patients perspective here going to be? I could see if a device company used a patient as a sounding board as an example in design but that doesn’t sound like what this is. Again most patients until they need one or want one are not interested in medical devices as they have enough on their plate working and trying to keep up in the world. BD
What role should patients play in the development and approval of medical devices? FDA is handing the Medical Device Innovation Consortium (MDIC) half a million dollars to try to answer that question.
The MDIC, a public-private partnership formed in 2012 with the goal of advancing regulatory science, will use the money awarded by the agency to fund its Patient-Centered Benefit-Risk Project, an effort that will bring together patient's advocates, industry representatives, regulators, and academics to find ways to bring patients’ perspective into benefit-risk determinations for medical devices.
“FDA has emphasized that ‘patient tolerance of risk and perspective on benefits’ is an important consideration, and the tools studied in this project will help both industry and the FDA to assess patient preferences for benefit and risk in a meaningful way,” Bill Murray, president and CEO of the MDIC wrote in an e-mail.
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