2015-12-14 16:49:11 UTC
Dec. 14, 2015
AGA expert authors blog in DeviceTalk about guiding the device community through this new patient-focused regulatory environment.
The AGA Center for GI Innovation and Technology has unique insight into device development thanks to its role guiding GI, hepatology, nutrition and obesity medical device and therapeutics innovators through the technology development and adoption process. To showcase its leadership in this area, Joel V. Brill, MD, FACP, AGAF, a member of the center’s executive committee, published a blog post on Device Talk offering guidance for medical device developers on how to incorporate patient preference data into medical device applications.
Over the past several years, FDA has worked to incorporate patient preference data into the review and approval of new medical device applications. Patient preference information could make a compelling case that a device’s efficacy outweighs safety concerns and can ultimately help FDA access a device’s benefit-risk profile. In his blog post, Dr. Brill encourages device developers to consider the following five points in order to succeed in this new regulatory environment.
- Begin by better understanding patients’ experiences, needs and views and applying this knowledge to medical product innovation.
- Whether by offering choices to patients or by observing the actual clinical choices made by patients, studies should take patient preference into account.
- Be open to understanding the patient’s perspective on the benefits, harms, uncertainties and risk of the product in question.
- Ask patients and families directly what they consider most important in treatment options.
- In your study, include questions patients may have about the product, implantation procedure and duration of effect.