The device prototype is evaluated in a controlled laboratory setting to provide researchers with important information about how the product may perform once it used in people. By refining the device during this phase, researchers work to reduce as much risk of harm as possible once the product moves into human use. Read about the Total Product Life Cycle here »
A growing body of literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s...
Through this project, MDIC brought together six heart failure device companies to work in collaboration to develop an understanding of what matters to patients living with heart failure, especially how those patients might be willing to accept potential risks from...
This whitepaper was authored by Margaret Sheehan and Anne Cohn Donnelly, who live with Parkinson’s disease and have participated as Patient Scientists on the MDIC PCOR project team along with representatives from the Michael J. Fox Foundation for Parkinson’s Research...
This study design guide provides an outline of the qualitative steps for initiating a patient preference study. The guide only includes qualitative steps used to develop the preference survey and does not include the development of the preference study protocol or...
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...