Summary MDIC designed a Science of Patient Input (SPI) survey to collect insights regarding the use of Digital Health Technologies (DHT) with a specific focus on generating data related to patient input that can be incorporated into the medical device ecosystem to...
Total Product Life Cycle: Discovery & Ideation Phase
When confronted with an unmet medical need, researchers in the device field will come up with an idea for a new product. Once they have a “proof of concept” plan, they will evaluate whether the idea is workable. Those concepts that exhibit promise move forward toward the next stages of development.
Discovery & Ideation
Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)
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...
MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials
MDIC created a “How-To” video to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations from the...
Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials
In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...
MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report
This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.” By...
Video Release for Patient Preferences for Heart Failure: A Collaborative Study
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...
Incorporating Patient Preferences in Clinical Trial Design and Research
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...
Patient Preference Study Design Guide – Qualitative Steps: First steps for sponsors initiating a patient preference study
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...
A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology
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...