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.

Read about the Total Product Life Cycle here »

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Discovery & Ideation

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)

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 Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series 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...

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

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

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...

Patient Preference Study Design Guide – Qualitative Steps: First steps for sponsors initiating a patient preference study

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

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...