Total Product Life Cycle : Pre-Clinical Phase

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 »

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Pre-Clinical

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...

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...