A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology

Jan 1, 2015Clinical, Discovery & Ideation, Invention & Prototyping, Patient Centered Benefit-Risk (PCBR), Post-Market Monitoring, Pre-Clinical, Product Launch, Regulatory Decision

Patient Introduction

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 benefit-risk and patient preference and discusses when in the product lifecycle such information might be collected. The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective can be incorporated into the regulatory approval process. This framework is of interest to patients as an overview of the medical device product development process and the opportunities proposed for patient preference engagement.

Summary

Given that there are no widely accepted approaches for assessing patient preferences that have been used in the regulatory process to date, MDIC saw an opportunity to help the industry and the FDA think about when and how patient preference information might be incorporated into regulatory decision making. The outcome of the work is this Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of Medical Technology (PCBR Framework).

The PCBR Framework is intended to improve the understanding of the medical device community of how the patient’s perspective might be incorporated into the regulatory approval process. This framework provides background on the concepts of benefit-risk and patient preference, discusses the potential value of including benefit-risk in a regulatory submission, discusses when in the product lifecycle such information might be collected, outlines factors to consider when selecting a patient preference method, and discusses considerations regarding the use of patient preference information in the regulatory process, reimbursement, marketing, and shared medical decision making.

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