The power of public-private partnership in medical technology innovation: Lessons from the development of FDA-cleared medical devices for assessment of concussion

Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public-private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) c...

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Bibliographic Details
Published in:Journal of clinical and translational science 2022, Vol.6 (1), p.e42-e42, Article e42
Main Authors: Singer, Michael E, Hack, Dallas C, Hanley, Jr, Daniel F
Format: Article
Language:English
Subjects:
Concussion
development
Head injuries
innovation
medical device development
medical devices
Medical equipment
Medical innovations
Medical technology
medical technology innovation
Review
Translational Research, Design and Analysis
Traumatic brain injury
traumatic brain injury (TBI)
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Summary:Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public-private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government-academia-industry PPP triad with a "collaboration towards solutions" Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.
ISSN:2059-8661
2059-8661
DOI:10.1017/cts.2022.373