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

Michael E Singer,Dallas C Hack,Daniel F Hanley

doi:10.1017/cts.2022.373

Abstract

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.

Highlights

Medical device development, from concept to US Food and Drug Administration (FDA) approval/clearance for product introduction into the market, can be challenging with a multitude of clinical, regulatory, technical, market, and financing hurdles to overcome [1]
The escalation of incidence and awareness of mild TBI/concussion (mTBI)/concussion due to the Global War on Terror and the strong American predilection towards competitive sports created an urgent need for innovation in an area within medical technology fraught with failure
Through long-term private partnership (PPP) between government, academia, and industry, which focused on clinical precision and regulatory compliance, a novel medical product category was created, and a unique FDA-cleared medical product addressing this substantial societal need was developed and introduced to the market

Summary

Introduction

From concept to US Food and Drug Administration (FDA) approval/clearance for product introduction into the market, can be challenging with a multitude of clinical, regulatory, technical, market, and financing hurdles to overcome [1]. Beginning in 2009, private industry and the government, including both Department of Defense (DOD) and FDA, worked in a public–private partnership (PPP) to create medical devices focused on TBI resulting in several products eventually receiving FDA clearance.

Results

Conclusion