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

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.

Keywords: Medical technology; concussion; development; innovation; medical device development; medical devices; medical technology innovation; traumatic brain injury (TBI).

Fig. 1.

Public-private partnership (PPP) Pathway to Create mild traumatic brain injury (mTBI) Diagnostically-Focused Product.

Fig. 2.

Clinical Trials Transformation Initiative (CTTI): “Collaboration Towards Solutions.” Source: Clinical Trials Transformation Initiative, Clinical Quality-by-Design (QbD): Principles to Practice, August 21, 2015, Page 7. CRO, Contract Research Organization; IRB, Institutional Review Board.