Advancing medical technology innovation and clinical translation via a model of industry-enabled technical and educational support: Indiana Clinical and Translational Sciences Institute’s Medical Technology Advance Program

Abstract

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the "translational valleys of death" requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine-engineering-industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.

Point of care approaches to 3D bioprinting for wound healing applications

“…Ultimately, successfully traversing bioprinting from bench to bedside for wound healing will require expertise from a vast array of areas. Early established and ongoing inter-disciplinary collaborations between not only researchers and clinicians, but also ethical, regulatory and commercialisation specialists are essential to avoid falling into the dubbed translational 'valleys of death' [94]. It is this tight-knit network that will facilitate the development of POC bioprinting systems which meet the needs of the patient, surgeon, and relevant regulatory approval body, leading to a paradigm shift in POC wound treatment for the better.…”

Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

“…To bring new and innovative medical devices to market efficiently and effectively, a greater understanding of challenges faced and how to overcome those challenges is needed. One area, for academic researchers, start-ups, and small companies in particular, is understanding the various regulatory processes that must be navigated before most products can be used in patients or commercially marketed [ 2 – 4 ]. A multi-stakeholder group representing a cross-section of the medical device field, including clinicians, academic researchers, industry professionals, and regulators from the United States Food and Drug Administration (FDA), all of whom play critical roles in maintaining a vibrant and productive network for the development of medical devices, prepared this review of salient points and best practices toward a goal of increasing knowledge and advancing medical device translation through the regulatory process from concept to clinic [ 5 ].…”