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.

Keywords: Translational research; academic–industry collaboration; engineering; medical technology; regulatory affairs.

Fig. 1.

Navigating Translational “Valleys of Death” with Assistance from Medical Technology Advance Program (MTAP). MTAP assists primarily with bridging the early gaps that exist between research and clinical/regulatory knowledge (Valley of Death 1). In partnership with Indiana University School of Medicine, MTAP assists with advancing viable medical technology into clinical implementation and commercialization (Valley of Death 2).

Fig. 2.

Medical Technology Advance Program (MTAP). Through MTAP, a combination of technical and educational resources is available to support advancement of investigator innovation toward clinical translation and implementation. Technology Development and Preclinical Studies help overcome “Valley of Death 1.” Clinical Studies and Translation to Product in partnership with Indiana University School of Medicine help overcome “Valley of Death 2.”