The broad and long term objective of this application is to directly impact translational medical device development in the USA via the creation of a novel action learning based educational experience for Biomedical engineers as well as other collaborating disciplines in the field of medical device development and reduction to clinical practice/commercialization. This NIH R25 Research and Education proposal aims to achieve a curricular and collaborative leap forward of an already successful Medical Device Innovation and Entrepreneurship Program (MDIEP) at the University of Cincinnati. MDIEP is currently the flagship interdisciplinary senior capstone experience for the undergraduate degree in Biomedical Engineering which also engages physicians from COM, students from other CEAS disciplines (EE, ME), the Schools of Design and Business working with physicians and program faculty (PI s Haridas and Privitera) to develop new medical device innovations. While program is well established and nationally recognized, there still remain challenges in terms of funding for improved clinical problem definition, realistic and functional prototyping, pre-capstone curricular needs, and expansion of collaboration across disciplines. To address these goals, we are proposing a multi-faceted curricular and collaborative expansion of mDIEP with the following specific aims to be accomplished in the 5 year period of this grant. SA1: Enhancement of Clinical Collaborations and Clinical Practicum Experience with the College of Medicine through the institution of a new Clinical Rotation & Practicum Fellowship experience to improve the latent needs identification process towards clinical problem statement development. SA2: Curricular changes to address needs in advanced medical device prototyping including training students in advanced CAD/CAM, additive manufacturing, design and fabrication of catheter based devices, and design/prototyping of shape memory/superelastic NiTiNOL implants/devices. SA3: Enhanced Senior Design-Engineering Prototypes for Preclinical Testing to improve significantly the quality of medical devices designed by students enabling realistic preclinical testing and translation to intellectual property. SA4: Expand collaboration across Colleges and Schools by formalizing the relationships with other engineering programs, as well other colleges including design and business.
Translation of medical technology based discoveries into commercial clinical relevant products is limited today by the level and quality of relevant trainin imparted to the growing Biomedical Engineering workforce in their undergraduate curriculum. While significant effort and funding is allocated for basic research, there remains a tremendous need to provide Biomedical Engineering undergraduate students with an education experience that also mimics the industry setting and prepares them to be more effective in interfacing with clinicians in terms of defining the unmet needs, clinical problems, and designing and building novel device based product solutions. This proposal addresses this very important issue of industry relevant training in medical device development at the University of Cincinnati by instituting major modifications to an already successful undergraduate program in medical device innovation & entrepreneurship (MDIEP).