Issues in Translation of Regulated Medical Products to the Marketplace

Although nanotechnology as a known concept has been applied for many years to medical products, it is currently a burgeoning field of research and development. The technology implemented as powders, surfaces, porous structures, suspensions, liposomes, micelles, etc. provides the properties needed for many devices, drugs and combination products in current therapeutic and diagnostic use. Common to other medical products, before implementation as clinical products, nanotechnology-based medical products must meet a rigorous set of safety and efficacy specifications. Test protocols may be run according to established standards for drugs, and for device biomaterials, components and finished products. But, because living tissues behave differently between nano- and larger structures, unique test protocols must be developed for the former. Conceivably, expenses incurred in qualifying new, potentially “disruptive” nanotechnology-based medical products may exceed those of more conventional products. As is often encountered in product development, there materializes the “valley of death” of a promising concept after “proof of principle” and before major resources are designated for application to the required development program. A successful outcome usually requires a strategy based on knowledge of potential resources, leadership in attaining the resources and passionate dedication of staff to executing the development plan. Before committing to such an undertaking, a set of “imperatives” stated in the oral presentation should be considered and “checked off” as potentially feasible. Failure to achieve even one of these imperatives would seriously compromise chances for a commercially successful product. Consideration of bridging the “valley of death” by a hypothetical combination medical product and a case study of a successful vs. unsuccessful medical device in light of the list of “imperatives” comprise an important section of the oral presentation.

coury-aArt Coury holds a B.S. degree in chemistry from the University of Delaware (1962), a Ph.D. in organic chemistry (1965) and an M.B.A. (1980) from the University of Minnesota. His industrial career included positions as: Senior Research Chemist at General Mills, Inc. (1965-1976), Director, Polymer Technology and Research Fellow at Medtronic, Inc. (1976-1993), Vice President, Research and Chief Scientific Officer at Focal, Inc. (1993-2000), and Vice President, Biomaterials Research at Genzyme Corporation (2000-June, 2008). He currently is a consultant and academic professor. His career focus has been polymeric biomaterials for medical products such as implantable electronic devices, hydrogel-based devices and drug delivery systems. He holds over fifty five distinct patents and has published and presented widely in his field. His prior or current academic service has included adjunct or affiliate appointments at the University of Minnesota, the Harvard-MIT Graduate Program in Health Sciences and Technology, the University of Cape Town, South Africa, the University of Trento, Italy, Sichuan University, China and Northeastern University. His professional service has included: Chair, Minnesota Section, American Chemical Society (1989-1990); President, Society for Biomaterials, USA (1999-2000); President, American Institute for Medical and Biological Engineering (AIMBE) (2003-2004) and membership on a number of university, professional society and corporate advisory boards. His recent recognitions have included the delivery of distinguished lectureships, receipt of the 2007 Innovation and Technology Development Award of the Society for Biomaterials, being named as one of “100 Notable People in the Medical Device Industry” by MD&DI magazine, 2008, induction into the National Academy of Engineering, USA, 2009, recognition on the University of Delaware alumni “Wall of Fame,” 2010, “The Man, the Myth, the Materials,” a symposium in honor of Art Coury’s 70th birthday, 2010, induction as an American Chemical Society Fellow, 2011, recipient of the Society for Biomaterials Founders’ Award, 2012 and its C. William Hall Award, 2013 , of the AIMBE Pierre Galletti award for 2012, of the University of Minnesota Outstanding Alumni Award for 2013, appointment as Honorary Professor, Sichuan University, Chengdu, China (2013), and University Distinguished Professor, Northeastern University (2014), and recognition with the Directors’ Award of the Harvard/MIT Joint Program in Health Sciences and Technology (2016).