title: Strategies for Derisking Translational Processes for Biomedical Technologies.
abstract: Inefficient translational processes for technology-oriented biomedical research have led to some prominent and frequent failures in the development of many leading drug candidates, several designated investigational drugs, and some medical devices, as well as documented patient harm and postmarket product withdrawals. Derisking this process, particularly in the early stages, should increase translational efficiency and streamline resource utilization, especially in an academic setting. In this opinion article, we identify a 12-step guideline for reducing risks typically associated with translating medical technologies as they move toward prototypes, preclinical proof of concept, and possible clinical testing. Integrating the described 12-step process should prove valuable for improving how early-stage academic biomedical concepts are cultivated, culled, and manicured toward intended clinical applications.
authors: Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany. Electronic address: mohamed.abou-el-enein@charite.de.
authors: Mohamed
authors: M
authors: Abou-El-Enein
authors: Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany; Julius Wolff Institute (JWI), Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.
authors: Georg N
authors: GN
authors: Duda
authors: R&D Consultant, 10 Ashwood Lane, Malvern, PA 19355, USA.
authors: Elliott A
authors: EA
authors: Gruskin
authors: Department of Pharmaceutics and Pharmaceutical Chemistry, University of Utah, Salt Lake City, UT 84112, USA; Department of Bioengineering, University of Utah, Salt Lake City, UT 84112, USA.
authors: David W
authors: DW
authors: Grainger
mesh_terms: D000465:Algorithms; D001709:Biotechnology / Q000379:methods / Q000458:organization & administration*; D018795:Device Approval; D017277:Drug Approval / Q000379:methods / Q000458:organization & administration*; D015195:Drug Design; D004867:Equipment Design / Q000379:methods; D019544:Equipment Failure Analysis / Q000379:methods; D017146:Models, Organizational; D012308:Risk Management / Q000379:methods*; D057170:Translational Research, Biomedical / Q000379:methods / Q000458:organization & administration*