Medical device development.pdfVIP

FutureTech Strategies, Inc. Medical Device Development Contrasting Key Elements with Drug Development Arthur H. Combs, MD, FCCP, FCCM FutureTech Strategies, Inc. An Entrepreneurial Perspective ? Basic Development Process ? Comparison with drugs ? Regulatory Pathway ? Comparison with drugs ? Cost and Time to market ? Venture Capital Investment ? Impact of Enabling Technology ? Device-Drug Comparison Matrix FutureTech Strategies, Inc. Medical Device Development ? Elegant technological solution to a real clinical problem or unmet need ? A substantial addressable market of customers who will pay for the solution ? A well designed product that meets customer needs in their environment ? Cogent strategy for regulatory clearance and market launch FutureTech Strategies, Inc. Basic Device Development Pathway Product and Process Design Final Design Freeze Mfg. Ramp Product Concept Design Concept Prototype Clinical Prototype Unmet Need Customer Require- ments R es ea rc h Market Assess- ment Product Develop- ment Plan D es ig n Va lid at io n P D P Regula- tory Pathway Clinical Testing Field Input Market Support Studies Regula- tory Clearance Final Product Product Launch Marketed Product Minimum 2 Years, Maximum 10 Years, Average 3-5 Years Create Make Go to Market FutureTech Strategies, Inc. Basic Drug Development Pathway 7 – 9 Years, Average 8 Years FutureTech Strategies, Inc. But… Preclinical Drug Development Preclinical Development Can Add 5-7 Years Industry Benchmark Major Pharmaceutical Companies: From NME to Market ~ Average 8–10 Years, $800 MM - $1.0 B FutureTech Strategies, Inc. Regulatory Pathway- Devices ? FDA Offices Involved ? CDRH – Center for Devices and Radiologic Health ? ODE – Office of Device Evaluation ? OIVD – Office of In Vitro Diagnostics ? 2 Major Pathways ? PMA – Pre-Market Approval Application ? 510(k) – Pre-Market Notification ? “Substantial Equivalence” to a previously approved device