MDDI_Medical Device & Diagnostic Industry

MDDI, October 2012

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So, what about the argument that the 510(k) program stifles innovation? We are excluding innovative business models (i.e., devices that are part product and part ser- vice), innovative marketing (i.e., direct sales to patients), and innovative manufacturing (i.e., molding rather than machining) of med- ical devices. Also, we are not talking about the PMA program, which requires FDA- supervised clinical trials, extensive data analyses by FDA biostatisticians, and de- tailed audits of design and manufacturing processes. That process takes considerable time, but we are obliged to balance that against practitioners and patients getting devices that are reasonably safe and effec- tive. In return, federal preemption shields the manufacturer. When you discuss innovation in the con- text of the 510(k) program, you are refer- ring to technological innovations. Marginal innovations are considered innovations in academic circles, but not by the public. Technological innovation is typically an incremental process, which may decrease cost, increase reliability, and so forth. Mar- ginal innovation is making a clone; it is not a significant improvement. For the 510(k), the issue boils down to figuring out how to do the testing neces- sary to support your claim that there is low or very low uncertainty about establish- ing reasonable safety and effectiveness for the intended use of the device. This often means recognizing what consensus stan- dards and engineering best practices apply to the device. Some are "horizontal" (i.e., electrical safety, biocompatibility, software development, and human factors issues) and some are "vertical" (they only apply to a specific type of device). In other cases, it means recognizing that particular special controls exist; all special controls are verti- cal standards. It can also mean doing a piv- otal clinical trial, because bench testing and animal testing are insufficient.3 To avoid wasting time, it's important to understand both the applicable consensus standards and any special controls and do the required testing. Have a third-party lab- oratory do the testing, or get help from an expert consultant. Conducting testing com- pletely and correctly and then presenting it clearly reduces the changes of delays. Some may say, "Well, that is not my experi- ence." But make sure you are not comparing apples and oranges. There is no justification MD+DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY for additional information (AI); if not, expect an AI letter. References 1. EM Rogers, Diffusion of Innovations, 5th ed. (New York City: Free Press, 2003). 2. E Mansfield, Industrial Research and Techno- logical Innovation: An Econometric Analysis (New York City: W. W. Norton & Co., 1968). 3. FDA, Draft Guidance for Industry, Clinical In- vestigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clini- cal Investigations for Medical Devices. August 15, 2011. G.M. Samaras is a biomedical scientist and engineer in private practice. He is a licensed professional engineer, board-certified human factors engineer, and an ASQ-certified quality engineer. He has worked at the FDA/CDRH as a reviewer and manager. 2 Custom Extrusion Insert Molding Striping & Multilayer Coextrusion Balloon Tubing Multilumen Tubing Heat Shrink Tubing Lead Tubing Injection Molding Balloon Molding Wound Drains Dip Casting Silicone Sheeting Balloon Blowing Rapid Extrusion Assembly & Secondary Operations Complete manufacturing and support services for your medical device. Vesta provides custom manufacturing solutions exclusively for the global medical device industry. Solutions include tight-tolerance silicone molding, precision extrusion of thermoplastics and silicone through our proprietary ExtruMed™ process, quick-turn extrusion and medical device assembly. Leveraging expertise in quality standards and design for manufacturability, Vesta infuses value at every stage of the product lifecycle. Visit us at: MD&M Minneapolis, booth 1230, or at vestainc.com 9900 57th OCTOBER 2012 | 35

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