This week on Beyond Clean we speak with Shawn Flynn, a Consultant, Entrepreneur, and Medical Device Inventor who is the founder and President of The Peritorum Group. Shawn gives listeners a look inside the process of gaining 510k approval and building a quality system that includes a risk analysis component. Dealing with various cycle times, the resulting bottleneck, and who to contact when dealing with smaller startup device companies is also covered. While there can be great pressure to cut corners in order to meet demand, Shawn encourages technicians and managers to have the backbone to say no and advises that the good device representatives will support the smart and safe decision. Hank and Justin then raise the topic of UDI regulation and the possible role it could play in improving communication, especially in regards to real time updates of the Instructions for Use. The interview closes with the feasibility of requiring manufacturers to choose from three standard processing options and if employing an expert in sterile processing would help the technical writers develop instructions that can be more easily interpreted.
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