< 1 min reading time I’m trying to put together a very high level view of medical device development for novice (meaning no prior experience in the industry, not just this is their first invention) inventors. I am interested to hear from others what (if any) role they have seen research play in the process of developing a new medical device, including at what point in the process the research occurred. Did most of the research occur pre-IP? Pre-POC? Did any occur after the design process (user requirements, design inputs, V&V plan, etc.) got underway? P.S. Does anyone here has been involved in medical device development at a medical device company think that a data collection activity (bench testing, clinical trial) done to verify or validate the design could appropriately be described as “research?” Marked as spam  Posted by Asked on August 30, 2018 9:20 am 276 views |
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 Private answer Caitlin Morse, PMP Working in development of devices, we typically used “research” to refer to 1) the technology development that precipitated the product development aka the “R” of “R&D” OR 2) Market research/user research done by HF&Marketing including clinical evaluation. Of course, research is a broad term and could apply to almost every dept at some point (patent searches, material properties, obscure standards, industry best practices, lessons learned including adverse events and recalls of predecessor products, you name it). I spend a lot of time giving clients this overview and walking them through what to expect for a product development lifecycle all the way through to manufacturing as it applies to their product type and risk analysis. Feel free to let me know if you have more specific questions M&M Consulting can help with. Marked as spam | |
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 Private answer Michael Tar Whatever the definition of research, or the type, or the stage of development, there’s a great reason for founders to engage third party help: confirmation bias.* When Founders get an idea they need money to develop it, and the best way to get that money is to devise a story that “sells” (or leads to an exit). That makes it very easy to “find what you’re looking for”, ignore hidden pitfalls, and go after the biggest fish in the sea rather than a smaller one that you can get into the boat. Your good idea can quickly turn into a brilliant idea, and subsequently fail, because you decided to climb Everest rather than a short flight of stairs. Here’s a link to our resource library which is a great place to start: * the tendency to interpret new evidence as confirmation of one’s existing beliefs or theories. Marked as spam |
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