Resource Centre
Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.
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Six common medical device product development destinations and overview of a High Level Program Planning (HLPP) approach.
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The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.
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Engineers, regulatory advisors, and patent filing teams should review the MAUDE database as part of development and due diligence process.
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Medical device CFD simulations allow you to generate images and videos with little effort to predict and optimize fluid and thermal paths.
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4 tips to collect meaningful user data for emerging medical device technology and take an appropriate level of risk and reward.
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Medical Device Development tools to select the right concept and make more effective technical decisions using the Concept Downselect Matrix.
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Microfluidic Development Tools in Medical Devices are an example of Medical applications enhanced by a whole host of adjunct technologies.
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Making a medical device manufacturable is a common scope of work. 5 ‘make it manufacturable’ suggestions for medical devices.
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ISO 10993-1 and Biocompatibility impact on Medical Device Plans. Financial impact of additional Medical Device testing will have a cost.
