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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Overview of the FDA action plan for AI/ML in software as a medical device (SaMD) and list of best practices.
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2021 top medical device commercialization videos cover 2021 updates, optimizing founder value, manufacturing for NPI, IVD insights. and more.
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2021 “most read” list: Electrical engineering and regulatory articles tie for the most popular blog topics.
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Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.
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Considerations when developing a diagnostic product that is intended for use outside a traditional laboratory.
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Five examples of Microfluidic Machine Learning enabling microfluidic technologies to push into new areas and applications.
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The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.
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The main success criteria for medical device companies after earning FDA regulatory clearance is securing positive coverage decisions from payers. While regulatory approval is sufficient to get a product to market, it has no bearing on product adoption. The availability of reimbursement has a direct impact on therapy adoption – it can “make or break” a product1. This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.
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FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.
