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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How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.
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Six BioManufacturing Trends to Watch in 2022 and the future of BioManufacturing analyzed by Bioscience and medical device experts.
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Developing Regenerative Medicine or Microfluidic-Based assays? 3 reasons why biotechnology companies should think Canada.
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Integrating Microfluidics into Biomanufacturing overview and top 4 enabling features of microfluidics for biomanufacturing.
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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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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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Medical Device Design for the Developing World – why are there so many nonfunctional and broken medical devices in low-income regions?
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Questions and resources to help you find the right medical device development partner for your unique needs and requirement.
