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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Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.
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Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.
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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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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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Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.
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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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Designing BLDC motor drive electronics focuses on the particular strategy of driving the motor windings with sinusoidal waveforms.
