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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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.
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Microfluidics for molecular and serological diagnostic tests enable shorter turnaround times, high accuracy results, and lower cost per test.
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Questions and resources to help you find the right medical device development partner for your unique needs and requirement.
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Verify Environmental stress cracking (ESC) quickly, it's one of the most common failure mechanisms in parts made of polymeric materials.
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RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.
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FDA ASCA Pilot Program is expected to bring medical devices to patients and users more efficiently by using ASCA-accredited labs.
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Medical device artificial intelligence (AI) overview of AI, applications and devices, investment landscape, and regulatory implications.
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Biotech in medical device companies: 3 compelling reasons to pursue a Bio Services career in medical devices.
