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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Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.
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Overview of Cleanroom Validation Testing for Medical Device Manufacturing Cleanrooms based upon actual Toronto facility experience.
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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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Considerations when developing a diagnostic product that is intended for use outside a traditional laboratory.
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Microfluidic Optics explores ways that lenses can be implemented on microfluidic cartridges can play an important role in microfluidic platforms,
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Designing Microfluidic Cartridges offers five critical considerations to increase success during microfluidic cartridge development.
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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.
