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  Developing a Diagnostic Product for Use Outside a Laboratory

  Considerations when developing a diagnostic product that is intended for use outside a traditional laboratory.

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  Microfluidic Optics in Diagnostic Platforms

  Microfluidic Optics explores ways that lenses can be implemented on microfluidic cartridges can play an important role in microfluidic platforms,

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  Five Critical Considerations in Designing Microfluidic Cartridges

  Designing Microfluidic Cartridges offers five critical considerations to increase success during microfluidic cartridge development.

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  Five Applications Using Microfluidic Machine Learning

  Five examples of Microfluidic Machine Learning enabling microfluidic technologies to push into new areas and applications.

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  Regulatory Checklist

  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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  US Reimbursement Codes for Medical Devices

  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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  Choosing a Medical Device Camera Sensor

  Medical Device Camera Sensor technical trade-offs to consider when incorporating a visible or near-infrared range camera sensor into a medical device. 

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  Optical Safety for Ophthalmic Instruments

  Optical Safety for Ophthalmic Instruments covers safety limits and maximum exposure limits of wavelengths in the IR, UV and visible light spectrum.

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  Strategies to Maximize Medical Device Optical Signals

  Maximize medical device optical signals by keeping sensor and control signals correlated and other strategies are discussed in this article.

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