Posts categorized as“Uncategorized”

Nathan Muller

3D Printed Parts Streamline Development Process

This blog provides a context for designers to streamline their development process using 3D printed parts as a part of their market-ready medical devices. 3D printing is disruptive. It challenges the way that designers consider product development. Contrasted with traditional fabrication methods, 3D printing offers several benefits along with certain limitations. Regulatory agencies are providing […]

Brian King

Coupling Light from LEDs and Light Guides in Medical Devices

Moulded plastic light guides are an inexpensive means to “pipe” light around inside a medical device. Their design process makes light guides amenable to a variety of shapes and sizes.  Applications include delivering light to an indicator, a switch, or a peripheral diagnostic attachment, thus, these optical guides are an attractive technology for solving a […]

Brian King

Five recommendations for approaching medical device optics projects

Five powerful perspectives for the Optics Laboratory Implementing medical device optics projects like a novel measurement scheme, or bringing up a breadboard prototype for the first time, is a dynamic and messy endeavour. I’d like to share five key recommendations for approaching such journeys based on my 25 years of designing and implementing laser-based measurements.

Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Laura Gouzecky

How ERP Benefits Medical Device Commercialization

I’m often asked how ERP benefits medical device commercialization. Enterprise resource planning (ERP) is a very powerful tool that helps many companies succeed.  The medical device industry faces unique challenges from FDA and CFR requirements, regulations, and standards. These challenges mean that ERP can aid medical device commercialization even more than other industries and products.

Nick Allan

How to research the Infectious Disease Diagnostics market potential

The internet is full of great research data. This blog shows how to research four questions one should address when considering Infectious Disease Diagnostics market potential by using public information. I explain how publicly posted research and reports can help analyse and build answers for activities like developing a new PoC Assay.

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]

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