Posts categorized as“Western Region”

Nadia Routhier

Cardboard Mock-Ups Vs. 3D Printing for Rapid Iterations

When I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new […]

Diana-Holden

FAQs for Potential EE Co-ops

Co-op students answer FAQs and share their experiences Want to experience the Biomedical Device industry from a front row seat? Consider doing a co-op term with an Electrical Engineering (“EE”) team. Diana Cancelliere and Holden Jones answer FAQs that potential EE co-ops may have. “The hands-on industry experience gained during our co-op term at StarFish […]

Thor Tronrud

Tips to Avoid Medical Device AI Pitfalls

Roughly 80% of human brain volume is made up by the neocortex, a set of highly interconnected layers of neurons that controls our higher brain functions, such as perception, cognition, motor control, and language. This massively parallel architecture is the initial inspiration for Deep Learning – a neural network paradigm that excels at pattern recognition […]

Alexandra Reid

Preparing EUA Medical Devices for Post-Pandemic Use

The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal […]

Alexandra Reid

Regulatory Science Tools Reduce Risk in New Medical Devices

The FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices. A Catalog of Regulatory Science […]

Nigel Syrotuck

How to Conduct Particulate Pre-Testing for ISO 18562-2:2017

Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger […]

Nigel Syrotuck

How to Perform Medical Device Drop Test

Medical Device Drop Test Per IEC 60601-1 Ed 3.2 Clause 15.3.4 Medical Device Drop Test and Push Test are part of IEC 60601-1. This blog describes two of the most common mechanical tests that medical device designers may want to perform in-house before sending a device for third party testing.

Aaron Philippsen

Three Physical Connection Methods in Medical Device Test Fixtures

Physical testing is an essential tool for product development, particularly when developing a novel medical device. When well designed, a physical test can accurately represent phenomena that are difficult to model, and physical tests can often be constructed quickly with a minimum of custom components. Here are three connection methods that I have found useful […]

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