Posts categorized as“Western Region”

Wayne Malone

Five Medical Device Commercialization Tips to Enable Success

Commercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product. This blog describes how our commercialization team “Make it Real” by developing robust commercialization strategies that engage a cross-functional team from engineering, production planning and supply chain.

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The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19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 […]

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