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.
Medical Device Supply Chain strategies have been evolving since the 1990s. It started with the famous “Pick two from: better, faster, or cheaper”. You could not have all three… Then in the 2000s with the rapid expansion of high-tech companies, the medical device supply chain strategy umbrella expanded to include better, now, cheaper, agile, global, […]
So, you have toiled through the design process and successfully launched a product to manufacturing and are looking to add value to your existing design. Where should you focus your budget? This blog outlines questions you can ask yourself to evaluate your device capability and reinvest in your product to add value.
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 […]
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 […]
My goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project. In my experience, dealing with the fires of the day always take precedent over managing things that […]
Developing innovative and life-changing products provides a wellspring of inspiration as our “destinations.” But “anything worth doing is never easy” and this is a pretty accurate capture of medical device product development. If we are going to spend most of our time on the journey, wouldn’t it be a whole lot more enjoyable if we […]
With the design and prototyping of exciting novel technologies dominating the spotlight in product development, medical device verification and validation (V&V) activities sometimes don’t get enough attention during project planning.
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 […]
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 […]
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 […]
Many techniques can be employed in order to simplify formal verification testing. These techniques expedite the product development process and reduce cost. During verification planning, the required sample size (and therefore the number of devices that need to be built prior to production), can be minimized by the choice of verification method.