This blog explores in silico medical device drop testing VS traditional benchtop methods. Medical device design must address how a device is used and handled (e.g., handheld, benchtop, self-supporting, etc.).
StarFish Medical YouTube subscribers grew 50% in 2022. What medical device commercialization videos were they watching?
Personalized medicine approaches can transform the field of biomanufacturing through the use of additive manufacturing technologies. Successful implementation of such processes requires an interdisciplinary effort with engineers, biologists, and clinicians working together to achieve success developing regenerative medicine, microfluidic-based assays, or cell therapy applications.
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 […]
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 […]
You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner? Finding the right development partner can be a daunting task, even in the best of times.
The job hunting landscape is always changing and over the past several years it has been increasingly challenging for candidates to find the right company. In response to the pandemic these trends have become more noticeable as we all learn to navigate the new and often remote workplace, see the impact of reduced work forces, […]
This blog shares how to identify which medical device standards apply to the device you’re bringing to market and provides an overview of major standards at various regulatory levels for novices.
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.
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’.
Developing a consumable for your point of care diagnostic solution? This blog highlights my top recommendations for translating point of care assays that are simple, low cost and easy to use.
Microfluidic systems, also referred to as “lab-on-a-chip” (LOC), “biochips”, or micro-total-analysis-systems” are widely used in the Biotech industry. This blog shares six tips for developing a “lab-on-a-chip” (LOC) solution.
