Lynne Lowry

International Women’s Day – Dr. Stephanie Willerth on her Career and Women in STEM

Women STEM Stephanie WillerthInternational Women’s Day (IWD) is that time of year when we celebrate the achievements of women all around the world, from political leaders and social activists to business visionaries and MedTech pioneers.
For me, as an executive woman in MedTech, IWD is a wonderful opportunity to recognize the women in my field who drive innovation and elevate and advance gender parity in technology – women, like Dr. Stephanie Willerth.

Continue reading »

Joris van der Heijden

A Guide to Lean and Agile Medical Device Product Development

Lean Medical Device DevelopmentThe success of development programs in the medical device and equipment industry almost always relies on hitting technical milestones that coincide with internal or external fundraising efforts.
Especially early in the program, it is critical to hit technical milestones in a cost-sensitive and timely manner. This will eventually determine if a program has legs or will be terminated.

Continue reading »

Susan Bantroch

Assay Verification in POC Medical Devices

POC Assay Verification Medical DevicesInterference Testing, Strategy, and Detection Case Study

The importance of performing assay verification BEFORE incorporation into a medical device can not be overstated. Countless hours and dollars can be wasted designing the perfect device if the detection assay fails in the field.
Successful Point-of-Care (POC) medical devices increasingly rely on new and innovative analyte detection systems. Rapid test results, faster disease assessment and reduced health infrastructure costs have led to an explosion of assay development.

Continue reading »

Nick Allan

Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference

Autonomous Clinical Chemistry Assay DesignThis review highlights how designing Autonomous Clinical Chemistry Assay diagnostic products with kinetic read outs helps mitigate challenges with interference that are especially relevant in point of care diagnostics (POCD).
Topics covered include Kinetic Assay Versus Endpoint Assay, Point of Care, Hook Effect, Clinical Laboratories Standards Institute, and real time laboratory diagnostics.

Continue reading »

Collins Nzom

What Recruiters Seek in Candidates

Medtech Recruiters Candidates InterviewA few weeks into my role as a recruiter at StarFish Medical, I was surprised to discover that while many positions had similar or even identical titles as seen on most job boards, the experience and skills required to perform them varied widely.
So, when I began recruiting for our open roles my first instinct was to search for candidates from within our industry that would have experience with the same kind of regulatory controls, quality management practices, and design and development tools we have here.  But I quickly learned that that was not enough, and why at StarFish, we take a different approach to finding new talent.

Continue reading »

Alexandra Reid

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

FDA Health Canada eSTARThe U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot.
The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for participating in the pilot are now open to a maximum of nine participants.

Continue reading »

Astero StarFish

Medical Device Commercialization Resolutions for 2023

Medical Device Commercialization ResolutionsHave you made your medical device commercialization resolutions for 2023? We polled our quality, regulatory, project management, manufacturing, and engineering experts for their New Year resolutions. De-risking early, communicating often, testing, and managing pivots were top themes for 2023.
Read their medical device commercialization resolutions below:

Continue reading »

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks