Mar 2
International 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.
Mar 2
A Guide to Lean and Agile Medical Device Product Development
The 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.
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Mar 1
Assay Verification in POC Medical Devices
Interference 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.
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Mar 1
Autonomous Clinical Chemistry Assay Design Considerations to Mitigate Interference
This 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 »
Feb 3
What Recruiters Seek in Candidates
A 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.
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Feb 3
3 Tips to FUNDRAISE IT FORWARD
Raise more money (and awareness!) for the causes you care about.
Is your company raising funds for community causes? The employees at StarFish Medical have more than doubled the money they donate to The Mustard Seed Food Bank annually under my leadership.
Learn how StarFish has become the Greatest Overall Contributor to the VIATEC Foundation Food Bank Challenge for the last three years in a row. Continue reading »
Feb 3
Client-value production in People & Culture (HR)
HR is not typically the first group you think of being focused on making sure clients get value from our services.
At StarFish, People & Culture are focused on providing the people and the culture that supports this effort.
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Feb 3
The Role of Diversity in Innovation
We’ve been hearing about it for years. Diversity. Diversity in the Workplace. Diverse teams. How does that make a workplace a better place? This blog is about how it makes StarFish Medical a better company. Continue reading »
Feb 1
Strategies to Maximize Outcomes During Pre-Submission Meetings
Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission.
However, if not properly planned or executed, the results of the meeting may frustrate sponsors and end up being and a waste of time for all involved.
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Jan 30
New Cybersecurity Requirements in the US
Cybersecurity is a key consideration in today’s market for medical device manufacturers and other industries. I have previously written about the FDA’s expectations for cybersecurity documentation for medical device submissions, and spoken about this topic at Medical Device Playbook Toronto.
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Jan 20
FDA and Health Canada streamline medical device submissions with joint eSTAR portal
The 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.
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Jan 12
Have 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.