We share our newest and most interesting blog posts in a monthly newsletter.
Inevitably some articles prove more popular than others, so we have consolidated a list of the most read 2022 Medical Device Articles determined by our readers.
Digital Health Technology (DHT) for Clinical Investigations – FDA Draft Guidance Analysis)
As we allow more technology in our lives, we can look forward to more guidance from FDA on how we can leverage the collected data. Raje Devanathan examines the latest draft guidance on Digital Health Technology (DHT) for remote data acquisition in clinical investigations.
Statistical Techniques for Streamlining Medical Device Design Verification
Statistics can help simplify formal verification testing, expedite the product development process and reduce cost. Ariana Wilson and Julian Grove explore statistical techniques for streamlining medical device design verification based on methods we use at StarFish Medical.
8 Tips to Manage Medtech Stakeholder Expectations
Managing stakeholder expectations is a key element in the successful development of any medical device.
Read tips and lessons learned from StarFish engineers, regulatory and quality assurance, system engineers, and project managers.
FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)
Artificial intelligence and machine learning technologies are already changing the world – including the way we look at our current health care practices. Taimoor Khan provides an overview of the FDA action plan for AI/ML in Software as a Medical Device and lists best practices.
Reducing Costs in Medical Device Verification and Validation
With exciting technologies dominating the spotlight in product development, verification and validation (V&V) activities may not get enough attention during project planning – often with costly results.
Matt Lemay shares hidden costs in medical device V&V along with mitigation measures we employ at StarFish.
Medical Device Development Resources
Where do medical device development professionals go for answers when they’re facing a tough question or challenge when developing novel medical devices?
StarFish employees share their favorite medical device development resources and tips.
7 New Developments That Impact Medical Devices
Our engineering and QA/RA leaders share which new developments are likely to impact medical devices in the near- and long-term future. Their responses cover a variety of topics including technology, regulatory, and supply chain activities.
What do Mil-Spec Anodizing Types and Classes Mean?
A core finishing technique around the world, anodizing is highly valued in the medical industry to promote longevity of devices
The different types and sub-types of aluminum anodizing can get confusing, so Nigel Syrotuck reviews the various types and classes per the Mil-Spec A-8625 standard.
How to Create a Useful Medical Device Project Plan
Doug Bailey offers three signs of a useful project plan, examines potential weaknesses of medical device project plans and shares his six principles that can help increase a plan’s overall usability and success.
Preparing EUA Medical Devices for Post-Pandemic Use
The US Food and Drug Administration (FDA) published draft guidance outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE).
Sandy Reid shares how the FDA expects manufacturers to prepare their EUA medical devices for post-pandemic use.
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Image Credits: see individual blogs
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaboration on all of our medical device development projects.
