Creativity, Collaborations and Culture from the Lens of a Systems Engineer
I have learned the most important lesson about innovation through my role as a medical device systems engineer: invention and adoption of new ideas is only possible through coherent and feedback driven...
View ArticleHigh Level Program Planning: A Journey, Not the Destination
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...
View ArticleRisk Management for Medical Device Projects
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...
View ArticleHow to Create a Useful Medical Device Project Plan
I could spend a lot of time trying to make sure my medical device project plan is useful. But most effective proof for me is hearing this phrase: “Hey Doug, I was looking at the plan…”. Let’s count the...
View Article30 Bucket List Vacation Plans
Still wondering what to do on your summer vacation. We asked StarFish Medical employees to share their bucket list vacation activities. It’s four years and a pandemic since our first Vacation Bucket...
View Article5 Tips for medical device cyber security
Editor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one here. In this modern world, cyber security and data...
View ArticleQuality Management System Regulation (QSMR) Alignment with ISO 13485:2016
Many organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step...
View ArticleDigital Health Technology (DHT) for Clinical Investigations – FDA Draft...
Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our...
View ArticleUK Medical Device Brexit Implications
On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom....
View ArticleWhy Laser Cutting is My New Go-To Iterative Design Tool
The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and...
View ArticleFAQs for Potential EE Co-ops
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....
View ArticleXR is about to Revolutionize Medical Device Design
Extended Reality (XR) is going to fundamentally shift how medical devices are researched, designed, and promoted. In this post, we’ll discuss how XR changes the future of medical device development and...
View ArticleCardboard Mock-Ups Vs. 3D Printing for Rapid Iterations
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...
View ArticleHow to get the most out of medical device user testing
Do you know the most overlooked step in creating a useful medical device? It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because,...
View ArticleCancer detection technologies on microfluidic chips
When you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to survive and it’s the start of a countdown to death. Most people only know...
View ArticleALARP to AFAP, the MDR and ISO 14971:2019+A11:2021
The risk management approach ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their...
View Article7 New Developments That Impact Medical Devices
We recently asked our engineering and QA/RA leaders which new developments are likely to impact medical devices in the near- and long-term future. Their responses cover a variety of technology,...
View ArticleTips for Better Medical Device Product Definition
The medical device product definition process can make or break a novel medical device. Our experts discussed the topic and offered tips in a recent medical device product definition roundtable. Their...
View ArticleFour Ways to Add Value Post Medical Device Transfer
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...
View ArticleHow to Build a Strategic Medical Device 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...
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