“AI seems to be a thing. Everybody’s excited about ChatGPT.” Asking ChatGPT to list current medical device trends as preparation for our monthly content meeting has turned into our latest group blog. Not surprisingly, the StarFish team identified the same trends proposed by ChatGPT- and more – with six of the most interesting trends making […]
I realized recently that I’ve been leading product development projects for more than a quarter century now, with a bunch more years of product design experience on top of that. Over this time, I’ve collected a list of project management tips that seem more and more valid to me as time goes by.
The 21st century is going to bring massive changes to the medical device development sector and the role of computational modeling and simulation-based medical device development is expected to increase further. In silico studies (physics based computational modeling and simulation) are already being used to virtually test medical devices.
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 […]
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.).
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.
Two new articles made the list of our most-read blogs for 2022. They join eight from last year’s top 10 covering a variety of topics including perspectives on equipment sterilization, firmware testing, and the impact of certain standards and compliances on labeling and vendor selection.
Commercialization of a medical device is the process of transitioning from design and development to a realized, manufacturable, and sellable product. This blog describes how our commercialization team “Make it Real” by developing robust commercialization strategies that engage a cross-functional team from engineering, production planning and supply chain.
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 outlines questions you can ask yourself to evaluate your device capability and reinvest in your product to add value.
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 tips range from general guidelines to regulatory, reimbursement, lean startups, architecture, and hazard management.
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, regulatory, and supply chain activities.
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 intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the […]
