Class II and Class III medical devices require user testing prior to market release, but recruiting medical professionals to participate in this essential practice can be a serious challenge. With demanding jobs that keep them overscheduled, doctors, nurses, and medical technicians are typically reluctant to make the time commitment necessary to be a user tester. But you absolutely need their participation. In this article originally published in Medical Product Outsourcing magazine, ICS’ Dorothy Shamonsky, Ph.D and Stephanie Van Ness offer four arguments to convince medical professionals to participate.

As consumer devices from mobile phones to smart appliances evolve to become more natural and easier to use, medtech users—physicians, nurses, techs and patients—expect medical device design to evolve as well. This expectation has increasingly compelled medical device developers to collaborate with usability professionals such as user experience (UX) designers in order to provide this heightened level of usability. A skilled designer can create a better user experience that makes your product easier to understand, more pleasant to use, and more successful with users and customers. In this article originally published in Medical Product Outsourcing magazine, ICS’ Dorothy Shamonsky, Ph.D and Stephanie Van Ness offer strategies for selecting the right design team for your specific needs, and incorporating UX into your existing product development process.

With four decades of experience in UX design, ICS' Dorothy Shamonsky, Ph.D has seen the evolution of design from its earliest days. In this episode of the Product by Design podcast we discuss the importance of good UX design, showing the value of UX, and understanding users. We also discuss the current state of UX and the changes to UX and design over the years, including the specialization and siloing of designers. We also discuss the future of technology, including AI and its implications on design. Finally, we explore natural user interfaces (NUIs).

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In this 30 minute Med Tech Gurus episode Milton Yarberry, Director of Medical Programs for ICS, outlines the challenges of design and how to consider clinical workflow early in the design phase. Milton also addresses knowledge gaps and why some knowledge you want on your team and other knowledge you just need to rent!

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Software defects are among the most common reasons for clinical or consumer medical device recalls. That means skipping or scrimping on software testing is not an option. Read our latest article in Medical Design & Outsourcing, written by ICS' Jay Noble and Stephanie Van Ness.

As we continue to expand our medtech practice, ICS has joined the Massachusetts Medical Device Industry Council (MassMEDIC), the largest regional medtech association in the United States. 

For more than a quarter of a century, MassMEDIC has been the voice of the groundbreaking medical technology industry in New England, advocating for sound public policy that supports innovation and fostering a community built on a shared purpose.

A string of IT breaches and ransomware attacks on HIPAA-covered entities has threatened patient care, led to substantial financial losses, and brought unwanted attention to healthcare organizations. In this Medical Design Briefs article, ICS’ Shane Keating and Stephanie Van Ness explore the need for end-to-end protection and offer some key measures to safeguard data and devices.

If misuse of your medical device can harm patients or clinicians, human factors engineering and usability engineering are important for products intended for the U.S. market. While most people working on medical devices are aware of the need, there’s less certainty about the method and decision points relevant to their unique device. ICS' Director of Medical Programs Milton Yarberry gives you things to consider when designing medical device user interfaces. Read the full article in Today's Medical Developments. 

Designing to Minimize Use Errors (PDF)