Human Factors Considerations as they Apply to Software as a Medical Device (SaMD)

What you'll learn: Designing SaMDs using human factors guidance

Most medical devices today include physical user interface elements… dials, knobs, levers, and other similar components used to control the device. As medical devices adopt more advanced technologies, their reliance on software has been increasing. Typically though, the software is accessed through a graphical user interface embedded in a physical device. Regardless of how much of the device controls are hardware versus software, human factors guidance and best practices should be applied to optimize the usability of the devices. Therefore, when Software is used as a Medical Device (SaMD) itself, similar guidance and processes should be applied. However, there is little regulatory guidance regarding assessing the risk and usability issues unique to SaMD.

About the presenters

Cory Costantino | Director, User Interface Design, HFR&D

Costantino is the Director of User Interface Design Emergo by UL’s Human Factors Research & Design (HFR&D) team. Cory has been with the team since 2010. Cory is a board certified human factors professional. He received his M.S. in Human Factors in Information Design from Bentley University and his B.S. in Industrial Design from Wentworth Institute of Technology. Cory oversees and contributes to a wide range of projects including software user interfaces, instructional materials, hardware/ergonomic design reviews, and multi-phase projects, where he often contributes to user research and usability testing. Cory has served as design director and co-founder of two start-up companies, an adjunct professor of design, and as a design consultant. For more than 20 years, he has helped guide products, from hand-held consumer electronics to medical devices and software user interfaces, from concept to production. His unique and diverse experience enables him to deeply understand the intersection of client resources, user needs and design vision.

Merrick Kossack | Research Director, HFR&D

Kossack is a Research Director based in Chicago, IL. Merrick has worked in human factors for over 25 years, predominantly in the medical device industry. He has a long history of developing successful strategies to address device manufacturers’ human factors engineering needs, particularly for complex and high-risk systems such as infusion pumps, dialysis equipment and robotic surgical systems. Merrick has developed and taught courses on human factors in medical device development and delivered numerous presentations on the subject including integrating human factors into a design and development process and conducting complex validation studies. He is also a contributing author to the book Applied Human Factors in Medical Device Design (2019). Merrick has been an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee responsible for the creation of human-factors-related standards and guidance.