The Consumer Medical Device Explosion

As the worlds of medical devices and consumer products converge, there are exciting new opportunities and challenges when companies expand into uncharted waters. But what are the primary pitfalls and missteps that can be avoided when entering this new space? Kevin Young, IDSA, of Continuum will share best practices and the story of the iluminage Skin Smoothing Laser—an FDA approved Class II consumer health device that’s one of the world’s first Internet of Things devices in the beauty category.

The Human Hand: Five Human Factors of Medical Design | Bryce Rutter

More than 95 percent of all the products we interface with daily involve the use of our hands in some way. We use this anatomic “tool” hanging from our shoulders to pull, twist, grip, pinch, move, steer, hold, squeeze, turn, lift, scratch, slide, tighten, bend, tap and open—among other motions. But how do we intuitively know which grip to use; how many fingers to use; how to sense the characteristics of the things we touch; and their temperature, mass, scale and form?

Our 10 fingers provide us with enormous capability.  In this workshop, Bryce Rutter, PhD, IDSA, illuminates five, key, human factors that impact medical design.



Turning Qualitative Insights from User Research into Value-driven Business Opportunities | Cheryl Kwinn | Scott Woodruff

Cheryl Kwinn and Scott Woodruff from Farm Design will take participants through a hands-on, interactive workshop focused on combining design research methods with strategic consulting tools. Working in collaborative groups, attendees will be introduced to several unique approaches to the business and industry-related challenges they currently may be facing. 

Kwinn and Woodruff will show how to take broad qualitative user feedback, and—through a process of data analysis and synthesis—filter a wealth of insights into a handful of actionable, financially viable product and service opportunity areas.

Usability and Hazard Analysis | Edith Maverick Folger

Usability studies gather structured users’ input for the design of both safe and popular products.  Early usability studies give valuable input, but later usability verification and validation protocols demonstrate that targets were met for compliance (IEC 62366). Usability validation tests the user-faced usability requirements, and the results provide input (confirmation/mitigation) into the project’s risk management file. 

Edith Maverick Folger of Boston Scientific will provide an introduction into the regulations around usability/human factors and how they fit within the Quality System Risk Management structure for successful product launch.

Using/Coordinating Multiple Research Methods to Guide Design | Brad Fain, PhD | David Cowan

Disability is a product of the interaction of a person’s functional capabilities and the environment. It is important that design professionals be able to identify and remove barriers to use for individuals experiencing diminished, functional, cognitive sensory or physical functional abilities because of chronic diseases. Brad Fain and David Cowan will discuss research methods and inclusive design practices that help ensure individuals who are managing chronic diseases,  are considered during the design process.