Carolynn Johnson, Daedalus Research Manger, recently presented Management System for a Pediatric Heart Pump: A Design Research Case Study at the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause.This year’s topics was “Advancing the Cause,” and presenters were asked to extend their message beyond “incorporate human factors” and “make it usable.” Carolynn’s message was that human factors and usability are NOT enough – a perfectly usable product that adheres to all human factors may still fail. Why? Because a paradigm shift is occurring in healthcare. Treatments previously only envisioned as taking place in hospitals and clinics are moving into the home. Too often companies seem to believe that medical equipment (usable and rigorously tested for use in clinics) can be cleanly transitioned to the home with a simplified user manual and additional training. They neglect to consider the fundamental differences between the users and the environments; differences that should impact their designs. The consequences can be deadly and illustrate that we simply cannot afford to rely on usability testing and human factors alone to inform our designs.