10/2/19 – MDG-Boston Design-for-Usability

Bayard Design LLC is pleased to continue its support of MDG-Boston and contribute to this important topic. Usablity and Usercentric design is key to proper product execution. A product can’t be properly engineered if it can’t be used properly. We’ll see you there!

Medical Device Product Development
Oct 2 – Wednesday
 Design-for-Usability is a Critical Aspect of
Medical Device Product Development

More than a third of medical device incidents involve a use error and more than half of all device recalls for design problems involve the user interface.

Because of this, the FDA has made medical device usability a key topic of concern and has issued guidance.

User experience plays a vital role throughout the development process from early feasibility to validation to prevent these user errors from occurring.

Evan Gyllenhaal, Senior R&D Manager, Boston Scientific
will be the MODERATOR for this panel discussion about the importance of Usability in medical device design from software, hardware, human factors, clinical and regulatory perspectives.

Dorothy Shamonsky, Chief UX Strategy Officer, Boston UX
In February 2016, the FDA issued final guidance to help reduce the frequency of use errors and injuries associated with Medical Devices through the application of Usability Engineering. In, Applying Human Factors and Usability Engineering to Medical Devices, the FDA details its expectations to industry. Part of fulfilling those expectations is a long journey through the Human Factors design process. In this presentation Dorothy will discuss some of the essential processes inherent in good usability design.
Dr. Jason Gee, Urologist, Emerson HospitalAs a clinician, Dr. Gee will address the importance of medical device usability from the user perspective and the importance of collaboration in identifying the most relevant clinical problems to address. Dr. Gee will discuss practical aspects of device development and clinical trial design from a physician/medical perspective.
Bruce Johnston, Senior Software Engineering Specialist, MedAcuitySoftware engineering plays a critical role in medical device usability. When properly implemented and tightly-coupled with a proactive human factors analysis, a software development team can effectively mitigate the risk of usability issues downstream, resulting in optimal project outcomes.

Scott Blood, Principal Quality and Regulatory Consultant, MEDIceptFrom a regulatory perspective, FDA and other regulatory bodies include use-centered studies as part of the validation that your device is safe and effective. The prevalence of home-use devices is making that a priority. It’s important to know the WHY’s as much as the HOW’s when developing your usability plan and protocols. Speaking eloquently to FDA (and others) with this knowledge will ensure success in your device clearance or approval.

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