Medical device usability is a critical, yet confusing component of medical device design, development, regulatory, marketability, and product success. Although three things are clear when it comes to your processes around usability for your medical device: do it early, do it right, and don’t try to cut corners. In this episode Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research, joins Jon Speer as his guest to discuss this topic, stressing the importance of usability and how you can integrate usability into your medical device. Some of the highlights of the show include: - Usability: Align and combine with other components to produce a successful medical device product and business. - Design Controls: Who are your users? What are their medical device needs? What appeals to them? What are they using now? - Risk Management: Start usability testing and human factors engineering early on and throughout the design process to mitigate errors and last-minute changes. - Perpetual Perfection: Why waste your time? Communicate with users to identify what problems need to be solved to intuitively and quickly use a medical device. - Founderitis and stagnated beliefs can prevent innovation and objective ideas that would otherwise be helpful to improve patients’ quality of life when designing, developing, and producing products. - Real World Usability Expectations: User testing, risk assessment, simulated environment with distractions, instructions/training, and documentation. - Usability Issues and Challenges: If you wait to wait to do usability and only do summative evaluation, unanticipated user errors arise and require changes.