Human factors and usability engineering aim to optimize the interactions between people and devices, which have grown nearly ubiquitous in recent years. Since 1996, the U.S. Food and Drug Administration (FDA) has recognized the significance of human factors in medical device design by working to incorporate human factors concepts into formal requirements. Many global product submissions now require a report documenting how human factors engineering (HFE) was considered in the design and risk evaluations of a medical device. And with good reason – a user’s ability to correctly and efficiently operate a device can impact its ultimate safety and efficacy.
In this webinar, hear from a medical device product manager with a deep understanding of the FDA submission process, and a human factors and user experience expert as they discuss the basic principles of HFE, the latest regulatory requirements for HFE in medical device design, tips for how device makers can tackle the discipline in-house, and the benefits that HFE offers to both users and companies alike.
Agenda topics include:
1. What are human factors?
2. What is the FDA’s perspective on human factors?
3. Case studies illustrating the good, bad and ugly of human factors design
4. Making a case for human factors design in your organization