RAPS Member: $30
Ever since a Quality System Regulation update made in 1996, there has been a mandate to apply human factors engineering (HFE) methods in the course of developing a medical device. Over the ensuing decades, the medical device industry first moved sluggishly and then more hastily to embrace HFE. In the intervening time, HFE became a mandate in the EU and several other regions. Today, it’s fair to say that HFE is standard practice, although the quality of HFE practice varies widely from company to company. Some companies have established robust HFE programs in their pursuit of excellence. Others have taken what can be called a minimally viable approach. The question is: What difference does is make whether a company takes an exemplary versus minimally viable approach?
During his presentation, Michael Wiklund of Emergo by UL, will share sobering data about the epidemic of medical device use error and associated deaths. He will speak about the medical device industry’s moral obligation to produce devices that protect against potentially harmful use error. He will also speak about the positive results that can arise from a major investment in HFE, going well beyond ensuring a device’s safe and effective use. Specifically, he will cite why $1 spent on HFE could return $5-$10 of your organization’s money. He will dive deep into why a product with a high-quality user interface can offer many more benefits including fewer product recalls or returns, reduced demand on customer support, simpler instructions, shortened training, good online reviews and enhancements to a company’s reputation (i.e., brand image).
This program is brought to you by the RAPS Wisconsin chapter and is intended to encourage professional development and engagement among regulatory professionals in the area. Dinner will be provided for all and RAC holders may claim two and one half RAC recertification credits.
Michael E. Wiklund, general manager – Human Factors Engineering, EMERGO by UL
Local contact: Adrienne Lenz, RAC, RAPS Wisconsin chapter
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at firstname.lastname@example.org.