Presentation
Designing Simple Instructions for Medical Products
DescriptionUntil recently, IFUs (instructions for use) accompanying a medical product, such as a medical device, combination product, or in vitro diagnostic device, have been undervalued. IFUs were considered by many to be obligatory – required by regulators. However, they were not considered key to a product’s success, at least not by most manufacturers. The prevailing view among many manufacturers was that product users did not read the instructions, so why invest in making them great? Today, the need to conduct human factors validation testing of Class II and III products seems to have changed the mindset.
Product developers have come to appreciate that a well-designed IFU can help people interact safely and effectively with a product in real-world use and during a human factors validation test. In the latter case, an IFU may prevent use errors and other usability problems that can derail validation efforts. For example, an IFU that clearly delineates the steps for applying a heart monitoring patch to the chest and recording cardiac symptoms can be the key to error-free use, which in turn may streamline regulatory approval and help drive the product’s commercial success.
This workshop focuses on the practicalities of designing IFUs that help to ensure the safe and effective use of medical products. During the workshop, Wiklund and Larson will draw upon their collective hands-on experience and the content of their new, co-authored book, titled “Designing Simple Instructions for Medical Products,” which is pending publication (Routledge Press, 2024). They will cover the following topics of interest:
The benefits and costs of an IFU
Developmental steps
Selecting and organizing content
Choosing an optimal format
Employing an optimal writing style
Communicating effectively with graphics
Differentiating and drawing attention to critical information
Preventing use errors
Creating visual appeal
Evaluating an IFU’s performance
The workshop will include both lecture and group exercises. Attendees should draw from the workshop a strong appreciation for IFU design excellence and working knowledge of how to achieve it.
Product developers have come to appreciate that a well-designed IFU can help people interact safely and effectively with a product in real-world use and during a human factors validation test. In the latter case, an IFU may prevent use errors and other usability problems that can derail validation efforts. For example, an IFU that clearly delineates the steps for applying a heart monitoring patch to the chest and recording cardiac symptoms can be the key to error-free use, which in turn may streamline regulatory approval and help drive the product’s commercial success.
This workshop focuses on the practicalities of designing IFUs that help to ensure the safe and effective use of medical products. During the workshop, Wiklund and Larson will draw upon their collective hands-on experience and the content of their new, co-authored book, titled “Designing Simple Instructions for Medical Products,” which is pending publication (Routledge Press, 2024). They will cover the following topics of interest:
The benefits and costs of an IFU
Developmental steps
Selecting and organizing content
Choosing an optimal format
Employing an optimal writing style
Communicating effectively with graphics
Differentiating and drawing attention to critical information
Preventing use errors
Creating visual appeal
Evaluating an IFU’s performance
The workshop will include both lecture and group exercises. Attendees should draw from the workshop a strong appreciation for IFU design excellence and working knowledge of how to achieve it.
Event Type
Workshop
TimeSunday, March 248:00am - 12:00pm CDT
LocationSalon A-3