Perspectives on Embracing Multiple Human Factors Strategies and Agilis Highlights from 2022 HFES Symposium
Perspectives on Embracing Multiple Human Factors Strategies and Agilis Highlights from 2022 HFES Symposium
The 2022 International Symposium on Human Factors and Ergonomics in Healthcare was held in New Orleans on March 21-23, to great success. Agilis presented three podium talks:
Well, It Depends: HF Consultants Discuss Embracing Multiple Human Factors Strategies to Get the Job Done, by Jessie Huisinga, PhD and Elise Edson from Tensentric
Developing a Common Language for Common Goals: Strategies for Integrating User Experience and Human Factors Research by Lauren Jensen, PhD, Rachel Talbott and Ben Purrenhage from Tekna
Connected Medical Products Require Connected Medical Users: Finding Gaps in User Group Technical Capabilities and Strategies to Test Them by Lauren Jenson, PhD and Blake Starnes
This newsletter will focus on the content of our Multiple HF Strategies presentation by Jessie Huisinga from Agilis and Elise Edson from Tensentric, but readers can download the other presentation from our Materials Library of free content.
The main learning objective for the consulting perspectives presentation was to create an understanding of the variety of perspectives and constraints that impact the implementation of human factors activities across sponsors. The goal of the discussion was to provide a perspective across sponsors to the spectrum of HF strategies, based on specific goals, that may be implemented.
The presentation highlighted three major areas that are important to understand when crafting a HF strategy:
Understand the impact different sponsor requirements and priorities have on a HF strategy
How to deal with regulatory evolution of perspective
Understand how alternative approaches may be best for the sponsors goals
Understand sponsor requirements
Sponsors often have a variety of priorities and considerations when they undergo human factors activities. Often, one of the major factors in strategy is the sponsors overall risk tolerance. We refer to this as how conservative a sponsor elects to be with adhering to regulatory guidance. FDA’s 2016 “List of Highest Priority Devices for Human Factors Review” outlines specific products that will have their HF data scrutinized, but this can incorrectly imbue sponsors with a high-risk tolerance for their HF activities.
For example, a client of Tensentric initially had a higher risk tolerance for their product where they were electing to have a smaller user sample size for the validation study because of the difficult logistics and longer timeline of recruiting and testing a larger user group. However, after intervention by a new senior manager, the sponsor elected for a lower risk strategy with a longer timeline. Similarly, an Agilis client initially started with a lower risk strategy by including the most conservative interpretation of potential user groups. After reviewing the cost associated with testing several user groups, the client elected to write justification for combining some of the groups.
Overall, a sponsor’s risk tolerance is affected by a variety of factors, including timeline and often cost. It is an incorrect assumption that cost is a bigger factor for smaller companies compared to very large companies with seemingly endless budgets. Within very large companies, individual business units or divisions have their own budget restrictions. As a result, cost can have a very big influence on the risk tolerance within a human factors strategy. The irony is that if an HF strategy is not sufficient, post-submission delays can be very costly and significantly impact time to market.
Evolution of regulatory perspective
Sponsors often focus on what they believe FDA or other regulators will “require” for HF data when planning HF activities. Importantly, regulators require that HF activities demonstrate that a product is safe and effective for use by the intended user(s). The data needed to demonstrate can vary, which is why it is important to remember that in HF we have regulatory guidelines, not rules. As a result, we must be ambitious in constantly listening to feedback and insight from regulators. For example, Hanniebey Wiyor, PhD from CDRH presented some invaluable perspectives on self-selection testing for OTC products at the 2021 International Symposium on Human Factors and Ergonomics in Healthcare. This perspective indicated expectations from CDRH that aren’t strictly written in any guidance.
It’s also important to follow the overall spirit of regulatory guidance rather than looking for very specific rules to follow. Along these lines, all agency HF guidance should be reviewed and considered when an HF strategy is created. For example, if a product is a strict medical device, do not only rely on CDRH guidance, CDER and DMEPA guidance should also be consulted.
Alternative approaches
It’s very common for sponsor organizations to create a generic RFP based on what they think is needed to fulfill HF requirements. Agilis works with sponsor organizations all the time with this approach, and what we see very often is that the RFP does not encompass what is necessary for the sponsor company to fulfill their HF needs. This mismatch between the RFP and actual requirements can be based on a variety of factors, but identification of incorrect user groups in an RFP is very, very common. Additionally, sponsors sometimes misidentify the components of a user interface that need to be tested or greatly underestimate the scope of what an HF testing session will entail. To avoid mismatched needs and expectations at the time of a project kickoff, Agilis recommends that sponsors invest in an initial consulting phase to fully lay out the overall HF strategy. One case study from Agilis was a sponsor company who was performing validation testing in the US and intended to use the data for submission to FDA and for regulatory submissions outside of the US. Late in the project, and close to the date of the validation study conduct, the sponsor shared additional components of the user interface with the Agilis team that were unexpected. When questioned, the sponsor indicated that those UI components were part of the user interface for submission outside the US. Agilis explained that if user interface components intended only for outside the US were tested, then that data couldn’t be used for FDA submission. The sponsor had to reevaluate their overall plan for validation data usage in light of the different user interface in the US and outside the US. This mismatch could have been discussed in a consulting phase and the overall HF strategy for the data usage streamlined.
Conclusion:
Overall, this symposium presentation benefitted attendees through a gaining in understanding the spectrum of perspectives that HF consultants see and assist clients with. The presenters provided a mini-immersion experience for attendees to see a diverse cross section of HF strategies and application of best practices. Please keep a look out for a webinar format of this talk from Agilis this summer with lots and lots of fun case studies!!
About the Author:
Jessie Huisinga, PhD
Dr. Jessie Huisinga is a Senior Human Factors Consultant with Agilis Consulting Group, LLC and an expert in assessing human performance with extensive experience working with individuals with neurological impairments. She has a background in Biomedical Engineering and Biomechanics, with specialized training in Neurology in order to evaluate movement patterns and task performance in persons with performance limitations. She has experience assessing a diverse spectrum of home and professional use medical devices and products as well as conducting in-home and actual use usability studies.