March 26, 2020
Without doubt, the COVID-19 pandemic has disrupted your personal life and professional life as it has ours. Therefore, first and foremost, we wish you and yours good health as we all take necessary precautions.
Meanwhile, your organization might be searching for ways to remain productive, specifically with regard to human factors work. Below, we share our latest ideas on how manufacturers can accomplish this goal. If Emergo by UL can help you in any way, we’d be pleased to talk about it. It may be that we can simply contribute advice and provide feedback regarding your ideas on a gratis basis. That said, there might be more substantial ways that we can help, such as by performing user research, performing analyses, and conducting evaluations in a manner consistent with social distancing principles. Please consider this our way of trying to make the current situation better for all, particularly at a time when bringing valuable, new medical products to market is so important to the world.
At a time when conducting user research on a face-to-face basis is not an option, you might pivot your effort to focus on documenting your HFE work. Depending on where you are in the product development process you can:
- Ensure you have thoroughly documented information about your users and use environments.
- Identify and analyze known use-related problems from MAUDE and other sources such as FDA recalls, ECRI, ISMP, and internal data (e.g., post-market surveillance data).
- Develop or update your use-related risk analysis. Reconsider how you identified use errors initially and if there’s any need to pursue additional use error identification methods (e.g., brainstorming, task analysis, hazard analysis, conducting interviews with end-users).
- Get an early start on drafting background sections of your HFE/UE report according to FDA’s guidance, even if you’re months (or years) away from making a submission.
- Review your post-market activities for legacy products to ensure they include gathering usability data, thereby easing the transition to the Medical Device Regulations (MDR).
- Write that HFE SOP and/or work instructions you’ve always wished everyone in your company followed, but you’ve never had time to create. And, if you still have more time, consider complementing that SOP or work instructions with detailed templates for core HFE deliverables.
Usability testing is certainly a dominant HFE activity, involving one researcher interviewing a representative user and observing him/her interact with a product. However, this activity is inconsistent with the imperative to practice “social distancing.” Therefore, while some usability tests might need to be postponed, the limitations on in-person activities do not prevent you from getting feedback on your design. Formative evaluations that you can still conduct include:
- User research via web- or phone-based interviews to understand user needs and user group characteristics either during a one-on-one call or a focus group-style conference call.
- An expert review, during which an HFE expert identifies the design’s strengths and opportunities for improvement.
- A remote, web-based usability test. Such testing straightforward when it involves the evaluation of software and instructional materials. Depending on the product, and with a bit of creativity, it can also be a feasible approach for some hardware-based designs (e.g., inhalers, over-the-counter products). Notably, the test participants can either be representative users, or coworkers who are unfamiliar with the project. When testing coworkers, you might not uncover all the same findings as when including representative users. However, your coworkers might encounter usability issues that you can address while awaiting your next opportunity for in-person research with representative users.
You can also leverage your “working independently time” to focus on instructional materials. For example:
- If you have not yet started, you can create the instructional materials, such as user manuals and quick reference guides. Even if the product is not yet fully designed, you should still be able to describe how to use the product in general. This activity can also provide insight in the product’s usability. If you are having trouble explaining how one should interact with a feature, it might signal an opportunity for design improvement.
- Regarding existing instructional materials, explore ways to increase the materials’ legibility, readability, approachability, etc.
- Confirm that existing instructional media are still aligned with the product design and internal documents (e.g., critical tasks identified in use-related risk analysis).
HF validation testing
Given government- or organization-imposed restrictions on in-person research, you do all of the preparatory work to be ready to conduct an HF validation when face-to-face research is possible. Here are some things you might be able to do now:
- Develop the test protocol, and double check that you have clearly documented all critical tasks with the associated use scenarios and pass/fail criteria.
- Create the test materials you will need (e.g., recruiting screener, moderator’s guide, data sheet).
- Speak with recruiting firms or internal collaborators (e.g., sales, marketing) to identify the best test locations to ensure you can access a sufficient number of participants.
- Assuming that it takes a while before the situation normalizes again, you can use this “waiting time” to pre-submit the test protocol to FDA. FDA’s feedback will help you ensure that the FDA generally approves of the test method.
Finally, if you have any colleagues who would like to become familiar with or deepen their knowledge of HFE, you can invite an experienced HFE specialist to deliver one or more webinars, online workshops, or coaching sessions. This focus on education could increase your company’s understanding of the HFE process and your colleagues’ ability to effectively execute HFE work down the line. Possible topics could include: Introduction to HFE, regulatory requirements, developing a use-related risk analysis, and moderating usability tests.
Tamara Will is Senior Human Factors Specialist at Emergo by UL’s Human Factors Research & Design division.
Learn more about HFE and usability testing for medical devices: