HUMAN FACTORS STUDIES - Human Factors Studies During a Pandemic: How One Company Adapted to Covid-19 Restrictions

INTRODUCTION

Because human factors and usability engineering rely on the interaction between people and medical devices, both activities were vulnerable to lockdown measures and social distancing guidelines when the pandemic began, thereby threatening the completion of medical devices currently in development. Human factors testing allows device designers to understand the ways people: perceive information from a device; interpret the infor­mation and make decisions about what to do; and how they ma­nipulate the device, its components or its controls.¹ Though it is possible to carry out use risk assessments, expert reviews and de­vice comparisons – which do not require contact with end users – these cannot fully replace first-hand user feedback. Observing users interacting with a device provides reassurance the devices are safe and effective for the intended users, uses, and use envi­ronments.

PLANNING HUMAN FACTORS STUDIES DURING COVID-19

To allow for continued medical device development, human factors engineers were faced with the challenge of adapting their methods to comply with local restrictions and maintain participant safety. Halting human factors testing was not an ideal solution, given that there was little certainty about how long the situation would last. Owen Mumford Pharmaceutical Services had con­ducted a large-scale formative study in January 2020 to test a platform autoinjector, and needed to confirm the design changes made after the study had improved the design with respect to the user interface. Rather than cancelling the follow-up usability study, we decided to adapt the study design.

ENSURING REPRESENTATION FOR PLATFORM DEVICES

For platform devices, it is especially important the user cohort is as inclusive as possible. Platform products are designed to ac­commodate a range of delivery capabilities, and formulations applicable for multiple therapy areas, and so the specific user group is not known. The sample user group for testing must therefore be as broad as possible, to ensure the needs of patients with varying physical and cognitive abilities have been taken into account. Recruiters for human factors studies must be given a thorough brief so they understand the process and aims of human factors studies, and can properly inform prospective par­ticipants.

In this example, we aimed to test patients who were likely to have the most difficulty using the product. The cohort included people with musculoskeletal and neurological conditions, and people with visual and hearing impairments. We also made sure to include both children and adults, and healthcare professionals. Not all participants had injection experience, so we could observe whether inexperienced people also found the product intuitive and easy to use. To facilitate travel during a lockdown situation, and to aid mobility-impaired participants, the chosen venue was in a suburban area with parking, and we encouraged participants to walk or drive rather than use public transport.

PROTECTING PATIENTS FROM INFECTION & INJURY

Maintaining patient safety during a pandemic extended the length of the study. A risk assessment was carried out in advance and any risks mitigated. Before each session, the testing room needed to be cleaned and ventilated. Prototypes were all packed at least 3 days in advance of the study by engineers wearing PPE, and were kept sealed until needed. Because moderators could not hand out prototypes – 15 autoinjectors in this case – they were numbered and placed in color-coded sections of a set of trays, so the moderator could easily direct participants during the ses­sion. Apart from infection risk, we also needed to account for the risk of needlestick injury while participants handled the autoin­jectors; moderators were highly vigilant, and there were no inci­dents.

CREATING A CLEAR STUDY DESIGN

Because there were multiple prototypes to be tested and compared, it was imperative for the study protocol and discussion guide to be as clear and simple as possible, especially as the moderator would have to describe actions they would normally demonstrate for participants. For this study, we also needed to gather anthropometric data to inform the product’s design, so the moderator described how to use the equipment to partici­pants. Overall, we focused on evaluating key parts of the device design to avoid complication.

CAPTURING PARTICIPANT FEEDBACK

The rapport between participants and moderators is an in­tegral part of human factors studies as participants should feel at ease, and free to interact with the device and express their views. Any pressure can constrain this freedom and affect the study results. At the same time, the moderator, client, and other observers need to be able to see and hear feedback first-hand. Fortunately, participants were pleased to be outside of their homes and this helped to build rapport. They appeared to enjoy testing the products and providing feedback.

Live video streaming with the help of a local video company allowed close observation throughout testing. We needed to be able to view the autoinjector up close as participants handled the product and clearly hear their reactions. For this, we used pro­duction-equivalent cameras that could transmit high-definition video feeds simultaneously. The Picture in Picture (PiP) capability enabled a close-up view of the autoinjector going into the injec­tion pad, and a wide view of the participants and their interaction with the device. High-quality microphones meant we could cap­ture audible feedback and participant responses. We used Mi­crosoft Teams to stream the content so representatives from Owen Mumford were able to ask the moderator questions about par­ticipant behavior during the sessions. The recordings were made available after the study so they could be analyzed.

LAUNCHING THE FINAL PRODUCT

The modified study was a success, helped by our partici­pants’ flexibility and their ability to adapt to the unusual condi­tions. We observed the restrictions, and changes did not seem to impact the flow of the study, participant recruitment, or how the participants interacted with the autoinjectors. The Owen Mumford team was able to progress to the design freeze stage, ready for product launch in late 2021. As circumstances continue to evolve, human factors studies are likely to require careful planning and modification, as well as additional risk assessment. However, it is certainly possible to conduct successful in-person studies and con­tinue to safely bring new medical products to market.

 REFERENCE

1. U.S. Food and Drug Administration, Human Factors and Medical Devices, September 27, 2018.

Miranda Newbery is a creative human factors and user research consultant with over 10 years of product development experience. She firmly believes in putting the user at the heart of the design process and combines her expertise in medical devices, human factors regulations, design, and user research to creatively identify unmet needs. She has a wealth of experience in combination drug delivery devices. She originally studied Mechanical Engineering at Cambridge University and Industrial Design at the Royal College of Art. She is a chartered ergonomist with the CIEHF and founded Inspired Usability in 2016. She previously worked as the lead human factors consultant at PA Consulting and The Technology Partnership in Cambridge, UK. She also runs the Medical Human Factors Network, UK, which is a networking group for human factors professionals in the UK.