Looking Ahead: Human Factors Activities in 2021
Looking Ahead: Human Factors Activities in 2021
Human Factors Considerations for 2021
In March 2020, I was in Europe conducting an international human factors validation study for a client and I was effectively chased home by the coronavirus (COVID-19). It was early March, before any shutdowns had started in the U.S., but there were clusters of cases happening in the area of Germany that I was supposed to travel to. I had already been in Europe for a week conducting the first half of the study, and there was a lot of uncertainty around staying in Europe for another week and what that meant when I tried to go back home to the U.S. Agilis shared the experience of transitioning the in-person study to remote moderation in our May 2020 newsletter. For many in the medical device industry, that feeling of uncertainty is still present 7 months later whether it’s related to work or home.
Image source: Google
Looking towards 2021, no one can say when everything might feel “normal” again, but human factors activities must go on! Many people in the medical device industry think of human factors as a usability study or some form of in-person testing. While Agilis is hard at work – for both human factors validation studies and formative evaluations – adjustments are necessary. As shared in our ‘How to Keep human factors (HF) programs moving forward’ newsletters (Part 1 and Part 2), there are a multitude of considerations that companies need to make as their human factors programs move forward. These adjustments will continue in 2021 as the pandemic makes returning to normal study activities unlikely. Regulators in the US and EU have recognized the impact that COVID-19 has had on the medical device industry and have also made adjustments in response. The largest impact has been in the EU where the EU Medical Devices Regulation (MDR) compliance was delayed. At FDA, there have been no new published guidelines, but representatives have commented on how they’re handling human factors reviews during the pandemic.
European Parliament voted in April to postpone the Medical Devices Regulation (MDR) by one year to May 26, 2021 after the European Commission proposed the delay due to the COVID-19 pandemic. This reprieve was likely welcomed by many manufacturers due to the scale of change from MDD to EU MDR, which is much longer and prescriptive. The messaging in February 2020, a few months before the previous May 2020 EU MDR compliance date, was that everyone was learning while doing and that there would likely be a period of adjustment as companies worked toward full compliance. COVID-19 also greatly slowed many manufacturers productivity in the Spring and Summer of 2020 as workers transitioned to work-from-home settings and clinical trials were put on hold. These delays mean there have yet to be extensive learnings about how notified bodies will review submissions under the new guidelines. Regardless, the implementation of EU MDR guidelines has a new date approaching in 2021 (7 months away!), so there is still much work to do in preparation of this new deadline.
In addition to overall EU MDR considerations, in June 2020, the first amendment of IEC 62366-1 was published as IEC 62366-1 Amd. 1 Ed. 1.0. In the amendment, references to other standards have been adjusted including the new ISO 14971:2019 and the ISO 13485:2016. Overall, these updates do not impact methodology, but do tweak definitions and some details in Chapter 5 related to the analysis of results. Annex E was also updated as it references the essential requirements of MDR 2017/745.
The FDA has not specifically changed human factors requirements for 2020 or 2021 due to COVID-19. However, this page from FDA can be used to obtain up-to-date recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts: FDA Emergency Preparedness and Response. Currently, a keyword search on this page for human factors does not yield any results. This indicates that the information given by FDA representatives from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) who attended the May 20202 Human Factors and Ergonomics Society’s virtual Health Care Symposium is still applicable:
For a Validation Study, it is strongly encouraged that approaches for remote study conduct be discussed with FDA, on a case-by-case basis. It would not be considered sufficient to pivot an already approved in-person Validation study to being remote without discussion with FDA about the methodology. This approach could put a manufacturer “at-risk” without having FDA feedback and agreement on the updated protocol.
Timelines for FDA review have not changed. There has been no indication from FDA that review timelines are being extended due to a need to prioritize COVID-related items or questions. However, it is possible that this could occur. FDA is prioritizing Emergency Use Authorizations (EUAs) and breakthrough devices and those submissions do follow a more expedited timeline.
Overall, there have not been major updates for human factors professionals to keep in mind moving into 2021, aside from the EU MDR implementation, but that was supposed to happen earlier and was looming before the pandemic. The lack of significant updates during this time likely signals that regulators, are not focused on big changes at this time as everyone is dealing with so much uncertainty. One thing that does seem certain though, is that there will not be changes coming to the medical device industry’s current work from home trends. With predictions about when a COVID-19 vaccine might be available and how many people will actually take it varying widely, our current work situation will be here to stay for a while.
Maintaining a Project Team Working Remotely
When seemingly the majority of medical device professionals shifted to work from home in March, there was a huge disruption for a lot of companies. Agilis did not feel this disruption internally, because our team has been working fully remote for the past 20 years! Currently, 62% of US employees are working from home due to COVID[1] and that percentage is likely much higher for medical device professionals. Working remotely while interacting with a project team has some significant challenges when those teams are used to working in the same building together. While there a multitude of articles on how to work from home effectively, Agilis has some best practices that are specifically suited to project work.
This category likely seems like a no brainer, but communication remotely has to be given special attention. It’s not possible to pop into a colleague’s office when working from home, and it may seem like a phone call is unnecessary when a question comes up. Avoid the urge to skip a phone call and figure out a problem yourself after you’ve already explored solutions. It’s very easy to get stuck on a problem or idea, and if you don’t reach out to a colleague, it’s possible time will be wasted. At Agilis, we are on the phone with each other constantly so that we can make sure we’re in alignment on both the little and big topics. Also, this keeps you connected to colleagues, so no one feels like they’re working in a void.
Internal messaging is an easy way to ask quick questions and many companies employ such software including us, but at Agilis, we find that making the phone call to a colleague is generally more effective. It’s faster to explain the issue and have a conversation that allows for back and forth clarifications rather than having extended messaging. Also, talking to a colleague often allows for exploration of the issue rather than only getting an answer to the starting question.
It is very important to have a general idea of what everyone in the team is working on. It may not be necessary to have the specifics of their to-do list, but a general understanding of a teammate’s priorities is important. This needs to be discussed because no one can see their teammate working across the hall anymore or have impromptu conversations to give updates. This understanding of what others are working on is important for a couple of reasons.
Everyone working remotely is likely focused on their own tasks, but on project teams, there are many documents that will be touched by multiple team members. No one can make a quick stop in someone’s office to let them know a document is coming their way. Everyone needs to have an awareness of what colleague’s bandwidth is for their upcoming responsibilities and have an appropriate timeline for document completion. As an example, Agilis has a very stringent quality control process for all client deliverables. I may be working on a study protocol for a study happening in a couple of weeks, but I will not be the only one to review the protocol before a draft is shared with the client. My colleague who will also be reviewing the protocol has responsibilities of her own, so I need to have an awareness of what her bandwidth is the week that I’m expecting her to do the review of the protocol so that I share the document on the appropriate day for her review.
If everyone has a general awareness of what others are working on, it is very likely that shared knowledge can be utilized for a project. Every team builds a portfolio of experience and treasure trove of proprietary knowledge, but not every team member may be aware of what other people know. With remote work, it’s less likely that impromptu conversations will happen between team members that trigger the sharing of this knowledge, but if I know that my colleague is working on a device type for the first that I’ve previously worked on, then I will undoubtably have insights for them that are important to share.
Mistakes will happen, as everyone knows. This difference in uncovering a mistake in a remote work team is that it will likely require a scheduled call to discuss what went wrong and how to fix it. In an in-person workplace, the same process happens, but it can be done much more casually by stopping into a colleague’s office to have a quick conversation. The onus of scheduling a call to discuss an issue can create anxiety and make it feel like the issue is bigger than it is. Regardless, everyone should make the effort to touch base and identify how the team can learn from the issue.
Similarly, when something good happens, that event should be acknowledged. It can be considered a win for a team member when an important document draft is finished and sent off for internal review. While the deliverable is not completely final, just getting the draft of a large protocol completed, for example, is a win. Completing the presentation of a webinar or even optimizing some settings on an internal file sharing system for the team are all wins. While it’s not necessary to give everyone a high five for completing tasks like these, acknowledging these wins on a team call is very positive and really helps people to feel less like they’re just going through the motions at home each day.
We know that many companies have elected not bring employees back on-location until at least 2021, but it’s unclear when it may happen next year. So many industry activities were impacted by the pandemic, that it’s not surprising that there are no major regulatory announcements for 2021. It seems everyone is still moving forward, albeit with uncertainty, but for better or worse, work from home for many is starting to become the new normal for the medical device industry. While Agilis has been effectively assisting our clients remotely for many years, we hope that all teams have been adapting successfully to this big change in work style.
Stay tuned for next month’s newsletter when we discuss wearables and human factors engineering
[1] https://news.gallup.com/poll/306695/workers-discovering-affinity-remote-work.aspx
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.