Reflecting on 2020: Agilis’ Year in Review
Reflecting on 2020 - Agilis’ Year in Review
When the pandemic arrived in the U.S in early 2020, Americans were forced to adjust their personal and professional lives to prevent the spread of coronavirus. Businesses across the country struggled with how to protect their workforce while continuing to provide goods and services. We witnessed the bravery and compassion of healthcare workers and frontline workers around the globe. We watched as pharmaceutical companies and device manufacturers worked swiftly to pursue development of vaccinations and therapeutics and to develop and increase testing capabilities using Emergency Use Authorizations (EUAs). We saw schools and businesses close and companies quickly transition to work-from-home operations when possible.
Despite all of these unfortunate events, the need for human factors (HF) research and testing within the medical device and combination product industry remained unchanged, and companies continue to struggle with decisions around planned HF activities, such as in-person testing with vulnerable populations, that may not appear to be feasible with the current climate. Often our clients ask, “What are the downstream impacts when HF testing cannot occur for safety reasons?”
Agilis has successfully worked with our client partners throughout 2020 to help them answer questions like this and to achieve their HF project goals. We’ve supported clients in safely conducting in-person and remote HF studies, IFU design, threshold analyses and heuristics analyses, among other HF activities. We implemented safety precautions that allow us to effectively collect data from participants to support device and combination product programs, and along the way we have used our experiences to continuously make our processes and study conduct during the pandemic more robust.
What has working during the pandemic taught us?
Agilis has had to adapt in many of the same ways that other companies in our industry have adapted to keep human factors (HF) programs moving forward. Agilis has had a productive year with many studies under our belt, both in-person and remote. We have been able to deliver quality HF services to our client partners despite the setbacks that have occurred due to the current pandemic situation.
Throughout the year in our newsletters, Agilis has shared insight and tips related to the lessons learned during the pandemic and how companies can continue to conduct important HF activities despite the uncertainties and hardships that exist today. The table below summarizes the key points in each of those newsletters.
What can we expect in 2021 for Agilis?
If 2020 has taught us anything, it is that nothing is certain. The coronavirus infection rates are constantly changing across the U.S., and state and local governments each have their own specific ways of addressing the pandemic. While we have some promising data around vaccinations and therapeutics, it may be some time before the benefits are apparent and the pandemic is behind us. Thus, Agilis expects to continue implementing our safety protocols in 2021 to conduct successful in-person and remote HF testing to support our clients in moving their HF programs forward!
Additionally, as a company, Agilis not only prioritizes the success of our client partners but we also value the well-being of both our employees and partners. We understand that the pandemic has been impactful on many work-related and personal levels for everyone. As we move towards the New Year, we leave you with these guiding principles that have helped our team through these difficult times.
Former FDA Regulator joins Agilis. Stay tuned for January’s newsletter and a few words from our newest Agilis team member – Shannon Hoste, Senior Director of Human Factors & Regulatory Strategy.
In addition to 20 years in the medical device, pharmaceutical and IVD industries, Shannon provided oversight to hundreds of human factors device and combination product submissions as an FDA reviewer.
Her invaluable industry and regulatory insights will enhance Agilis’ pre-market and post-market human factors and risk management client services.
Together with the entire Agilis team and our clients, we welcome Shannon and look forward to our continuing success in 2021!
About the Author:
Deb Billings Broky, PhD
Dr. Deb Billings Broky, PhD, is a Senior Human Factors Consultant with Agilis Consulting, LLC and provides human factors expertise across all stages of medical device design. She is involved in early prototype evaluation, development of formative and validation research plans, data collection and root cause analysis, and identification of performance-based recommendations for UI design optimization. Billings Broky has extensive experience with a wide variety of medical devices, such as combination products and mobile apps to more complex surgical devices. She is also a contributing author to several recently published books, including “Applied Human Factors in Medical Device Design” (2019) and “Development of Biopharmaceutical Drug-Device Products” (2020).
AAMI Book
Applied Human Factors in Medical Device Design