Are We Resilient?
Clients and Colleagues in the healthcare, medical device, pharmaceutical and life science industries:
It is January, I think we are all happy about the new year. I send a toast for us to have a positive and productive 2021. If we haven’t already met, please allow me to introduce myself. I’m Shannon Hoste and recently joined the Agilis leadership team as Sr. Director of Human Factors & Regulatory Strategy. I’ve worked in the medical device, pharmaceutical and IVD industries for 20+ years! I spent several of those years as a Team Lead and Human Factors reviewer for FDA – both CDER and CDRH. My experience both in the trenches and as a regulator, has given me a unique and (hopefully you’ll agree) valuable perspective; which leads me to ask the question: Are we resilient? Can we continue to adapt and help ourselves, and each other, maintain energy and motivation? We made it through the last year and many of our challenges persist, we are working on them, but they did not go away with 2020.
You are probably seeing the word ‘resilience’ word a lot lately. Meriam-Webster defines it as “an ability to recover from or adjust easily to misfortune or change”. If this were a product requirement, e.g. ‘The system shall be resilient.’ I would have a whole lot of questions, such as, how would you define ‘easily’? We are going to need to dig deeper.
First a confession: My graduate work was focused on resilience. I picked up this line of study because I was seeing field issues on combination products and I wanted to understand how to better design for the seemingly infinite variety of situations that the device could be used in. With this I have considered ‘resilience’ academically and then applied those concepts to projects and processes within the medical device, in-vitro diagnostics and combination-product industries. Over my career in industry and at the FDA I have seen various levels of resilience and the counter concept to resilience: brittleness. So, at this turning point after a year of challenges, I would like to reflect on 2020 and tell you what resilience means to me, and give you my answer to the question: Are we resilient?
The concept of resilience applies to products, processes, systems, people, etc. It provides a lens for analysis for whatever level of ‘system’ is being looked at. Each ‘system’ has its intended purpose as well as its ‘expected/normal’ operating conditions. To me resilience is a measure of the ability for a ‘system’ to respond to conditions outside of the expected operating conditions. For example, how well does a product development team adjust to a notification from their supplier that their micro-processor is going end-of-life, when said notification is received during Design Verification? Or how well does a remote interface for a continuous glucose monitor support the user’s ability to respond to a loss in connection? Or how do entire industries respond to a global pandemic?
I would argue that the measure of resilience is not only in the response to said challenges; but, also in the ability to identify, evaluate and remove the sources of brittleness in the systems. Un-expected events stress our system and shine light on sources of brittleness. These situations can highlight areas that are vulnerable, and they also open a window for improvement and change. With this perspective challenges become true opportunities.
Over the last year, within our industries we have all been faced with significant challenges: consider the supply chain challenges in the spring, onsite and remote workforce balance, conducting in person studies, public health communications, etc. These, among others were all areas that exposed themselves as brittle under these conditions. They required us to adjust and deal with the current problems at hand; but also, they highlight opportunities for us to build a better system, better industries.
Are we up for the challenge of building better systems? Have you ever paused to look around at the people in this industry, your colleagues, collaborators, competitors? This is an amazing group of people. Globally committed to spend their talents, experience, and energy to take on present challenges and change the human condition. This was evident in 2020. Within product development there were new technologies and therapies rapidly developed and tested, up to and including vaccines for COVID-19. At the same time the regulatory agencies responded, within their authority, to promote the public health during this time of rapid change. This was seen in the review and approval/clearance of products and in public health communication strategies. Another U.S. Regulatory Agency example that comes to my mind is the vigilance on the hand sanitizer testing and the necessary recalls. And my final example is the response to supply chain challenges and how shortages in personal protective equipment and home health products, such as hand sanitizer, disinfectant, and well, toilet paper, were addressed.
I am in awe of how our industries and organizations have pulled together to face these challenges, head on. Well done and kudos to each of you! Can we continue to address challenges and resolve sources of brittleness? If, we continue to support and cultivate the talent and resolve of this community, then evidence indicates that yes, indeed we can!
At a personal level, I am honored to be part of this community and I am confident that we will continue to improve. This line of thought is exactly why, at this point in my career, I have moved to Agilis Consulting. I want to be available to use what I have learned over my career to help improve medical products and industry practices.
Within our industries and companies, we have many new products, procedures, and therapies to develop and to deliver on our missions. Based on 2020, not only are we are up for it; but, along the way we have learned to better collaborate, as the saying goes, 'it takes a village', or maybe in this case a global community. And the window for change is wide open.
At Agilis, in 2021, we look forward to supporting this evolution. We have expanded our staff to further support human factors and instructional design needs from initial concept through validation and post market. In addition to this we are building out our capabilities to support product risk management needs. We are working on opportunities to enhance understanding around human factors, instructional design, and risk management within our industries. All of this is to address our mission and help clients to develop safe and effective medical devices and combination products while achieving regulatory success and speed to market - the first time.
With this, I do have a favor to ask you. I have listed out a few areas of our capabilities; but, please, let us know what services/support you would like from Agilis. What can we do to better serve you and your needs? I hope to hear from you soon.
To wrap up, cheers again for a fulfilling and productive 2021 and I look forward working with you!
Best regards,
Shannon Hoste
Sr. Director of Human Factors and Regulatory Strategy
Agilis Consulting, LLC
About the Author:
Shannon Hoste
Shannon leads the high-performance team of experienced human factors, biomedical engineers and instructional design experts to support Agilis’ US and global clients from early-stage user research, through regulatory submission and post-market surveillance. She is an expert in human factors and product development processes with over 20 years of experience in the industry.
AAMI Book
Applied Human Factors in Medical Device Design