Human Factors Takeaways from 2022
What we learned:
Highlights from the events we attended in 2022
Keeping abreast of regulatory and industry trends is a priority for Agilis Consulting Group. This year we participated in 10 industry events, upgrading our knowledge as well as extending knowledge to the industry. We also held our first Summit, launched a podcast, drank 8,000 cups of coffee and had fun helping our clients navigate regulatory guidelines in human factors.
Below are the highlights from all the conferences we participated in:
Location: Anaheim Convention Center
Dates: April 12-14, 2022
MD&M West brings together medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and life-changing medical devices.
Shannon was invited to present the following:
Shannon Hoste presenting “Combination Products Human Factors Considerations”
Ask the experts. Ask Shannon Hoste, Susan Neadle, Jennifer Riter, and Kim Tratuman, your meaningful questions in an interactive panel discussion.
Location: Virtual
Dates: May 4 - 6
This conference is hosted by RAPS and AFDO Healthcare. It is co-sponsored by the FDA.
Shannon Hoste and fellow industry experts presented:
Current perspectives on Lifecycle Risk Management
This panel explored the current landscape of Risk Management and ISO 14971 implementation, including EN harmonization. This discuss traversed lifecycle management of use-related risks and discussed considerations and best practices for the transition of risk management activities from pre-market to post market. Panelists: Taylor Dieringer (MEDIcept), Ed Bills (Edwin Bills, Consultant), Shannon Hoste
Location: Austin, TX
Dates: May 10 - 12
the[PACK]out Conference is led by healthcare packaging professionals who simply want more. More connections. More innovation. More investment in this industry we love.
Curated educational tracks for any level. Whether you’re new to healthcare packaging or a seasoned healthcare packaging professional, join us to grow your expertise and knowledge of the industry.
Shannon Hoste and Jessie Huisinga, PhD presented:
Unpacking Human Factors and Usability Engineering
Regulation and guidance on Human Factors continue to evolve as a key area of focus in ensuring products are safe and efficacious for their intended use(s), both domestically and abroad. This focus involves addressing use-related risk-based considerations for packaging and packaging systems. This presentation will provide attendees an introduction to Human Factors principles, specifically to better understand how packaging and packaging systems are evaluated in usability studies.
Location: Phoenix, AZ
Dates: Sept 11 – 13, 2022
RAPS Convergence provides regulatory professionals key regulatory knowledge and resources on medical devices, IVDs and biopharma to help you successfully navigate today’s regulatory landscape.
Agilis teamed up with Userwise to present a preconference workshop, outlined below. And we outline additional highlights from conference sessions:
Preconference Workshop – Shannon Hoste and Denise Wagner from Agilis teamed up with Shannon Clarke and Denise Forkey from UserWise to deliver a full day preconference workshop on “Integrating Human Factors into Your Next Regulatory Submission”. This hands on workshop walked participants through the entire HF process through applied exercises which included scoping HF deliverables and activities, preparing HF data for submissions and interacting with regulatory bodies.
Robert Califf, commissioner of the US Food and Drug Administration (FDA), and Tony Humphreys, head of the European Medicines Agency’s (EMA) task force on regulatory science and innovation, spoke virtually about some of the challenges and opportunities regulators have learned from their response to COVID-19. While they noted that scientists, industry and regulators across the globe came together to develop vaccines, drugs, and diagnostics, they also highlighted the unprecedented political interference and misinformation.
A panel discussion on “A Brave New World” discussed what the future of Healthcare will look like including additive manufacturing, artificial intelligence and virtual reality/augmented reality. Merging these technologies together will reframe the way we think about personalized patient care. Industry and regulators will need to come together to address technology and regulatory hurdles for integrating and regulating these new innovations.
MDR Implementation Session: with the 2024 deadline looming and limited Notified Body capacity, Gert Bos, President of RAPS’ Board of Directions suggested manufacturers should:
1) have clear communication with their notified body with clear plans and timelines for getting their product to market
2) be selective about their product submissions
3)conduct mock audits and dossier reviews and
4) avoid potential delays by preparing for worst-case scenarios by stockpiling products and having their derogations in place.
Location: Scottsdale, AZ
Dates: Oct. 4 – 7, 2022
We recently had the opportunity to gather as a team for the first time in company history! The event, held in Scottsdale, Arizona, was a time for professional development, goal setting, and comradery.
First Aid Training: A critical life skill and mandatory for our moderators. We set up an hybrid/interactive session through the American Red Cross. Today all Agilis employees are First Aid and CPR certified, and we will continue to offer this training yearly.
Pro tip: For any company event first aid training can serve as a great ice breaker.
Reflections and Goals set the stage for brainstorming new ideas and growth opportunities. Keeping in mind the purpose for our work, to make medical products safer, we listened and learned from one another and industry experts. In these couple of days we grew as a company through friendship and common goals.
Teamwork: The Summit would not have been complete without a little challenge designed for teamwork and FUN. The Agilis Team put on their walking shoes to explore Old Towne Scottsdale, completing fun challenges along the way.
Location: Arlington, VA
Date: Oct. 17 - 19, 2022
For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for medical device experts who want to be up-to-date on the latest developments, changes, and trends in health technology standards and regulations.
Keynote with Dr. Jesse Ehrenfeld, President-elect of the AMA discussed challenges in the future of healthcare which included: increased digitization across healthcare and business, continued rise in chronic disease, major public health events (the next COVID), an aging population, increasingly diverse patient communities, growth in remote patient care, and augmented intelligence. The keynote focused primarily on the adoption of digital tools which has grown significantly among physicians regardless of age, specialty, or gender. The adoption of remote care tools such as tele-visits and remote monitoring had the largest increase.
The adoption of augmented reality was discussed in several sessions. Take aways include: physicians are more optimistic and trusting of AI than patients, FDA should require clinical validation before AI products are marketed, the end user should have a voice in the development of AI technologies, attention must be given to what type of training should be provided for end users of AI systems, and policies & regulations for AI in healthcare and medical devices is behind. Several AI working groups are being established to create AI standards.
Location: Palm Springs, CA
Dates: Oct. 18 – 19, 2021
The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference will continue to build on the reputation of past events while bringing to light the latest advances in the field.
The PDA Pre-Filled Syringes and Injection Devices Conference had a successful turn out, including members from R&D, to manufacturing, to commercial. As has been an increasing trend, there were several presentations on the use of platform devices for pharmaceutical manufacturers as a way to reduce the replication of work where applicable. This includes early collaboration between device and drug manufacturers to align on planning and determining what testing and information can be leveraged throughout the product lifecycle.
Multiple presentations touched on the benefits of patient support programs throughout patients using the products, not just when they are first introduced to the product, as issues can arise even after long term use. There were discussions on the benefits of the development of smart injectables, along with several of the hurdles involved. These hurdles include the data collected (what to do with the data, who owns the data, how to store the data), usability (how does the addition of the connected piece impact safe and effective use), development, quality, and regulatory (how to handle software/firmware development and updates in an agile environment while inside a traditional QMS), and manufacturing (how to add on smart components, how to update a platform device with smart components).
Location: Columbus, OH
Dates: Oct. 25 - 27, 2022
This artificial intelligence summit is where world healthcare leaders come together. Artificial Intelligence (AI) is being used in pharma, biopharma, and medical devices!
Explainability and Transparency
The AI Summit focused on the differences between these concepts.
Explainability is essential for end users to be able to determine whether a device is effective for them and their needs.
Transparency is needed to ensure accuracy of AI when applied to a given dataset and to ensure scalability when increasing the data pool.
Regulations and Guidelines
Regulatory guidance for AI-enabled devices is still needed in the healthcare and medical device space.
Key pain points include:
Change Control
Transferability / Cost Effective Scalability
"Augmented Intelligence" vs. "Artificial Intelligence"
Experts in this field have shifted focus to the term "augmented intelligence" when describing AI-enabled devices, since the end goal of the relationship between healthcare and AI is to provide an enhanced user experience or improve patient outcomes.
Location: Columbus, OH
Dates: Nov 7-9, 2022
The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community.
Shannon Hoste, Stephanie Canfield, and Jennifer Mead attended the Combination Products Summit in Columbus, OH. The summit was presented by AFDO and RAPS and sponsored by Agilis Consulting and Eli Lilly and Company. This conference spotlighted key aspects of combination product quality and regulatory strategies. Almost every presentation included a speaker from the FDA, either the Office of Combination Products (OCP), CDRH, and Digital Health Center of Excellence.
A workshop led the Summit with the topic, Managing Risks and Presentation Changes for Combination Products and Covered Risk Management Fundamentals, Real World Risk Management Challenges, and Overview of FDA Expectations. The workshop covered an overview of the FDA 2019 draft guidance “Bridging for Drug-Device and Biologic-Device Combination Products” and described a suggested approach for identifying the minimum viable data needed to bridge prior conclusions of product safety, efficacy, and performance between drug delivery device presentations. Courtney Evans, the team lead for Injection devices at FDA-CDRH discussed analyzing the risk profile of each component of a system which should be included in the company’s risk management documentation. A group activity led by Ryan McGowan and John McMichael (AstraZeneca) and Jiaying Shen (Merck), Bridging Between Combination Product Drug Delivery Device Presentations: Strategies to Leverage Data and Minimize Patient Burden, included case studies and bridging scenarios for the groups to identify. Shen presented Combination Product Bridging Toolbox and each available combination product bridging tool (e.g. analytical, human factors, real world patient handling study) and provided recommendations for when the bridging tool is most appropriate. The FDA also provided attendees office hours for anyone who signed up and had items to discuss.
DAY 1 - The first day of the Summit included presentations and discussions around successfully navigating global regulatory environments as they evolve. A lot of discussion was centered 14971 with a focus on the patient first, then measuring the benefit to the patient against the risk to the patient (probability of hard x the severity of harm). It was recommended to develop products as if we were the patient. The FDA provided insight into their current thinking and expectations on the updated requirements. There was an engaging analysis of the updated ISO 11608 ‘Needle-Based Injection Systems’ standard and essential performance requirements. Additionally, a presentation on quality management system (QMS) strategies for device and non-device digital health technologies in a pharmaceutical company. Considerations include software that starts out as a non-device, but later device functions are added. A strategy for a consistent approach to lifecycle for device and non-device software was presented by Charlotte Brandt (Novo Nordisk) and Mary Beth McDonald (Glooko, Inc.).
Lastly, Shannon Hoste (Agilis Consulting) and Shannon Clark (UserWise) presented on leveraging data in human factors validation. Shannon Hoste emphasized the importance that every part of the development process should point back to the use-related risk. Additionally, Hoste explained how the human factors effort can be scaled or tailored according to device complexity and user expertise. An example was given on the task of suturing. If suturing is a standard practice, if yes, then there is no need to assess it in human factors validation testing. Furthermore, comparative analysis, an expert (Usability) review of the differences and similarities identified can be presented in a side-by-side comparison table to help facilitate FDA’s evaluation of the information.
DAY 2 - The last day of the Summit provided insights into the challenges within EU MDR and what can trigger/threshold for a Notified Body Opinion (NBOp). Currently, there is no mechanism in place by which a NB can determine whether a specific change to the device (constituent) part of would trigger the need for a NBOp. Additionally, NBs (as per their accreditation) are not allowed to consult. In addition, the FDA shared case studies of latest 483’s, warning letters (visible particulates, inadequate design controls and purchasing controls, altered data for Lot Release, autoinjectors failing to activate), and what to watch out for in the combination product space. The topic of Digital Health Technologies in Clinical Programs was presented by Anindita Saha, Assistant Director, U.S. Food and Drug Administration, Digital Health Center of Excellence and Katie Chowdhury (AbbVie). The Summit was closed with a lively panel of FDA members who answered audience member questions for over an hour.
Coming into 2022 we took a step back and started with the basics. Keeping the basics as our constant has been integral as we have grown. Every year we like to reflect on what we have learned from the industry. We share these important trends with you as we all look to incorporate this knowledge into our business practice. Going into 2023 we want to become the leaders in many of the growing areas for human factors and we hope to do that with you as our partner.
About the Author:
Agilis Team
Agilis’ team are all seasoned human factors experts, many of whom are considered industry thought leaders. We strive to maintain consistency of your Agilis team throughout the project lifecycle. Our unabashed commitment to quality is evidenced by a rigorous internal quality control system including on-going professional development for all Agilis team members.
