What we learned: Highlights from the events we attended in 2021
What we learned:
Highlights from the events we attended in 2021
Keeping abreast of regulatory and industry trends is a priority for Agilis Consulting Group. Here are some key takeaways from the conferences, webinars, and workshops we attended in 2021.
Location: Virtual
Dates: February 3-4, 2021
The Xavier Health EU MDR workshop was held in early 2021 and Jamie Jackson attended to provide these key takeaways:
For medical products regulated by the European Medicines Agency (EMA), the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are now in force, superseding the Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).
New submissions and supplemental submissions to notified bodies need to be compliant to MDR or IVDR.
Conference presenters warned of a potential delay when submitting products to Notified Bodies (NBs) for review.
At the time of the conference, only 18 NBs were certified to review for compliance to MDR and 4 NBs were certified to review for compliance to IVDR.
Very few MDR or IVDR submissions have gone through NBs to date meaning there is little data on timeline for review and level of scrutiny during reviews.
Presenters from NBs stated that the MDR and IVDR clearly state that manufacturers shall employ risk management processes per ISO 14971 throughout the product development lifecycle.
Additionally, risk management processes should prioritize use of the device. Not just manufacturing risk. Manufacturers should focus on the end user, patient and other users that could be exposed to harm.
Based on the requirements of ISO 14971 and IEC 62366, products submitted for conformance to the MDR or IVDR should ensure all foreseeable use-related risks are identified and assessed. Additionally, risk control measures implemented to mitigate use-related risks should be assessed for effectiveness during usability evaluations.
Location: Virtual
Dates: April 12 – 16
The Annual HFES International Symposium on Human Factors and Ergonomics in Health Care was held virtually in 2021, and the attendees were able to experience panel discussions, keynote talks, town halls, and poster presentations with relative ease. The Agilis consulting team attended all four days of the symposium and participated in poster and panel presentations.
Agilis provided an in depth review of the presentations in an earlier article this year, including a review from Hanniebey Wiyor, Human Factors Regulatory Reviewer, CDRH on FDA guidance for OTC.
See all the takeaways here
Location: Las Vegas
Dates: August 9 – 13, 2021
Dr. Lauren Jensen and Rachel Talbott attended the Healthcare Information and Management Systems Society (HIMSS) 2021 conference in Las Vegas and connected with several insightful companies from a variety of backgrounds. The slogan for this year’s conference was “Be the Change”, which was timely and reflective of the tumultuous space that healthcare and health tech is in.
There was a full day Cybersecurity Forum, during which prominent speakers emphasized the necessity for increased attention in the cybersecurity space. An alarming study[1] was discussed which determined that data breach remediation efforts were associated with deterioration in timeliness of care and patient outcomes, and even an increase in fatal cardiac events.
There was also a concurrent full day Patient Experience and Engagement forum during which healthcare providers, engineers, and developers came together to discuss the current hurdles and biases faced in providing care to patients today. Often overlooked, patient satisfaction and social determinants that affect patient experience were discussed in an effort to develop strategies for improving patient care and engagement.
The main event highlighted the evolving regulatory landscape of cybersecurity, the exponential growth of telehealth capabilities, and the increasing emphasis on interoperability, and how these concepts are driving developments in the healthcare space.
The conference sessions touched on the usability and human factors of many aspects of healthcare, and Agilis is looking forward to the possibility of providing additional insights in 2022.
Host: Dynamic Global Events (DGE)
Location: Virtual
Dates: Sept 9 – 10, 2021
Clayton Smith and Abby Pandey attended the Dynamic Global Events 2nd Human Factors Engineering and Usability Studies Congress. The keynote address was given by Hanniebey Wiyor, Human Factors Regulatory Reviewer, CDRH on Training decay called: Justify the Training Decay Duration for Complex Systems or Long Distance Travel Users.
Below are the key takeaways from that presentation.
Training Decay Duration
Training Decay Duration (TDD) is the learning decay (“falling off of knowledge”) that occurs between training and the first time the training is used.
An indication of the simulation’s fidelity/effectiveness of training material.
If used as risk mitigation, TDD can be a source of use error.
Address training decay as early in design development as possible!!
Easier to control the cost of testing.
Shows the FDA how the training has evolved with the device.
Create training decay duration based on:
Research on predicate devices.
Expert review.
Formative testing.
Understand the relationship between device complexity and user’s level of experience.
Overall decay period runs from an hour to 5 days.
Generally, the novice practitioners need a shorter decay duration while the experienced practitioners need a longer decay duration.
Another presentation Agilis would like to highlight is from a panel discussion called Envision the User Safety Requirements for Home-Use Devices that included speakers from within Hoth Therapeutics, Abbvie, Amgen, and Genentech.
Home Use Devices
Think beyond submission
Close calls may be difficult to track post market, as they may not be reported or the situation itself may not be clear.
It’s important to fully investigate use errors and close calls during simulated use testing to mitigate potential errors early.
Product Design
Design for Need vs. Design for Preference
Preference is not just secondary, it’s important for continued adherence and behavior.
If the user feels comfortable using the product, they will be more likely to adhere to their prescribed treatment plan.
Labeling/Packaging Recommendations
Consider packaging design - Important material may not be as clear to the user if package is opened improperly.
Balance regulatory expectations
IFUs tend to be text heavy to please regulators, which may reduce the likelihood of users reading it.
Ensure balance of regulatory expectations with a presentation that considers navigation and understanding by the user.
Tips for IFUs - Benefit information (including the “why”) can help prompt and influence behavior.
Location: Virtual
Dates: Sept. 24 – Oct. 1, 2021
Stephanie Canfield attended the 2021 Xavier Combination Product Conference. This conference spotlights key aspects of combination product quality and regulatory strategies. Of the topics discussed, several included human factors relevant topics.
There were presentations and discussions on platform devices. When executing this strategy with the FDA, industry proposed submitting platform-specific data (data that is not drug-dependent) in a device master file, and product-specific data in the individual NDA or BLA. For human factors engineering, data that would go into the master file would include platform assessments, such as a Task Analysis, platform formative studies, general intended use, users, and use environments, and training programs. Summative studies with product-specific labeling and patient population would then be submitted in the NDA/BLA, along with the leveraging strategy for the data in the master file. The Agency requested to align with them to ensure they approve of the platform strategy, as there is no official definition of platform, and sponsors have varying interpretation of what a platform entails.
There was a presentation by the FDA’s Division of Medication Error Prevention and Analysis (DMEPA) on the importance of a robust Use-Related Risk Analysis (URRA). Product URRAs need to assess all the steps involved for performance, typically based on a Task Analysis, and determine errors users may commit during use or specific tasks users may fail to execute. Once these are identified, the potential clinical consequences (harms) for each use error and task failure are established, along with the risk-mitigation strategies for reducing risk and their respective validation methods. URRAs additionally need to identify all critical tasks, where a critical task is “a user task which, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.”[2]
Several sessions had mentions of HF-relevant information, including the following points:
Human Factors is a part of Design Validation but is not the entire Design Validation. Ensure to validate all specifications with appropriate methods.
When bridging combination products of the same drug to a different device, human factors studies typically are required.
Can perform a Human Factors type study to validate the specification of adhesion for on-body wearable devices by having users performing allowable activities while wearing the devices for the maximum amount of time in the label, and then measuring amount of peeling and the level of pain during removal.
Location: Virtual
Date: Oct. 14, 2021
Both Shannon Hoste and Dr. Lauren Jensen attended the FDA virtual public workshop on transparency in Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices. The workshop covered a variety of topics and perspectives from the public and private sectors. As AI/ML-enabled devices in the healthcare space become increasingly prevalent, considerations for the user should be at the forefront of these developments. To improve the user interface of these devices, Agilis recommends the development of a standard label, which could be compared to a food and nutrition label, that could be easily accessed and understood by a variety of users.
For developers of these devices, human factors evaluations of user interfaces should include the comprehension of AI/ML capabilities and inherent limitations and the use-related risk involved with their adoption and continued use in the medical field. Throughout the session, topics and questions were raised by health care practitioners and developers alike around the capabilities, model transparency, diversity of the base data, and brittleness of the AI/ML. These may be newer questions to the field of healthcare; however, decades of research around these topics and questions exist in the fields of Cognitive Systems Engineering and Resilience Engineering. As we consider how healthcare is impacted by these technological advancements, would it not behoove us to also collaborate with other safety critical industries in addressing how AI/ML advancements best integrate into our society?
In summary, from the virtual public workshop the following points resonated with Agilis:
Establishing a common language (vocabulary and grammar) around AI/ML in health care that can be leveraged to educate and inform health care practitioners and the public.
Establish a cross-functional board to generate guidance for a best practice risk management framework for AI/ML bringing in product safety risks, use related risks, resilience, systems integration, cybersecurity, etc. Establish a cross-functional board to generate guidance for best practice TPLC framework for AI/ML reporting, data sharing and issue investigation.
Location: Virtual
Dates: Oct. 18 – 19, 2021
Both Shannon Hoste and Dr. Jessie Huisinga attending the AAMI International Conference on Medical Device Standards and Regulation. This regulatory conference focused heavily on updating the medical device community on updates to standards and regulation as well as efforts of specific regulators to improve processes and workflows. Speakers from Center for Devices and Radiological Health (CDRH) provided updates center successes over the past year and strategic priorities. In addition, CDRH emphasized the need for patient voices and input during device assessment. CDRH also discussed their COVID-19 response efforts and emphasized the different EUAs issued since March 2020. CDRH emphasized that current EUAs and COVID-19 guidance are temporary and shared information on the device transition guide: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2022-fy2022
Successes from the Digital Center of Excellence were highlighted along with some presentations on AI standards and cyber security. There was also a case study presentation on consumer facing health AI which emphasized that while AI done right can improve outcomes, lack of transparency around AI use threatens trust of the systems by medical providers. Updates were provided for European Medical Device Regulations along with an IVDR Update, ISAID COVID-19 Medical Device Regulatory Convergence Project and Coalition for Regulatory Convergence in the Medtech Sector, Update on the Developing Regulatory Regime in the UK, IMDRF Update.
The first newsletter we shared in 2021 was about being resilient as we entered into new business norms driven by the pandemic. Over the course of the year many conferences moved to a virtual platform, while others implemented protocols for in person events. The concept of resilience applies to products, processes, and even people. It provides a lens for analysis for whatever is being viewed. We believe the life sciences and medical device industry has been resilient to the many challenges over the last year and Agilis has spent a good part of 2021 applying this lens as we expand our services to better serve the industry. We are excited to see what 2022 will bring!
References:
[1] https://krebsonsecurity.com/2019/11/study-ransomware-data-breaches-at-hospitals-tied-to-uptick-in-fatal-heart-attacks/
[2] U.S. Food and Drug Administration. “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications.” 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contents-complete-submission-threshold-analyses-and-human-factors-submissions-drug-and-biologic
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.