By Korey Johnson and Jackie Ulaszek
The Human Factors and Ergonomics Society (HFES) hosted its annual healthcare symposium last week in Chicago. Our team was out in force and had a great time connecting and reconnecting with friends and colleagues around the industry. If you missed the conference, in addition some great content, you also missed your chance to test your claw machine skills with us.
Aside from having fun, we also had the opportunity to hear about some great work that our human factors colleagues are doing around the industry, and present some of our own work. We attended many sessions and heard good discussion around FDA and regulatory perspectives, use of technology in research, interesting research methods employed, and cross-industry collaboration, among others.
Here are a few of the most interesting and useful insights our team brought back from the conference, most from the medical and drug delivery device track, but some general insights as well. Thanks to those responsible for the contributions summarized below, as well as those who made contributions elsewhere!
Statistics on HFE submission success rate
(From Pre-Symposium WK1: Improving the Safety & Effectiveness of Medical Devices Through Human Factors Considerations; MDD8 – CDRH/CDER FDA PANEL)
Note the common HFE deficiencies in submissions to help plan realistic timelines for human factors related efforts during development.
During the Center for Devices and Radiological Health (CDRH) workshop, the Human Factors Pre-Market Evaluation Team (HFPMET) provided the usual overview of the FDA organization and regulatory review pathways. They also provided some hypothetical case studies to point out common Human Factors Engineering (HFE)-related things that go wrong in submissions. According to the HFPMET team, some of the more common deficiencies in submissions from an HFE perspective that require at least one request for additional information (and therefore delay the development process) included:
- Incomplete / missing data for user groups or use environments (i.e., insufficient exploratory research or documentation thereof)
- Incomplete / missing analysis of known use issues (i.e., insufficient post-market surveillance or documentation thereof)
- Critical tasks not clearly identified, or not all critical tasks assessed (i.e., insufficient use-related task/risk analysis or documentation thereof)
- Insufficient linkage between use-related risk analysis (URRA), critical task definition, and task success criteria
- Reporting only performance rates and/or using preference ratings as a component of acceptance criteria
This year, the CDRH team went a step further and provided some statistics around HFE submissions. Of 184 510(k) HF/UE reviews in 2018, only 21 made it through without requests for additional information from the HFPMET reviewer. Of 157 Q-Subs, only 6 resulted in agreement on a human factors validation protocol. Not surprisingly, these 6 are all included in the 21 submissions that did not require additional information. These types of statistics can be useful to highlight the importance of planning for realistic timelines around human factors-related efforts during development, and we are looking forward to seeing more of this type of reporting from the FDA in the future.
Interesting regulatory and legal perspectives
(From MDD3 – PRE-CERTIFYING EXCELLENCE IN DIGITAL HEALTH: HUMAN FACTORS AND USER EXPERIENCE PERSPECTIVES; MDD7 – HUMAN FACTORS AND MEDICAL DEVICE INSTRUCTIONS FOR USE: IT’S NOT JUST GOOD BUSINESS IT’S THE LAW; MDD9 – REGULATORY IMPERATIVES; Posters, and others.)
Applicants in the FDA’s Pre-Cert Program for SaMD will be assessed on the extent to which they have robust human factors processes in place, and the FDA is seeking input from industry to help define how a manufacturer can demonstrate this!
Trying to design to avoid litigation makes no sense – litigation will happen regardless. But acknowledging this eventuality can serve as another arrow in the quiver for human factors practitioners vying for the resources to document a robust human factors effort during product development.
The general message for the largely US-based audience from the EU-based speaker regarding the new EU MDR was to keep calm and carry on.
There were a few panels and presentations that highlighted forward-looking regulatory / legal perspectives.
In one Bold Insight-led panel, human factors and regulatory experts from industry and the FDA described the Software As a Medical Device (SaMD) Pre-Certification Program, focusing largely on the Excellence Appraisals that will be required in order for a manufacturer of SaMD to become pre-certified. The panelists addressed the question – What does “good human factors” look like from an organizational perspective and what types of processes and metrics can manufacturers present during an Excellence Appraisal to demonstrate a culture of quality and excellence as it pertains to human factors? The panel was intended to be informational for those unfamiliar with the Pre-Cert Program, as well as a call to action for the entire HF community to contribute their examples of organizational processes and metrics directly to the FDA docket for the program. (This is a topic we have been following closely; read one of our past posts, FDA’s digital health precertification program emphasizes importance of post-market surveillance, and find more information available about the program on the FDA’s website.)
In another Bold Insight-led panel, instructional material was discussed from the perspective of human factors experts contributing to the design of the materials, and the perspective of litigators and expert testimony from the HF domain. The intent of the panel was to provide the predominantly development-focused attendees with the novel perspective of how documented human factors efforts during development can help protect a manufacturer from liability in future litigation. The attendees were presented with a number of fascinating (and in most cases, tragic) examples of cases where design for safe and effective use was called into question during litigation. The take home message was that trying to design to avoid litigation makes no sense – litigation will happen regardless. But acknowledging this eventuality can serve as another arrow in the quiver for human factors practitioners vying for the resources to document a robust human factors effort during product development.
Finally, an update was provided on the new EU Medical Device Regulation (MDR). The general message for the largely US-based audience from the EU-based speaker was – keep calm and carry on. The new MDR is largely bringing medical device regulation in the EU into more alignment with how the FDA regulates medical devices in the US, at least from a human factors perspective. Under the new regulation, “The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector” (http://europa.eu/rapid/press-release_MEMO-17-848_en.htm). This initiative will be enforced starting in 2020, with all medical products needing to be recertified by 2024 at the latest.
Use of VR in research
(From CCIT5 – MIXED REALITY; MDD6 – CONTEXTUAL RESEARCH AND VIRTUAL REALITY; Posters, and others.)
The industry is increasingly incorporating VR and/or AR into device prototyping and research deliverables with positive results.
While virtual reality (VR) has been leveraged in many industries over the past several years, including healthcare, it is gaining traction not just as a tool to be used in the field, but also one to be used during research and development. Many universities are utilizing “mixed reality”, a combination of augmented reality (AR) and VR, as an advanced training tool. For example, overlaying patient data, such as the progression of a gunshot wound over time, on top of a physical mannikin and viewing these injuries through a headset while performing the physical actions on the mannikin. In research and development, device prototyping software can be easily integrated into a VR program to conduct expert evaluations and comparative analyses, as well as understand spatial relationships and context of use without the costly expense of physical prototypes.
Lastly, for contextual research, a demonstration was provided in one session of how stakeholders can be provided with a more impactful deliverable than a standard research report. By leveraging VR, stakeholders can review insights generated by the research as they virtually walk through the research conducted, jumping to physical locations to review research findings tagged to physical objects in the environment.
(From MDD5 – DEVICE TRAINING PROGRAMS; Many posters, and others.)
As an industry, we are making progress towards a more consistent and practical approach to adequately simulating memory decay in operational context of use without unnecessarily burdening research timelines and budgets. But we still have a ways to go.
Of course, training decay was a popular topic in both the workshops and panels with the FDA, as well as in several other sessions and posters. Many perspectives were presented, including:
- The cost associated with extended decay periods that may not be necessary.
- The need to more effectively leverage seminal research such as the Ebbinghaus forgetting curve, as well as the extremely large body of memory-related research that has been conducted since the 1880’s in finding a reasonable solution for adequately simulating extended decay periods.
- Primary research that is currently being conducted with support from the FDA to assess the extent to which performance decrements exist for variable decay periods in the context of training specifically for medical device use.
There was quite a bit more presented and discussed on this topic. We are making progress, and hopefully some of the ongoing initiatives will give us some recognized empirical basis for decay periods in medical device human factors research that adequately simulate operational context of use without unnecessarily burdening development timelines and budgets.
While there seems to be increasing acknowledgement of the value that a strong human factors presence within hospitals and clinical networks offers, there were few solutions to overcome the budgetary constraints that often stifle this effort.
There seemed to be more discussion at this symposium around efforts to increase human factors presence within hospitals and clinical networks. Though many hospitals and clinics have recognized the importance of including human factors in their processes and procedures, many barriers for complete integration still exists. Both HF professionals and clinicians agree that what the other does is important but neither fully understands the ins and outs of the other role, making it challenging to find common ground for measuring improvement.
Hospitals with an HF champion have had the most successful integration; however, the role and impact of change may be limited depending on the champion’s leadership role in the organization. Even for hospitals that have the stakeholder buy-in and access to HF professionals, many times the HF expert or team is stretched thin across engagements and cannot attend to on-site demands.
Lastly, after all the above is considered, HF personnel working in hospitals most often do not have the budget necessary to seek external support when demands on the HF function are high. Most of the discussions we participated in and overheard throughout the symposium were focused on the recognition that this is an area for improvement, as opposed to discussions around solutions. However, there were a few promising cases where it seems that the right relationships have been formed to really get buy-in for human factors from a hospital administration perspective – hopefully this becomes more of a trend.
On the cross-industry collaboration front, hfMEDIC continued to gain momentum and interest as it organizes under the NSF’s Industry-University Cooperative Research Centers (IUCRC) Program. There are several pre-competitive research opportunities that routinely emerge at this conference and others, for which a vehicle such as hfMEDIC could be extremely valuable. We hope to support the development of this program and work with the existing members to drive research forward that will be of value to the industry as a whole.
What did you take away from the symposium?
These are just a few of the topics that stood out to our team, and there were many others! These also sparked discussion amongst our team:
- Attention was drawn to the inadequacy of currently available ergonomic and biomechanical normative data for use in the design of medical devices (e.g., for specific patient populations).
- Deception was used in a study presented to enhance the fidelity of simulated use, which sparked some interesting conversation within our team.
- Some very interesting case studies were presented where stress was simulated with a high degree of fidelity.
And more! Let us know what your key takeaways were!