Last week, the annual Human Factors and Ergonomics Society (HFES) Health Care Symposium 2023 brought together over 700 delegates from the Human Factors community around the globe. Ian Culverhouse and Tina Krolo from Rebus Medical attended the event and presented a poster titled ‘Is HF Required for Drug Products’ on the Tuesday evening. The three days were packed with content from industry, both client side and consultancy, as well as input from regulators. Below is a synopsis of our key takeaways and themes from the event.
Empathy matters, from all angles
As HF professionals, we often find ourselves working with excessively lengthy spreadsheets and 100+ page reports. However, behind all of this data and process are real people; patients, caregivers and healthcare professionals. The importance of creating empathy amongst development teams was especially inspiring in a talk by Rachel Poker of AstraZeneca, who spoke about stakeholder immersion in patient journeys. There was also a panel discussion looking at life on both sides of the coin from clients and consultants and how we can work together more collaboratively. Other talks discussed building empathy with the role of regulatory review teams (e.g., FDA) and the underlying intent behind questions or requests for Additional Information. In the words of Peter Weinstock, Executive Director & Chair at the Immersive Design Systems (IDS), during his keynote, “loving the learner” is a fundamental principle to taking a holistic human centric approach to designing systems and great products.
Looking beyond the regulatory submission
Since the release of the ISO standard 62366-1 and FDA HFE Guidance, much of the industry’s focus has been towards the design and reporting of successful HF Validation studies. While this remains ever-present, it was refreshing to hear many talks discuss the role that HFE has to offer after pre-market approval is granted once the device enters the market. Not a new topic, and a crucial part of ISO 14971:2019, it was great to see an entire session dedicated to the topic of post-market surveillance and the value that can be gleaned from designing and integrating HF principles into the collection of PMS data. Of note, the following key topics were highlighted:
- Applying an HF focused mindset to the design of technical support helpline questions and tools.
- Defining ‘pick lists’ for support staff to work from, with traceability to the Use Related Risk Analysis (URRA) to help categorization of potential usability issues in the market and support downstream trending and data analysis.
- The importance of starting small, but aiming for scalability that will work across a company’s entire product portfolio. Demonstrate the value through a pilot project and a lean approach to gain trust and value proposition internally, without the effort being considered to be excessively burdensome with limited rewards.
Strategic planning of HF Activities
The conference showed that the HF community within medical devices and combination products is evolving and maturing as industry reflects on how practices and processes have changed over the past 10-15 years. Key topics of interest included “When is it appropriate to forego HF Validation Testing?” by Emergo by UL, as well as a presentation sharing the research findings of experiences dealing with Threshold Analysis and Comparative Use Human Factors Studies for generic drug drive combination products under an ANDA submission pathway. These talks illustrated that, while in some cases, it might be possible to justify that an HF Validation study is not required, it is important to remember that HF Validation is only one part of the overall Design Validation activity, a key part of 21 CFR 820.30 Design Controls, as well as ISO 13485.
Looking ahead
Returning to the UK after HFES HCS, our team are enthused and energized to continue pushing the boundaries of applying best practice HF thinking to the design of medical devices and combination products for our clients. We are already looking forward to returning next year for HFES HCS 2024 which will be held in Chicago, IL.