Human factors engineering (HFE) has been an essential element of medical device and combination product development for some time. Some development teams, however, may still struggle with fully integrating HFE principles into product lifecycles, instead treating HFE as a single ‘validation’ task.
Shannon Hoste, president of Agilis Consulting Group, will explore HFE principles and methods in the upcoming session at the Design. Engineer. Build. Conference at MD&M West, “Combination Products Human Factors Considerations,” on Wednesday, April 13 at 3 PM. She plans to address common questions about human factors and discuss challenges and potential solutions. She will then join the “Interactive Panel Discussion: Ask the Experts” at 4:00 PM.
MD+DI asked Hoste a few questions in advance of the session.
Have expectations for human factors studies for combination products evolved recently because of new standards, regulations, or guidance in Europe, the U.S., or anywhere else? If so, how?
Hoste: Yes and no. Let me start first with a definition. On the FDA website, “human factors” (HF) is described as the study of how people use technology. It involves the interaction of human abilities, expectations, and limitations, with work environments and system design. The term “human factors engineering” (HFE) refers to the application of human factors principles to the design of devices and systems.
In medical applications, HFE helps improve human performance and reduce the risks associated with use error.
Consider the scope of this field as understanding the interface of people and technology. Then take into consideration the regulatory lens of understanding how products improve human performance and reduce the risk associated with use error. With these perspectives, as new technologies evolve, then so do the human factors questions that need to be addressed.
How to go about answering these questions, however, is something we understand. The human factors/usability engineering process has been defined in its current state for quite some time and the field of human factors and human performance is well established. What we have been seeing, more prolifically in the medical device and pharma sector in the last 10 -15 years, is how the human factors process can support product development, risk management, and regulatory decisions.
Within the U.S., FDA has identified guidance around application of human factors for medical products. Globally, international standards for this process exist. In addition to the guidance and standards, EU regulations, MDR and IVDR, identify the following General Safety and Performance Requirements:
- In eliminating or reducing risks related to use error, the manufacturer shall:
- reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
- give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
Any other new regulatory changes on the horizon?
Hoste: Regulatory science must evolve with technology advancements. My best recommendation is to stay aware of the landscape and what data can best support regulatory decisions. Regulators help us with this by publishing guidance documents and white papers and by funding research.
Are there any particular functions (injection, storage, reconstitution, reuse, drug identification, etc.) that should be more closely studied?
Hoste: It is a risk-based approach, so the focus is based on the potential harms associated with a given technology and indication. Research into known use problems can help. Research into the users, where, when, why, and how they use a product can help. Evaluating potential use errors and having a cross functional team, including clinical, and identifying potential outcomes/harms, helps, too.
What entity is responsible for HF studies—the drug manufacturer, the drug-delivery device manufacturer, or both? How should these entities cooperate?
Hoste: As HFE is a risk-based approach, it is often difficult to truly map the use-related risks of the product without considering all of the constituent parts and the intended use. For example, I could conduct HF research on an injection device, however this data alone may not be sufficient to support a given drug in this injection device being used by a specific user group. Taking this further, I could evaluate the device use with general adult lay users. However, if this device is then used to treat anaphylaxis in pediatric patients, I now have users, uses, and use environments that may not have been evaluated. I also potentially have higher severity harms outcomes than had previously been considered.
What are some of today’s biggest challenges in conducting HF studies, and how can you help?
Hoste: At Agilis Consulting Group, we focus purely in the space of human factors, risk, and instructional design so that we can stay up to date on the evolution of practice, methods, and regulatory expectations. Our goal is to help our clients with this perspective as many companies, small to large, may not have the in-house resources to dedicate to monitoring this landscape.
What do you hope attendees learn from your two presentations and do differently afterward?
Hoste: HF is not just a test. Although the understanding has improved, I feel there is still a perception that human factors is a validation test. If I can help add some clarity around this, I think patients will be better served by the products that we create. HF is a lifecycle process that is interwoven with risk management, supports pre- and post-market activities, and may include a validation study.
Join us for the Design. Engineer. Build. Conference at MD&M West session, “Combination Products Human Factors Considerations,” and then the “Interactive Panel Discussion: Ask the Experts” at 3:00 PM and 4:00 PM, respectively, on Wednesday, April 13, in Room 210AB.