Human Factors Engineering or Usability Engineering has become a major focus of global regulatory bodies in recent years, not just for medical devices and combination products, but also for certain drug products administered to specific patient types.

Presenters Alison Sathe (Founder, Regulatory Mark) and Valerie Fenster (Director of Insights and Human Factors, Kaleidoscope Innovation) provided a quality perspective on Human Factors engineering during the recent Redica Systems webinar, “Human Factors | Compliance and Applications.” In addition, Sathe and Fenster looked at recent global regulatory developments in this area.

[Related: Miss the webinar? You can download a full recording and the slides here.]

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Human Factors: Not Just for Medical Devices

Human Factors must be accounted for across a range of products. These include:

  • Medical devices (professional use devices, home use devices, Software-as-a-Medical-Device such as mobile and Web apps)
  • Drug products (pediatric use, complex dosing regimens)
  • Combination products (drug delivery systems, IVD companion diagnostic devices)
  • Packaging and labeling (instructions, trays, device labels, etc.)

“When we used to refer to Human Factors and usability engineering, we used to think of it in terms of devices, and now it is well accepted and well known that Human Factors and usability cross all the different products in medtech,” Sathe said.

Human Factors engineering generally follows a similar approach that accounts for how users might approach different product types.

“When we’re taking a look at our users and taking a look at the studies that have to be run and how we’re developing the product, we have to look at the physical and the cognitive characteristics of the users in correlation with that product,” Fenster explained. “We need to look at the hazards and the harm inherent in the design of the device in combination with the introduction of the human being.”

The combination of use-related hazards with device failure hazards results in use errors (Figure 1).

Figure 1 Use-Related Hazards and Device-Related Hazards
FIGURE 1 | Use-Related Hazards and Device-Related Hazards

Human Factors and Design Control

21 CFR 820.30 mandates the use of human factors as part of robust design control.

“Human Factors is implied as part of the robust design control,” Fenster said. This includes:

  • Design input
  • Design verification
  • Design validation

“Human Factors is now an integral part of the design control process to make sure that you are identifying use risks and mitigating those use risks through your usability and Human Factors programs,” Sathe said. “It certainly needs to be captured in the documentation that you are generating.”

[Author’s Note: For more on strategy considerations for human factors engineering testing, check out this video clip from the webinar.]

Human Factors Regulatory Strategy

Regarding a strategy, Sathe always recommends starting with the end in mind. 

“Always when we are starting out a project looking at our regulatory strategy, what are those submission types that we need to make to domestic and international regulators and what content is going to be required in those submissions?” She asked.

Other questions to ask are:

  • Are we developing new technology or using the same drug delivery device?
  • Do we have available data on known industry problems and will this device help?
  • How many studies need to occur?
  • Can we repurpose work and negotiate a reduction in studies with FDA?
  • Where should studies occur?
  • When will Human Factors studies occur?
  • When is Human Factors validation needed to support the filing?

Differences in Global Regulatory Submissions

Sathe and Fenster also covered the different Human Factors requirements among global regulatory agencies, primarily FDA, EMA, MHRA, and China’s National Medical Products Administration (NMPA). 

With FDA, the focus is on class II and III devices and the high priority list. 

“Human Factors testing should be expected in design and development for all classes of products,” Sathe said. “But really, the focus for regulatory submissions is those higher risk products or products that have unique usability risks.”

We need to look at the hazards and the harm inherent in the design of the device in combination with the introduction of the human being

With the EU, “the EU Medical Device Regulation and the harmonized standard 62366 are guideposts there,” she said. Unlike the U.S. FDA, the Human Factors considerations are incorporated into regulatory submissions for all products.

Similar to FDA, the NMPA in China focuses on medium and high-risk products. In fact, they explicitly exclude IVD reagents and class I medical devices.

Global Human Factors Testing Requirements Differ

There are further differences when it comes to terminology among global regulatory agencies. Anyone marketing a product in those regions will need to adhere to the Human Factors testing requirements of the relevant health authority. 

FDA recommends seeking Institutional Review Board approval for Human Factors studies. The agency does not have a requirement for a specific sample size for formative studies but a sample size of 5-8 is generally acceptable with rationale. The study must also be conducted in the United States. 

Human Factors is now an integral part of the design control process

Within the European Union, “what we do see are typically smaller sample sizes,” according to Sathe. As far as the United Kingdom, MHRA released a guidance on applying Human Factors and usability engineering to medical devices, including drug/device combination products in January. Like FDA, MHRA has a recommended minimum sample size (15). MHRA also emphasizes Human Factors engineering during development and post-market changes.

NMPA emphasizes training, requiring development of a training program document for high-risk devices. All participants in samples must be Chinese residents and testing must take place at a state-owned laboratory.

Human Factors Enforcement Trends

But what does the enforcement data say when it comes to Human Factors? Sathe and Fenster used Redica Systems Enforcement Analytics to review FDA 483 observations on the topic. (Editor’s Note: If you do not have access to Redica Systems, click here to see how Enforcement Analytics can help you and your organization.)

  • A June 6, 2019 observation involving failure to complete Human Factors validation testing for an EpiPen autoinjector
  • A December 12, 2018 observation that complaints were not included in risk management
  • A January 9, 2012 observation that a firm failed to identify and mitigate use-related hazards

“Human Factors is such a critical piece of design and development and there is a lot of benefit in implementing a really good Human Factors program in terms of the problems it prevents. And that is what it is for. It is making sure you have quality devices at the end of the day that are safe and effective,” Sathe concluded.

[Related: Miss the webinar? You can download a full recording and the slides here.]

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Human Factors – Compliance and Applications

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Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

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