Leveraging and Communicating the Value of Pre-Validation Human Factors Work in Your Human Factors Strategy
Event Type
Discussion Panel
TimeWednesday, April 1411:00am - 12:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionSince publication of the 2015 update to IEC 62366, Medical devices – Part 1: Application of usability engineering to medical devices (and its amendment in 2019) and the FDA/CDRH Guidance Document, Applying Human Factors and Usability Engineering to Medical Devices (2016), industry has learned the regulatory expectations for conducting (summative) human factors validation studies. It has also learned about formative human factors evaluations: that they exist, they can (and should) be performed, and multiple evaluation methods can be applied during product development, prior to the summative/validation stage.

However, too many companies do too little human factors work prior to validation. This short-circuits the intent of both the guidance and the standards to design-in usability that supports or even enhances safe and effective use. Missing opportunities to identify user needs and potential use-related problems often leads to difficulties that can delay or derail your project, including difficulties such as:
• Sub-optimal medical device designs,
• Unexpected validation study results,
• Uncomfortable and difficult interactions with development collaborators,
• Need to implement additional design modifications and repeat the testing,
• Longer timelines and higher costs,
• Awkward regulatory submission documents,
• Uncomfortable and difficult interactions with regulatory agencies, and
• Possible failure to get devices approved.

This panel will explore the many human factors methods that can be applied before the (summative) human factors validation study is conducted that can improve the quality of medical devices and the user experience, reduce the occurrence of use errors, de-risk the validation study, and avoid having human factors issues prevent regulatory approval. These methods can be applied from the earliest stages of development, when the product is only a concept, through a sequence of design iterations of multiple possible design alternatives, to refinement of a final design that is confidently ready for validation.

Just as implementing design controls for medical devices involves not just verification & validation, pre-validation human factors work can inform user needs by utilizing a variety of different methods to evaluate a design iteration. These methods are different from the techniques applied to validate a final design, and they vary widely in their scope, effort and cost.
Some examples of pre-formative human factors work that will be discussed by this panel are the following:
• At the earliest stages, contextual inquiry can help define the users and determine user requirements, including environmental constraints that directly impact medical device design and ensure that the product architecture is appropriate for the entire system of stakeholders. This work gets to the root of user needs.
• The device design can be further explored through the use of in-depth interviews (IDI) or focus groups to understand the past experiences and future wishes of groups of users.
• Bench testing, such as heuristic analyses or cognitive walkthroughs, can provide a quick and simple initial evaluation of an interface design to identify its strengths and weaknesses prior to testing with intended users.
• Expert reviews can be an efficient way to get feedback from key stakeholders or opinion leaders and can provide user perspectives on a device design and/or its instructions prior to having fully functional prototypes.
• Often, formative human factors evaluation is only considered to include only formative usability tests, executed as mini-validation studies. However, formative usability testing can be conducted in a dynamic manner, in which the medical device design is iterated rapidly and each new version is tested in turn over the course of a week or two. Often, this type of dynamic iteration can be conducted using low fidelity mock-ups of user interfaces and can help develop early insights into the overall system. Formative usability tests can be much more interactive than summative/validation studies, leading to an in-depth exploration of users’ interpretations of a user interface, as well as their perspectives, frustrations, expectations, and wishes. This information can then be used to evaluate the user interface and determine key areas for iteration, not only on the medical device design but also on the product labeling, the training materials, and the product differentiability (if applicable).

The four panelists have a combined total of more than 87 years of experience doing human factors work for medical devices, pharma/combination products, surgical systems, software, laboratory applications, aviation, home health, telemedicine, universal design, assistive technology, research, and academia. They bring a wealth of experience, knowledge and perspective to this important topic.
Senior Director/Senior Advisor
Sr. Director Human Factors & Regulatory Strategy
Senior Principal, Human Factors Strategist