A solid commitment to human factors in the design process can be critical to a medical device’s success.
MaryBeth Privitera, HS Design, a SteriPack company
[Image from Pixabay]
In some early education circles, there is a philosophy that one can learn from testing. If you want a child to know vocabulary words, you can have them briefly study, then give them a quiz, show them what they missed and do the quiz again — all in hopes for a better score without a concerted effort towards improvement. In medical devices, some may approach human factors as simply a test to meet a regulatory imperative. It’s a test that must get done but not one that truly informs design. The testing becomes the focus, the driving force viewed as another task rather than a powerful tool.
Ultimately it is the device design that matters. Through innovative technology design, we have new opportunities to advance clinical care. Through advanced material exploration, we can improve manufacturing processes, device functionality, and potential clinical utilities and outcomes. Through industrial design, we can provide product embodiments which respect the user and their expectations. However, through applied human factors, we achieve designing the right product for the right person regarding their context. Applied human factors ultimately improves clinical outcomes, meets the regulatory requirement, but most importantly, it makes for happy customers. Thus, for ultimate success in the marketplace, a strong commitment to human factors in the design process can be critical to success.
Applied human factors in design results in a total solution for the user. A better design can happen by taking a holistic approach and considering the physical interactions and the mental workload (perception and cognition) required to use a device. This includes understanding basic human skills and abilities that a user possesses; that anthropometry and biomechanics of users are clearly delineated regarding use interactions; that accessibility and/or cross-cultural/cross-national design implications be factored into the design.
Technological advancement will always offer new opportunities for innovative design, and sound design is innovative. However, creative technology development must work with innovative design to be successful. Good design makes the product worthwhile. All these elements are true regardless of designing a consumer product or a medical device. The design must meet the functional criteria and the psychological and aesthetic criteria in the user’s viewpoint. In doing so, usefulness is emphasized.
Designers have the responsibility to use the information provided inherent to their design processes — the principles found in the knowledge, skills and abilities (the human factors) of our users — to go beyond the demonstration of acceptability. They must go beyond the “don’t make me think” mantra of device users and into designed experiences involving artistry and elegance providing device users something they “want” to use, not just something they “need” to use. This full understanding of the user (capabilities, limitations, anthropometry, biomechanics, etc.) in consideration of the context of use (working and social environment) cohesively impacts safe and effective device use. Thus, ultimately the likelihood of regulatory approval but also success in the marketplace.
For example, you design a medical device for an elderly market with some limited cognitive disabilities. In your human factors planning, you might ask: What defines the elderly? What does “limited cognitive ability” actually mean? Or you’re designing a combination device aimed at children, and in some instances, they may self-administer. In your human factors plan, you might ask: What’s the role of the caregiver or parent? What are the sub-groups of pediatric patients, and how will this best be determined? Detailed questions can and will impact device design and the workflow of a device. If they are not clearly defined, how can design achieve desirability? How can risk assessments be thorough?
Agencies require that devices be safe and effective, that they must be usable, and that there is evidence to back it up in the submissions. However, there are additional benefits to adopting a user-centric approach, wherein the design of the device user interface aligns with the user’s wants, needs and preferences. Let the human factors drive design and use the testing to prove it. You won’t be sorry.
Mary Beth Privitera, Master of Design, PhD FIDSA is a principal at HS Design (HSD), a Morristown, N.J.–based product development firm, responsible for human factors and research. She also serves as faculty and co-chair of the Association for the Advancement of Medical Instrumentation’s Human Engineering Committee.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.