Introducing Gilero’s New Director of Human Factors & Design

Grant Leffingwell is the most recent addition to Gilero’s leadership team. In his role as the Director of Human Factors and Design, Grant provides support and leadership to the human factors team at Gilero, ensuring we provide top-notch usability engineering to our medical and drug delivery device clients. Keep reading to learn more about Grant and the future of Gilero’s human factors program.

What was your career experience prior to joining Gilero?

“I’ve spent the better part of the past two decades performing human factors, usability engineering, and user experience research for programs in the healthcare, government, and commercial industries. This research supported the development of countless products, many from initial concept to successful market approval.”

What is your human factors experience as it relates to medical devices?

“The past 12 years of my career have been focused on the medical device industry, improving the usability of medical devices through human factors research and human-centered design. I’ve worked on products ranging from simple, single-use medical devices to advanced robotic surgical systems, with a heavy focus on combination products. I transitioned to working on medical devices in the late 2000s, shortly after the FDA issued their first draft guidance for human factors in the medical device industry. Up until then, human factors was a ‘nice to have,’ but the FDA made it clear that human factors considerations would soon become a requirement for medical device and pharmaceutical companies to achieve regulatory clearance.”

Aside from FDA requirements, why do you think human factors is such an important part of the product development process for medical devices and combination products?

“A poorly designed medical device can put lives at risk. Having a robust human factors and usability engineering approach as part of the design and development process can help to identify and mitigate risks before the device ever reaches the hands of an end user. For the healthcare industry, in particular, the success or failure of a product can sometimes be measured in lives saved or by the improvements in a patient’s quality of life, so getting it right is critical. All of the scientific advancements and breakthroughs in our industry are meaningless if they don’t impact lives in a positive way. Investing in human factors is not only the right thing to do, but it’s beneficial from a business perspective as well. Companies who have spent time and resources on human factors activities like user research and formative studies can be confident that their product was designed safely and effectively before it is released in the market.”

What led to you choose a career in human factors?

“I think human factors is a natural place for empaths. Caring about people and their outcomes draws you to a discipline like this. I started out writing instructions for use (IFUs) and user manuals, and that led me to start thinking about how and why people use things and how to make these products better. I learned that I enjoyed talking to users and seeing the world through their eyes. Being able to synthesize that information into an actionable path forward to improve the product or process is very valuable. I don’t think there is a better or more immediate way to impact the well-being of people other than the healthcare industry. Medical device human factors work is extremely rewarding.”

Why come to Gilero?

“Gilero is a growing company that has a strong commitment to getting things right, for both our clients and the patients who will end up using these products. We’re large enough to offer a full suite of services from concept development through finished device manufacturing, but still small enough to remain nimble and pivot when a project requires it.”

What do you see for the future of Gilero’s human factors program?

“I see human factors growing significantly as one of Gilero’s service offerings. The existing Gilero human factors team already has a wealth of experience in medical device usability engineering. My plan is to take that, along with my expertise and knowledge, and build on it to make Gilero a leader in human factors the same way we are in engineering. I also want clients to know that human factors is not just a checkbox activity for us, it’s something we take very seriously for the benefit of patients and users and their quality of life. We have the expertise to do more than simply meet regulatory and design goals. We want our clients to feel confident that human factors is a worthwhile investment that can help make their product as successful as possible.”

If you need human factors support with your next medical or drug delivery device project, Gilero can help. Contact us today to learn more about our service offerings.