An Interview with Gilero’s Director of Human Factors & Design

Human-centered design is a core part of the Gilero process.  We strongly believe that by bringing user needs into focus early within the medical device design and development process, we can deliver products that users readily embrace and can be operated safely in real-world conditions.  The Gilero human factors team can conduct market evaluations, user research, formative and summative studies, and a variety of other human factors activities.  Jay Zignego oversees this team as the Director of Human Factors and Design.

What is human factors?

“When we use the term human factors, it means that we want to make sure we consider the end user throughout the design and development process.  Human factors has to be an essential part of product development, especially when the product is something like a medical device that has potential to cause harm if used incorrectly.  We put so much emphasis on human factors to make sure the product is safe and effective before it gets into the hands of an end user.  It’s also important to get user feedback in order to make sure the product will be marketable and that people will buy it.  It’s a multi-faceted tool.”

Tell me a little bit about your background.

“I’ve had a broad range of experiences that have led me to where I am today.  I started my career working in research and development at a children’s hospital.  There, I was able to collaborate directly with the CEO to help foster technologies that could improve the lives of patients right there in the hospital.  Working in product development with physicians in the hospital made me realize early on how important it was to work with or observe actual end users.  After that, I worked at a design firm to engineer prototypes and conduct usability testing for consumer products and medical devices.  I taught at Montana State University for a while and even operated a luxury watch company where my wife and I designed watches from unique materials.  I also ran my own design firm doing product design and development.  Eventually I ended up at Gilero.”

Why come to Gilero?  What did you hope to accomplish here?

“I joined the team at Gilero as a senior design engineer.  At this point, Gilero was already doing some human factors and user research for customers, but we weren’t really promoting it.  Early concept development is one of my core strengths along with user-centric design and user experience.  Since I had done a lot of product design and human-centered design, it made sense that I would sort of step into that human factors role at a director level.  We built up Gilero’s human factors program as a way to provide more value for our customers.  By understanding user needs early on in the design and development process, we can create better, more effective designs for these medical and drug delivery devices.”

Are there any interesting insights you’ve gained by running the human factors program?

“Every time we bring in a user and watch them use a device we get unique insights.  When you’re an engineer working so closely on a product design, you sometimes fail to look at the big picture.  With user testing, users often point out things about the design that we haven’t even considered.  Seeing your product design through a different lens and watching real people actually use it is invaluable.”

What is your favorite part of your job?

“The opportunity to help people and design medical devices that make lives better is, in my opinion, the best thing about this job.  It is so humbling and rewarding to know that a device we develop here could end up making a difference in the lives of hundreds or thousands or millions of patients.  On the other side of that, if we aren’t careful throughout every step of the design and development process, and the products we make are unsafe or ineffective, we can do a lot of harm.  Our goal is to catch any usability problems during the design process and fix them before the product goes on the market.  If we pay attention and triple check our work, I believe that we can do a lot of good for a lot of people with the devices that we make.”

What types of human factors projects does Gilero work on most often?

“We work on a little bit of everything, from consumable medical devices to drug delivery systems to medical mobile applications.  I would say that combination products make up the biggest piece of our human factors business right now.  Combination products by definition are already combining two different products (most often a medical device and a drug or biologic) that may not have been put together before.  This requires extra attention to make sure that the product functions as intended and that patients and caregivers know how to use it correctly.  We have provided human factors services for a variety of medical devices and combination products, including several different inhaled therapies, hazardous drug handling systems, prefilled syringes, and more.”

What does the future of human factors look like, both in general and at Gilero?

“We plan to grow and expand our human factors team and the services that we offer. Because of COVID-19, we’ve been doing more remote user studies rather than inviting participants into our offices. Surprisingly, this has worked out really well. The ability to be invited to a user’s home (virtually) allows the user to be more comfortable and provides us with an opportunity to watch them use the device in their own environment. Not every human factors study can be completed remotely, however, the ability to do some virtually opens up an opportunity to expand more quickly while keeping cost down for our customers. I think as a whole, the demand for human factors is going to increase greatly as more companies realize the value it can bring.”