AAMI News December 2017

One on One with Tim Reeves

Tim ReevesTIM REEVES is the managing director of Human Factors MD, a consultancy that he founded in 2001. Reeves is a member of AAMI’s Human Factors Engineering Committee and teaches AAMI University’s Human Factors and Medical Devices course.

Q: How did you first get interested in human factors?

I was first exposed to human factors in graduate school, where I majored in cognitive psychology. I met and conducted research with a psychologist who was also part of the industrial engineering faculty. For someone like me who was looking for a career path, the thought of marrying psychology with engineering was very compelling.

Q: Why did you decide to focus on healthcare?

My first job out of school was with IBM. I worked as a human factors engineer on a document imaging system used for scanning paper documents into a form that could be distributed electronically. (OK, I’ve been around for a while—it’s a problem people used to have, honest.) IBM was a great place to start a career, but after a couple of years, I took a position as a human factors specialist with a medical software company that developed radiology and surgery applications. My first project with this company was redesigning the user interface for a neurosurgical image-guided navigation system, the first system of its kind approved by the Food and Drug Administration (FDA). I went instantly from document imaging in the mail room to brain surgery! I’ve been hooked ever since.

Q: Why did you decide to start your own company?

I was working in the medical space when the FDA released a guidance document on human factors and risk management. This seemed like an excellent time to hang out a shingle and start a consulting firm, but my timing was off (by a decade). That was 2001. In the early years, work at Human Factors MD was slow but steady. In 2011, the agency released a draft of the current guidance for human factors, and our phones started ringing. They haven’t stopped ringing since.

Q: What is the best part of your job?

I think almost everyone who works in the medical device industry gets some satisfaction from knowing that what they do has a positive impact on other peoples’ lives. When you conduct studies with patients who might benefit from the medical device you are helping develop—that hits home. I also enjoy the relationships I have with our clients. When clients invite you to help make decisions about the products they are developing and are invested in, it’s a big confidence boost and professional accolade.

Q: What is the biggest mistake medical device manufacturers make when it comes to human factors?

Companies misinterpret what the FDA intends for human factors. The agency wants products that are safe, and it views human factors as a useful tool for achieving this objective. However, so much emphasis has been put on human factors validation testing that some companies view human factors as a hurdle that needs to be overcome rather than a tool that can assist with product development. These companies are reluctant to engage in human factors activities when they are developing a product because they are worried that when the FDA sees the results, any problems that were identified will raise concerns with reviewers.

In fact, the opposite is true. The FDA wants to see the results of human factors activities conducted during product development to gain confidence that manufacturers looked for use problems and made efforts to address them. A lack of focus on human factors during development makes reviewers question claims related to safety. This has created a situation where manufacturers don’t want to conduct activities that might uncover use problems, while the FDA wants evidence that manufacturers have conducted these activities, discovered use problems, and addressed them.

Q: How can this issue be addressed?

Educational programs such as AAMI’s Human Factors for Medical Devices course help get the word out about the contributions human factors can make to the development of medical devices and combination products. Regulators can help as well by placing greater emphasis on the upfront work a manufacturer should do to better understand user requirements and by rewarding efforts to uncover and address use problems earlier in the device development process.

Q: What is the best career advice you were ever given?

It’s a mixed sporting metaphor, but it stuck with me: “If you can’t hit a home run, make sure to move the yardsticks.”

Q: What is something people might not know about you?

During the summer, I live in an old log house on a lake in the middle of nowhere.