AAMI News February 2017

Life Lessons Spur Teacher's Focus on Human Factors

Edwards Brothers
Evan Edwards (right) and his twin brother Eric

Evan Edwards, who teaches AAMI University’s course on human factors for medical devices, has a particularly unique connection to the field—one that started because of his relationship with food.

“I think I was 21 when I had my first egg. It was phenomenal,” Edwards recalled excitedly. “I must’ve gained 10 pounds in a month just because of cake and pastas and donuts.”

Edwards and his identical twin, Eric, were born with life-threatening allergies to nuts, seafood, shellfish, eggs, bee stings, and multiple antibiotics at a time when there were few resources and little public awareness about severe allergies. At school they were labeled the “weird kids,” and the brothers had to contend with the potentially deadly hazard of peanut butter and jelly sandwiches on a daily basis.

“Like many other allergy sufferers, we were supposed to carry a potentially lifesaving dose of epinephrine with us at all times,” Edwards explained. But this was a struggle, as the epinephrine autoinjectors they were given were not easy to carry around all of the time.

As he got older, Edwards grew out of his allergy to eggs, but his continued vigilance against other allergens prompted him to wonder if there was a way to create a new, user-friendly autoinjector. So in 1999, while attending the University of Virginia’s engineering program, Edwards, alongside brother Eric, started a drug delivery device company called Intelliject—now called Kaléo Pharma.

“We wanted to create another option for patients—a product developed using human factors engineering; a product developed by patients for patients, which was rather unique in the industry at the time,” Edwards said.

Edward’s mechanical and systems engineering background with a focus on human factors helped guide the fledgling company. “I used a lot of my work and graduate research on implementing human factors engineering into the design control process,” he said.

It was during this time that Edwards was first introduced to AAMI. “As I did my research on systems engineering and utilizing human factors engineering and design controls, I started learning about some of the publications that had been developed through AAMI around human factors and the human factors committee,” he said. “I started sitting in on that committee and other AAMI-sponsored groups as a graduate student. I realized that this was a small community of people who are really passionate about human factors, usability, and patient safety, especially for medical devices.”

As an AAMI University faculty member, Edwards has the opportunity to share his belief that human factors and medical devices can make a profound difference in people’s lives.

“You’ve got to wake up every single day and remind yourself that the products we create could impact someone’s family,” he said. “When you are looking at the importance of human factors as it applies to these products, it’s not just the product, it’s the management, the education part, helping people understand more about these disease states and how individuals and families are affected.”

And Edwards would know. Since their product was approved by the Food and Drug Administration, both he and his brother have had to use it to save their own lives.

A Crisis Averted

A few years ago, while attending a conference in Texas, Evan Edwards was served a bowl of pumpkin soup that he was told was garnished with pumpkin seeds. The “seeds” were actually almonds—a mistake that could have proved fatal due to Edwards’ serious nut allergy. Fortunately, he was carrying one of the autoinjectors he and his brother had designed. “I knew the minute I took a bite and did not hesitate to use it for one second!” Edwards said.