A medicine can’t help patients if the packaging goes wrong or the device needed to administer it doesn’t work as expected. Witness the senior citizen who isn’t strong enough to open the cap on a prescription bottle, or the asthma patient who struggles to use an inhaler.
CSL Behring, a business of CSL that specializes in medicines that are infused either intravenously or subcutaneously, uses human factors research to help answer this question: What will happen at the moment a patient encounters a product or a medical device, like an autoinjector?
Human factors researchers, including CSL’s Monica Tavanti, are trained to consider human behavior and psychology as they analyze what might happen. They consult past research; design instructions, including text and visuals; and make a risk assessment to identify all that could go wrong, said Tavanti, who works in Bern, Switzerland, where she’s Associate Director, Human Factors, Global Medical Devices & Primary Packaging. She leads a small team of two, including Human Factors Engineers Janina Medina and Dhruv Pandya.
“We try to anticipate and mitigate for all the possible use failures,” Tavanti said.
Then they advance the study to the next stage, testing the device with actual patients to see what people do in the real world, but patients don’t actually dispense medicine in human factors research, she said. It’s only a test. After 20 years in the field, Tavanti says having a measure of humility comes in handy.
“People are very surprising. It is in the surprises that we can make a difference,” said Tavanti, who previously did human factors research with MRI and CT scan machines as well as cardiac catheter laboratory equipment. The switch to pharmaceuticals meant a shift because she was now applying her expertise to much smaller devices, such as a single prefilled syringe, she said.
Human factors research got its start in World War II and was initially intended to improve the performance of military planes, ships and vehicles. Back then, the research looked closely at design, how training was done and who was best equipped to fly planes and operate war ships and tanks, according to the Human Factors and Ergonomics Society (HFES). The human factors discipline grew in the decades that followed and now applies to many fields, including transportation, architecture, environmental design, consumer products, electronic devices, energy systems, medical devices and others.
Today, in the United States, 75 undergraduate and graduate programs train students for thousands of roles, according to the HFES. Human factors research has contributed to the design of many medical devices and systems, such as blood glucose meters, health information systems and platforms to assist the elderly in managing their daily medications.
Researchers must comply with strict rules when doing human factors studies about medical devices, Tavanti said, because the devices deliver critical medicines. Like clinical trials for new treatments, the research must meet ethical and regulatory standards and get approval from an institutional review board, which reviews research project plans.
After completing a human factors analysis, researchers could determine that the device performed as expected or they could recommend a change in the instructions or a change to the device itself. As the HFES defines it, human factors research strives to “achieve compatibility in the design of interactive systems of people, machines and environments to ensure their effectiveness, safety and ease of performance.”
The World Health Organization says human factors principles also can improve health care. In its patient safety guidance, WHO says that the success of aviation – which has a long track record or very few plane crashes – has much to teach other industries about human factors and how to create systems that acknowledge that humans are not machines. For instance, people are distractible and often make poor decisions when hungry or tired. But the human brain is also powerful, flexible and good at making sense of things, the WHO says. When systems are designed with real humans in mind, it can lead to more productivity, better accuracy, more creativity and even job satisfaction.
When conducting research, Tavanti said the team must consider everything, the upsides and downsides of being human, including that participants might feel nervous because they’re being observed.
“It’s about understanding the thought process of people,” she said.