Human factors studies can be a chance to set your company’s device apart from the competition. Here’s how one human factors study did just that.
Glucagon Nasal Powder (GNP) is in Phase III clinical trial testing to treat severe hypoglycemia.
Human factors studies are conducted to help companies understand how their products will be used and to avoid releasing products that don't work as intended. But there’s another reason to consider human factors studies—sometimes they can give a product an edge.
That was the case for Glucagon Nasal Powder (GNP) from Montreal-based Locemia Solutions. A study presented in September at the European Association for the Study of Diabetes annual meeting showed that users in a human factors study were able to administer GNP more quickly and with a higher success rate than injectable glucagon. In addition, the different administration method of GNP seemed to reduce the risk of erroneously administering insulin instead of glucagon.
On October 9, Locemia announced that Eli Lilly and Company acquired worldwide rights to the intranasal glucagon, which is being tested in Phase III clinical trials to be the first non-needle rescue for severe hypoglycemia.
Adam Shames, CEO of Core Human Factors, Inc., helped design the GNP study. Shames spoke with MD+DI recently about the details behind a well-executed human factors study. Human factors experts focus on whether a product can be used as intended. This study focused on the safe and effective use of two alternative medical devices.
According to the study abstract, insulin-using people with diabetes were randomly trained on one of two glucagon therapies: injectable glucagon sold commercially or GNP. They then instructed their caregivers on how to use the therapy. In a simulated setting one week later, these caregivers had to treat a mannequin that they were told was suffering from severe hypoglycemia. The process was repeated for the other therapy as well.
Besides caregivers, the study also included acquaintances, who do not provide care for a person with diabetes and did not receive any product training, but did have the chance to look at each product before administering each therapy in the same simulated setting.
Shames says that it often matters whether users (and therefore study participants) have experience with similar products or prior medical training since that may bias their use of a new product. "The whole point of the study is to assess that bias. That's why it's not implicitly good or bad, it is just what it is. If a user of a product has a prior experience with a similar product, or maybe it's a completely different product, but they're applying that experience, that knowledge, to the way this new product works, and sometimes that works in their favor and sometimes it doesn't. That's not a problem with the user, that's a problem with the design of the product," Shames says.
In a real-world example of this, Shames points out that while most autoinjectors are designed with a protective cap over the needle, some have a cap over the button on the opposite side. Because of what Shames says is called the "negative transfer of learning," this might lead to a patient injecting into their thumb, not their leg.
The study participants were also given a backpack with the glucagon product, as well as a glucose meter and strips, insulin, and insulin syringe, then asked to find the correct therapy in the backpack. The contents and layout of the backpack were intended to reflect what a person with diabetes might carry with them at all times, Shames says. That meant the diabetes kit with insulin was at the top of the backpack while the glucagon kit was at the bottom.
Shames explains, "We wanted to make sure that we presented everything in a realistic manner. So we thought a lot about where a diabetes kit might fit in someone's bag versus their glucagon emergency kit and it was quite apparent to us that your glucagon emergency kit, that's something that hopefully you will never use, but of course you need to carry it in case of emergency, whereas your diabetes supply kit, you're using that all the time . . . it was apparent to us that it would be your insulin that would be at the top because that's what you're accessing all the time and your glucagon would be behind that, to some degree."
In keeping with the goal of mimicking closely a realistic level of stress and what might take place in the real world, the simulated setting also included loud sounds and distractions. These distractions included a loud beeping sound that became more frequent over time, loud knocking at the door, a ringing phone, and someone speaking from a script giving updates or urging the participant on at specific time points. In addition, participants were reminded repeatedly that they were being videotaped. "In real life, if someone is unconscious due to hypoglycemia, you're not going to use the product . . . sitting at a table in a conference room in a calm, orderly fashion," Shames says.
The results of this user study were compelling for GNP. Almost all of the caregivers and acquaintances gave the appropriate dose of GNP to the mannequin (15 of 16 caregivers and 14 of 15 acquaintances) but almost none of the participants gave the correct dose of the commercial injectable glucagon. Two of 16 caregivers and none of the 15 acquaintances gave the full dose, although six caregivers and three acquaintances gave a partial dose.
What’s worse was the potential for mixing up injectable glucagon and insulin. Three caregivers and one acquaintance administered insulin instead of injectable glucagon. This, of course, could endanger a severe hypoglycemic patient.
Shames explains that going into the study, one concern he had was being able to find enough users who did not have prior experience with injectable glucagon, to equalize the experience level between the two glucagon products. He expected that this would be a challenge, since anyone who is at risk of hypoglycemia or cares for someone with this risk should know how to use injectable glucagon. Instead, it wasn't hard to find these participants, he says. "It was fortunate for us, but quite unfortunate for society . . . there are lots of people out there who . . . should have this as a life-saving option, and they don't. It's never been offered to them, they've never been introduced to it."
The study abstract concludes that "The data indicate that delivery of GNP is easier for non-medical third parties to administer successfully and suggest administering glucagon using a different route and dosage form than those used for insulin may also reduce the risk of accidental delivery of insulin."
Shames says these kinds of studies are important for all medical device makers. "Use-related issues, we're talking about deaths that are preventable, suffering that is preventable, sky-rocketing costs that are preventable. Paying attention to these issues—it's really just common sense," he says.
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[Image courtesy of LOCEMIA SOLUTIONS]