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Identify When to Bring Human Factors Into Projects

A Roche human factors engineer and psychologist by training talks about projects that benefit from human factors input, the patient-centricity of simplified manufacturing, and why raising the bar above regulatory requirements shouldn’t be a bad thing.

A patient with a given disease state may have physical impairments—including comorbidities—that affect how they interact with a product and package.
A patient with a given disease state may have physical impairments—including comorbidities—that affect how they interact with a product and package.
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There are a variety of valuable human factors (HF) updates that fall outside of what the packaging and medical device communities think of as the “regulated space,” according to Tiffany McIntire, principal human factors engineer at Roche Pharmaceuticals.

In her years of experience, McIntire—also a psychologist—has worked on over 10 submissions with the FDA and has transitioned from working on combination products to looking at the wider portfolio at Roche.

At Pharmapack Europe, she discussed how she and her team identify human factors projects, including several questions to ask as you evaluate conventional use and packaging. 

Knowing when to bring human factors into a project

McIntire highlighted a checklist she uses in packaging projects to determine if human factors should be involved. “The motivation behind this was when I first came into Roche, I was given a project where we had a bottle configuration for the U.S. and then a bottle with oral syringes and a press-in bottle adapter in Europe. The thinking was that in the U.S., we don't have to co-package because all this is going to be available in the pharmacy. We're going to make it look like another product that we had on the market,” she said. “But when I started looking at the project more closely, there was a short in-use period so they would have to do several different steps: mix with water at home, put in the press-in bottle adapter, and extract the dose that they need. For me, that was immediately a red flag. It fell outside of what I would call conventional use. That’s one of the things we benefit from—having a cross-functional team full of people from different nationalities in Switzerland,” to understand use cases in various countries.

McIntire highlighted a checklist she uses in packaging projects to determine if human factors should be involved (Image: Roche/Tiffany McIntire via Pharmapack Europe)McIntire highlighted a checklist she uses in packaging projects to determine if human factors should be involved (Image: Roche/Tiffany McIntire via Pharmapack Europe)

Questions on the checklist include whether the product is intended for pediatrics or elderly patients, if an over/under/missed dose requires medical intervention, and if it has a complex dosing regimen. These can greatly affect what McIntire calls PCA: perception, cognition, and action attributes, and their related impairments.

  • Perception is the way we receive information (considerations include visual or hearing impairments)
  • Cognition is the way we process information (considerations include cognitive fog from pain, chemotherapy; overstimulation; or processing issues from age or disease)
  • Action or physical characteristics are the parts of the body we use to accomplish a task (considerations include hand dexterity issues or limited mobility) 

In the small molecule space, products tend to be developed first for adults as oral tablets, then they are transitioned for use in pediatrics. “We have to make a decision for the pediatric patient, how is that going to get into their body? From zero to six months, you're probably only consuming liquids. And then after that, you could be having whole foods,” she noted. “How easy is it to get a liquid into the child's mouth versus having potentially mini tablets and sachets? [Consider] the constitution steps that can happen at home. These are a lot of the conversations that we're having upfront with small molecule development now. But really, it came from a trend of getting projects or getting assigned to projects later on in development.”

McIntire credits colleagues on the packaging team that began bringing her into the process, which is where the questionnaire was born. “This is given to every packaging engineer when they get a project, and it essentially tells them whether or not they need to bring me in,” she explained. “Right now we're working to get involved a little bit earlier in the process with the technical development teams, the CMC teams, small molecule formulation, large molecule formulation, to give them similar questionnaires, to get them to think about the complexity of the products that they're putting out into the market, and how people are actually going to use them and whether that's going to be acceptable.”

She highlighted a few other key questions:

  • What physical issues might the patients typically have, including comorbidities, sensory, or cognitive issues? “Rheumatoid arthritis is something that usually comes to mind, if you have a patient who has diabetes, they could have neuropathy, hearing issues, visual issues, even age can be related to these. So that comes into play with the assessment quite a bit,” she said.
  • Is the process and delivery of medication acceptable? McIntire offered a recent example in which a colleague asked if it’s acceptable for the patient or caregiver to have to mix something for 10 minutes. “The answer is that it depends. Do they have to shake the bottle for 10 minutes? Do they have to do this every day? How many other medications are they managing? What's the therapeutic benefit of the product?” she said. “Anyone that works in medical devices or pharma in general knows we talk about risk-benefit all the time. The risk is probably non-compliance. Then the benefit—they could be motivated into compliance, even if it's inconvenient, because the therapeutic benefit is there. For example, if you don't have to have an intrathecal (spinal) injection, and you have to just shake a bottle for 10 minutes once a week, people may be motivated to do that. So it's never really straightforward or clear cut. But at least in my opinion from this checklist, if you can check yes on one of them, then I start to look at the problem and hash out those details.”

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