Dots and an arrow signify where to open the carton. Credit: Roche via Pharmapack Europe.
There are a variety of valuable human factors 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 packaging solutions that unfolded from smaller projects. A key takeaway: not every package update needs to be a major, labor-intensive redesign—sometimes you can find quick wins.
After learning from human factors workshops with cross-functional teams, understanding production needs and writing requirements, then it’s time for early design iterations. McIntire noted that her team starts out with low-fidelity 3D prototypes—even pulling from other examples or making them from clay to introduce the concept—as well as digital prototypes.
This gives people an idea of the potential look and feel. “With new prototypes, or new fidelity levels of the prototypes, we made sure that we were still being traceable to the requirements, we updated the requirements every time because sometimes when people get something in their hands, new things come to mind. ‘What about this? What about that?’ ‘We don't want to have sharp edges.’ ‘I don't think our manufacturing line can actually make this shape.’ So you start to get more out of people,” she noted.
Through those iterations, they down-select before performing usability studies. “You'll notice we didn't create a prototype and then directly go to usability testing. That's the most expensive development path that you can go down, and a lot of companies do it,” McIntire said. In her perspective, it’s preferable to trust your colleagues to do fast and cost-effective iterations using each other's experience and brains to just go through these iterations yourselves, as she noted, “because if you put it in front of the patient and you ask them, you're going to spend a lot more time doing that.”
Quick wins
McIntire highlighted examples of two packaging updates from colleagues in which they weren’t starting from scratch, and instead made relatively quick improvements to existing designs. In these cases, projects were initiated by packaging engineers, who checked in with human factors folks throughout. “That's one of the cool things about having a patient-centric culture is you don't have to rely on one function to do the job. It becomes everybody's job to have patient-centricity in mind,” she said.
Evolution of a tamper-evidence seal and openability (from packaging development engineer Monica De Bardi):
Dots and an arrow signify where to open the carton. Credit: Roche via Pharmapack Europe.
At left, the package has a tamper evidence seal, and checks the boxes for regulations, but patients had trouble with how to open the box.
As McIntire explained of the design at center, “We put an opening underneath the tamper evidence seal, but people still couldn't really see it. In this illustration, you can see it quite clearly. But on the box, it's a tiny perforation with clear tape. We were still getting reports of difficulty and of people using tools to open it, and that's not ideal. That's a requirement of ours now that people shouldn't have to use tools to open a box.”
They arrived at a carton (at right) which is now their standard. “We have the dots and the arrow featured very clearly. People can see that they push their thumb in and open the box,” she said. This didn't require requalification, as it was a quick artwork and labeling redesign.
Clinical trial packaging update (a project by Miriam Lauras, global packaging engineer) :
Adding simple sun and moon illustrations and colored lines to a blister offer patients helpful cues for which pills to take in the morning and evening. Credit: Roche via Pharmapack Europe.
In one clinical trial dosing regimen, patients had to take three pills in the morning and three pills in the evening. A blister package was selected over a bottle for dose tracking (left).
Adding simple sun and moon illustrations and colored lines (at right) offered patients helpful cues for which to take in the morning and evening. “They can even keep track themselves— it may sound silly, but even if it's upside down,” she said. “If you've ever tried to take medication consistently, at some point, it gets a little disorienting. We had a few different iterations from [Lauras] the packaging engineer. Then our team reviewed them and gave some quick feedback. In a day or two, we had something that was an improvement. This is the stuff I love doing.”
Digital leaflets: more work needed
When an audience member asked about digital leaflets, McIntire noted that there are still some difficulties in the market despite sustainability benefits. While Europe as a whole is closer than the U.S. to eliminating the folded paper leaflet in favor of a digital option, she said QR codes—which have made many headlines for their usability—may not have come quite as far as people think. “In the COVID situation, you would have expected that we were using more QR codes in the U.S.,” she said. “I went to the Human Factors Ergonomics Society last year, and there were some statistically significant studies where over 50% of people didn't know what a QR code was, didn't know how it worked. They thought they had to have an app on their phone in order to open it.”
Beyond consumer/patient acceptance, she said there’s work to be done among brand owners themselves. “I think it would take a new department of 120 plus people to be able to actually realize digital leaflets. If you look at the current processes that we're doing right now, the maintenance behind them, the updates, the cybersecurity, all of that for the different affiliates, it requires a lot of manpower,” McIntire explained. “So, I think until there are regulations that are asking us to have digital leaflets—it's going to be something where industry might be trying to push the health authorities—but I don't know if it's going to happen even in the next 10 years. I would like for it to.”
Safety Resource
McIntire highlighted the resources on the Institute of Safe Medical Practices site. They have a newsletter that includes events that have happened in pharmacies. “So you can kind of get a feeling for these case studies, different use errors that are happening,” McIntire said.
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
