The packaging and med device communities are, of course, well-versed in the need for patient-centered design in boosting adherence. Nonadherence to drug treatment is estimated to be responsible for 125,000 deaths annually in the U.S. alone.
But with multi-faceted challenges, one-size-fits-all answers are hard to come by. Even among patient populations for a given therapy, there are differences in user abilities and it’s difficult to standardize a package or device for best use across all patients. At Pharmapack Europe, panelists were asked what challenges they still see in their respective areas.
Personalized dosing: Aline Noizet, founder of Digital Health Connector, noted that standardized dosing reduces efficacy. She explained of data from a recent Closed Loop Medicine presentation that many women are over-dosed, while patients over 80 kg are often underdosed. In tests, personalizing dosage for individuals showed efficacy in 80% of the cases. “So it shows that there's really an issue here with having the right dose for the right person,” she said. Obviously, packaging plays a key role in unit dosing and while variable dosing options exist, some convenient solutions come pre-dosed.
A second, related problem that still needs to be addressed is inclusion in clinical trials. “We know that most of the drugs that exist today have been developed for white males. A consequence is that those drugs, those treatments are not so efficient for women, or for people of color, or different ethnicities,” she added.
Related reading: PFAS: Navigating Materials of Concern in Life Science Packaging
Sustainability: Sustainability is something that touches most people’s hearts in our industry, said Oliver Haferbeck, head of innovation and advanced technologies at Gerresheimer. “If we don't find solutions concerning the environment, and being environmentally friendly, we're going to run into huge problems,” he noted. “You can take a look at this from every single perspective, whether it's in the healthcare industry, whether it's in mobility, tourism—you can take a look at every single sector. If we don't find sustainable solutions, we're going to be out of business. It just won’t work.”
This can lead to competing priorities, highlighted Tom Oakley, VP of design and development at Springboard, who said, “We often get asked, ‘Why don't you just make things easier for the patient? Why don't you just go ahead and make things much simpler?’”
When designing and developing devices and packaging, there are other considerations that often go into conflict with simplicity for the user. “Sustainability is an extremely important subject. Let's take the example of a device that you want to make reusable for sustainability reasons. If you make it reusable, you typically involve extra user steps with loading a drug or removing a needle or some form of cleaning, etc. Those steps all make things harder for the user,” Oakley said.
Anti-tampering and cost: Next, Oakley discussed anti-counterfeiting. In the effort to make it difficult to switch or tamper with drugs inside of packaging, the packaging typically requires some level of robustness, which may make it harder for the user to open. “Another one would be cost. People are somewhat resistant, particularly payers, to increases in cost if that's what's needed for extra patient-centricity,” he said.
James Fries, CEO at Rx-360 said that counterfeiting and safety are top of mind for him, but that there’s a cyclical nature to topics like these in the industry. “Some days the flavor of the day is counterfeiting and some days it's not. When it's not, that's when our guard is let down and those are the type of problems that when we address them retrospectively, we're already behind,” he explained.
He encouraged attendees to consider early in the design process that there are bad actors out there attempting to infiltrate while life science companies look to improve patients’ lives. “Sometimes patients aren't always aware of that. I think it's incumbent upon us, as industry professionals, to hold up that end of the [safety] bargain,” said Fries.
Data: On the topic of connected devices, Eric Chanie, director, core team leader, connected pens at Merck, discussed some benefits of the data collected, not only for adherence to a given schedule but even for guidance. By recording the orientation of the pen or the length of the injection, a provider can coach the patient on whether they need to adjust the injection angle or wait another few seconds before removing the device.
But the user-friendliness of the data should not be overlooked. He said it’s important to consider how you present data to the physician and caregiver: “We have to give them an additional layer of simplifying the information, and providing them only what’s relevant for that particular patient. That is probably the next challenge and quite a complex one.” He also explained that while connected devices offer benefits, sustainability should be considered. How are the materials—electronic or not—recovered, reused, or recycled?
Developing a best-fit design is not impossible. But it’s important to acknowledge these challenges and balance needs when developing effective packaging and devices for the user.
