The last decade has seen a real philosophical change when it comes to drug delivery, shared Doug Boyd, vice president of medical device solutions for Battelle. “Drugs, devices, and patients are now actually all a system,” he told MD+DI. The days of drug development teams working on their own and then throwing it over the wall to the packaging and container team “are done,” he said. “Drugs have unique needs that impact the container closure system, the delivery system, and the user experience. It’s all a system now.”
The greatest example of that change in the last five years is the emergence of autoinjectors, he says. The development of monoclonal antibody therapies such as Trulicity, Taltz, and Humira have required advanced devices that allow users to deliver their own injections, he said.
Next on the horizon for drug-delivery device innovators will be increasing the convenience and intuitiveness of systems that support ambulatory use and perhaps personalized medicine while also improving patient outcomes, lowering the cost of care, gaining reimbursement, even addressing emerging circular economy initiatives. It’s quite a challenge to meet all these demands, but advances in sensors, artificial intelligence, IoT, mechanics, and new “green” materials may help innovators deliver.
Convenience and usability are key, Boyd said. “Patients are becoming advocates for their own well-being and treatment. Usability is a regulatory need now, but it is also becoming more important from a consumer side,” he said. “Devices that are more easily used are preferred by the population and by the physicians who are prescribing them. So I think there is a push from that side; I’m not necessarily seeing that come from payers yet. I’m always expecting to see a compliance aspect come in that’s going to push that even further. I think that’s going to [involve] connected devices and things like that. When someone can crack the 'I can show that with my drug-device combination, I’ve got a lower cost of care,’ I think we’ll start to see payers drive toward different devices.”
Another factor to consider in drug delivery is the trend in healthcare to treat patients in lower-cost settings, such as treating them at home instead of at an infusion center, he added. “I think this is leading to the activity in wearables and delivering higher drug volumes over longer periods of time. This is where there is a convergence of convenience and the business side of healthcare driving to these lower-cost care settings.”
Developing devices for a circular economy is also emerging as a need, Boyd said. New materials and design approaches will be needed to make devices durable, not disposable, he said. Innovators must balance sustainability initiatives with quality of care. Design flexibility is another goal, especially given the trend of moving away from glass to polymer-based containers, he added. Battelle has an advanced materials group working to identify “greener” materials such as soy-based polymers, he said.
There is also a “continual push toward personalized medicine,” and next-generation devices may be able to help. “Sensors could be combined with devices to provide a biofeedback loop to ensure a patient is getting a dose at the exact rate their body needs to metabolize as opposed to what most people need,” he said. Battelle is also researching ways patients could take pictures of their meals and then have artificial intelligence inform them on insulin dosing.
Tech advances are needed to realize new drug-delivery devices. “We are getting inquiries for larger-volume delivery devices and ambulatory wearable pumps,” he added. “And that brings forth the need for improvement in batteries and in adhesives. And as people are going to more home health and ambulatory delivery settings, advances in batteries, sensors, adhesives, and even new mechanisms for better form factors will be needed.” Battelle is working on new adhesives as well as designs for higher-viscosity drugs. It is also looking into repurposing and reengineering existing wearables for new drugs.
Connected health has been discussed for years, Boyd added. “We see the potential of connected health and IoT, but the struggle is establishing the business case. So, if it’s going to be a larger investment to get something connected, do I get a preferred position with payers so I can command a premium because people on my drug will have a lower cost of care?”
The utilization of telehealth and remote care during the pandemic may set the stage for future progress. “I do think we’ve learned a lot that will ultimately change things—people are used to being remote, so I think once connected devices emerge, they will be more accepted because of what people have done over the last year and a half,” Boyd said.
Ultimately, devices have to be intuitive and fail-safe, and they should be less intrusive and less painful, he said. “We’ve developed injectors that hide the needle and those reduce anxiety and improve patient preference,” he explained. “We’ve also been working on how to get more of the existing energy out of a spring, so that bigger springs are not necessary to deliver a higher-viscosity drug; or how to use gas instead of a spring. Mechanisms are changing that are improving form factors, shortening time of delivery, and improving usability.” New modalities could be another big change—can you deliver a drug in a pill or under the tongue rather than an injection, he mused?
“I refer to the Kano model a lot—it talks about today’s delighters, so the things that are exciting today will be expected tomorrow,” he said. “You always have to look one step beyond and continue to delight your audience, whether it’s the user with a more-usable device or the healthcare professional with a better outcome. You can’t sit on your tail and just be glad about what you’ve accomplished. You might be world-class today, but tomorrow you could be ordinary. If you want to continue to stay at the front, you’ve got to keep pushing.
“It all goes back to outcomes, which points to usability. The best device that no one can use does no one any good. It all has to be intuitive and able to be used by your target population, safely and effectively,” Boyd concluded.