中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

1-3 September 2021 | SWEECC H2&H4

Your Chance to Drive Innovation in Medical Device Packaging Image by Gerd Altmann from Pixabay

2020-12-16

Kilmer Innovations in Packaging (KIIP) is a new, industry-collaborative effort that seeks “to improve patient outcomes and clinical delight through the science and engineering of sustainable packaging,” according to its mission statement. The group grew out of the 2019 Kilmer Conference, an event hosted every three years by Johnson & Johnson to discuss sterility assurance issues and named after Fred Kilmer, J&J’s first director of scientific affairs. KIIP draws from Kilmer’s tradition of collaborative innovation in aseptic practices and focuses on tackling challenges such as healthcare-associated infections through medical device packaging innovation.

Kilmer Innovations in Packaging (KIIP) is a new, industry-collaborative effort that seeks “to improve patient outcomes and clinical delight through the science and engineering of sustainable packaging,” according to its mission statement. The group grew out of the 2019 Kilmer Conference, an event hosted every three years by Johnson & Johnson to discuss sterility assurance issues and named after Fred Kilmer, J&J’s first director of scientific affairs. KIIP draws from Kilmer’s tradition of collaborative innovation in aseptic practices and focuses on tackling challenges such as healthcare-associated infections through medical device packaging innovation.

Rod Patch, senior director, package engineering & product labeling, for Johnson & Johnson Vision, and Jennifer Benolken, MDM & regulatory specialist, packaging engineering, for Dupont, discussed KIIP’s plans during the Virtual Engineering Week session, “Driving Innovation in Medical Device Packaging.”

Patch said KIIP’s touchstone “is about improving patient outcomes—what can medical packaging professionals do such that the end result of a patient outcome is improved?”

For instance, he asked, “Are we ensuring that the packaging system provides functionality of aseptic transfer and providing that functionality robustly, consistently, and in a trustworthy manner? One of the concerns of any hospital or healthcare system is a hospital-acquired infection—we call them HAIs. HAIs are a tremendously negative impact to a patient outcome. . . . If our packaging systems can reduce even at the slightest level of percentage the rate of HAIs—that’s a tremendous impact on the healthcare system and a tremendous impact on the patient.”

Patch shared that KIIP is focusing on four programs to address industry challenges:

•  Aseptic presentation. Patch called this “a foundational building block topic” but said that available information on the “proper technique . . . lacks in evidence, lacks in publication, lacks in consistency.” He added that “opinions vary around the world on how to do this and on how to train healthcare professionals.”

He added that “this concept of the sterile barrier is universally accepted . . . but not universally adopted as a practice on how to provide things into the sterile field,” he added.

•  The last one hundred yards. “If you roll back five years, you might have heard our group talk about the last mile,” said Patch. “What they are really focusing on is what happens when a device leaves a transit center and is trying to be delivered to a destination and in that transit, what might be occurring to that device—what are the forces, the shock, the vibration, the temperature, the environmental conditions, all these things we would call hazards. . . . I like to tell people, ‘we have already solved this—we know what happens in that last mile and know pretty well how to test our devices against those hazards.’ It is when it arrives at the destination that we have a low knowledge . . . of the last hundred yards, inside that hospital system.”

Patch says it is important to “collaborate” with these hospital customers to understand how they are storing and handling products. “To get those answers, we need customers to be engaged in the conversation. We need to collaborate better with customers. We need to collaborate better with end-users. We need to collaborate better with the individuals who have made decisions on how they are going to store and how they are going move product. Are they moving them on carts or moving them on trolleys or putting them in bins? These are all the things we are trying to understand in the last hundred yards.”

•  The “Let’s speed things up” topic. “How do we leverage the knowledge we have to be able to be more broadly available and acceptable for use?” Patch asked? He said that “many companies have this information in the vaults of their systems and documentation. They have solved this problem but no one else knows about it. Or company X, Y, and Z have all solved the same question multiple times over, yet it cannot be outside their vaults of knowledge and information because it’s too intricately entwined in the proprietary information of their products. How do we unravel all that knowledge that could be leveraged and make it more broadly accessible and acceptable?”

Benolken described the effort this way: “Each individual company might be trying to solve a particular problem . . . and it might take them five years to solve that problem, whereas if they got together . . . the right people in the right room at the right time . . . if those five companies got together, maybe they could solve it in one year and get that technology out to industry and for their own use a lot quicker than had they each tried to solve it on their own. So there’s where some innovation can come in as well—getting the right people in the right room at the right time—collaboration.”

One project in this group is called Wicked Stability, Patch said. “Many of our organizations have already [answered the question], ‘Is this packaging system stable to the requirements that we identify in ISO 11607?’ Company X and Y have solved this question, sometimes numerous times within the company. Why don’t we present to industry the opportunity to say, ‘If you choose this packaging system, it is stable at minimum for this amount of duration, in this use case or in this scenario’. . . so we aren’t starting from zero time and having to prove it’s safe for use every single instance of application at every single company. We could start from some other time point—at minimum it’s ‘this’—and then you need to demonstrate your application is still acceptable, is still safe, and still performs—you still have additional requirements for your specific device, but you are not starting from time zero. Wicked Stability hopes to bring that knowledge to bear . . . for potentially accelerating innovation.”

•  Sustainability and end-of-life solutions. “Our space is an area where polymers are heavily used,” said Patch. “It is quite right for a topic to think about how our packaging systems are being mindful of their end-of-life state, their end-of-use state, and how is that mindfulness being connected to what should be considered all of our requirements to be sustainable in design and sustainable in practice, mindful of our communities, mindful of our climate? These are things that haven’t always been center and core to the conversation—we felt it is an important topic.” Benolken asked, “How can people get involved?”

“Fundamentally, we want those who have any passion, interest, or desire to be active—those who are willing to bring their passion, practice, and knowledge—to help us collaborate to innovate,” Patch said.

He added that “we are looking for diversity of thought. . . representing more end-to-end of the supply chain, [such as] material creation and material formation, the design, the form-fit-function aspects of design, the process and equipment, the test methods, the end user, and the state of use.”

To get involved, Patch and Benolken encouraged attendees to join the LinkedIn Group, Kilmer Innovations in Packaging.