Medical device manufacturers (MDMs) should not have to reinvent the same package over and over again. If one company has proven that a sterile barrier system is stable, as required by ISO 11607, other companies shouldn’t have to start back at zero when using the same package. They should be able to start their development work from a later time point — on the hypothesis that the package is safe up to “here,” for example — and then test from there to show that the packaging is acceptable and safe for their specific device.
This process could potentially accelerate packaging innovation by bypassing repetitive, time consuming, and expensive stability testing of well-known sterile barrier materials.
This is the purpose of Wicked Stability, a project of the group Kilmer Innovations in Packaging, and led by Rod Patch, senior director, package engineering and product labeling, for Johnson & Johnson Vision. Innovations in sterile medical packaging have a direct impact on patient outcomes, and that is the goal of the KIIP group: to improve patient outcomes, while also delighting clinicians who use the packaging.
The team is getting closer to achieving its goal. Project Wicked Stability has just won a $9,500 research grant from AAMI Foundation’s new Kilmer Fund, which provides funds for research designed to “advance the science of microbiological quality and sterility assurance.”
“Project Wicked Stability received the unanimous and enthusiastic support from the Kilmer Fund Committee,” says Steve Campbell, executive director of the AAMI Foundation. “The submission was exceptional and the intended goals of the project admirable and in line with the mission of the Kilmer Fund. We’re excited to see the research move forward.”
One of the objectives of Project Wicked Stability is to create a predictive stability model for common sterile barrier materials of construction (MOC). Turning stability testing data generated by individual MDMs into open-source data could be a game-changer for medical device packaging development overall. It should lead to more efficient packaging development by consuming fewer personnel resources and should speed up delivery of life-saving medical devices.
The results of Project Wicked Stability’s study should help medical device manufacturers market their products globally in a safe, yet accelerated, timeline.
AAMI says most grant recipients will probably use the money to offset costs associated with buying materials or services that are critical to the research. That is the case with KIIP, says Patch. The group will use the grant dollars to pay for costs associated with the testing needed confirm the predictive stability model.
Patch explains, “We have some science behind a model related to our topic of stability. To confirm that model is true and accurate, we would have to do some confirmation studies. Those will take funding and [have] some costs associated with samples, testing, evaluation, results, and reporting.”
KIIP’s lofty but worthy goals.
Wicked Stability is one project of Kilmer Innovations in Packaging, which has a broader goal for sterile medical packaging. KIIP’s vision is: (1) to improve patient outcomes and (2) to delight clinicians through the science and engineering of sustainable packaging.
“Improving the outcome for the patient is paramount to the priority of the organization’s efforts. It’s going to do that through the science and engineering of medical packaging,” Patch says. “We also believe clinician delight is an important factor in that conversation, such that clinicians have experiences through medical packaging that are delightful … not frustrating, not harmful, not dissatisfying. But delightful.”
Members of KIIP’s Project Wicked Stability team include:
• Team leader Rod Patch, senior director, package engineering and product labeling, Johnson & Johnson, Vision
• Henk Blom, Ph.D., vp of research and technology, PAXXUS
• Jordan Montgomery, distinguished packaging engineer, Medtronic
• Dan Burgess, fellow, packaging engineer, Boston Scientific
• Wendy Mach, senior manager, technical consulting, Nelson Laboratories
• Chris Sarantos, vp, product development, SmartStart Medical
• Jennifer Benolken, CPPL, MDM and regulatory specialist, DuPont
To learn more, join the Project Wicked Stability LinkedIn group.
You can also hear more about Project Wicked Stability (along with other medical packaging hot topics) during the session “Rapid Fire with Medical Packaging Trailblazers” as part of Virtual Engineering Days, at 3:15 to 4:00 pm (EDT) on Tuesday, June 15, 2021. Registration is free.