Unlike the 1962 Ray Bradbury novel, however, Wicked Stability (WS) has nothing to do with creepy traveling carnivals. News of this ambitious and ground-breaking Kilmer Innovations in Packaging (KiiP) project is traveling fast, and its implications are timely, relevant, and positive.
To help promulgate Wicked Stability throughout the medical packaging industry, we asked members of the WS Core Team to shed some light on this visionary effort, including: Henk Blom, PhD, VP Research and Technology, PAXXUS, Dan Burgess, Fellow, Packaging Engineer, Boston Scientific, Jordan Montgomery, Distinguished Packaging Engineer, Medtronic, and Rod Patch, Sr. Director, Package Engineering & Product Labeling, Johnson & Johnson Vision
The Birth of Wicked Stability
Jordan Montgomery clearly recalled the genesis of Wicked Stability. “It goes back to the Kilmer Conference, 2019. This was where the first KiiP meeting took place. Kilmer was saying that they’d like to see more of a packaging presence in sterility assurance. Later at the event, I was talking with Dr. Jan Havel from TUV SUD. He looked at me and said, ‘Jordan, there is a lack of peer reviewed journal articles in packaging. If we look for sterilization, there are a lot [of published papers]. Our people read these and learn. With packaging, we’re just not seeing it.” That conversation, among others, started a lot of thinking—and more conversations.
After the conference, knowing what KiiP was looking to do, Rod Patch, Dan Burgess, and Montgomery met to brainstorm on two umbrella goals:
1) to improve what we do as packaging engineers
2) to publish back out to industry
Montgomery explained, “Aging was among the potential projects we talked about, and it became the thing we wanted to work on first. We wanted to improve the stability testing industry. Today, we’re basically running these studies as compliance exercises. We aren’t proving or learning anything new. By bringing material science back into testing, we believe we can eliminate redundancy in stability testing, putting us in a better place. We are hoping to prove our hypothesis and be persuasive with the results. From there, the project became known as Wicked Stability—to show how we could work together and challenge the fact that the industry’s definition of state-of-the-art hasn’t really changed in over 30 years.”
The group’s discussions resulted in a working hypothesis that they have set out to prove:
Wicked Stability Hypothesis
The effect of real time aging, post sterilization, on commonly available non-hydroscopic sterile barrier packaging systems (SBS) materials, is not significant. Therefore, it is proposed that the typical Materials of Construction (MOC) for SBS’s do not need to start from time zero, but rather, enough supported data exists to show that certain MOC combinations and Modalities of Sterility (MOS) treatments could be placed on market with a known and supported minimum shelf life.
Beyond the Hypothesis
We first asked each of the Wicked Stability core team members to define the concept and share their thoughts on priorities. Blom noted, “We hope to develop a scientifically grounded and data-driven approach to real-time and accelerated aging of medical device packaging materials that ensures product efficacy and patient safety, while also reducing time to market.”
Burgess went straight to the pulse of proof. “Wicked Stability aims to establish an analytical process for determining stability or shelf-life baseline for commonly used sterile barrier packaging materials such as polyethylene.”
Patch expanded on the issue of blindly pursued stability testing. “Wicked Stability is tackling the problem of repetitive stability testing without any new knowledge or value being generated from those tests. MDMs are testing the same MOCs to the same standards and hazards only to say once again, the material is stable. How do we leverage the knowledge the industry already has and accept that knowledge as acceptable for use?”
No Rest for the Wicked: Why they Signed On
While the concept and hypothesis of Wicked Stability sounds like a dream come true, the project is also, quite frankly, hair raising. Given the tremendous workloads every medical packaging professional across the board is experiencing, what inspired these leaders to take on such a labor-intensive endeavor?
Henk Blom had no hesitation. “It offered an important opportunity to work with thought leaders in our industry on problems that really matter. It also offered me the opportunity to bring some of the technical expertise I have been able to acquire over the years to these challenges.”
Dan Burgess told us, “A key driver for me was to end the repetitive testing of these materials that occurs year after year. Engineers are often challenged with trying to assess differences between prior aging studies and the need to meet new requirements. My hope is that by describing the engineering-first principles associated with material degradation, and how they impact material performance, we can move the industry toward the understanding that tested and proven materials no longer require further evidence of their ability to be stable over time.”
Jordan Montgomery saw WS as a way to help patients sooner. “Many of us have been working in standards for a long time; they are important, but the process is slow. KiiP is exciting right now because we have a lot of freedom. It is rare to find ourselves in a space determining the best path forward, with the chance to see that path followed. Using our collective knowledge and experience, even coming together with those we might see as competitors in some ways, Wicked Stability is exciting to be a part of. We hope others will feel the same way about what we’re doing.
Rod Patch was pleased to address this long overdue issue, seeing it as a stepping stone for other industry challenges. “There is no value to the company in tests performed just for the purpose of checking a regulatory box. There is no value to the customer or patient. This is not making products safer for patients. If anything, the industry is consuming resources to document a test where the answer is already known. Those resources could be redirected to make improvements in packaging designs or processes that could lead to patient safety improvements. We look to start a shift in status quo through the work we will be doing.”
Seeing the Future: Five or 10 Years Out
While it is critical to remain in lockstep to the analytical progression, there is value in foresight. Where do these groundbreakers see Wicked Stability in the years ahead?
Burgess reported that he hopes to see the established stability baseline for common materials, and the resulting gift of time. “We can use the additional time and resources to address unmet patient needs. We’ll also have established a process for others to follow. Perhaps in 10 years, most materials will have worked through this process and have established stability baselines.”
Montgomery noted, “If we can prove our hypothesis and be persuasive, there are three outcomes I can see in the years ahead. First, we will improve how sterile barrier stability testing is done and reduce redundancy. Second, Wicked Stability should be strongly positioned to influence industry standards, evolving our industry’s state-of-the-art to a more effective and efficient state. And third, we will have fostered industry experts coming together as we are doing to solve problems.”
Rod Patch responded, “We cannot predict the future, but we can aspire to accomplish results! I see Wicked Stability as a journey that shifts the industry from reactive measurement systems for stability to predictive measurement systems of stability. Wicked Stability aspires to move towards predictive measurement of thermal-oxidative degradation and to use this as a more accurate and truthful indication of material stability with the hope of significantly decreasing test durations, improved quality of results, and enhanced indicators of patient safety for sterile barrier packaging systems."
And Blom summed it up: “In five years, I hope this project will have laid the basic scientific foundations for a new approach to aging studies for a few basic materials, and that in 10 years, others will have accepted the challenge to extend the approach to other materials.”
Tückische Stabilität: Unlimited Potential?
There is unity, passion, and drive in this brain trust that indicates Wicked Stability could bring transformative change in the medical packaging landscape. Wondering if they saw it too, we asked whether this project could lead to answers to other big challenges within industry.
Montgomery envisioned Wicked Stability as square one. “Yes, we see this as a framework for addressing other industry problems. Wicked is focused on stability. And if we can create an output that pushes the industry forward, we can advance our discipline and produce meaningful outcomes for patients and customers. There is no shortage of ideas, and there are other problems to solve. We know that everyone involved in KiiP is interested in doing their best work for the biggest challenges out there.”
Blom agreed. “Hopefully, success in this project will inspire others to challenge the status quo and develop more scientifically grounded approaches to other challenges in our industry.”
Burgess felt that the collaboration of this inaugural team would provide a path for solving other industry problems using the Wicked approach. “In my experience, the medical device packaging community (MDMs, suppliers, and regulators) is a key enabler. We all know that we’re faced with a difficult task of bringing safe and effective life-saving technologies to market. Delivering compliance and conformance on top of an ever-growing list of regulations, standards, and business requirements requires a lot of effort. If the industry can collaborate on projects like this (without infringing on individual companies’ proprietary work) there is potential to do more in less time. If successful, we will have many more opportunities to Wickedly improve patient outcomes.