Back by popular demand. A few weeks ago, we published a blog article: Something Wicked This Way Comes to Packaging. In it, we highlighted a ground-breaking new KiiP project called Wicked Stability … a project that could make a significant impact in medical packaging in the future.
That article was so popular, sparking a lot of positive discussion within the industry, that we decided to highlight even more information from the project team below. Enjoy Part 2 of this series.
Can Wicked Stability Fail?
The consensus was that anything, including WS, can fail. For Rod Patch, the biggest hindrance to success could be the pace of change. “Change in the Medtech industry is notoriously slow. That allows topics to dissolve before science can support the change. The team is passionate today. Keeping that passion and enthusiasm high throughout the scope of work needed to demonstrate a step-change will require patience, commitment, and industry influence.”
Jordan Montgomery expanded, saying, “If we can’t objectively prove our hypothesis, that would be the first potential failure. Second, and just as important, we would need to prove our hypothesis as well as persuade others with our results. Industry must be compelled by this work to act differently on a massive scale. If no one acts, nothing changes.”
Dan Burgess could not overlook the limitations of time. “We’re all volunteering our time and we have our day jobs. We are always balancing how much time is available for this effort against competing priorities. Also, the challenge may seem simple at face value, but it’s part of a complex system with many inputs. Because there is so much variation, it will be key for us to show what the big levers are when it comes to impacting degradation and product performance. Those factors must be acknowledged and managed, or they are a failure risk.”
Henk Blom addressed potential practical considerations. “The Wicked Stability team could fail to accomplish its goals if we fail to gain full regulatory buy-in for this new approach. Another risk is a loss of focus, such that the project gets to be too broad. And finally, the bottom line that we face in all avenues of industry, the work will require funding to complete.”
Bring on the Regulators
So, what about regulatory and notifying bodies? That’s a whole new avenue of effort. Blom confirmed, “As this project progresses, we will continue to engage regulatory bodies in the conversation. A key aspect of Wicked Stability is the publication of technical papers that regulatory agencies can reference in their own work.”
Burgess agreed, adding, “Yes, the team has been in contact with several regulatory representatives and shared the approach at venues where regulators can learn about the project. This work will continue as it ensures the success of Wicked Stability. If we don’t have buy-in from regulators, then it will be difficult to apply our learnings, leading to another potential cause of failure.”
Rod Patch noted, “As this idea blossomed, we took a moment to pause and collect feedback and peer review. Connecting with market access authorities was deemed important and necessary. Their feedback was positive and enthusiastic. There was real support in demonstrating our hypothesis with scientific confidence. The dialogue was in partnership and shaped what would have to be true for the authorities to endorse, but with fully supportive responses. As we progress, we will remain in touch with market access authorities and maintain open channels of communication.”
Montgomery reported that, with the hypothesis shaped around oxidative induction time data, some of the team’s work sought out key material experts as well as influential regulators. “We want to understand their position on the work so we can continue to calibrate the project. We’ve got to include regulators and beyond to get Wicked Stability out there and hold up our work to the scrutiny of peers. In 2022, we have taken it to the public at the[PACK]out and MDM West with more to come. Socializing Wicked Stability is how we will produce great work and it absolutely should include those who are regulating us.”
Calling All Wicked Professionals
There is an unlimited amount of work to be done. It must be conducted with structure, clarity, methodology, and precision. Fortunately, that’s what medical packaging professionals thrive on! We asked the WS core team what many would like to know: Is there opportunity for others to get involved if they are interested? If so, how?
Patch welcomed the question, saying, “Yes, indeed, there are opportunities! We welcome contact from passionate professionals with interest in this topic. He also noted that the timing is ideal, as the WS core team will be adding workstreams focused on MDM data, MPTP data, supplier data and test method development.
Burgess added, “The workstreams will facilitate a divide and conquer approach. In addition to those mentioned by Rod, we will also have workstreams for publications and communications. Any of us are happy to discuss what’s needed and invite industry colleagues to reach out.”
WHERE TO CONNECT: ASSETS AND EVENTS
Jordan Montgomery closed on their hope that industrywide conversations will help get the word out about Wicked Stability. So far in 2022, the WS Core team has been on the stage at the[Pack]out and MDM West. Watch for them at MDM Midwest in November, and for more Wicked Stability news to come. We hope you’ll all join us in support and furtherance of Wicked Stability—and industry success.