Kilmer’s innovations in packaging drive innovation in medical device sterility

Kilmer Innovations in Packaging (or KiiP) is a collaborative effort across the sterility assurance value chain focused on medical device packaging with the goal of fostering bold and unprecedented innovation. Their tagline is “Solving Tricky Problems in Healthcare Packaging,” adopting a phrase originally coined by Dr. Laura Bix at a previous HealthPack conference; Dr. Bix brought it back into the conversation during KiiP’s training. The idea behind KiiP and its tagline is that solutions to these thorny issues will improve patient safety, while improving the experience of healthcare workers, among other benefits.

For a bit of context: The Kilmer Conference is put by Johnsons and Johnsons once every three years, with the next scheduled for 2022. This is a prestigious, invitation-only event focused on infertility assurance.

Jennifer Benolken, MDM & Regulatory Specialist, Packaging Engineering at Du Pont explained that a group of colleagues sat down at the last Kilmer conference in 2019 and asked how they could attract more people to the next conference who are passionate about packaging. What started as a conversation about socializing the Kilmer Conference concept among packaging professionals has evolved into an industry initiative in the spirit of the Kilmer Conference to collaborate to innovate. They’ve made a lot of progress over the past two and a half years, and it’s turned into a KiiP Group on LinkedIn of over 300 members who have broken down value chain silos from medical device manufacturers to end users and healthcare professionals.

The four program focus areas within KiiP are:

  • The last 100 meters
  • Aseptic handling
  • Speed ​​things up
  • Durability

Benolken, who leads The Last 100 Yards, said the interesting thing about KiiP’s efforts is that they require a mindset shift for many participants. Typically, in the medical device industry, there is a fairly clear goal or end state (and a process to get there). Whether updating a standard, implementing a new package or a new machine, etc., there are defined processes, workflows, steps, etc.

This type of innovation is much less straightforward, with no prescribed path to follow. It requires participants to be open to questions, with no clear objective…until it emerges. In many ways, this is akin to the research phase of a new product development process – they have to find the problem to solve before figuring out how to solve it. It’s well outside a lot of comfort zones, but it will ultimately lead to important learnings – via failure, pivoting and finding new victories – to move the industry forward outside the constraints of a single business. By breaking down silos, the conversations are rich and the learning is immense. They find that it takes time to understand the importance of the same concept to others in the value chain – they often use similar vernacular, but the way they are applied and understood is sometimes different. It becomes a lot to understand.

“This type of innovation is much less straightforward, with no prescribed path. It requires participants to be open to questions, with no clear goal…until it emerges. akin to the research phase of a new product development process – they have to find the problem to solve before figuring out how to solve it.” —Jennifer Benolken

Benolken pointed out that there are still silos that can exist. It’s not just between suppliers, manufacturers and healthcare providers, but often within companies themselves. For example, the sterility assurance and packaging groups typically report to different managers and have different metrics. Discussions are ongoing on how the groups could work together more closely to find ways to strengthen bonds and solve problems together, while avoiding potential pitfalls, as sterility assurance and packaging do not cannot carry out their mission completely by themselves.

On the sustainability front

One of the main takeaways from their panel at MDM West was that sustainability is more than just recycling (something health care packaging has covered in the past, including our 6 Drivers of Sustainability video). Of course, there are groups that work in parallel, such as the Healthcare Plastics Recycling Council (HPRC), focused on making progress in recycling efforts.

As Jenn Goff, Global Director, Product Strategy at Oliver Healthcare Packaging, noted, KiiP is also studying upstream how to remove waste from the system before it is even introduced. There are many ways to make sustainable choices and being innovative in packaging design can result in the reduction of waste as a by-product. One thing panelists touched on is that healthcare systems are now considering sustainability in purchasing decisions, providing a competitive advantage to companies that make and articulate more climate-friendly choices.

Kiley Djupstrom, Business Development Manager at plastic ingenuity, discussed that they have been in talks with groups like Practice green health, which released its guide to sustainable procurement for health systems last year.

Incubator concept

“A lot of our team members come from big companies and piloting something in a big company can be a bit daunting, going through that stage process,” Djupstrom told the MDM panel. “So if we want to quickly test something or pilot an idea, we’ve come up with this incubator concept and it’s a dynamic framework to pilot a sustainable solution, whether it’s a process, a design or material.” For example, the group could take a material proposed as a sustainable alternative through the advanced recycling process and carry out a scientific study.

The incubator concept goes beyond sustainability, and Benolken noted that across KiiP, the various programs can ultimately be considered incubators in their own right. When new materials or means are developed by suppliers, it usually takes a long time for manufacturers to be able to implement them. “KiiP teams can deliver the platform so that basic data and testing is available to everyone from the get-go, and make that product or process valid from day one instead of waiting for somebody adopt it,” she said. “So I think it will be a nice result as well. We may be able to introduce different materials and processes much faster than how they have been done in the past by one company. »

Questions and answers with Kiip

What is a global concept addressed in all groups?

KiiP raises awareness of the importance of packaging. Packaging often goes unnoticed until something goes wrong. If we do our job properly, users may not necessarily listen to the packaging because it has done its job transparently and effectively protecting what’s inside. So that makes our job interesting, how do we get recognition for packaging when our objective is not to be seen?

What is the involvement of regulators such as the FDA or Notified Bodies (NB) in Europe?

KiiP has had discussions with regulators, but they won’t be a big part of the conversation until we identify potential solutions or pathways to them. Not all KiiP projects will be regulatory in nature.

What are some of the biggest obstacles?

  • It is worrisome to potentially expose gaps or problems in established concepts. We ask tough questions in the name of innovation and patient safety and seek either validation of what is there or improvement to a better place.
  • KiiP wants these initiatives to be free enough for creativity, yet have some structure to move the needle forward.
  • There are also tangible obstacles like how KiiP handles money to fund projects. If we are not officially established as an association or non-profit, how can we accept funds without conflicts of interest arising? We are working to find the right way to achieve this. Another hurdle is that some companies have expressed concern about intellectual property when collaborating with others – we focus on working on topics for which there is currently no solution, in a way that collaborates a solution for all to help us get there faster than when we work on it individually. In many cases, KiiPsters find that the challenges are greater than any individual or company can handle.

You ask great questions. Have you ever had failures or innovations?

This is a huge learning process for everyone involved. We are all grateful to be able to work on these important topics with our fellow KiiPsters – although no “failure” has occurred so far, we have had many pivotal moments and conversations about the direction in which we are heading and whether this needs to be changed or not. A huge success was the podcasts that IAHCSMM invited KiiP to participate in because the conversations we had in our team meetings needed to be heard by more than those in the meeting. Another success we’ve seen is attending events such as MDM West and other venues to get people talking about what ‘could be’ to solve these big, thorny issues the industry has been grappling with for years. .

If you are looking to get involved with KiiP, check out their LinkedIn group here. They are looking for people to participate on a voluntary basis, and there is no cost to join.

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