The Material Development Process

Every material development effort starts with a customer request, a performance gap, or an unmet application need. The first step is defining the scope—what the material must do, how it will be used in packaging, what product(s) will be packed, how the product will be sterilized, and just as importantly, what is out of scope.

This stage also includes a business case and evaluating the competitive landscape. There also needs to be portfolio alignment and long-term market opportunity to justify the cost of development.

Once the scope is clearly defined, the process moves into design ideation. This is where engineers translate the findings into performance and physical property requirements like seal behavior, puncture resistance, and sterilization compatibility. Where possible, the critical quality factors and potential risks are identified and documented.

At this point, there are often a number of potential solutions that are then narrowed down by scrutinizing in-house and external capabilities, raw material availability, and portfolio alignment. In cases where novel technologies or concepts come into play, the intellectual property (IP) landscape is also reviewed to ensure there is no risk of infringement on existing IP and evaluating the opportunity to protect the new design.

Because a promising design must be manufacturable and reproduceable at scale, the next stage requires close collaboration with production teams or external partners to align on processes, capabilities, and constraints. This includes validating a stable supply of all the material components and ensuring regulatory and sustainability requirements are met.

The verification stage is where the defined performance and quality requirements of the design are confirmed. Lab evaluations also take place which may include mechanical properties, such as seal strength, puncture resistance, as well as aging, and sterilization compatibility. If the evaluations fail, the material goes back into the design stage for reconfiguration.

Once the design is verified, validation follows. Guided by established quality systems and ISO requirements, materials must be validated internally and, when customer specific, validated again using the customer’s process. This includes compatibility with sterilization modalities along with machine validations.

This stage emphasizes why upfront planning matters. Customers invest significant time and resources in validation. Delivering something that is “almost right” is not good enough.

Throughout each step, it’s critical to review whether the project still aligns with the original assumptions and scope, or if those requirements have changed.

As stated previously, a successful design needs to be reproduceable at scale. Once validation is completed, the material is launched in a controlled manner. Initial commercial orders are closely followed to ensure that all quality and customer requirements are consistently met.

It is important to note that a material is commercialized for a defined purpose, based on the application it’s designed for. While industry experience may indicate where else a material could perform well, successful commercialization balances flexibility with intention.

Throughout the entire material development process, one principle holds true: experience and a deep understanding of the base materials improves outcomes. That expertise is what enables teams to design materials that not only meet today’s requirements but continue to innovate for the future.