Medical Device Overmoulding: Key Trends, Compliance Requirements and Design Considerations
Looking for expert insights into the latest medical device overmoulding trends? Our Operations Manager, Michael Lawrence, shares what he is seeing across customer projects, including rising compliance requirements, increased validation expectations and the growing importance of early design involvement. This interview highlights how Lawrence Engineering applies industry-leading overmoulding expertise, in-house tooling capability and advanced process development to support reliable, high-quality manufacturing for medical device customers.
Q- From your perspective, what have been the main overmoulding trends over the past year?
One of the most noticeable trends has been increased focus on compliance, particularly around connector standards. We’re seeing more projects where overmoulded components must conform to ISO 80369-7 standards, especially for luer connectors.
Customers are increasingly aware that these parts must conform not just dimensionally, but functionally, to ensure compatibility and patient safety.
This shift has had a knock-on effect on metrology and validation expectations. . Customers are more willing to invest in the additional cost and lead time required for detailed dimensional studies, including CT scanning, to ensure components meet regulatory and functional requirements.
Q- What about materials, are you seeing much changes there, or more of a focus on sustainability?
From a material perspective, material choices have remained fairly consistent. Most projects still use established medical-grade polymers, such as Pebax, polycarbonate, ABS, Nylons. To date, we haven’t received requests for medical grade recycled plastics. Bio absorbable and implantable materials do come up in discussion, but not yet in active overmoulding projects.
From a sustainability and waste management perspective the most meaningful opportunities arise at the design stage. This is where material usage and waste reduction can be optimised while still ensuring robust manufacturability.
Q: How important is early design involvement for overmoulded parts?
This is crucial to successful overmoulding project. Many of the challenges we see arise when designs are largely finalised before manufacturability is properly considered.
Overmoulding introduces constraints around core pin access, wall thickness, part handling, alignment and moulding strategy. If these factors aren’t considered early, you can quickly reach a point where something is theoretically possible but not practical or is difficult to run consistently.
We have seen time and time again that early involvement saves both time and costs. When process, tooling and dimensions are considered together from the start, issues like voids or dimensional drift can be solved before they become expensive problems.
Q: What differentiates Lawrence Engineering when it comes to overmoulding?
Our biggest differentiator is our depth of process development expertise and the fact that we design and manufacture our own tooling in house. This gives us a unique understanding of how tool design, part design, and processing parameters interact from day one.
Instead of pushing parts through and fixing problems later, we invest upfront in building a stable, repeatable, fully validated process. That foundation is what consistently delivers high quality, reliable overmoulded components.
Q: Looking ahead, do you see major changes coming?
From an industry perspective, no not really. The fundamentals of overmoulding remain the same, but customer expectations around validation, compliance, and traceability will likely continue to increase. Our focus is to stay ahead of those requirements through ongoing capability development and investment.