Your Full-Service Partner in Injection Mould Tooling for Medical Devices

At Lawrence Engineering, we specialise in injection mould tooling for the medical device industry, offering a complete end-to-end service. This includes discrete moulding, micro moulding and overmoulding. In particular, we have strong expertise in overmoulding applications onto extrusions, metal components and hypo-tubes.

Whether you’re developing a new product or scaling up an existing solution, we guide you through every stage of the manufacturing process from concept to cleanroom production, ensuring quality, compliance, and cost-effectiveness every step of the way.

Stage 1 – Design and DFM
As the design of medical devices becomes more complex, involving your tooling partner early in the process is essential for success. Our in-house design experts will work closely with you from the start, to ensure the manufacturability of the components, and to provide optimum design and functionality in a cost-effective way.

We’ll help you:

• Optimise geometry and tolerances for precision moulding
• Apply DFM (Design for Manufacturability) principles to avoid potential downstream challenges
• Identify opportunities to simplify tooling without compromising performance

This proactive, hands-on approach results in smart designs, better functioning tools and fewer delays. So whether you’re prototyping or preparing for full-scale manufacturing, we’ll help you build it right, from the beginning

Stage 2 – Proof of Concept with Rapid Prototyping
If required, before committing to a full tool build, we can additionally provide you with a 3D printed solution to provide a proof of concept before going ahead with the tool creation. This allows you to visualise and test the form and function of your component early in the development cycle, reducing risk and ensuring alignment between your design intent and manufacturing reality.

Stage 3 – Mould Production
We manufacture both prototype and full production moulds depending on your needs. To offer additional flexibility and cost savings, we also have a range of in-house mould bases, allowing you to invest only in custom mould inserts, if preferred.

All our moulds are produced using fully hardened steel, ensuring a high-quality tool whether for prototyping or full-scale production.

Stage 4 – Mould Try-out & FAT (Factory Acceptance Test)
Once the tooling is complete, we will complete a mould try-out to prove out correct tool functionality, identify and de-bug of any issues, and to ensure the products meets all relevant criteria.

Further to this, we can facilitate Factory Acceptance Testing (FAT) of mould tooling at our cleanroom facility. We have developed our own in-house FAT process, in which we carry out a comprehensive review of the mould tooling and develop a moulding process in line with the principals of Scientific Moulding. We will develop a process window, parts from which will then be submitted to our customer and retained for First Article Inspection (FAI).

Further to FAI, we can also perform Capability Studies on the product’s critical dimensions, in doing so we can ensure that the mould tool, can produce product, that meets and exceeds predefined capability indices. This will ensure confidence that the mould tool and the moulded product will pass any subsequent process validations.

Our FAT process ensures the moulded components meet all performance and dimensional specifications.
Customers can be present during the try-out and FAT activities if required. We can also facilitate FAT in line with customers own procedure.

Stage 5 – Validation
Where required we offer a comprehensive validation service which ensures that our processes are fully qualified before manufacturing begins. Our service includes both Process Validation and Test Method Validation depending on your requirements.

Our in-house validation includes:

• PFMEA (Process Failure Modes Effects Analysis): Evaluates each process, identifying which elements are deemed as being CTQ (critical to quality).
• IQ (installation Qualification): This verifies that new or modified equipment is installed correctly.
• OQ (Operational Qualification): This verifies that the process produces parts within specification across its intended operational range.
• PQ (performance Qualification): Demonstrating that the process consistently delivers results within specification under normal conditions.
• Test Method Validation (TMV): Ensuring that measurement systems deliver accurate and repeatable results

We manage the full validation process, reducing the resource burden on your team, accelerating timelines, and ensuring smoother production start-up. Our on-site toolroom allows us to fine-tune quickly if needed keeping projects on track.

Stage 6 – Cleanroom Manufacturing (Moulding & Sub Assembly)
Following FAT or validation, your tool moves directly into production in our Class 8 cleanroom, equipped for both low- and high-volume moulding.

We also offer sub-assembly services, helping you streamline your supply chain by managing multiple stages under one roof, improving efficiency and quality control.

Why Choose Lawrence Engineering?
With over 40 years of experience and a specialised focus on the medical device sector, Lawrence Engineering offers a seamless, fully integrated service—from concept to cleanroom production. Our customers value our technical knowledge, collaborative approach, and consistent delivery of high-quality solutions for complex moulding challenges.

If you’re developing a medical device and need a partner who understands the full journey, get in touch today.