Plastic injection moulders for medical and healthcare industry
OGM is a contract manufacturer that provides medical injection moulding for the healthcare, pharmaceutical, and life sciences sectors from its UK facilities in Oxford and South Wales. Services include design for manufacture, medical-grade tooling, ISO Class 7 cleanroom moulding and assembly, insert and over-moulding, quality validation to ISO 13485, and post-moulding processes like ultrasonic welding and packaging.
Plastic injection moulding for medical devices and components
Our injection moulding services for medical devices
- Dedicated Project
- Manager from start to finish
- Design For Manufacture: including full 3D CAD modelling and simulation (Moldflow®)
- Medical Grade Tooling: including rapid 3D additive manufacturing of tool inserts
- ISO Class 7 (Class 10,000) Cleanroom for moulding and additional assembly operations, including packaging
- Injection moulding: including insert moulding (e.g. needles) and over-moulding
- Assembly and testing: full cleanroom assembly areas
- Complete quality control throughout working to ISO9001 and ISO13485
- Validation of part and mould process using Full PPAP
- A range of post moulding services including ultrasonic cleaning, ultrasonic welding, EMC/RFI coating and Hot Foil printing
We can also reduce injection mould tool modification or repair times from weeks to just days and shorten the overall product development lead time.
Precision manufacturing for medical devices: from design to injection moulding
Our full design for manufacturing services ensure you can bring new products to market quickly and safely. Our goal is to help our customers design and develop medical devices and components that are injection moulded efficiently, cost-effectively and offer the required performance, strength, reliability, and biocompatibility.
Design for injection moulding, injection moulding, assembly, testing, and validation are all handled in one of our UK facilities in Oxford or South Wales.
Design and
prototyping
Injection mould
tool manufacture
Validation
services
Plastic injection
moulding
Component assembly
and packing
Project
management
Post moulding
services
Reshoring your plastic
injection moulding
Medical grade cleanliness
Medical device and component applications
We specialise in high-volume production of plastic parts using precision-controlled robotics and automation technologies.
Our experience spans the injection moulding of parts, components, and assemblies, for single use and biodegradable medical devices, in our industry leading ISO 7 clean room facility. Applications include:
- Implants and Orthopaedic devices
- Procedure testing kits
- Dental equipment
- PPE
- Mixing bowls
- Syringes
- Housings for electronic devices
- Surgical instruments
- Components for diagnostic equipment
Materials for medical injection moulding
We work with a wide range of advanced plastics and can advise on medical grade materials that meet your product specifications, including biocompatibility, strength, flexibility, chemical resistance, colour and cost.
Our experience includes medical injection moulding TPE’s, polycarbonate, ABS, Eastman tritan Copolyesters, DupontTM Crastin® PBT-SAN, polystyrene, polypropylene and polyethylene COC, polysulphone, PEEK and bioplastics.
Additives and coatings are also available with specialist properties, such as antimicrobial and biodegradable properties, and electromagnetic compatibility (EMC).
Rapid injection mould tooling technology for medical devices
Our investment in cutting-edge 3D hybrid metal additive manufacturing technology enables us to reduce the production time for complete injection mould tools and more importantly the time required for modifications or repair to days rather than weeks, as has traditionally been the case.
We use a combination of standard bolsters, with custom designed mould tool inserts, produced using our advanced hybrid additive manufacturing system. All design and engineering work is carried out in-house by our skilled and experienced engineering team, to ensure a prompt and efficient service at competitive cost.
- For new mould tools, insert repair or modification
- Reduced tool lead times
- High quality, custom designed inserts in either tool steel or stainless steel
- Built in features for gas venting or 3D conformal cooling as required
“OGM has provided us with medical components for over 20 years and we have an excellent working relationship. The OGM team is extremely reliable and can get high quality parts to us really quickly. They keep us informed with weekly conversations, working really closely with our NPI and quality assurance teams so we don’t experience any production problems.”
Frequently Asked Questions
Cleanroom injection moulding takes place in a controlled environment where dust, bacteria and other airborne particles are kept to a defined minimum. It's needed wherever contamination could compromise a device's safety or function — surgical instruments, implants, drug delivery systems and diagnostic devices are typical examples.
OGM's medical cleanroom is ISO Class 7 (Class 10,000), covering both injection moulding and assembly operations, including packaging. Five dedicated injection moulding machines feed into the cleanroom.
Components and assemblies for single-use and biodegradable medical devices, implants, procedure testing kits, dental instruments, drug delivery systems, diagnostic device housings and surgical instruments, among others.
ISO 13485 (medical devices), ISO 9001 (quality management) and ISO 14001 (environmental management), with part and mould process validation carried out using full PPAP (Production Part Approval Process).
A range of medical-grade plastics and high-performance polymers selected for biocompatibility, strength, chemical resistance and sterilisation compatibility, including materials meeting ISO 10993.
Yes – ultrasonic cleaning and welding, EMC/RFI coating, hot foil printing, automated high-volume component washing, sterilisation, and hand or machine packaging, either to a standard or customised specification.
OGM has supplied medical device companies for over 20 years, with its first cleanroom built in 2000.
Yes! OGM works with UK medical equipment manufacturers moving production back from overseas suppliers, with all manufacturing, assembly, testing and validation carried out at its Oxford or South Wales sites.