Healthcare innovation moves at a relentless pace. Every day brings advances in surgical instruments, diagnostic technologies, and wearable devices, pushing medical companies to develop products more efficiently, intelligently, and cost-effectively than ever before.
Yet transforming a medical device from concept to market is rarely simple. Strict regulations, rigorous quality standards, and tight timelines often create significant hurdles. Outsourcing certain processes can help, but working with multiple suppliers can introduce new challenges – delays, miscommunication, and compliance gaps among them.
So, the question becomes: how can medical device manufacturers accelerate their path from idea to launch without sacrificing quality or compliance?
That’s precisely the question OGM aimed to answer. Our fully integrated pellet to product approach consolidates design, tooling, moulding, assembly, validation, and logistics under one roof. In plastic injection moulding, the journey begins not with a finished component, but with small plastic pellets – the raw material that, once heated and moulded, becomes the precise medical parts used in critical applications. By managing every step of this transformation in-house, we help innovators reach the market more swiftly while reducing regulatory and operational risks.
Why integration matters
Medical device development is a team effort – but having too many suppliers can make it harder, not easier. Each exchange between partners can create opportunities for misalignment, extended timelines, and unexpected costs.
OGM takes a smarter approach by acting as a single, accountable partner throughout the entire development process. By integrating every stage, we help ensure projects stay consistent, reliable, and on schedule – letting development teams focus on what truly matters: innovating and getting products to market faster.
Solving challenges across the product lifecycle
Different stakeholders in medical device companies face different challenges. Here’s how an integrated manufacturing partner can make life easier.
For Product Development Managers
Pain point: Juggling multiple suppliers can often lead to project delays and compliance risks.
Solution: OGM can provide end-to-end support from DfM through to assembly and testing – meaning fewer handoffs, clearer accountability, and faster launches.
For R&D and Design Engineers
Pain point: Prototypes that fail in production or designs that aren’t scalable.
Solution: With early DfM input we can help refine CAD designs for manufacturability. Rapid prototyping and seamless scale-up options can help you move from prototype to validated production with confidence.
For NPD Directors
Pain point: Pressure to deliver projects within budget and on time, while minimising capex risk.
Solution: OGM offers a predictable, variable cost model and proven expertise to bring new products through the pipeline efficiently.
For Quality & Regulatory Managers
Pain point: Compliance gaps, audit pressure, and traceability concerns.
Solution: OGM’s single QMS covers the full manufacturing process. With ISO 13485 and ISO 9001 accreditations, plus detailed validation documentation, we simplify compliance and reduce audit stress.
For Procurement & Supply Chain Managers
Pain point: Multiple partners and unreliable overseas transport.
Solution: OGM is a UK-based partner offering a consolidated, integrated service that streamlines your supply chain, reduces administration, and simplifies invoicing.
The pellet to product advantage
Here at OGM, we specialise in medical-grade plastic injection moulding and assembly. Our services include:
- Design for Manufacture (DfM) – optimising your designs for scalability and compliance.
- Precision tooling and injection moulding – with over 60 years’ experience, supported by the latest 3D printing and CNC capabilities.
- Assembly and cleanroom operations – ISO Class 7 cleanrooms to meet strict hygiene and regulatory standards.
- Testing, validation, and compliance support – from IQ, OQ, PQ protocols to full PPAP documentation.
- Logistics – streamlined delivery of finished, validated products.
With every step under one roof, we cut complexity, avoid duplication, and ensure seamless collaboration.
Proven in practice
Our approach has already helped medical innovators bring their products to life.
- NeuPulse, a UK medtech start-up, partnered with OGM to refine its wearable device for large-scale manufacturing. By optimising the design for injection moulding and simplifying tooling, we helped accelerate their path to market while ensuring compliance.
- During the COVID-19 pandemic, we developed ConformL Cool, an advanced mould tooling innovation that reduces reject rates and improves production efficiency at a time of extreme supply chain pressure.
In both cases, integration was key: fewer handoffs, fewer risks, faster results.
Simplify your path to market
Medical device development is inherently complex, but your manufacturing process can be streamlined. Deciding to partner with OGM provides you with a single, responsible supplier that manages every step – from pellet production to the final, validated product.
No matter what stage you’re at – prototyping, scaling, or regulatory prep – OGM ensures faster delivery, lower risk, and full compliance.