From Pellet to Product: A Strategic Guide to Medical Device Manufacturing with OGM

From Pellet to Product:
Streamline Your Medical Device Manufacturing

A practical guide for R&D engineers, product development managers, quality leads, and supply chain professionals to accelerate device development, simplify compliance, and reduce operational risk.

The Challenge of Medical Device Development

Innovation drives healthcare but developing medical devices is complex. From early prototypes to regulatory approvals, manufacturers face:

Regulatory complexity: MDR, UKCA, CE, ISO 13485 compliance.
Time-to-market pressures: Tight development windows with no room for error.
Cost constraints: R&D, tooling, cleanroom facilities, and high-tech processes.
Quality demands: Every device must meet exacting standards to avoid recalls or compliance issues.

Did you know?

Over 15,000 medical technology patents are filed annually with the European Patent Office.
Managing these challenges while coordinating multiple suppliers can slow development, increase risk, and complicate compliance.

A Better Approach with OGM

OGM’s Pellet-to-Product model simplifies medical device manufacturing. We provide a fully integrated, end-to-end solution:

Design for Manufacture (DFM)
Tooling and injection moulding
Cleanroom assembly and component manufacturing
Testing, validation, and regulatory support
Logistics and supply chain management

Why it works: A single accountable partner reduces handoffs, shortens timelines, and maintains quality across every stage—from raw materials to validated products.

Solving Role-Specific Pain Points

Medical device development involves multiple stakeholders. Here’s how OGM helps:

Role	Pain points	How OGM helps
Product Development Manager	Multiple suppliers, project delays	One partner for moulding, assembly, and testing → faster launches, fewer handoffs
R&D / Design Engineer	Prototypes fail, DFM challenges	Early DFM input, rapid prototyping, seamless scale-up to production
NPD Director	Budget overruns, Capex pressure	Variable cost model, predictable scale-up, proven partner
Manufacturing / Process Engineer	Scaling from prototype to volume	End-to-end validation, ISO 13485 cleanrooms, in-house QA + SPC
Quality / Regulatory Manager	Audit pressure, traceability gaps	Single QMS, full traceability, ISO certifications, validated testing
Procurement / Supply Chain Manager	Supplier sprawl, logistics complexity	One UK-based supplier, simplified logistics & invoicing

Real-World Success Stories

NeuPulse: We helped a UK startup refine its wearable device from prototype to production-ready design, optimising moulding, material selection, and assembly to accelerate regulatory approval.

ConformL Cool Innovation: Using hybrid additive and CNC manufacturing, OGM created advanced mould tools with improved cooling efficiency—reducing waste and improving part quality during global supply disruptions.