For medical device manufacturers, the distance between a validated design and a reliable production process is often shorter than expected—and longer than it should be. Tolerance stack-ups, inconsistent manual assembly, and improperly designed fixturing are among the most common causes of production delays and non-conformances in med-device facilities. MTD Precision Engineering, one of Ireland's leading precision engineering companies, is addressing this challenge directly with a fully integrated design-to-manufacture service for custom jigs and fixtures.

Based in Little Island, Cork, MTD Precision Engineering has worked with some of the world's leading medical device and biopharma companies — including Stryker, DePuy Synthes, and Janssen — for over two decades.

The company's in-house engineering team covers the full development cycle: from initial brief and concept design through to prototyping, iteration, and production-ready validated tooling. This single-partner approach is proving to be a significant operational advantage for medical device manufacturers who are under pressure to move quickly without compromising quality or regulatory compliance.

Why Generic Fixturing Needs To Be Purpose-Built

Assembling medical devices is challenging. The parts are tiny, and there is little room for error. Incorrect assembly of a product can result in serious issues. Regular jigs often need adjustments, which can introduce risks that precise processes cannot handle. Operators might use fixtures not designed for specific parts, making it difficult to ensure everything is correct. Validating operator adjustments is particularly tough.

MTD's approach starts from the opposite end. Rather than adapting a standard solution to a non-standard problem, the team designs fittings around the precise requirements of the component and the process. Every degree of freedom that needs to be constrained is constrained. Every critical dimension that needs to be referenced is referenced. The result is a jig or fixture that not only holds a part but also supports the quality of the operation.

"When a medical device manufacturer comes to us with a fixturing challenge, the conversation rarely starts with the fixture itself. It starts with the process — what needs to happen, in what sequence, to what tolerance, and under what conditions. The fixture is the answer to those questions, not the starting point," said a spokesperson for MTD Precision Engineering

From Brief to Validated Tooling: The MTD Process

At every stage, the MTD design-to-manufacture process relies on close collaboration with the client's engineering team. Initial consultations focus on understanding the assembly or inspection task in detail, including any existing quality data that points to where the process is losing control.

From there, the MTD team develops concept designs, produces prototypes for evaluation, and refines the design through iterative testing before moving to final manufacture.

For med-device clients operating under ISO 13485 or FDA quality system requirements, the documentation trail that supports this process matters as much as the tooling itself. MTD Precision Engineering helps clients during the validation phase by providing the necessary 2D and 3D drawings, material certifications, and process records to meet the requirements of a regulated quality system. The company holds ISO 9001 certification and has extensive experience working within the documentation requirements of the med-device sector.

"We understand that for our clients in medical devices, a jig or fixture is not just a production tool — it is part of the quality system. We build the documentation and traceability from the start, so the validation process is supported rather than scrambled for at the end," stated a spokesperson from the commercial management department of MTD Precision Engineering.

Reducing Time to Production Without Cutting Corners

One of the persistent tensions in medical device manufacturing is the pressure to move quickly in an environment that rewards caution. Product launch timelines are fixed. Production ramp schedules do not flex easily. But the validation requirements that govern fixturing in a regulated facility are non-negotiable. The manufacturers that navigate this tension most successfully are those that engage their precision engineering partners early — before the design is frozen and before the timeline is already under pressure.

MTD's ability to carry a project from concept through to validated production tooling within a single facility — without handoffs between external design houses, prototype shops, and manufacturers — compresses the development timeline significantly. When questions arise during prototyping, the same engineering team that drew the concept is in the room.

“We make changes faster, test them sooner, and document them as they occur. Companies that benefit most from a partnership like this involve us in the design stage, not after they commit to production, “ MTD Precision Engineering's management said. "The earlier we are involved, the easier it is to validate tooling."

About MTD Precision Engineering

Founded in 1996 and headquartered in Little Island, Cork, MTD Precision Engineering is one of Ireland's leading precision engineering companies. With a particular focus on the biopharmaceutical and medical device sectors, MTD provides design, prototyping, and manufacturing services to some of the world's most recognisable life sciences companies. Over 60% of the company's work comes from existing clients — a figure that reflects the depth and consistency of the partnerships MTD builds over time.

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