Extending the lifecycle of single-use advanced tubing systems

How we enabled an EU-based manufacturer of surgical devices to future-proof their large tubing system portfolio for Minimally Invasive Surgery kits. By transferring manufacturing to Malaysia, strengthening supply chains, managing sterilization validation, and aligning compliance across markets, we helped them deliver products to market through on-site material holding, flexible manual lines and a fully localized supply chain located just 6km from the port.

The challenge

An EU-based medical device company’s portfolio of single-use advanced tubing systems, including IV and irrigation sets composed of tubing, drip chambers, clamps, filters, and connectors, was at risk of discontinuation. Rising labor costs, sterilization fees, and import tariffs had eroded margins, and with further cost increases deemed inevitable, the portfolio was in danger of no longer being commercially viable despite continued clinical demand.

The complexity of these multi-SKU sets made the challenge of devising a new, commercially sustainable solution even greater: they required precise manual assembly, low-particulate cleanroom environments, validated sterilization, and strict compliance – high value capabilities which can be challenging for OEMs managing multiple portfolios to maintain profitably in-house.

The solution

To protect continuity and alleviate commercial pressures, we collaborated closely with the customer to devise a validated manufacturing transfer to Ensera’s certified cleanroom facility in Malaysia. Our integrated, customer-focussed approach ensured the solution was tailored to their specific portfolio needs. The strategic plan included:

Recreating the assembly flow with manual and semi-automated workstations to match the complexity of their multi-SKU sets.
Localizing the supply chain by qualifying regional suppliers for tubing, clamps, and connectors, while introducing approved material substitutions.
Introducing traceability controls, including bill-of-material traceability and RFID tagging, to ensure compliance across SKUs.
Eliminating logistics lanes by switching sterilization partners to a global provider with local operations, validating a new release site, managing documentation, and reducing costs while maintaining quality and shelf life.
Validating DEHP-free and alternative materials to align with evolving safety, compliance and sustainability requirements.

For the customer, this meant the difference between discontinuation and market continuity, securing product lifecycle extension, compliance, and a sustainable cost base.

The execution

Executing a fast, smooth and disruption-free global manufacturing transfer from Europe to Ensera’s certified cleanroom facility in Malaysia required rebuilding processes from limited documentation while keeping the customer’s timelines and compliance goals front of mind. Ensera’s project management team coordinated engineering, sourcing, regulatory, and quality functions to manage risks and maintain momentum.

We reverse-engineered undocumented OEM processes, validated alternative materials, and designed and fabricated customized jigs and tooling to ensure quality and repeatability. Dual cleanroom-certified assembly cells were established to replicate and improve the original set-up. RFID-based traceability and customized adhesive bonding techniques were introduced to strengthen quality, control and operational resilience.

We also managed the full preparation of documentation required to update the Device Master Record (DMR) and secure approval for the new sterilization release site, ensuring audit readiness with no disruption.

The impact

Ensured market continuity – by maintaining production despite limited OEM documentation, avoiding costly redesigns or requalification.
Streamlined supply chains – by eliminating international sterilization lanes and validating a new EU release site.
Ensured a smooth regulatory pathway – by managing the Device Master Record DMR for a required site change notification and approval.
Enhanced patient safety and compliance – through the switch to DEHP-free and alternative materials.
Secured long-term financial sustainability – by eliminating dependence on costly tooling.
Strengthened brand control and IP security – with manufacturing consolidated under one certified cleanroom facility in Malaysia.
Achieved logistics-related CO₂ reductions as part of a cost-optimized, streamlined supply chain.
Reduced supply chain risk – with lead times reduced significantly to 14 weeks through regional sourcing.
Created a future-proof platform – by designing a scalable process adaptable from manual to semi-automated assembly.

Looking to extend your product lifecycle through manufacturing transfer?

From tubing set lifecycle management to full OEM transfers, we deliver speed, compliance and continuity for complex sterile medical systems. Get in touch today. We’re ready to help.

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