OPENMIND · Project

On-Demand Custom Medical Devices: Automated Production of Personalized Surgical Tools

healthTestedTRL 6

Surgeons who operate inside blood vessels use tiny guide wires and tools — but today those come in standard shapes, like buying shoes in only three sizes. OPENMIND built a fully automated production line that can manufacture each tool customized to what a specific surgeon needs, even if it's just a single piece. The system uses advanced fiber-reinforced composites shaped by laser and coated with markers, all monitored by smart software that learns from every run to speed up the next one. Think of it as a 3D-printing-style approach, but for precision surgical instruments.

By the numbers

consortium partners across 6 countries

78%

industry ratio in the consortium

SME partners involved in development

demonstrated hardware/software modules completed

total project deliverables produced

The business problem

What needed solving

Surgeons performing minimally invasive vascular procedures must choose from a limited catalogue of standard medical devices, even though each intervention and each physician's technique is unique. Manufacturing custom devices today is prohibitively expensive and slow because production lines are built for mass production, not single-piece or small-batch orders. This forces physicians to compromise on tool design, potentially affecting procedure outcomes.

The solution

What was built

An operational, fully automated production chain for customized minimally invasive medical devices, demonstrated with guide wires. The system includes 6 completed modules: micro-pullwinding for fiber-reinforced plastic shafts, laser ablation for shaping, coating application, radiopaque marker printing, inline image acquisition for quality control, and a central HMI with graphical user interface. A data mining toolset monitors all process parameters and predicts optimal settings for new product variants.

Audience

Who needs this

Medical device manufacturers producing guide wires and catheter-based instrumentsComposites manufacturers seeking small-batch or on-demand production capabilitiesHospital networks wanting surgeon-specific customized surgical toolsContract manufacturers serving the medical device industryQuality control system integrators for regulated manufacturing environments

Business applications

Who can put this to work

Medical device manufacturing

mid-size

Target: Mid-size medical device companies producing minimally invasive surgical instruments

If you are a medical device manufacturer dealing with long lead times and high costs for custom surgical instruments — this project developed a fully automated, modular production chain that can produce personalized guide wires and similar devices down to single-batch sizes. The system includes pullwinding, laser ablation, coating, and marker printing modules all controlled through one interface. With 78% of the consortium being industry partners, the technology was designed for real factory floors.

Advanced composites manufacturing

SME

Target: Companies producing fiber-reinforced plastic components for precision applications

If you are a composites manufacturer struggling to offer small-batch or one-off customized parts economically — this project built a micro-pullwinding process combined with laser ablation and inline quality monitoring that enables on-demand production of fiber-reinforced plastic profiles. The data mining toolset predicts optimal process parameters for new product variants, cutting development time. The operational system with 6 demonstrated hardware modules is ready for adaptation beyond medical devices.

Hospital procurement and surgical planning

enterprise

Target: Large hospital networks and surgical departments performing complex vascular interventions

If you are a hospital procurement department limited to choosing from a fixed catalogue of surgical devices — this project created a system where surgeons can specify the exact handling and visibility characteristics they need in a guide wire, and have it produced on demand. Each device is manufactured in a fully monitored, quality-controlled process chain with 16 deliverables covering every step from design input to finished product inspection.

Frequently asked

Quick answers

What would custom devices like this cost compared to standard products?

The project does not publish per-unit pricing. However, the entire system was designed to make single-batch production economically viable by automating 6 production modules (pullwinding, laser ablation, coating, printing, imaging, control) into one continuous chain. The data mining toolset reduces development time for new variants by predicting process parameters from past runs.

Can this scale to industrial production volumes?

Yes — the system was built for both small-batch and continuous production. The operational OPENMIND system integrates all hardware, software, and metrology modules into one automated chain. Statistical process control was specifically developed for varying lot sizes, from single pieces to larger batches.

Who owns the IP and how can I license this technology?

The consortium of 9 partners across 6 countries jointly developed the technology, coordinated by Fraunhofer (Germany). Fraunhofer is Europe's largest applied research organization and routinely licenses technologies to industry. Specific licensing terms would need to be discussed with the coordinator directly.

Does this meet medical device regulations?

The project used guide wires as a demonstrator device, and the process chain includes comprehensive monitoring and quality control. However, regulatory certification (e.g., CE marking under MDR) for specific medical devices would still require separate validation by the manufacturer. The inline monitoring and data traceability built into the system support regulatory compliance documentation.

How long would it take to integrate this into an existing production facility?

The system is modular — each sub-module (laser ablation, coating, marker printing, pullwinding) was built as a standalone unit integrated through a central HMI with graphical user interface. Based on available project data, the modules were demonstrated as operational during the project period (2015-2018). Integration timelines would depend on your existing infrastructure and the specific modules needed.

What data and software capabilities come with the system?

The system includes a comprehensive data mining toolset that monitors all relevant process parameters and uses similarity algorithms to predict optimal settings for new custom products. It also features automated process optimization during production runs and an image acquisition solution for inline quality inspection of fiber-reinforced profiles.

Consortium

Who built it

The OPENMIND consortium is unusually industry-heavy for an EU research project: 7 out of 9 partners are from industry, giving a 78% industry ratio, with 5 of those being SMEs. Only 2 partners are research organizations, led by Fraunhofer — Europe's largest applied research institute with deep experience in technology transfer. The consortium spans 6 countries (Czech Republic, Germany, Spain, France, Ireland, Italy), providing broad European market access. This composition signals that the technology was developed with real manufacturing constraints and commercial intent from the start, not as a purely academic exercise.

IN-CORE SYSTEMESparticipant · FR
BLUEACRE TECHNOLOGY LIMITEDparticipant · IE
FONDAZIONE POLITECNICO DI MILANOparticipant · IT
IRIS TECHNOLOGY SOLUTIONS, SOCIEDAD LIMITADAparticipant · ES

How to reach the team

Fraunhofer Gesellschaft (DE) — contact through SciTransfer for a warm introduction to the project coordinator

Order a report on this consortium

Next steps

Talk to the team behind this work.

Want to explore how on-demand custom medical device production could fit your product line? SciTransfer can arrange a direct introduction to the Fraunhofer-led team and prepare a tailored technology brief for your specific application.

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