To enable innovation to drive forward, Medical Device Companies face a dynamic regulatory landscape where requirements to bring medical devices to market are constantly evolving.

Market entry comes with more challenges than ever and ongoing effort ensuring compliance with regulatory requirements and maintaining high-quality standard is paramount.

Navigating complex medical device compliance requirements necessitates having an experienced team to support throughout the Medical Device Lifecycle, from the initial design stages to market launch and ongoing lifecycle management.

At SPT Vilecon we have extensive capabilities covering the full medical device product lifecycle, from concept development to prototype to regulatory support to scale-up manufacturing living the mindset that compliance and quality systems are not barriers but enablers.

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Research and Development (R&D) isn’t an independent phase in our development process, it’s an all-round mindset and our R&D department work at the intersection of curiosity and precision, driving innovation across MedTech through deep technical exploration, system-level thinking, and rapid experimentation.

From early feasibility studies to functional prototypes, we anticipate challenges before they arise accelerating development with purpose-built solutions that are always tailored, never off-the-shelf.

That’s how we stay ahead and help our partners lead with custom made solutions.

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We specialise in delivering precision-driven and custom prototyping solutions across a diverse range of materials and technologies. With a multidisciplinary approach, we offer end-to-end prototyping capabilities in metal, electronics, and advanced plastics, enabling rapid development and validation of our partners innovative devices.

Our in-house expertise allows for seamless integration of mechanical and electronic components, ensuring functional, user centred, and accuracy from concept to prototype. Whether it’s a single part or a complex assembly, we provide tailored prototyping services that support iterative design, reduce development time, and accelerate time to market.

With a commitment to precision, flexibility, and innovation, SPT Vilecon is a trusted partner in transforming ideas into tangible, testable realities.

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At SPT Vilecon, mould engineering is a core competence anchored in our process from concept to mass production. Our specialists possess deep knowledge of materials, temperature behaviour, curvature dynamics, mould flow and surface requirements, which is all critical factors in designing and producing high-performance moulds.

This expertise enables us to develop and manufacture complex tooling solutions in-house, supporting both prototyping and serial production. With advanced machining capabilities and a strong understanding of process requirements, we ensure that each mould meets exacting standards and performs reliably under demanding conditions.

Our ability to translate design intent into precise, functional moulds is key to accelerating development and maintaining quality throughout the MedTech lifecycle.

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At SPT Vilecon, we design and build intelligent systems where mechanics, electronics, and software converge. From high-precision actuators and sensor integration to real-time embedded control systems, we deliver tightly integrated, custom-built solutions.

Our cross-disciplinary teams collaborate seamlessly from concept to code to component, enabling rapid development and reliable performance in even the most demanding MedTech environments. It's this integration, foresight, and agility that brings joy to our team and to our partners.

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Our manufacturing capabilities are made for precision, complexity, and full regulatory compliance. We specialize in high-performance injection moulding across a range of thermoplastics, including silicones, and operate advanced systems such as 2K injection moulding for multi-material components.

With both cleanrooms and ESD-safe assembly areas, we support the full spectrum of MedTech production from mechanical parts to complex electro-mechanical and embedded systems.

Every step, from tooling to final assembly, is tightly controlled and seamlessly integrated with development ensuring speed, traceability, and custom-fit solutions that meet the high industry standards.

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We are proudly certified in accordance with ISO 13485:2016, ensuring robust quality management systems for the design and development of medical devices.

Additionally, our commitment to environmental responsibility is reflected in our ISO 14001:2015 certification, supporting sustainable practices across our operations.

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