Debiotech


Debiotech is a Swiss company with over 30 years of experience in medical device development, focusing on innovative, complex, and technical medical devices. They support other companies with software, mechanics, and electronics development services and project management, aiming to improve patient health through innovation and collaboration. Their expertise includes medical software and hardware design, innovation management, and compliance with international standards. Debiotech has developed notable products such as the DebioJect Microneedle system and has been involved in space applications and COVID-19 vaccine delivery innovations.

Industries

biotechnology
diabetes

Nr. of Employees

small (1-50)

Debiotech


Products

Syringe-less contrast-media injector (prototype)

Three-way injector architecture enabling direct injection from dual contrast media bottles and a saline bag without syringe filling; includes air detection and cassette-based pressure control.

Constant-flow bolus injector (fluidic resistance)

Bolus injector delivering a near-constant flow rate using self-regulating fluidic resistance and a pressurized reservoir; supports a wide flow-rate range and optional pressure-based safety shutoff.

Microneedle intradermal injection system

Hollow microneedle arrays and disposable insertion devices for intradermal delivery of liquid formulations (up to ~0.5 mL in seconds), produced using wafer-level MEMS fabrication to support high-volume manufacture.

Aseptic vial reconstitution and sequential multi-fluid delivery systems

Devices enabling direct vial-connected reconstitution of lyophilized drugs and sequential injection of two stored fluids into a single syringe using pressure-activated bypass mechanics.

Portable dialysis system (concept and prototype)

Conceptual and prototype development of a compact portable artificial kidney using compact component integration and sorbent-based dialysis fluid processing; includes staged lab testing and clinical planning.

Precision MEMS pump engine (prototype)

A MEMS-based precision pump engine designed for very low flow-rate accuracy (reported ~±5% at sub-µL/hr rates) suitable for programmed delayed injections and repeatable low-flow delivery scenarios.

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Services

Medical Device Development Services

End-to-end engineering support from feasibility and concept through prototyping, verification & validation, and design transfer for industrialization of regulated medical devices.

Medical Software Development and Cybersecurity Services

Development of embedded and clinical software with integrated cybersecurity and supply-chain security practices, including threat modeling, SBOM/CVE management, SAST integration and coordination of penetration testing.

Mechanical Design, Prototyping and Usability Engineering

Mechanical concepting, CAD, simulation, iterative prototyping and ergonomic/usability integration aimed at reliable, manufacturable device designs.

Drug Delivery and Fluidic System Engineering

Design and development of injectable drug-delivery mechanisms including fluidic control, syringe-less and bolus injectors, wearable/on-body platforms, aseptic connectors and multi-fluid sequencing systems.

Regulatory, Technical Documentation and Innovation Management

Preparation and structuring of technical documentation, regulatory strategy support, market and partner identification, business-model definition and fundraising support for medical-device projects.

Expertise Areas

  • End-to-end medical device development
  • Regulatory compliance and standards (ISO 13485, MDR, CFR, IEC series, ISO 14971, ISO 14155)
  • Embedded medical software and cybersecurity
  • Wearable/on-body injector platforms
  • Show More (8)

Key Technologies

  • MEMS-based pumps and microfabrication
  • Peristaltic pump technology
  • Gas-propelled (vapor-pressure) pump engines
  • Hollow microneedle arrays (wafer-level MEMS fabrication)
  • Show More (8)

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