Fraunhofer IMTE

What Fraunhofer IMTE does

Fraunhofer IMTE is a non-profit applied research institution headquartered in Lübeck, Schleswig-Holstein, Germany, and a constituent entity of the Fraunhofer-Gesellschaft. Established in its current form in December 2020 through the strategic realignment of the former Fraunhofer EMB, the institute focuses on individualized medical technology, combining expertise in biosensor technology, cell technology, imaging, magnetic methods, mechatronics, additive manufacturing, artificial intelligence, systems engineering, and regulatory affairs. It serves medical technology companies (from startups to established MedTech enterprises), clinics and hospitals (notably UKSH), research institutions, and policymakers/funding organizations by providing integrated development support from initial concept through prototyping, testing, clinical validation, and regulatory approval.

The institute operates an extensive research portfolio spanning seven core platforms: the Lübeck Innovation Hub for Robotic Surgery (LIROS) including the TINUSA, SURREAL, HOSPIBOT, and Water Rescue Drone projects; magnetic methods such as Kolibri-Halbach MPI, INSPECT, CF-INSPECT, NeuroMap, Hyperthermia, and magnetic microrobots for theranostic applications; mechanical ventilation solutions (PreVent, CMS4Vent); X-ray imaging (TX2.0, ASAP); musculoskeletal and prosthetic technologies (SmILE, GLUCOSole, SimFRAK, MURDOCK, AI-Motion Labs); cardiology and endovascular devices (Langendorff Heart Model, MEVAR, STEVN, CardioHope); and residual marine biotechnology capabilities maintained at the Büsum facility. AI is embedded across the portfolio through Edge AI biosignal processing, intelligent image reconstruction, AI-supported motion analysis, and AI-assisted surgical robotics.

Fraunhofer IMTE's revenue model is a hybrid of public grant funding and fee-for-service research collaborations. Approximately €64.9 million in cumulative government support has been committed since 2021 (initial €12.1 million state grant, ~€29 million EFRE 2023-2026, and a €23.8 million Minister-President decision in 2024), with industry contract revenue from development services, accredited non-destructive CT testing, clinical trial planning, and regulatory affairs consulting supplementing institutional funding. Pricing is project-based and quote-driven rather than publicly disclosed. The institute operates with approximately 90 employees under the leadership of Managing Director Prof. Dr. Thorsten M. Buzug and Director Prof. Philipp Rostalski, and holds no independent legal status apart from its parent Fraunhofer-Gesellschaft.

Name

Fraunhofer IMTE

Legal name

Fraunhofer Research Institution for Individualized Medical Technology and Engineering IMTE

Website

https://imte.fraunhofer.de

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

51–100 employees

Short description

Fraunhofer IMTE is a non-profit applied research institute in Lübeck, Germany, that develops individualized medical technology — covering medical robotics, magnetic particle imaging, AI-supported software, additive manufacturing, and regulatory affairs — for MedTech companies, hospitals including UKSH, and research institutions, funded primarily by state and EFRE grants.

Ownership category

akta.pro rank

Product category

Medical Technology Research and Development Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Electromedical & Electrotherapeutic Apparatus (3845), Services-Testing Laboratories (8734), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO)

akta.pro secondary industries

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI)

Keywords

• Medical device development
• Magnetic particle imaging
• Robotic surgery research
• Additive manufacturing services
• Regulatory affairs consulting

Headquarters

HQ city

Lübeck

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Government Funding: Fraunhofer IMTE receives substantial government funding from the state of Schleswig-Holstein. Initial funding of 12.1 million euros with 90% funding quota was approved, with additional 29 million euros earmarked for EFRE period 2023-2026. A 23.8 million euro funding decision was delivered by Minister-President Daniel Günther.
2. Research and Development Services: Fee-for-service research collaborations with industry partners including development projects, prototyping, testing, and validation services. Supports companies from startups to established MedTech enterprises in bringing products from idea to market-ready state.
3. Clinical and Regulatory Services: Planning and realization of clinical trials, regulatory strategy development and implementation for medical devices including IVDs, and support for conformity assessments and approvals.
4. Non-destructive Testing Services: Accredited CT testing and material testing services for quality assurance, component analysis, and reverse engineering.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Fraunhofer IMTE is a non-profit applied research institution that develops individualized medical technology and provides contract R&D services for MedTech companies, clinics, and research partners. Its offerings span the full device lifecycle - from concept, additive manufacturing prototyping, and pre-clinical testing through accredited non-destructive CT testing, clinical validation, and regulatory affairs support for MDR/IVDR conformity assessments. The institution also operates specialized research platforms such as the Lübeck Innovation Hub for Robotic Surgery (LIROS), AI-Motion Labs, and accredited testing laboratories that clients can access for project-based collaboration.

Product overview

Fraunhofer IMTE is a research institution offering an integrated portfolio of medical technology development services rather than commercial products. Their offerings span multiple research domains: (1) Medical Robotics including TINUSA, SURREAL, HOSPIBOT, and the Lübeck Innovation Hub for Robotic Surgery (LIROS) platform for robot-assisted surgery; (2) Magnetic Methods including Kolibri-Halbach MPI, NeuroMap, Hyperthermia, and various Magnetic Particle Spectroscopy technologies for imaging and therapy; (3) Mechanical Ventilation including PreVent and CMS4Vent systems; (4) X-ray Imaging including TX2.0 and ASAP automation; (5) Muskuloskeletal technologies including SmILE, GLUCOSole, SimFRAK, and AI-Motion Labs for motion analysis; (6) Cardiology devices including Langendorff Heart Model, MEVAR, and CardioHope; and (7) Support services including Additive Manufacturing, Non-destructive CT Testing, Clinical & Regulatory Affairs, Device Development, and Medical Software Solutions with AI capabilities. The institution focuses on accompanying clients from initial concept through prototyping, testing, and regulatory approval for market-ready medical products.

Differentiator

Problem solved

Functional benefit

Products and services

• Lübeck Innovation Hub for Robotic Surgery (LIROS) Comprehensive research and transfer environment for robot-assisted, automated, and AI-supported surgery, featuring a realistic operating room setup for developing, testing, and validating surgical systems. Offered to industry partners, clinics, and research institutions for project-based collaboration.
• AI-Motion Labs - Motion Analysis AI-supported movement analysis laboratory service for kinematic assessment, movement disorders, biomechanical assessments, and rehabilitation research. Provides motion capture and analysis for clinical and research clients.
• Non-destructive Material Testing (CT)
• Additive Manufacturing Services
• Clinical Affairs Services
• Regulatory Affairs Services
• Device Development Services
• Medical Software Solutions (SaMD)
• Model Design and Simulation
• Test System Development
• Magnetic Measurement Services
• Battery Attest (X-ray Battery Certification)

Quantifiable outcome

• Magnetic microrobots demonstrated steering through cerebral aneurysm phantom using magnetic particle imaging for real-time tracking
• +1 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature11 records

Partnerships

Four partnerships are on record, tiered core.

• University Medical Center Schleswig-Holstein (UKSH), Lübeck CampuscoreStrategic or Co-development Partner · 7 July 2021Collaboration with UKSH Clinic for Radiology and Nuclear Medicine and Clinic for Neuroradiology for development and testing of medical technologies including magnetic microrobots. UKSH radiologists and neuroradiologists (Dr. Franz Wegner, Dr. Hannes Schwenke) collaborated on steering microrobots through cerebral aneurysm models for potential treatment applications.
• Technische Hochschule (TH) LübeckcoreStrategic or Co-development Partner · 6 July 2021Kooperationsvereinbarung (cooperation agreement) between Fraunhofer IMTE and TH Lübeck to deepen collaboration in medical technology. The agreement focuses on establishing the Regulatory Affairs research area with Prof. Dr. sc. hum. Folker Spitzenberger leading the effort to support IMTE in building a regulatory affairs research group alongside his teaching at TH Lübeck. TH Lübeck has had a chair for Regulatory Affairs for Medical Devices since 2016.
• University of Lübeck (Universität zu Lübeck)coreStrategic or Co-development Partner · 26 May 2021Extended long-standing collaboration with University of Lübeck and its Institute of Medical Technology (IMT) and Institute of Medical Electrical Engineering. Fraunhofer EMB was expanded to include the medical engineering sector through this partnership, enabling holistic approach to individualized medical technology from basic research to device construction and clinical application.
• Fraunhofer-GesellschaftcoreOthersFraunhofer IMTE is a constituent entity of the Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V., headquartered at Hansastraße 27c, 80686 München. Fraunhofer-Gesellschaft provides organizational oversight, executive board leadership (President Prof. Holger Hanselka, members Prof. Constantin Häfner, Prof. Axel Müller-Groeling, Elisabeth Ewen, Dr. Sandra Krey), and institutional support.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• TÜV SÜD: Global testing, inspection, and certification organization operating medical device and IVDR testing services. Comparable as a European medical device conformity assessment and regulatory testing services provider, though far larger and more diversified.
• Siemens Healthineers: Global medical imaging, diagnostics, and digital health leader (€20B+ revenue). Overlaps with IMTE in CT/X-ray imaging development, MPI-adjacent modalities, and AI-enabled diagnostics; significantly larger and commercially focused.
• Intuitive Surgical: Global leader in surgical robotics (da Vinci platform, ~$25B+ market cap). The dominant commercial player whose installed base and clinical data advantage sets the standard that LIROS-based research aims to support or compete against.
• Helmholtz Center Munich: Large-scale German public research center with biomedical engineering and imaging translation programs. Comparable as a publicly funded German medical research organization, though broader in scope and far larger in headcount and budget.

Direct peers

• NAMSA: US-headquartered medical device-focused Contract Research Organization providing regulatory, clinical, and laboratory testing services. Comparable on the fee-for-service MedTech CRO business model, particularly for regulatory and clinical trial services offered by IMTE.
• Fraunhofer IPA: Stuttgart-based Fraunhofer institute covering production technology and materials science, with significant medical device manufacturing and automation overlap. Most directly comparable Fraunhofer peer for applied medical technology R&D services and industry collaboration model.
• Fraunhofer MEVIS: Bremen-based Fraunhofer institute for digital health, AI-enabled image analysis, and medical software development. Direct comparable on AI/ML for medical imaging and software-as-a-medical-device (SaMD) development.
• Karlsruhe Institute of Technology (KIT): German public research university with strong medical engineering and robotics institutes performing industry-funded contract research, including surgical robotics and AI. Comparable as a publicly funded German MedTech research services provider.
• Fraunhofer IZM: Berlin-based Fraunhofer institute for reliability and micro-integration, providing electronics, sensor, and packaging R&D services used in medical device development. Comparable as a fellow Fraunhofer applied-research services provider for medical technology.
• Bruker Corporation: Manufacturer of scientific instruments including micro-CT (Skyscan) used at IMTE's accredited lab and a commercial provider of pre-clinical MPI systems. Comparable on magnetic particle imaging instrumentation and high-resolution CT testing services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/fraunhofer-imte

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Fraunhofer IMTE