SEMECO

SEMECO

We help to shape the future.

Working together to increase the speed of innovation in the development of secure and efficient medical technology.

The healthcare system faces significant challenges, and technological innovation plays a vital role in addressing them. Yet, progress in medical technology is often slow, complex, and highly regulated—for good reason, as human health is at stake.

To meet future demands, it will be essential to enhance connectivity between medical devices and enable seamless communication with cloud infrastructures. This will unlock valuable data to optimize processes, improve products, and drive smarter healthcare solutions.

Faster innovation cycles are needed to bring new medical technologies to patients more quickly—ensuring safer, more efficient care.

That is exactly what SEMECO aims to achieve.

Two doctors working on a tablet in the OR.

The future of medical technology lies in the combination of improved approval processes, greater security and digital innovation.

What it's all about

SEMECO – Secure Medical Microsystems and Communications – is a collaborative network of academic institutions and industry partners dedicated to accelerating the development and approval of next-generation medical devices and implants with digital and electronic components.

The initiative focuses on advancing artificial intelligence (AI) and secure hardware and software platforms to enhance the safety, efficiency, and regulatory readiness of medical technologies. By streamlining these processes, SEMECO aims to bring innovations to patients faster and improve healthcare outcomes globally.

Recognized as one of the winning projects in the Clusters4Future competition organized by the German Federal Ministry of Education and Research, SEMECO stood out among 117 applicants in the second round. Physicians, researchers, and industry experts now work hand in hand to accelerate innovation and overcome long-standing barriers in the medical technology sector.

More information on the SEMECO initiative

Who's Participating & Our Role

A diverse and highly motivated community is coming together to tackle the challenges addressed by SEMECO—and we are proud to be actively involved.

The Institute of Communication Technology at the Technical University of Dresden (Faculty of Electrical and Computer Engineering) is leading the project’s research coordination. The Else Kröner Fresenius Center for Digital Health is also a key contributor.

At ZEISS Digital Innovation, our Health Solutions business unit brings extensive experience in the end-to-end development of modular, cloud-based platforms and in enabling connectivity and communication for complex medical devices. Our specific contribution lies in the Q1 subproject “Secure & Trustworthy System Architectures.”

In this subproject, we work closely with secunet Security Networks AG and Deutsche Telekom MMS GmbH to lay the technical foundation for fast, secure, and cloud-enabled use cases in medical technology—such as remote device management. Beyond infrastructure, our collaboration also enables the evaluation of heterogeneous medical data to support improved patient care and unlock new data-driven business models.

Timeframe & Initial Steps

For the subproject “Secure & Trustworthy System Architectures”, the first steps involved setting up the team structure and planning the composition of the expert group. The project officially launched on May 12, 2023, and will run through May 2026.

Where the Collaboration Happens

SEMECO is a predominantly regional initiative where partners from medicine, science, and industry join forces to make cutting-edge digital innovations in medical technology more quickly accessible. Dresden, as one of Europe’s leading academic and industrial hubs for microelectronics, communications engineering, and artificial intelligence, offers ideal conditions for collaboration within the SEMECO Future Cluster.

Current Project Status (as of End of 2024)

As part of the SEMECO research project, we at ZEISS Digital Innovation (ZDI), together with our partners, have made significant progress by the end of 2024. Our goal is to develop a secure, flexible, and interoperable platform for medical applications that meets regulatory requirements while unlocking innovation potential in the MedTech sector. In close collaboration with consortium partners, MedTech companies, and cloud providers, we have gained numerous insights and realized the first prototype components. The following sections summarize our results to date and outline the next development steps.

Requirements Analysis and Architecture Design

At the beginning of the project, we worked with our partners to identify the functional and non-functional requirements of the SEMECO platform. We supported the definition of key KPIs and developed an initial security architecture. This serves as a foundation for selecting appropriate cloud-hosting and edge-gateway solutions, and for the implementation of specific components.

We iteratively refined the security architecture—developing concepts for device security, update and upgrade processes, and the virtualization infrastructure. These efforts are crucial for establishing a cloud infrastructure in the MedTech domain that meets the highest standards for data protection, cybersecurity, and regulatory compliance.

Our research and analysis have shown that international hyperscalers such as AWS, Azure, and Google Cloud—with their certified healthcare services—are especially suitable for scalable, global applications, while regional providers like StackIT and SysEleven offer high data sovereignty and straightforward GDPR compliance. For SEMECO, we therefore recommend a hybrid multi-cloud approach that combines the strengths of both. This enables maximum flexibility, innovation potential, and full regulatory alignment.

Analysis and Prioritization of Platform Components

In analyzing standard medical use cases, we collaborated with our partners to identify and structure key service categories. Based on market analyses, user interviews, and use case evaluations, we prioritized services with the greatest potential for advancing digitalization in healthcare processes.

Our top priorities are:

  • Priority 1: Patient data anonymization, SDC-based interoperability, clinical workflow components
  • Priority 2: Consent management, device/fleet management, device retrofitting
  • Additional services: Audit logging, data processing, pseudonymization

Our extended market research on existing healthcare cloud services included platforms such as Google Healthcare, AWS HealthLake, Microsoft Azure, IBM Cloud for Healthcare, BrightInsight, Euris, and regional providers like StackIT and SysEleven.

Based on these findings, we recommend a hybrid approach: Generic infrastructure services (e.g., compute, storage) and industry-specific cloud solutions (e.g., FHIR databases) should be sourced from established platforms. Our in-house development efforts are strategically focused on innovative, healthcare-specific capabilities such as anonymization, interoperability, and workflow components.

Development of Specific Components

  • A key development objective is to create a flexible, privacy-compliant software solution for anonymizing DICOM data—particularly in light of the upcoming European Health Data Space (EHDS). As health data is increasingly used for secondary purposes such as product development and research, strict adherence to data privacy standards is essential. We developed a Java-based library that can function as an embedded component or, in the future, as a standalone microservice. It enables differentiated handling of identifying, quasi-identifying, and non-sensitive attributes, leveraging standards like k-anonymity and tools such as dcm4che3 and ARX.

    Our solution was first implemented as a command-line tool demonstrator. The library allows flexible configuration of anonymization parameters and can be integrated into existing clinical or research systems. Interviews with MedTech companies and research institutions confirmed a clear need for standard-compliant, high-quality anonymization.

    Learn more about data anonymization here.
    Learn more about the EHDS here.

  • Another key area is device interoperability at the point of care. We developed a component-based software solution based on the Service-oriented Device Connectivity (SDC) standard and created initial prototypes. This component enables standardized, vendor-neutral communication between medical devices in compliance with ISO/IEEE 11073.

    We have defined use cases such as dynamic device pairing, data aggregation, surgical data visualization, and orchestration of multiple SDC devices. Technical implementation concepts were developed accordingly. The first implementations—including libraries, interfaces, and architecture models—are undergoing internal testing and will be demonstrated in future pilots.

  • In Q4 2024, we began evaluating the potential for vendor-neutral fleet management together with our partner secunet. The goal is to support healthcare providers in operating and maintaining diverse device fleets—covering task and status tracking, remote services, and maintenance planning.

    Our market analysis—including offerings from Siemens Healthineers, GE HealthCare, and Philips—shows increasing demand for efficient, interoperable solutions. Our focus lies on modular, easy-to-integrate components tailored to specialized use cases.

Next Steps (until May 2026)

  1. Build Demonstrators
    We will develop demonstrators to showcase our DICOM anonymization and SDC-based interoperability components in real-world environments. These serve both internal validation and external stakeholder engagement.
  2. Advance Interoperability Components
    We will expand the SDC components with additional use cases—such as device orchestration, data visualization, and automated transfers—and move them progressively toward production readiness.
  3. Analyze Medical Workflows
    We are modeling representative medical workflows (e.g., brain tumor resection) to derive new requirements and workflow-oriented platform components.
  4. Expand the Platform Portfolio
    Based on our prioritized services, we will assess additional solutions such as consent management, pseudonymization, patient engagement, and fleet management, and prepare them for the next project phase.
  5. Make Strategic Technology Decisions
    In line with economic and technological scalability, we will make informed make-or-buy decisions—determining which components to develop in-house and which to source externally.

Looking Ahead

We are currently working with our partners to plan and apply for the next funding phase of SEMECO (May 2026 – May 2029). This phase will focus on further developing the current services, increasing their technical maturity, and designing additional platform modules. Our goal is to evolve SEMECO into a comprehensive, modular infrastructure for secure and trustworthy MedTech applications—with a strong emphasis on interoperability, safety, and regulatory compliance.

Have questions about the initiative or how we are contributing?

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Dr. Andreas T. Bachmeier

Presales Lead & Senior Solution Specialist
Health & Life Science Solutions
  

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