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SDC end-to-end journey

Enhance Your Medical Device's Point-of-Care Impact

with the SDC Interoperability Standard

Fast-track your SDC journey with our comprehensive support from strategy to market success

Maximize Your Medical Device's Impact at the Point-of-Care with the SDC Interoperability Standard

In many European clinics, the emphasis remains on inter-facility and intra-facility interoperability, with standards like FHIR taking center stage. However, evolving regulatory landscapes indicate that point-of-care interoperability is the next frontier. Enter SDC (Service-oriented Device Connectivity), a pivotal standard for seamless cross-vendor device-to-device communication.

SDC not only facilitates the semantic exchange of data between devices but also empowers automatic and remote device control. This innovation significantly reduces setup times and enhances precision, thereby alleviating the workload of medical professionals in operating rooms, intensive care units, and ambulance settings. Embrace SDC to differentiate your medical device in the market and elevate its impact at the point-of-care.

Explore How We Can Support You along Your SDC Journey – From Strategy to Implementation

No matter where you are in your SDC journey, we support you throughout your entire SDC journey, whether you are enabling SDC for your overall point-of-care solution portfolio or a specific solution or whether you are starting to explore the standard for your medical devices or want to get implementation efficiently and effectively done ensuring long-term success for your products. Our end-to-end enablement covers everything from strategy to partner management to implementation and market-entry, ensuring a smooth and fast-tracked transition to SDC for your point-of-care medical devices through our expertise and experience.

Discover the Details of our Comprehensive Services

  • Interoperability strategy concept workshop / consulting

    • Analysis of the current interoperability strategy, including the maturity level of the technical implementation, as well as further development of the strategy to ensure semantic interoperability for the product portfolio.
    • Goal: Creation of a clear roadmap for the integration of networking technologies (SDC, FHIR, DICOM) to reach interoperability functions for products.
    • Output: Strategy and roadmap for cross-manufacturer product networking tailored to the own product portfolio.

    Use case discovery workshop

    • Identification of relevant interoperability use cases based on the IEEE11073-SDC standards family and development of product-specific and cross-vendor added value features.
    • Goal: Identification and analysis of the potential of SDC networking for possible device combinations.
    • Output: Collection and prioritization of relevant SDC use cases for the customer's product portfolio, including possible partner devices.

    Product ideation & enduser validation

    • Transfer of new use cases into a product vision that is powered by interoperability features and support of validation activities with and by end users.
    • Goal: Ensuring that the developed products meet the actual needs of stakeholders and the market.
    • Output: Documented product vision, validated user requirements, and decision template for further development of prioritized ideas.

    Point-of-care product design

    • Design of SDC-enabled products for a specific treatment environment, e.g., operating room/intensive care unit, that meet the specific requirements of the environment and your product quality.
    • Goal: Design of new products with identified target functions for the implementation of SDC-supported treatment functions.
    • Output: Product requirements, system design, UI/UX concepts, and mockups focusing on usability, workflow compatibility, and regulatory requirements for point-of-care applications.

    Competitor & business case analysis for SDC introduction

    • Combined analysis of the competitive landscape and development of financial models to assess the potential of SDC-enabled use cases and networking strategies. This includes identifying strengths and weaknesses of other providers, as well as evaluating partner products and strategic alliances.
    • Goal: Identification of market opportunities, differentiation features, and financial justification to strengthen the market position and support investment decisions in SDC networking technologies.
    • Output: Comprehensive report on the current market situation regarding SDC networking aspects, including a business case with cost-benefit analysis, RoI model, and a decision template for internal stakeholders.
  • Partner activation

    • Activation and support of partners to promote the implementation and use of networking technology to achieve the intended SDC-enabled use cases in the customers targeted point-of-care.
    • Goal: Establish a strong network of partners who can support your intended interoperability strategy with their own SDC-enabled products.
    • Output: Partner profiling, activation strategy and engagement.

    Device profiling

    • Joint creation of the SDC-compliant representation of your products according to the standards Domain Information and Service Model (incl. Medical Device Information Base) as a basis for all further development activities.
    • Goal: use a consistent and controllable description of your product across different internal development teams and activities.
    • Output: Versioned, Standard-Compliant and File-based Product Representation (MDIB file), including documentation for further implementation steps.

    Rapid prototyping

    • Rapid development of prototypes based on open-source IEEE 11073 SDC reference implementation libraries to validate ideas and concepts and as a basis for demonstrators.
    • Goal: Acceleration of the development process and minimization of risks through early feedback with potential for first marketing measures.
    • Output: Functional prototype (SDC/mock device), source code documentation, and demo scenarios for internal validation or KOL presentation.
  • Product implementation service with our SDC Library

    • Support for the implementation of the SDC interface in current and future products with a high degree of automation and maintainability incl. risk management, cybersecurity and quality assurance tasks in alignment with the customers development processes. The ZEISS SDC Interoperability Kit can be used for this purpose.
    • Goal: Ensuring timely and effective implementation of SDC.
    • Output: Integrated SDC interface in the target product, accompanying technical documentation for interface component.

    UX Design consultancy including risk management & mitigation

    • Consulting in the area of user experience (UX) with expected changes to the product using SDC-enabled features with a focus on usability and safety-by-design.
    • Goal: Improvement of user-friendliness and safety of products in alignment with new interoperability features to increase acceptance.
    • Output: UX guidelines, wireframes, risk assessment (e.g., according to ISO 14971), including action plan for risk mitigation.

    Product validation strategy development

    • Definition of a validation approach with reference to the existing IEEE 11073 SDC specifications and integrate into the current test management strategy for the target product.
    • Goal: Reach SDC self-conformance capabilities inside your QM system and adopt to evolving external conformance requirements.
    • Output: Validation strategy document including test methods, traceability matrix, metrics for goal achievement, and self-conformance approach.
  • Product validation implementation

    • Implementation of validation approach with reference to the existing IEEE 11073 SDC specifications. Execution of the current test management strategy for the target product. 
    • Goal: Reach SDC self-conformance capabilities inside your QM system and adopt to evolving external conformance requirements. 
    • Output: Validation documentation along your TMS and self-conformance approach.

    SDC device test services

    • Testing services for SDC-capable devices to ensure functionality and interoperability aligned with the customers` internal validation strategy.
    • Goal: Outsourcing identification and resolution tasks for SDC-related risk, cybersecurity and functional issues during development and before handover to test houses/notified bodies.
    • Output: Test report with test results (e.g., MDPWS, BICEPS, nomenclature), error analysis, impact analysis input incl. recommended action list for further development.

    Usability testing

    • Conducting usability tests together with end users using proven protocols to ensure that the required and expected usability as well as security and performance features are achieved.
    • Goal: Identification of improvement opportunities to optimize the user experience.
    • Output: Usability test report according to IEC 62366 with user feedback, identified usability issues, and concrete improvement suggestions.

    Real-lab evaluation at partner facility

    • Conducting product evaluation with focus on new interoperability features in near real-world scenarios in a controlled laboratory environment together with partner products to validate the intended SDC-enabled use cases and your product.
    • Goal: Ensuring that the intended SDC-enabled product has the required user and market fit.
    • Output: Structured user survey and study outcome summary according to a jointly developed and objective criteria catalog.
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Why choose ZEISS Digital Innovation for your SDC journey?

We are a trusted partner with the expertise, experience and commitment to deliver exceptional SDC solutions. As part of the ZEISS Group, we offer long-term dedication to your needs and innovation. With years of market experience and active involvement as a board member of the SDC user association - OR.NET, we provide reliable support from strategy to implementation and market readiness, offering forward-looking and advanced SDC services. Our team of experts is well-versed in SDC, understands point-of-care landscapes and user requirements, ensuring you receive exceptional support throughout your journey to empower connectivity at the point-of-care and transform device insights into action.

Join the growing number of medical device manufacturers that have already embraced the SDC standard. Contact us today to learn more about how we can support you to benefit from our extensive SDC expertise and experience.

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Dr. Max Rockstroh

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ZEISS Digital Innovation Health & Life Science Solutions

  

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Richard Bieck

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ZEISS Digital Innovation Health & Life Science Solutions

  

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Our mission is to create digital solutions today that will improve people's health tomorrow. We are a member of the ZEISS Group and your specialized partner for custom health software development and quality assurance.

We speak health & digital: Together, we accelerate your digital health innovations. We look forward to meeting you and discussing how we can help you implement your digital roadmap!

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