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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 workshop / consulting

    • We analyse your current interoperability strategy, including the maturity level of the targeted products, as well as any gaps that need to address to introduce SDC features into your 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

    • In a joint workshop format, we identify relevant interoperability use cases based on your product roadmap and connectivity needs in alignment with the IEEE11073-SDC standards family.
    • 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

    • We transfer new use cases into a product vision that is powered by interoperability features and can be validated through stakeholder interviews.
    • 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

    • We design your SDC-enabled product for a specific treatment environment, e.g., operating room/intensive care unit, that meet the specific requirements of the environment, end-users and your own product vision.
    • 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

    • We perform a comprehensive analysis of the competitive landscape and to assess the potential of SDC-enabled use cases and networking strategies. In the next step, we identify strengths and weaknesses of other providers, where your product business can excel with SDC including a first look into ROI opportunities.
    • 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

    • We support you in finding and activating the right vendors to achieve the intended SDC-enabled use cases in your 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

    • We jointly create an 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: You 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

    • In a rapid development of prototypes, we use preferably open-source IEEE 11073 SDC reference implementation libraries to validate your SDC ideas and concepts.
    • 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

    • We support your implementation actions of the SDC interface in current and future products with a strong focus of automation and maintainability, incl. risk management, cybersecurity and quality assurance tasks. The ZEISS SDC Interoperability Kit would be the ideal choice for this task as it comprises all our efforts to make this process as developer-friendly and streamlined as possible.
    • 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

    • We consult you in the area of user experience (UX) with expected changes to your 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

    • We define a validation approach with reference to the existing IEEE 11073 SDC specifications and align it with the current test management strategy for your product.
    • Goal: You have defined the procedure and work steps to reach SDC self-conformance capabilities inside your product lifecycle.
    • Output: Validation strategy document including test methods, traceability matrix, metrics for goal achievement, and self-conformance approach.
  • Product validation

    • We implement the validation approach with reference to the existing IEEE 11073 SDC specifications into your software development lifecycle with a strong focus on automated testing and continuous integration of SDC in your product.
    • Goal: The validation baseline is reached for your SDC self-conformance in reference to the external conformance requirements.
    • Output: Validation documentation along your test management strategy.

    SDC device test services

    • We provide testing services for your SDC-capable devices to ensure that the intended functions are compliant with the specifications of the SDC standard and are aligned with the your product strategy.
    • Goal: Outsourcing the first technical check against the standard 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

    • We conduct usability tests together with your end users using proven protocols and adopted to your target point-of-care 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

    • We are conducting the product evaluation of your intended SDC-enabled use cases in near real-world laboratory environment together with likely partner products.
    • 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 and 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

Senior Business Development Manager
ZEISS Digital Innovation Health & Life Science Solutions

  

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Richard Bieck

Senior Solution Specialist
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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