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FEATURE


ELECTRICAL & ELECTRONIC COMPONENTS


a co-creaTion approach To medical producT developmenT


Medical devices and medical networks need cybersecure gateways for the digitisation of healthcare. To help, S.I.E and congatec have entered a partnership to develop dedicated medical edge


gateway platforms that enable all players utilising this new medical technology platform to reach their digitisation goals faster


T


he classic concept of collaboration is where companies join forces to develop new products and then offer them on


the market. In this case, however, the two companies offered individual co-creation services, allowing medical device manufacturers and hospital IT providers to procure and implement better solutions much faster. One of the first customers to take advantage


of this offering, which is based on agile development methods, is secunet Security Networks. In just a few months, the companies developed a new class of secunet gateway in two variants. Besides a controllable information flow for medical digitisation concepts, this also offers a protected connection to centralised services and a secure execution environment for the users’ own applications. With secunet medical connect Carna, the


partnership has created a medical device gateway for the point-of-care (POC) environment. The gateway is designed for use as a medical


IT accessory as well as for medical device approval. For safety-critical networking scenarios, it therefore not only provides the functions but also the necessary formal requirements from a single source – including essential approval information and evidence of quality management system ISO 13485:2016 or risk management ISO 14971 compliance. This gateway separates the connectivity layer


of medical devices from the actual medical device, which makes it possible to regularly update the interface to the outside world without having to recertify the medical device itself. This ensures that the security and operation of the various interfaces that change over time is always up to date. The medical device itself remains in the field unchanged. The 19-inch rack server family, Athene, was


built for data-intensive use cases or clusters of medical technology devices, and can be deployed in individual department networks or centrally in the hospital data center. Depending on the design, it can be used either as a cloud frontend, security gateway or as a secure execution for AI tasks close to the medical data source.


open and secure – The challenge


Such application-ready medical gateway and server platforms are immensely important as digital healthcare transformation poses major challenges for all players involved. Medical


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device manufacturers must open their systems so that the collected data can be exchanged. They must, however, also meet the highest security standards to protect this data exchange and their devices. Hospitals, on the other hand, must open their


IT networks for such devices, while at the same time meeting legal requirements to ensure critical infrastructure (CRITIS) security and data protection (GDPR). As a result, all companies involved in the digitisation process must pay constant attention to the IT security aspects of critical medical technology and its sensitive data. But, this is not a core competence of the


medical OEMs nor of the hospital operator. That is why secunet, as one of Germany’s leading cybersecurity companies, has joined forces with S.I.E and congatec to develop medical-device-compliant solutions that meet this need. The focus is on compliance with numerous standards and regulations – from EN 60601-compliant interfaces, to MDR and FDA cybersecurity guidelines to ISO 80001. “We have benefited immensely from the


strategic value-added partnership between S.I.E and congatec and their co-creation offering. Development has been a truly joint effort, from product ideation to manufactured gateway. This has enabled us to significantly accelerate our time-to-market and better address our customers’ needs, from hardware through to application,” explained Torsten Redlich, global head of business development and deputy head of eHealth at secunet Security Networks.


co-creaTion


To co-create these products, the companies got together very early on for hardware and software system integration. Functional prototypes were in place after just four and a half days, whereas with a classic approach it would have taken months for anything comparable to emerge. This is because internal company secrets and added value are normally protected and sealed off from other companies. A system design and integration house


like S.I.E, which also takes care of the series production and assembly of such OEM platforms, does not usually bring its module supplier to the customer’s table during a pitch. The module supplier could all too easily decide to cooperate directly with the customer. However, considering the high division of labour within the embedded and edge computing


3 DESIGN SOLUTIONS DECEMBER/JANUARY 2023


supply chain, the immense lead times from initial idea to first prototype or finished series product are severe bottlenecks for OEM customers. To break down the walls between departments and companies, they are therefore looking for holistic solutions. Ultimately, they’d like all development tasks to


run in parallel and in continuous synchronisation with customers to create best-practice solutions. congatec and S.I.E have taken on this challenge and formed a co-creation team that offers joint project and product development in collaboration with customers and the customer’s customers.


The focus shifTs


The advantage of such holistic co-creation offerings is that it is possible to think across the entire value chain in the design sprints. Development can therefore focus fully on creating added value for the product end user. “Classically, it is the OEM customers who


initiate embedded computing business. While they usually know exactly what kind of system they need, they may not have considered every aspect, where the supplier often has more expertise. However, it is the customer’s requirements specification that sets the delivery expectations for the embedded computing supplier. So, if you start communicating before all the details are nailed down, you can already exchange ideas in the important creative phase,” commented Josef Krojer, general manager at S.I.E System Industrie Electronic GmbH. The conventional development process


upstream along the supply chain resembles the children’s game of ‘Chinese whispers’, where it is basically preprogrammed that information will be lost or misinterpreted and then passed on incorrectly.


proToTyping


In this case, the prototype was developed jointly by secunet, S.I.E and congatec right from the start – and then once it was operational, the end customers were also involved. This enabled them to also provide active input at a very early stage in the proof-of-concept phase and gave them the opportunity to shape the design of the product that they would ultimately be using. During the design of medical connect Carna


and Athene, both the medical technology manufacturers (who want to be able to connect their devices securely) and the hospital infrastructure operators and their service


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