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Gatekeeper in digitalized medical technology

Published on 08.11.2021

S.I.E and its partner secunet Security Networks AG are committed to digitalization in medical technology. The companies’ focus here is on the interaction between humans and machines.

Digitalization and disruption. Terms that change industries, open up new paths and technologies for people, and stand for the times we live in like no other. While development in areas such as industry is advancing rapidly, the healthcare sector and the entire medical technology sector are faced with the challenge of having to deal with sensitive patient data in complex operator networks as well as across operator boundaries. The protection of such data must be ensured, but also the premise of “function before safety”, which is common in medical technology (MIT), must be adhered to. The well-being of patients comes first.

Two pioneers in the digitalization of medical technology are the embedded systems specialist S.I.E and its partner, the IT security specialists at secunet Security Networks AG. During the research for this article, the two companies gave us an exclusive look behind the scenes of two digitalizers, or rather, digitalization enablers. The companies’ focus is particularly on the further development of an entire industry. “Digitalization only works if we enable ourselves and the entire industry environment to share a common foundation of know-how and technology. At this point, it is much less about marketing service than about basic work to enable real innovation and disruption in the context of digitalization in medical technology as well,” says Josef Krojer, one of S.I.E.’s managing directors.

In order not to let digitalization hover over an industry as a buzzword and sword of Damocles, but to actually break it down in a tangible and understandable way, S.I.E has developed its own digitalization model. Sami Badawi, Head of Marketing and co-developer of the model explains, “In digitalization, we don’t focus on linking and listing hardware, software and various layers up to the cloud. Our focus is on human-machine interaction. To this end, we have broken down both systems, the digital world and the physical world, and taken a process approach to representation. We are concerned with digitalization as a transformative process. We understand it as the analysis of processes in the physical world and the mapping of digital counterparts in the digital world. In particular, we need to look at the interfaces between the worlds – so that users perceive machines as a friend and helper rather than a threat or hindrance. Machines should help with decisions and only take responsibility where it is possible and makes sense.” Taking a closer look at the model, especially the digital world, it becomes clear that interface technologies for the secure transport of signals between sensors and computer systems such as cloud, Fog, and edge computing devices are the most important foundation of digitalization.

This is precisely where S.I.E and secunet Security Networks AG have chosen their entry point for the joint digitalization roadmap for medical technology, thereby further expanding their joint activities for the digitalization of healthcare. An initial contribution has already been made by the secunet konnektor, the security technology heart of communication in the telematics infrastructure. Doctors in private practice, pharmacies, and large hospital infrastructures and data centers will thus have access to the digital health network. Torsten Redlich, Deputy Head of Division eHealth at secunet Security Networks AG, says: “Another important aspect besides secure patient data processing via the telematics infrastructure is the protection of decentrally operated medical technology. Together with S.I.E, we want to advance the topic of Medical Technology 4.0 and enable operators and distributors to securely integrate medical devices into operator infrastructures. A device designed for this purpose with IoT interfaces for securely connecting medical devices to operator infrastructures has already been seen as a valuable first step by many medical technology distributors.” The comprehensive networking of devices and their intermingling with IT-supported systems is the key driver of new digital business models in medical technology and only enables the processing, correlation and analysis of generated data volumes.

However, this level of networking and distributed data processing inevitably leads to new challenges and security risks for operators and manufacturers of such devices. Practical experience has shown that there is an acute and omnipresent threat to networked medical technology from cyber attacks and that protective measures must be taken and permanently maintained for equipment and transferred data. However, medical technology regulations restrict the modification of IT components. Medical technology products must comply with legal quality specifications, which undergo extensive testing and approval prior to release for use. This poses a problem for rapid software updates and upgrades. Now, in order to be able to respond to the rapidly changing IT influences and arm oneself against current IT threats, protection concepts are needed that work flexibly on and around the medical technology itself.

This is precisely where the joint approach of a gateway and interface technology comes in: a “trusted edge platform” as a secure system environment protects connected medical technology from external influences in the sense of a protective shell and provides an execution environment for reloading and executing individual applications around which medical technology cannot normally be easily retrofitted. Accordingly, operators and distributors of medical devices as well as service providers can take advantage of the flexible concept of the Trusted Edge Platform and securely integrate their IT services into operator infrastructures, securely transfer data in and out of IT services via directed and controllable communication channels, protect medical devices at the same time, and develop new digital business models on this basis.
develop. To this end, the companies are already in workshops and concrete development of digital business cases with several well-known med-tech in-transit providers. Josef Krojer explains, “It goes without saying that the development of a Trusted Edge Platform, i.e., a solution consisting of hardware and software, for connecting med-tech devices to individual infrastructures is a complex and operator-specific challenge.” To this end, S.I.E together with secunet Security Networks AG offers interested parties various workshop formats for analyzing current business cases and possible use cases for digitalized medical technology.

While the Trusted Edge Platform has already been finalized to a large extent, the individualized choice of hardware design, the connection to various forms of operator infrastructures, and the design and integration of apps, operator feeds, and even the opening of individual channels for third-party providers must be clarified and implemented on a case-by-case basis. “The only possible way to realize this is a collaborative, open development approach. The workshops and also the deeper collaboration in product and digital business case analysis and business modeling are a quantum leap compared to classic requirements specification developments of the past. We can only master digitalization in medical technology together in large know-how clusters and with co-creation approaches,” says Josef Krojer.

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