Why do we need digital transformation for medical devices?

People in a laboratory at ERNI Spain.

By Sandra Müller (ERNI Switzerland)

For hospitals, it is not up for discussion as to whether they want to digitalise. The increasing age of the population in western countries and the progressive shortage of medical professionals mean that without digitalisation, the healthcare system will not be able to provide the quality that patients want in the future.

Medical technology companies are expected to support the healthcare system on the path to digital transformation through innovative solutions. This means that more efficient work is made possible not only through pronounced user-friendliness (usability) but also by incorporating upstream and downstream processes in line with the customer journey. Today, tests, measurements and results must not only be visible on the PC in software but also on the medical device itself. It must also be possible to transfer them to a hospital information system (HIS) or medical practice software; interoperability is no longer negotiable. Repetitive processes or work where humans tire quickly, such as analysing MRI images, can be supported by machine learning (ML) or artificial intelligence (AI) to help healthcare professionals better evaluate and diagnose. Swiss hospitals are already analysing MRI images from partner hospitals at a distance, as the latter cannot have qualified personnel on site 24 hours a day. Good care even in rural or structurally weak regions can be ensured thanks to digital transformation – including methods such as remote assessment and computer-aided diagnosis as well as ML/AI. This technological progress also offers emerging and developing countries opportunities to rapidly improve their healthcare systems, as fewer highly qualified professionals need to be available throughout the country for certain processes and treatments.

Educated patients and HealthCare instead of SickCare

There is a clear trend among the population to move from SickCare to HealthCare. With SickCare, one waits until the disease appears and then treats it. With HealthCare, people invest in maintaining their health, i.e. they take preventive measures to avoid getting sick in the first place. With the internet, today’s patients are more educated and better informed than ever and often want to see their values or measurement results and understand their diagnosis. Prevention is much more important today than it was twenty years ago, enabling new business models for MedTech companies. Also, after discharge from hospital, the modern patient expects that remote patient monitoring will detect an escalation of the disease at an early stage and preventive intervention will avoid readmission. This also conserves scarce hospital capacities. The electronic patient dossier (EPD) in Switzerland and the electronic health record (ePA) in Germany are important pillars on the way to the healthcare of tomorrow.

Are there also opportunities for MedTech companies?

Of course, price and competitive pressure also mean that today’s medical products must constantly be developed further. But do only patients and medical professionals benefit from the digital transformation or do opportunities also open up for MedTech companies? In our opinion, new technologies and increasing people’s affinity for technology offer many new opportunities for the MedTech sector. Companies must make good use of these and invest in the development of solutions. Through the IoT (Internet of Things), also called the IoMT (Internet of Medical Things) in medical technology, medical devices, wherever they are used, can send their encrypted data to the cloud, for example. This offers advantages not only for patients and hospitals to retrieve the data from anywhere, in almost real time as well as retrospectively in a web application, but also enables new business models for MedTech companies. For example, Software as a Service (SaaS) can be offered for a web application where the user pays a subscription fee or a payment model per patient or per test/measurement performed. It also makes it possible to make the service business more professional since, thanks to the IoT, it is known which device is in use with which firmware. The manufacturer, local authorised representative, importer or dealer can arrange for on-site maintenance and the required spare parts much more precisely as they know how the device is being used by the customer and what condition it is in. For traceability, as well as the post-market surveillance required by the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as well as the US Food and Drug Administration (FDA), the IoT also offers new opportunities.

If the manufacturer collects data from the devices used, it can, for example, more quickly identify the conditions under which undesired behaviour occurs. This helps in continuously improving the products. Clinically too, new possibilities are opening up through the compilation of anonymised data from countless patients from a wide range of hospitals and countries. It is only through a large amount of good-quality and structured data that physicians and researchers, together with data science specialists, can improve diagnoses and uncover correlations in the coming years that are not yet known today. It also gives us new insights into the prevention, treatment and incidence of diseases. This, in turn, relieves the burden on health personnel.

At ERNI, we also support you on the path of digital transformation through our digital business and technology consultants, be it in the (further) development of innovative solutions and new business models or in the implementation as software partner. Together, we enable you to seize your opportunities!

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