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MedTech companies often find themselves at the crossroads between regulatory compliance and innovation. On one hand, standards and rules are becoming more complex and growing exponentially. On the other, technology is advancing rapidly, and so are unforeseen problems.
“Regulatory burdens are growing and diversifying,” explains Carsten Leischner, Head of R&D for Intensive Care devices at Germany-based MedTech and safety equipment company Dräger. Dräger is present in 190 countries around the globe and its medical division provides hospitals world-wide with therapy and monitoring devices, IT solutions, consumables and services.”
“15-20 years ago, once you reached a certain feature-set, you published software for a medical device and didn't touch it unless there was a critical error potentially causing patient harm. But now you have to constantly monitor it for cybersecurity issues, regularly evaluate your third-party software, and fix flaws in a short time frame. From writing requirements to software architecture and designs, you need organized and documented proof that everything is tested and compliant with the requirements of different regulatory bodies in different countries.”
Technology is Advancing Faster Than Regulations
Regulators are demanding sustainability in medical device design and manufacturing. For instance, in the US, the Food and Drug Administration is reportedly looking to introduce regulations in this area and is reportedly conducting pilot programs. The EU has already introduced directives for supply chain sustainability and reusable packaging, and the UK is considering amending current regulations to include a sustainability appraisal in medical devices.
This is an example of how complex compliance and regulations are becoming. But as confusing as regulations may be, they are critical and necessary because human lives depend on them. At the same time, technology and connectivity continue to advance. Today, 3D-printed devices, smart devices, connected devices, and AI and machine learning-enabled devices are changing the landscape of the MedTech industry. However, regulations have yet to catch up in this area.
“Regulators and legislators have been holding back from specifically mentioning artificial intelligence within the guidance for MedTech regulations in Europe,” says Stephen Gilbert, Co-Author of a paper on AI-based approaches for personalized drug and cell therapies in Precision Oncology and Professor of Medical Device Regulatory Science at Dresden University of Technology.
“Even with the introduction of the EU AI Act, this will not be particularly resolved. You will still have vertical legislation or sector-specific legislation alongside this new horizontal legislation across AI, but there's no clear guidance on how to apply these together. So, this would be a challenging job for the regulatory agencies and notified bodies.”
Ronald Boumans, Regulatory Consultant and former Senior Inspector for medical technology with the Dutch Competent Authority, points out that today, MedTech companies need to map out the specifications of their products, risk classes, and standards and be careful about regulations that border other legislations.
“I have seen a large IT company try to avoid becoming a medical device company. After the date of application of the MDR (Medical Devices Regulation), they suddenly found themselves selling software that was considered a medical device. They couldn't rely on the legacy status of their self-certified device. They had to take it off the market, which was an expensive mistake.”
How to Accelerate Technological Innovation and Regulatory Compliance
Experts say that shift-left testing, code coverage, and ensuring sustainable growth pathways are crucial in this context. They help streamline processes, boost efficiency, and expedite time to market while meeting stringent regulatory requirements.
Gilbert says, “You need to identify early what the risks will be. Shift-left testing is a core part of thinking and software development, and any sensible company in the MedTech sector should be thinking of it because the risk assessment process is so absolutely critical.”
A recent report on trends in medical device regulations estimates that since 2015, regulations have increased by 64%, with more than 13,000 individual regulations in place. According to some studies, MDR regulations in the EU have seen certification costs for device manufacturers rise tenfold. For instance, the EU MDR 60601-1 comprises a staggering 400 individual clauses for MedTech approval.
In this context, the role of the right technology partner is crucial. Innovators can lean on compliant technology platforms such as Qt’s Axivion SCA to ensure code quality and compliance with regulatory standards. It is certified for suitability in safety-critical systems according to IEC 62304 up to Class C and can help MedTech companies significantly reduce development time and costs.
Leischner expands, “Software is at the heart of a medical device. It's obviously essential to have an excellent IT and OT infrastructure to roll this out to all the different devices so the devices will become connected. Ideally, you have a whole toolchain or digitized toolchain—from defining your device to building your device and software and rolling it out into the market and hospitals.”
“We're using this core software platform and network platform in all of our devices with a user interface built on Qt so that we don't have to redo the basic infrastructure for each device again and again and ensure this basic infrastructure is compliant. By doing this managed reuse, we're able to focus our resources on innovation instead of repeatedly doing the same thing for many devices,” he explains.
That’s a smart strategy because, in the future, the lines between MedTech and Digital Health Technology (DHT) will start blurring, and product development cycles will need to be reduced significantly.
Experts predict that MedTech and medical devices will be organized as suites of systems, particularly in the areas where they interact with home-based care and consumer health. That would lead to individual digital health devices being grouped with regulatory approvals and clinical use cases being grouped into suites of devices that could be remotely monitored or used in smart clinics.
Boumans concludes by saying, “There’s a lot of startup energy invested in new technologies. In a way, that’s interesting because it leads to survival of the fittest. However, in the case of MedTech, the fittest technology is not always the technology that survives. It is a company that has outstanding technology that has access to the market.”
