Beyond the band-aid: Unlocking healthtech innovation

Digital health technologies are driving a profound transformation of healthcare, reshaping practices that have remained essentially unchanged for decades.

“Healthtech innovation is enabling the transition from a curative approach to preventive, precise and personalised medicine,” confirms Françoise Liners, Director of Health Technologies at the Luxembourg Ministry of the Economy.

This personalisation of care is made possible by digital tools that provide data-driven insights, enabling doctors to make more precise diagnoses and recommend treatments tailored to the specific conditions of each patient. They also help identify potential health issues at an earlier stage and suggest preventive measures.

Healthtech innovation is enabling the transition from a curative approach to preventive, precise and personalised medicine. 
Françoise Liners, Luxembourg Ministry of the Economy

Digital technologies also help healthcare organisations become more efficient – a crucial move as many countries across the globe face an increasing shortage of medical staff. “Offering all patients access to personalised medicine with fewer resources is a complex challenge, but digitalisation can lead to a sustainable solution,” says Dr Liners.

She points out that the integration of artificial intelligence in health technologies, products or services accelerates the transformation further. “This isn’t merely a trend – it’s a revolution that should be human-centred.”

Building trust in digital health

The transition of the healthcare systems towards personalised medicine was already at the centre when the Luxembourg government selected health technologies as one of the pillars for economic diversification nearly two decades ago. In addition to generating economic value and jobs, the ambition was to have a positive impact on the Luxembourg society. A dynamic community of healthtech companies has emerged as a result, focusing particularly on medical devices, in vitro diagnostics and digital health.

We must consider the readiness and willingness of healthcare professionals and patients to use, adopt and find such technologies useful, including those that AI fuels. This is essentially a matter of trust.
Françoise Liners, Luxembourg Ministry of the Economy

“These fields are essential for enabling personalised medicine,” Dr Liners points out. However, having good digital health tools is not enough to make it happen. “We must consider the readiness and willingness of healthcare professionals and patients to use, adopt and find such technologies useful, including those that AI fuels. This is essentially a matter of trust.”

Navigating new EU regulations

To ensure that digital health tools can be trusted and that personal data is handled with care, the European Union has recently adopted several new regulatory frameworks complementing general legislation on personal data protection. Those impacting healthtech innovators include:

• European Health Data Space (EHDS): Set up to create a secure and harmonised framework for the exchange and use of electronic health data across EU member states. It facilitates the primary use of health data for better individual healthcare, as well as the secondary use for research, innovation and policy-making.
• AI Act: The AI Act provides compliance requirements for AI applications depending on their risk levels. AI-enabled medical devices, which are considered “high-risk”, need to comply with additional requirements for transparency, data management, ethics and human oversight.
• Medical Device and In Vitro Diagnostics regulations also set rules and processes to ensure that digital health technologies or products with a medical purpose are safe and effective for patients.

From compliance to competitive advantage

Navigating the regulatory landscape may be complex, but it is necessary for businesses targeting the European market. “My recommendation is to embrace the regulations and understand that compliance provides value and helps build user trust,” says Dr Liners. Luxembourg has implemented several measures to help healthtech companies achieve compliance with regulations from the outset.

The healthtech track of the renowned startup accelerator programme Fit 4 Start, open to both local and international participants, raises companies’ regulatory awareness from day one. It helps them take requirements into account from an early stage, rather than discovering them once the solution is finalised and having to redevelop all or part of their solution to achieve the necessary compliance.

My recommendation is to embrace the regulations and understand that compliance provides value and helps build user trust.
Françoise Liners, Luxembourg Ministry of the Economy

A second programme, Fit 4 Innovation – Healthtech Market, provides healthtech startups established in Luxembourg with access to specialised expert consultants who can help them define their regulatory roadmap for an EU market launch.

Luxembourg’s strategic investment 

Another priority for the Luxembourg government is to foster innovation by facilitating companies’ access to high-quality standardised health data in a secure, federated and interoperable manner. Health data use cases such as the patient cohorts of the National Centre of Excellence in Research on Parkinson’s disease and those set up under the international project focusing on personalised medicine of specific inflammatory diseases, demonstrate Luxembourg’s strong capabilities in setting up key data processing environments.  

Deriving insights and developing new applications from large amounts of health data requires considerable computing power. Companies can rely on Luxembourg’s business-oriented high-performance computer MeluXina, which is soon to be complemented by a second supercomputer purpose-built for AI and a quantum computer.

“These are major investments, also supported by European funding,” underlines Dr Liners. “They testify to Luxembourg’s commitment to becoming by 2030 one of the leaders in the sovereign data economy, in Europe but also globally. By catalysing innovation, these investments will also contribute to positioning the country as a European healthtech hub for the development, evaluation and adoption of digital health technologies in the European market.”

Photo credits: Luxinnovation/Capsule