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The Covid-19 pandemic has accelerated the global development and adoption of emerging medica...
• Devices – e.g. digital blood pressure monitors or glucose monitors
• Diagnostics – non-invasive in vitro diagnostic (IVD) tests such as those based on blood, urine or other tissue samples
• Digital health – tools or services that use information and communication technologies to improve diagnosis, treatment and management of someone’s health.
These tools have potential to transform our health care, improving the quality and efficiency of healthcare systems and enabling and empowering people to live well for longer.
In Europe, the medical technologies market has grown rapidly in the past two years. Covid-19 has accelerated innovation in this area. In 2020, more than 14,200 patent applications were filed with the European Patent Office (EPO) in the field of medical technology a 2.6% increase compared to the previous year . We look at some current trends in the growing sector.
One of the key trends in the medical technology sector in Europe is the introduction of new regulations in 2022 affecting classification of IVDs.
The IVD sector currently conforms to a Directive (98/79/EC) which groups IVDs into four categories. Previously, the classification of IVDs into these categories was broadly left to manufacturers’ interpretation. However, from 26th May 2022, a new IVD Regulation will classify IVDs according to the risk the diagnostic poses to the health of the public and or an individual as result of an incorrect test result.
The new Regulation requires manufacturers to define the ICD’s intended use, which will determine a) whether it is considered an IVD and, b) which of four risk classes (A, B, C and D), it belongs to. The changes also increase the scope of the Regulation, covering all reagents, apparatus and even software.
Although the changes will bring the Europe into line with ICD regulation in other countries, it will take time and effort for manufacturers to ensure IVDs comply with the new regulation and can be marketed in Europe. Moreover, the change will also impact clinical laboratory end-users who develop their own assays for specialized diagnostic applications, as only IVDs that meet the new Regulations will be approved for use in the clinical setting.
A key trend in medical technology is the development of digital health support tools that help to support an individual’s progress in managing their health or a long-term condition. This ranges from using mobile communication technologies for telemedicine, wearables and apps for monitoring health, to the possibility of using artificial intelligence (AI) to deliver ‘virtual care’. These tools can provide real-time feedback to healthcare professionals on an individual’s wellbeing, vital signs and symptoms in between clinic appointments and have potential for a wide range of applications, from monitoring women’s health during pregnancy, to managing diabetes, and providing support for people with mental health disorders.
Before the pandemic, only a handful of countries in Europe had implemented digital health tools and/or made progress in putting in place appropriate financial and regulatory frameworks for supporting their introduction into healthcare systems. One of the main hurdles remaining is reimbursement for these products, which made it impractical or impossible for healthcare professionals to prescribe digital health tools to patients even if they might be helpful.
In May 2021, Germany passed a new Digital Health Care Act, which allows a sensor or app that is medically approved to be prescribed by doctors and reimbursed through the health insurance system. It was hoped other countries would soon follow suit, and this would open the door to many more prescriptions of these products, and drive innovation in the digital health sector. However, according to one report, the new legislation hasn’t yet translated into more digital prescriptions for several reasons, including lack of clinical evidence and investors reluctant to back products designed for a German healthcare system. Although this trend is here to stay, it remains a thorny area of development for innovators.
POC diagnostics are tests and tools that can be used at or near the patient in any setting, allowing diagnosis to be done quickly by patients at home or in a community care setting, such as a care home, GP surgery or pharmacy.
While the European regulatory environment for IVDs and digital health tools remains challenging and variable between countries, there is still a growing market for point-of-care diagnostics. The European POC testing market was worth more than EUR 6.5 billion in 2022, and is estimated to reach around 10.5 billion by 2027.
There are several drivers for the shift towards POC tests. One is that our existing healthcare system cannot cope with the increasing burden of managing complex diseases in an aging population of people living sedentary lifestyles with poor diets. A second driver is the recognition by both healthcare professionals and the public that early diagnosis and swift intervention is instrumental to successful prevention or management of most complex diseases.
There is therefore a growing need for efficient, easy-to-use, faster POC testing across a wide range of health applications: from monitoring cancer biomarkers during treatment, to measuring fertility, and testing for an infectious disease. The challenges in addressing this need is the coordination required between healthcare providers, manufacturers and researchers, regulatory and reimbursement barriers, and encouraging healthcare professionals to shift to novel models of care.
Another trend in Europe is the recognition that medical data is a unique asset rapidly growing in size and value with the advent of new medical technologies. Already, a single patient generates up to 80 megabytes of data yearly in imaging and electronic medical records. Currently, much of this data exists in silos and inaccessible both to both patients and researchers.
In a move to unlock this data’s potential, the European Commission recently announced plans to establish a Common European Health Data Space (EHDS). The goal is to provide “a consistent, trustworthy and efficient framework to use health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with the EU's high data protection standards”.
The EHDS will allow researchers, innovators, public institutions or industry to have access, under strict conditions, to large amounts of high-quality health data. In doing so, the EC hopes to foster a genuine single market for digital health services and products.
During the Covid-19 pandemic, healthcare providers had to rapidly place their trust in new medical technologies and digital health tools when face-to-face interactions were impossible. Many companies managed to pivot their business models to become tech developers and providers, accelerating digitalization of their products. There are still regulatory hurdles to navigate, but standards for interoperability and frameworks for data flows are emerging that will help pave the way for the development of the next generation of innovative medical technologies in Europe.