26 July 2022
The ongoing global semiconductor shortage is severely impacting the manufacturing and assembly of medical technologies, i.e., medical devices and in vitro diagnostic (IVD). These industries combined use approximately 1% of the current global supply of semiconductors, and yet even this small amount is under threat of undersupply. The gap between supply and demand is likely to increase even further in the months and years ahead, as demand for medical technologies is expected to grow continuously.
Ramping up medical technology supply to meet demand is essential, if healthcare systems are to clear the significant COVID-19 related patient backlogs that still persist in many Member States, while continuing to tackle the chronic challenges of ageing population and the resulting prevalence of chronic conditions and the aspiration for a digital transformation of healthcare that is desired in order to ease these pressures.
It is therefore critical to ensure a continuous and sufficient supply of semiconductors, to meet the growing demand of healthcare systems for medical technologies needed to deliver patient care.
Call for Action:
Immediate global and European actions are needed to safeguard against harm to patients and healthcare systems stemming from the semiconductor shortage, including:
1 Regulation 745/2017 on medical devices (MDR) and Regulation 746/2017 on in vitro diagnostic medical devices (IVDR)
Semiconductors are an essential part of all electronic medical devices and IVDs, and thus are relevant for a huge number of healthcare services.
It is often well-established second or third-generation semiconductors of proven reliability that are used. They are usually supplied as part of pre-assembled electronic components or printed circuit electronic boards which in turn enable various critical components to function, such as: motors, power supplies, sensors, touchscreens, other displays cameras, lasers, data processors, memories, diodes and more.
These components are then integrated into medical technology products, such as:
There are many more medical technologies that rely on semiconductors. The list above demonstrates that semiconductors availability is important for effectively all disease and treatment areas within healthcare.
In addition, semiconductors are needed to produce the machines used in the manufacturing of medical technologies. Sufficient availability of those machines is needed too.
To allow for the continued production of needed medical technologies, despite the existing semiconductor shortages, manufacturers have already taken extraordinary mitigation measures in the past months, including:
Some manufacturers also look to replace or re-engineer components in their products in order to move to alternative semiconductors, where possible and available. This however is not straightforward to do quickly, as it triggers the need for validation of the new semiconductors, which could trigger regulatory consequences under the sectorial medical technology legislation, i.e., the MDR or IVDR.
These mitigation measures already have a significant impact on the costs and lead time of medical technology production, and this creates unpredictability about when newly-manufactured products can in practice be delivered to the healthcare systems which need them.
While these short-term measures have for the most part enabled medical technology manufacturers to partially compensate in the past months for the ongoing semiconductors shortage, the challenges for the healthcare sector will continue to exacerbate if the situation is not resolved in the longer term. These short- term measures alone are not sufficient to keep the sector afloat in the months and years to come.
Broad and systemic measures are therefore needed to safeguard against further disruption of medical technology supplies to healthcare systems. We call on the European Institutions and Governments to facilitate tangible, bolder action.
MedTech Europe suggests the European Union and Governments to take a range of actions to:
The most important measure is to:
Further measures:
About MedTech Europe
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations that research, develop, manufacture, distribute and supply health-related technologies, services and solutions.
For more information, please contact: Jesus Rueda Rodriguez
Director General - Strategies, Special Projects & International Affairs j.rueda@medtecheurope.org [3]
For media enquiries, please contact: Caroline Moulins
Senior Manager Communications c.moulins@medtecheurope.org [4]
Links:
[1] https://ec.europa.eu/newsroom/dae/redirection/document/83095
[2] http://www.medtecheurope.org/
[3] mailto:j.rueda@medtecheurope.org
[4] mailto:c.moulins@medtecheurope.org
[5] https://www.medtecheurope.org/