Developing for eternity: Why reliability and long-term availability are crucial in medical electronics
Medical electronics must not only function but also be reliable, available and traceable for years to come. New requirements such as EU Regulation 2024/1860 or the obligation for Unique Device Identification (UDI) are increasing the pressure on manufacturers. At the same time, the requirements regarding selection, validation and documentation of components are growing. Taking reliability into account from the outset lays the foundation for compliance, market access and economic resilience.
Medical technology in continuous operation
Medical technology such as dialysis machines, implants or imaging systems often run non-stop under thermal, mechanical and electrical stress. A component failure can not only interrupt operation but also put patients at risk. Added to this are high recall costs, loss of reputation and, in the worst case, loss of market approval. In this context, reliability becomes a basic requirement for every new development and is strictly regulated by regulations and standards.
Increasing regulatory requirements
Regulation (EU) 2024/1860 added Article 10a to the Medical Device Regulation (MDR). Manufacturers of medical devices are now obliged to report impending interruptions to supply at an early stage – especially if patient care or public health could be affected. At the same time, Unique Device Identification (UDI) is becoming increasingly important. Class I devices have also been subject to UDI since May 2025, and EUDAMED registration could become mandatory from 2026.
Further requirements arise from ISO 13485, with requirements for quality management systems, and ISO 14971, specifically in relation to risk management. They require design controls, technical documentation and consideration of lifecycle risks, including traceability and validation of every change. For manufacturers, this means that technical and regulatory requirements must be taken into account as early as the development process phase.
Reliability starts with the design
Those who rely on resilient components, clean derating concepts and thermal reserves prevent failures at an early stage. Methods such as the Highly Accelerated Life Test (HALT) or Highly Accelerated Stress Screening (HASS) reveal weak points on the prototype before they become a problem in the field. Validation under real environmental conditions such as temperature cycles, humidity or vibrations is particularly critical. Without early long-term simulations, any predictions about the product service life remain of limited value. But even the most robust design does not protect against the short product lifecycle of many components.
Actively managing obsolescence
The half-life of electronic components is increasingly shrinking. Many integrated circuits (ICs), sensors or displays are only available for a few years. End-of-life notifications force manufacturers to respond quickly. Those who have not made any provisions in this case risk lengthy redesigns or even the loss of approvals.
Strategies such as second-source designs, early lifecycle analyses or long-term framework agreements with suppliers help avoid supply gaps. Tools such as product change notification databases, obsolescence forecasting, and lifecycle risk management are becoming imperative. Today, lifecycle management is seen as a continuous process that also needs to take account of geopolitical and technological trends. Complete traceability is likewise crucial in order to be able to respond appropriately to component changes or failures.
Traceability and UDI: obligation with potential
UDI systems, serial numbers, batch record documentation, supplier certificates – the documentation obligations are extensive. Every change to a product, whether technical or organizational in nature, must be clearly documented and, if necessary, reassessed from a regulatory perspective.
With the Guideline MDCG 2025-7, the Medical Device Coordination Group specifies the implementation timelines and use cases for the Master Unique Device Identifier - Device Identifier (UDI-DI), in particular for individualized visual aids such as contact lenses and spectacle products. The aim of the Master UDI-DI is to simplify traceability. Those who work digitally here, with versioned technical documentation and automated change tracking, save valuable time in the event of an audit. However, traceability alone is not enough, as the availability of components must also be ensured.
Making supply chains resilient
The pandemic and geopolitical tensions have highlighted how risky global dependencies can be. That is why strategies such as China+1, nearshoring and multisourcing are becoming increasingly important. Manufacturers are well advised to work from an early stage with Electronic Manufacturing Services (ESM) partners who specialize in medical technology and have internalized regulatory requirements. Digital supplier documentation, robust quality agreements, second-source strategies, and transparency at material level – for example, through bills of materials management tools – are crucial to sustainably strengthening supply security.
Outlook for the future: How AI and digital twins can help
Technological progress also plays a key role in increasing reliability. Modern tools such as digital twins allow a consistent simulation of product behavior, maintenance intervals and aging. They can be linked to real usage data and enable predictive maintenance. According to McKinsey, digital twin platforms can help to significantly shorten development times, accelerate product validation, and simulate regulatory requirements at an early stage.
AI models also help in test automation, for example, to improve aging forecasts, dynamically adapt test scopes, or detect anomalies in production at an early stage. However, this requires a solid foundation of data from development, quality assurance and use.
Reliability as a strategic opportunity
Reliability in medical technology is not voluntary but a regulatory obligation. Without strategically planned long-term availability, approval, market access and patient safety are at risk. Those who consistently focus their development, supply chains and documentation on service life will not only be audit-proof but also create tangible competitive advantages.