Medical device software has become a catalyst for progress in the life sciences, transforming how data is collected, analyzed and used to shape decisions and strategies. By integrating advanced algorithms, machine learning and artificial intelligence (AI), software has taken research to new heights and provided tools that bridge the gap between theory and practice.
It is common to encounter terms such as Software as a Medical Device (SaMD) and Medical Device Software (MDSW) within Medtech. SaMD refers to software that is intended to be used for medical purposes without being part of a hardware-based medical device. It usually runs on a common platform, such as a personal computer, a mobile device or in the cloud. MDSW refers to software intended to be used, either alone (SaMD) or in combination with specified hardware, for a purpose specified in the definition of a "medical device" under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The versatile use of the software
One of the main contributions of software in life sciences is the emergence of precision and personalized medicine. Software has also accelerated the drug development process through advanced simulation tools and virtual testing environments. In medical image analysis, software makes it possible to detect and diagnose diseases at early stages. Using advanced algorithms, medical images can be analyzed faster and more accurately, leading to faster treatment decisions and improved patient care. The software enables real-time monitoring and management of patient data, which is essential to optimize care. Through the integration of sensors and wearables, healthcare professionals can make quick decisions based on current health status. These advances are essential to meet future challenges in medical research and care.
Whether or not the software you develop is a medical device depends entirely on its intended use. The key is whether the product has a medical purpose and it is the responsibility of the manufacturer to clearly define this purpose. For example, some heart rate monitors are considered medical devices if they measure heart rate and oxygen saturation, while other heart rate monitors are not. The difference lies in how the manufacturer formulates the intended use of the device.
Even if the software does not directly affect the medical purpose, it can still play a crucial role in risk management, i.e. taking measures to prevent, reduce or manage risks, injuries or threats.
MDR and IVDR: safety and performance requirements
The revolutionary role of medical software in life sciences opens up new opportunities and challenges. The future is characterized by the integration of AI, blockchain and other advanced technologies.
The MDR and IVDR provide clear frameworks for medical devices and diagnostic products. These regulations set clear requirements for medical software to ensure safety and performance throughout its life cycle. This includes requirements for risk management, performance analysis, clinical evaluation and adverse event reporting. To meet MDR and IVDR requirements, developers and manufacturers should follow international standards specific to medical software.
ISO 13485 is a basic standard for quality management systems, while ISO 14971 focuses on risk management. ISO 62304 is particularly relevant for software development in Medtech and specifies requirements for the software development process. In addition to these standards, usability and cybersecurity are key aspects regulated by IEC 62366-1 and IEC 81001-5-1. These standards aim to ensure safe and effective interaction between users and medical devices, including software. Together they provide a comprehensive framework to ensure quality, safety and compliance in medical device software development.
The choice of standards to be met depends on the function of the software in the product and the specific installation environment. Whether the software runs on a general platform or is designed for the purpose in a specific hardware will influence which standards are relevant. In addition, communication with external actors will dictate the need to consider specific cybersecurity standards.
The software development process and the application of a development model are also crucial factors. It is important to stress the importance of building a robust framework from the beginning, rather than trying to adapt standards after the software product is already finished. A successful strategy involves integrating standards and following a structured approach from the beginning of the development phase.
Software development in Medtech
The software development process is a central component in the creation of high quality and reliable software products. A documented, clear and repetitive development process is fundamental to achieving more efficient development cycles and minimizing the number of bugs, although the goal of bug-free software is generally considered to be a utopia.
IEC 62304, a standard aimed specifically at software development within Medtech, identifies five essential processes to ensure structured and high-quality software development. These include the software development process, maintenance of released software, risk management with a special focus on traceability to implementation, version management and management of software problems during development.
A potential challenge with IEC 62304 is its general wording, but this is deliberately done to be applicable to different development models, including the classic waterfall model and more flexible Agile development models. Importantly, the software processes clearly describe how the work is actually carried out to ensure consistency and quality in software development.
Challenges and adaptations for the future
Meeting MDR and IVDR requirements for medical software poses significant challenges in the rapidly evolving technological environment. The integration of medical software in Life Science requires not only the exploitation of its potential but also a smooth adaptation to MDR, IVDR and applicable standards to ensure safety and regulatory compliance.
In the emerging era of medical software and life sciences, it is necessary to embrace the technology, meet regulatory requirements and actively shape the future of medical research and care. Being aware of technological advances, adapting to future requirements and continuously considering and complying with international standards will be essential to meet the challenges of the future medical device landscape.
