Systems engineering in medical device development
Building a complex medical device in today’s environment involves many subsystems. The design and development of these subsystems require a systems engineering approach.
Systems engineering is a challenging task that requires a wide variety of cross-functional engineering skills and the ability to effectively accommodate the thoughts and sometimes difficult discussions that must take place between cross-function team members. It takes a technical moderator with sufficient technical skills and expertise to identify technical risks, challenge design decisions, and bridge the gap between the functional elements of the product development process.
Systems engineers are involved in multiple stages of the design and development of products and work directly with diverse stakeholders during the development of the product to create cost-effective solutions. In doing so, it is vitally important for the systems engineers to help clarify the problem and support the delivery of safe and affordable products onto the global market.
What does a systems engineer do?
A systems engineer oversees the technical, business and management aspects of a project, system development, and ensures that all parts of the developed system work together properly. In addition to engineering aspects, systems engineers deal with a wide-ranging part of a project and must consider details such as costs, schedules and social aspects that may be associated with a project.
Systems engineers play a major role throughout the life cycle of a medical device product, starting with precisely defining and documenting the product requirements. This is followed by design, which involves ensuring that the developed product corresponds to its intended use, right up to the disposal/decommissioning of the product.
Systems engineers work with programme management stakeholders to achieve success, and their major responsibilities are:
- Plan and lead overall design and development activities relating to the product.
- Define the concept of the product design with appropriate technologies and implementations.
- Document user, product and design requirements, along with specifications.
- Control of product and process risk management activities.
Standard systems engineering execution process
The general process structure of the ISO/IEC/IEEE 15288 standard has been established for systems engineering execution, and it is used to effectively operate systems engineering throughout the entire system life cycle. Figure 1 below describes the flow of processes.
Figure 1: System life cycle processes
Figure 2: Associated system life cycle processes
The system life cycle processes define a set of associated processes from an engineering perspective. These processes are applied at different stages of project execution and can be tailored as needed. Figure 2 describes the associated processes of the system’s life cycle.
Benefits of having a systems engineering practice
- Allows for more effective management and control of project costs and time.
- Provides a better understanding of the customer needs and supports program managers.
- Enables control and understanding of the requirements, interfaces and problems of the project, as well as the consequences of any changes.
- Helps to effectively manage change and configuration throughout the entire project life cycle.
Conclusion
Systems engineering for medical devices is not similar to systems engineering in other industries. Furthermore, compliance with country-specific medical device regulations and product-specific international harmonised standards needs to be taken into account during each stage of the development process.
Systems engineering practices need to be applied to the medical device industry in a customised manner. In fact, different segments of the medical device industry can take significantly different approaches to effective implementation of systems engineering thinking and practice.
Decos Services
Decos has highly competent and deep cross-functional systems engineers, who confidently support medical device manufacturers. Our engineers consistently meet customers’ expectations by delivering quality outputs that are compliant with standards like IEC 60601, IEC 60645, and other collateral standards.
Decos’ engineering services include stringent design controls, technical design reviews, design verification, risk management and analysis. Our service support in the product development process is time-tested and ensures good practice in full compliance with client-specific quality management systems like ISO 13485 and country-specific regulations like the European Union Medical Device Regulation (EU MDR) and United States Food and Drug Administration Quality System Regulation (US FDA).
References:
[1] Is a new 510(k) required for a modification to the device? | FDA
[2] Premarket Approval (PMA) | FDA
[3] Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff (fda.gov)
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