By leveraging advances in technology, the medical device industry has an unprecedented opportunity to develop healthcare products that improve patient outcomes at lower costs. While the competitive edge and patient care benefits associated with these advances can be impressive, manufacturers that are implementing new technologies can face numerous obstacles.
The reality is that medical device manufacturers are now also becoming software companies, fusing the technological capabilities of electrical, mechanical and software components into a new generation of innovative products and services.
Many companies are being challenged by this trend. In addition to confronting complexity, time to market and competitive challenges, organizations that create medical devices must also address the increasingly strict regulatory standards for quality and patient safety mandated by the FDA and other agencies.
A holistic approach to systems engineering and software development is needed if medical device manufacturers are to rapidly deliver innovative, high-quality products that improve healthcare. This approach integrates five key disciplines that span the systems and software development lifecycle:
- Requirements management helps you manage system and software requirements and confidently track conformance to those requirements and compliance to regulations.An effective solution enables engineers to compare changes against requirements to avoid wasting resources on unnecessary functionality and provides a backbone to change management.
- Model-driven development enables graphical modeling of the requirements, behavior and functionality of systems and software. The design can be iteratively analyzed, validated and tested throughout the development process and then automatically transformed into production-quality code.Visual models improve a team’s understanding of the design and facilitate communication among the engineers and other stakeholders.
- Collaboration and change management provides a central communication point and workflow support across the lifecycle so diverse, distributed teams can work together efficiently, continuously, and iteratively.By leveraging the familiar technologies of the internet, global teams can effectively collaborate across time and geographic differences; latest project information and status are available in real time; contributors are more rapidly identified and accessible for live chats and other forms of communication; and bottlenecks are removed that so often inhibit rapid innovation and quality delivery.
- Quality management creates a collaborative, customizable central quality management hub that unites all stakeholders and provides an enforceable process workflow. The ideal solution delivers a test management environment for test planning, execution, tracking and traceability and supports greater transparency via automated reporting.
- Automated report generation gathers specific information from artifacts produced by the key disciplines described earlier and formats it into documents for internal stakeholders as well as regulatory agencies.This is a critical because creating documents and keeping them up-to-date is a time consuming and error-prone task.With changes happening constantly across the medical device development lifecycle, documents are often outdated by the time they are produced.By automating this process, teams can spend less time on tedious, manual document creation and maintenance and instead, focus on their primary business objectives.
Bringing it all together: an integrated approach
Integration across these five areas helps ensure cross-discipline communication and linkage of requirements, models, tests, change requests, etc. all the way to developed artifacts for traceability and auditability.
In bringing these disciplines together, it is important to make sure that the process is iterative, rather than a waterfall process where systems engineers build a requirements model that is “thrown over the wall” to developers.
There are many benefits to adopting a more iterative, collaborative approach. For example, the requirements model may have fundamental issues that are normally not discovered until later in software development.In this late stage, systems engineers must change the requirements, causing churn across the downstream stakeholders.
A more iterative, collaborative approach supported by the appropriate process and tools keeps developers in sync with these changes.As shown in Figure 1, below , the whole process is seamless only with strong cross-discipline collaboration.
Figure 1. Key disciplines for medical device development
Understanding and tracing the impact of change
During the development of a medical device, it is critical that the design team understands the impact of changes to requirements and can also demonstrate traceability from requirements through to the final code.
When a change request is proposed, understanding the impact on requirements as well as downstream designs, tests and code is essential in order to determine the feasibility of the change and its cost and schedule impact.
If traceability has been established between levels of requirements (i.e. market, product, component, etc.) and through to designs and tests, then areas potentially impacted by a change request can be automatically identified. A thorough impact analysis supported by integrated disciplines enables more informed decisions on whether to implement a change request, reject it or table it for a future product version.
Achieving complete traceability from requirements to lines of code is also of great importance as it is mandated by regulatory agencies.It is also important to ensure that your design documentation accurately conveys the concepts in the code and reflects what is in the code.
Demonstrating this level of traceability with traditionally manual methods is very tough. Incorporating a model that remains synchronized with your actual code automates this process. Engineers can import and visualize existing code within the modeling environment with requirements traced to design elements in the model.Visualization of existing code improves understanding of the design.
The modeling environment can synchronize any updates to the code so that they are reflected within the model. Additionally, code can be generated from the model itself. A robust model driven development solution maintains synchronization between a model and its corresponding code regardless of whether developers prefer to make changes to their models, code, or both, and traceability can flow easily from requirements through the model to the code itself.
As software becomes an increasingly critical driver for innovation in medical devices, new approaches are needed to support and manage the processes that deliver it while ensuring patient safety and meeting regulatory guidelines.
Systems and software delivery systems should be based on robust processes and tools that help minimize waste, uncertainty, and poor communication while supporting the needs of engineering and business stakeholders.
By incorporating a holistic approach to medical device development that encompasses requirements management, model driven development, collaboration and change management, quality management and automated report generation, medical device manufacturers can confidently proceed with complex device projects while meeting internal and external demands.
Ravi R. Patil is a market segment manager for IBM Rational Software . He has a Bachelor of Science in Mechanical Engineering and a Master of Science in Mechanical Engineering from MIT and a Master of Business Administration from the University of Michigan Ross School of Business.