Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units so the system can be evaluated holistically and by each constituent part. This approach is critical to how we align Jama Connect™ to tackle the daunting complexity of medical device development.
In our experience working with some of the market’s foremost medical innovators, we’ve seen that teams who embrace systems thinking are better-positioned to modernize and improve their product development processes. Jama Connect is informed by systems thinking and regulatory requirements, while its framework remains flexible enough to accommodate the unique needs of diverse development teams.
In this post, we’ll lay out how and why complex medical device development teams should be using systems thinking to streamline and strengthen processes, according to a recent webinar.
Why Systems Thinking?
Complex medical device development teams use systems thinking as a diagnostic tool: a disciplined approach to examining problems more completely and accurately before taking action. Systems thinking encourages teams to ask the right questions before assuming they know the answers.
A systems thinking approach opens up your team and organization to procedure-level improvements and the ability to take full advantage of solutions that support them.
Even manufacturers developing complex systems that involve multiple disciplines and require the management of numerous subsystems may not be realizing the full value of systems thinking for managing design, collaboration and traceability across teams.
Visibility and Collaboration
With a systems thinking approach, teams developing complex medical devices can improve their processes by enhancing visibility and enabling more seamless collaboration and coordination between stakeholders.
Complex medical device development requires that the right people have visibility into the relevant parts of the system, and a systems-thinking approach helps ensure that the right questions are being asked and addressed.
Systems thinking also drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more effective when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.
Design History File, Verification and Traceability
Systems thinking also gives teams better tools for managing complexity and change during the design process. With an applied systems approach, organizations can realize and resolve inefficiencies in their product development processes while producing the necessary outputs for the design history file (DHF). Jama Connect, designed to support systems thinking, aligns how your team works with the artifacts required for compliance and the DHF.
If you’re following ISO 13485 and the FDA regulations for design control, for instance, you’re already driving toward a general systems approach. The regulations require the definition of user and patient needs and the tracing of engineering responses to those needs as design inputs. However, the regulations rightly leave room for manufacturers to define their own procedures, so long as the outcome demonstrates the relationship between the needs, the subsequent design inputs and the resulting design outputs and verifications.
Applying a systems approach to how you work means that the value of understanding the interrelatedness of the design requirements doesn’t just live in the trace matrix document. This value is realized when you can visualize and interact with the trace during your design definition activities and beyond. The trace must be maintained throughout the design process to be helpful. Thus, the matrix you need for your DHF becomes a byproduct of how you work, not something you stitched together at the end of the design stage when you needed that documentation.
The same can be said for your design input files and other artifacts: They’re most valuable when they are considered as byproducts of how you work.
Additionally, verification and quality teams can leverage systems thinking to assess and define verification activities for the system even as other teams explore their responses to the system needs.
Since lower-level requirements and outputs are defined within the context of a specific system need, traceability allows teams to understand that context and the downstream impacts of any change made.
Customized Solutions for Medical Device Developers
Our professional services team has also established a recommended framework for Jama Connect via our Medical Device Services. This framework, informed by systems thinking, guides regulatory compliance while remaining flexible enough to accommodate the diverse needs of teams and organizations.
In this framework, the need for documentation informs rather than constrains, and it isn’t at odds with your drive to improve your process or the solutions you deploy to realize those improvements.
Stay tuned for more posts about improving medical device development and the integral role Jama Software is playing for its customers. In the meantime, get a deeper dive into how Jama Connect helps developers balance medical device compliance and innovation by watching our webinar.