Vigilance Process
The term “vigilance” refers to a mandatory process outlined in the Medical Device Regulation. This regulation specifies the requirements for reporting various events to different stakeholders. Flowcharts can be utilized to visually present the process, making it easier to understand.
The process requirements apply to all medical device manufacturers, including class IIa custom-made devices. The requirements associated with the mandatory process have evolved over time. There are also voluntary concepts linked to this process.
The mandatory process holds manufacturers accountable for these events, which are of greater harm. The voluntary process is an extension of the minimum requirements outlined in the regulation. The voluntary process focuses on improvements and learning from events of lesser harm. However, how can the complete process be better understood?
Understanding the Process
A clearer understanding of any process can be achieved during the Define phase of the DMAIC methodology. The Define phase sets the foundation for the entire DMAIC cycle, meaning that any lack of attention in this phase may impact the later phases. One key step is the characterization of the process, which involves process mapping. The results of this thesis included swimlane diagrams to visually present the process (Granbåge, 2024). However, what is a sufficient level of detail for process mapping?
This question emerged during this thesis and remains open for further exploration. The sufficient level of detail is subjective because it depends on the individual reading the flowchart. One size rarely fits all. It was also difficult to predetermine the sufficient level of detail. This intangible target was resolved through iterations and communication with the commissioner throughout the work. How can the findings be effectively communicated in this article?
During the writing of this article, it became clear that a detailed explanation of the results would conflict with the main idea of the thesis. In the thesis, textual information was visualized through swimlane diagrams, while this article aims to articulate those diagrams in written form. Therefore, it is advisable to refer directly to the thesis for a comprehensive understanding of the findings (Granbåge, 2024).
Visualizing the process proved to be valuable in understanding the complex workflow. The use of swimlane diagrams provided a clear way to communicate the process to other stakeholders. Additionally, voluntary concepts were also integrated into the mandatory process. What other points of interest can be derived from this thesis?
The Importance of Planning
The master’s thesis highlights the importance of having a common understanding of how to operate in a process. Additionally, the thesis underscores the benefits of using standards and already known and proven methods to solve challenges. Developing with these methods can produce outputs that are useful and new. Reinventing the wheel is an inefficient use of time and other resources.
Furthermore, the thesis demonstrates the importance of planning and defining development work. When the development work is well defined and understood from the beginning, it creates a strong foundation for the next phases of the project. Well-planned is half done.
Planning helped to avoid potential pitfalls in the project management throughout the development work. Another recommendation for similar projects was to divide the work into smaller, manageable segments rather than attempting to address everything within the scope of a single thesis. Reflecting on the project, establishing a realistic schedule was essential for ensuring steady progress.
The results of this thesis provide a foundation for future development work. Future development could involve advancing to the next phases of the DMAIC methodology or iterating the Define phase. Continuous improvement is important, and it is hoped that this thesis encourages others to delve further into this topic.
References:
Master’s thesis:
Granbåge, N. (2024). Vigilance Process: Class IIa Custom-Made Devices [Master’s thesis, Turku University of
Applied Sciences]. Theseus. https://urn.fi/URN:NBN:fi:amk-2024102726873
Image:
Morillo, C. (2018, June 22). White Dry-erase Board With Red Diagram [Photograph]. Pexels.
https://www.pexels.com/photo/white-dry-erase-board-with-red-diagram-1181311/