Lean Process Transformation in Medical Engineering
The customer is the US subsidiary of a global German technology group from the medical engineering industry. Strict market regulations require compliance with FDA, IEC 62304, and many other standards. Very high quality standards also apply to product, process, and tool verification and validation.
The company structure was based heavily on departments. Teams very rarely collaborated outside of their department and seldom coordinated interface documents or handover points. The resulting quality varied greatly, some development steps had to be performed multiple times or were dependent on the involved people. Compared with competition, this all resulted in significantly higher development costs.
The challenge of the project was to realize a transformation to a universal, cross-department process flow without violating existing regulations.
Project Duration/Volume (employee months)
0,5 consultant (full time)
Supported by Method Park consultants, the processes in the individual departments were documented based on the Lean Six Sigma method "SIPOC" (supplier, input, process, output, customer). Each department created a list of desired input and target output products together with the required process steps. The SIPOC tables were then imported into the Method Park process management tool Stages. Process visualization with Stages revealed the process flows fully automatically; optimization potentials, such as redundant starting products and work steps, uncoordinated work products, or improved responsibility structures, were visualized right away.
The new process flows were optimized and harmonized in a series of workshops together with department managers. As a result, the customer has achieved cross-department process understanding and has also harmonized and simplified workflows significantly. The new process landscape was rolled out in development teams quickly and easily thanks to the automatically visualized process chains in Stages.
Documentation of SIPOCs
Import of SIPOCs to Stages
Visualization of process flows
Establishment of new, optimized processes
With these measures, the company has reduced the complexity of its processes by around one-third. Today, the departments collaborate much more closely, enabling them to permanently reduce their error rate in the field to "almost zero". The successful certification of products in the USA was no issue for the medical engineering manufacturer.
Process complexity reduced by over 30%
Sustained "almost zeroerror " rate in the field
Successful certification and validation of products