Lean Process Transformation in Medical Engineering

The challenge

The U.S. subsidiary of a global German technology group in the medical device industry needed to transform and harmonize processes while maintaining operations. Strict market regulations require compliance with FDA, IEC 62304 and many other standards.

The company structure was based heavily on departments. Teams rarely collaborated outside of their department and seldom coordinated interface documents or handover points. The resulting quality varied greatly, and some development steps had to be performed multiple times or were dependent on the involved people. Compared with the competition, this all resulted in significantly higher development costs.

The customer needed to realize a transformation to a universal, cross-department process flow without violating existing regulations.

Project duration

1 year

Our approach

• Documentation of SIPOCs.
• Import of SIPOCs to Stages.
• Visualization of process flows.
• Establishment of new, optimized processes.

UL Solutions experts helped document the processes in the individual departments 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 Stages, our process management tool. Process visualization with Stages revealed the process flows automatically. Optimization potentials, such as redundant starting products and work steps, uncoordinated work products, or improved responsibility structures, were visualized immediately.

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 quickly rolled out in development teams thanks to the automatically visualized process chains in Stages.

Benefit

• Process complexity reduced by over 30%.
• Sustained reduction in error rate in the field.
• Facilitated the successful certification and validation of products.

The company reduced the complexity of its processes by around one-third. Today, the departments collaborate much more closely, enabling them to markedly reduce their error rate in the field. The successful certification of products in the USA was no issue for the medical device manufacturer.