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Quality | Medical Technology & Pharmaceuticals

Quality Management Consulting for Medical Devices at a Leading Medical Technology Supplier

A leading medical technology company was struggling with sharply rising quality costs and a lack of transparency regarding the actual cost drivers. Through targeted quality management consulting for medical devices, KBC uses a structured Total Cost of Quality analysis to provide, for the first time, complete clarity on all quality-related costs along the value chain, thereby laying the foundation for a sustainable quality initiative.

Quality Management Consulting for Medical Devices: By the Numbers

Identified qualitative areas requiring action
Potential benefits identified and evaluated 
Subprojects
for sustainable cost reduction 

The Customer

Medical technology suppliers in need of professional quality management consulting for medical devices

The customer is one of the internationally active suppliers in the medical technology industry and develops and manufactures plastic components for medical applications, such as tubing, catheters, and packaging solutions for well-known medical device manufacturers. 

In light of rising customer expectations and increasing quality standards in the markets, professional quality management is becoming increasingly important to the company from a strategic perspective. Significant costs associated with nonconformities—such as complaint and goodwill costs—as well as a perceived burden of testing costs further intensified the need for action and made expert quality management consulting for medical devices essential. 

In addition, there was a lack of adequate methodology for capturing compliance costs—such as those associated with preventive quality measures—which further underscored the need for structured quality management consulting for medical devices. 

The Project

Total Cost of Quality Analysis and Q-Scan as a Foundation

As part of its quality management consulting services for medical devices, KBC’s consulting team first identified all quality-related costs across the entire value chain and used this information to determine the appropriate levers for change and specific actions. Through a comprehensive Total Cost of Quality analysis, KBC created transparency for the first time regarding compliance and non-compliance costs in both value-added and non-value-added processes. 

In addition, KBC introduced its proprietary “Q-Scan” methodology and, together with managers and employees from Quality, Development, Purchasing, and Production, evaluated 19 quality-related categories. Based on this, the team identified 129 specific areas requiring action, which were then traced back to their root causes through a root-cause analysis: KBC specifically traced selected top error patterns to the processes causing them, thereby uncovering structural weaknesses along the entire process chain. 

Building on this solid foundation, our team of consultants worked with the client to develop ten prioritized subprojects—ranging from quality strategy to customer-oriented requirements management and supplier monitoring—that translate successful quality management consulting for medical devices into concrete implementation steps. 

A portrait of Tobias Budde, Managing Partner at Kemény Boehme Consultants, smiling at the camera with both hands in his pockets
A portrait of Tobias Budde, Managing Partner at Kemény Boehme Consultants, smiling at the camera with both hands in his pockets

This Is How We View Quality Management Consulting for Medical Devices

In our view, quality management consulting for medical devices only works when transparency and accountability go hand in hand. Only when quality costs become visible along the entire value chain can the right levers for change be identified and translated into sustainable improvements in collaboration with the people on the ground.

Tobias Budde, Partner at KBC

The result

A Cost-Effective Quality Initiative

What began as a lack of cost transparency was transformed, through KBC’s quality management consulting for medical devices, into a robust set of figures that showed the client for the first time where real action was needed. The quality-related costs of approximately €14.57 million per year were broken down in a fully transparent manner into prevention, testing, and internal and external defect costs. 

Based on the identified areas requiring action, KBC developed ten specific subprojects and evaluated their costs and benefits using business cases. The agreed-upon measures address key weaknesses, such as the lack of a comprehensive quality strategy, inadequate requirements management with customers, and supplier monitoring that needs improvement. 

By combining top-down analysis (Q-Scan) with bottom-up error tracing, we were able to identify both structural and error-specific causes. Overall, as part of its quality management consulting for medical devices, KBC identified and evaluated a potential benefit of approximately €15.17 million with an implementation cost of approximately €3 million, thereby demonstrating a clear path to reducing annual quality costs by up to 31 percent.

Other Projects That Make a Difference

A portrait of Tobias Budde, Managing Partner at Kemény Boehme Consultants, smiling at the camera with both hands in his pockets
A portrait of Tobias Budde, Managing Partner at Kemény Boehme Consultants, smiling at the camera with both hands in his pockets
Tobias Budde
Partner

Facing a similar challenge? Talk to us

Whether you need support with quality management, optimizing testing and process costs, or implementing an end-to-end quality control system: In a brief discussion, we’ll determine which steps make sense and how KBC— an international boutique consulting firm based in Munich —can help you move forward. 

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