Risk Taxonomy for Medical Device Manufacturing

Client background 

Our client was a UK-based, innovative, entrepreneurial and fast-growing firm that develops and manufactures point of care medical diagnostic platforms employing c. 1200 people globally.

The challenge 

The firm had invested in an integrated risk platform on which to manage its operational risk and was keen to improve maturity of operational risk management across the firm.  

The client wished to design and embed a proportionate risk management framework to achieve the following objectives: 

  1. Enable risk-based decision making 

  2. Maximise the opportunities presented by the investment in the risk platform, including accelerating change 

  3. Identify potential vulnerabilities in the supply chain through scenario analysis and take pro-active steps to address those vulnerabilities 

  4. Respond quickly to stressed conditions by embedding consistent risk management practices across the firm 

  5. Improve forward planning and understanding of what it takes to launch and distribute a new product to customers. 

Our approach and contribution 

Working in close partnership with the Chief Risk Officer, we: 

  • Produced a multi-level risk taxonomy documenting the risks faced by the firm, and example activities that might lead to those risks. 

  • Aligned the risks to activities in the firm’s product life cycle.

  • Captured the firm’s risks in the risk platform.

  • Facilitated a Risk Framework Workshop to socialise the idealogy with the firm’s Compliance function.

  • Developed a road map and supporting materials for partnering with senior leadership team ‘Risk Ambassadors’ to further develop and embed the risk framework.  

The outcome 

As a result of our engagement, our client was able to:  

  • Remove subjectivity from the firm’s risk discussions by utilising the risk taxonomy. 

  • Present a business case to the CEO demonstrating the benefits of adopting a consistent risk framework across the firm, and secure investment and sponsorship for ongoing embedment of the framework.

  • Build a plan for roll-out of the risk framework across all business functions.