Situation
The company was saddled with product recalls and FDA warning letters, which in part led to declining market share and increased costs, highlighting the business’s fragility.
Task
Tasked by the BOD and CEO to assess declining organizational, financial performance, and quality control issues.
Actions
- Conceived program and established program management office and governance structure to assess the organizational, financial, and quality control issues experienced by the company. Key highlights of the program included:
- Assessment of all major functions of the enterprise
- Analyzed the company’s past performance and future business trends, looking at key metrics such as revenue growth, profitability, headcount, and organization
- Developed future-state organizational models
- Identified and quantified opportunities for cost reduction across the organization
- Identified significant issues with the corporate quality assurance function and developed corrective actions
- Support corporate response to FDA warning letters
- Assessed Product Life-cycle Management (PLM) issues and developed corrective actions
Results
Results were driven through a program management office and presented to the Board of Directors. Highlights included:
- Complex operating model, resulting in poor organizational efficiency and effectiveness
- Increased costs and difficulties achieving economies of scale
- $325M+ in net cost savings were identified
- Overcame quality management issues and FDA warning letters through a structured programmatic process
- Addressed PLM issues by providing used diagnostic equipment to service providers with outdated equipment, changing leasing arrangements, and increasing prices for consumables