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Case Study 1

From Recurring Product Recalls to Zero Recalls

Profile

A global HealthCare company with rising costs of non-quality (CONQ), repeat Field Change Orders (FCOs), and deteriorating product reliability in a Class II medical product line. 

Challenge

At its peak, the product experienced 8 FCOs in a single year. 

  • A global FCO exposed critical gaps in alarm functionality and safety claim compliance
  • Lack of structured decision-making led to increased product complexity and missed edge cases 
  • The aging platform lacked modern design principles and robust testing framework, resulting in system fragility
  • At the time of analysis, software defects were responsible for 85% of all failures

Approach

Establish a strategy-to-execution plan to stabilize the product line while laying the foundation for a more robust successor platform. Turn strategic quality goals into executable roadmaps that reduces FCOs, enhances testing, and improves organizational collaboration.

We led a cross-functional turnaround focused on four strategic levers:

  1. Design Simplification: Reduced feature complexity, updated battery software architecture, and conducted external expert reviews
  2. Testing Overhaul: Transitioned from reactive to proactive testing – expanding unit, regression, and system-level coverage. Integrated Automated Test Hooks, power profiling, and real-world hardware scenarios such as battery drainage and recovery testing into every release cycle
  3. Process Improvements: Embedded IEC 62304 compliance into workflows, mandated code reviews and static analysis at build stages, and aligned governance with risk management tools like FMEA and APQP 
  4. Cultural Shift: Enabled early test team involvement, encouraged quality-first decision-making, and reinforced cross-functional accountability

Results

  • No mandatory FCOs have been issued since improving R&D processes, design, culture, and introducing a new testing framework (3 years and counting)!
  • Within the first year, improvements reduced customer complaints by 2% year-over-year, despite a 7% increase in unit shipments across over 100,000 units.
  • Organizational confidence restored, enabling faster, safer development of the platform’s next generation
Line graph showing the number of product recalls over 15 years since launch, with a peak of 8 recalls around year 6 and a steady decline to zero recalls in recent years.

Why It Matters

This case illustrates how strategic clarity and operational discipline can turn around even mature, complex products. For healthcare firms managing legacy portfolios or scaling innovation, this example proves that sustainable quality comes from integrated leadership – where design, testing, and culture align by intent.

At ClariVantage, We deliver precisely that.

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​Whether you’re scaling a HealthCare startup or transforming legacy systems, ClariVantage delivers actionable expertise across the product lifecycle.

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