Case Study 2

Profile

Leading embecta’s Class II medical device strategy and execution from feasibility to FDA 510(k) clearance (April 2022 – September 2024).

Challenge

​embecta hired me in early 2022 with an ambitious goal: bring a promising product for a Class II medical device to 510 (k) clearance within 30 months. Internal misalignment, and executional silos threatened both speed and success.

Approach

Build an environment of transparency, mutual trust and possibility thinking across all teams. 

• Align R&D, Quality, V&V, and Regulatory functions 
• Stand up a LEAN PMO structure and processes to enable transparency, faster decision-making and risk mitigation 
• Preempt regulatory hurdles by integrating FDA feedback loops early 
• Take initiative on deliverables without waiting for input; accelerates progress and reduces bottlenecks

Results

Why It Matters

• Time to clearance: 29 months
• Successful regulatory clearance can be achieved because of: 
  1. Early risk alignment 
  2. Full program transparency via a centralized view and daily management
  3. Proactive knowledge transfer from past programs 
  4. Structured cross-functional planning
  5. Cultural change from “we cannot because …” to believing in possibilities 
• Cross-functional stakeholders engaged: 8 internal teams and 12 specialized subcontractor firms across R&D, Quality, Regulatory, and Manufacturing

This success story exemplifies ClariVantage’s core philosophy: strategy isn’t just a slide deck – it’s a series of operational decisions that must cascade seamlessly from leadership vision to day-to-day execution. When you close the gap between boardroom and bench, FDA clearance becomes not just faster, but smarter.