Addressing Insufficient Supply: Replicating FDA-Approved Colorectal Cancer Screening Line to meet market demand
Challenge
- The customer was unable to produce enough colorectal cancer screening products to meet the growing market demand, leading to supply shortages and delays.
- The demand for colorectal cancer screening products had been rising due to growing awareness and the importance of early detection, making it crucial to scale up production capabilities.
- They client needed us to address the insufficient supply of FDA-approved colorectal cancer screening products by reverse engineering an operational manufacturing line while overcoming technical, regulatory, and market challenges to ensure timely and sufficient product availability for medical professionals and patients
Our Solutions
- Site visit for understanding machine features and functionalities.
- Review of GA drawings, controls architecture, URS and FRS of the existing line and creating a Requirements Traceability Matrix for the proposed design
- Classification of modules between custom design and standard off-the-shelf solutions for minimizing Iterations and optimized schedule.
- Validation Master Plan for compliance of proposed design for meeting FDA requirements
Results
- Reverse engineered existing machine without dismantling.
- Provided RFQs for all off-the-shelf modules along with vendor recommendations.
- Conceptual sketches for custom design.
- Use of Requirements Traceability Matrix and Validation Master Plan to ensure adherence to the specifications of current machine.