Executive Summary

The manufacturing site needed to transition from the Varipulse platform to the next-generation Isopulse platform. The program required complete manufacturing line conversion, equipment validation, documentation readiness, and production transfer while minimizing operational risk and protecting launch timelines.

Objectives

• Coordinate manufacturing line conversion from Varipulse to Isopulse
• Validate and prepare high-value manufacturing assets for production
• Govern technical documentation and regulatory readiness
• Support production transfer, ramp-up planning, and launch continuity

BEPC's Role

BEPC provided engineering project management and 11 engineering resources across staff engineering, senior engineering, and validation engineering roles to support the complete NPI process over approximately 10 months.

Scope & Approach

• Coordinated manufacturing line transformation and equipment deployment
• Supported equipment qualification and validation execution
• Managed documentation governance and cross-functional readiness
• Supported production transfer, ramp-up stabilization, and regulatory readiness

The team combined cross-functional project governance, equipment validation, documentation control, manufacturing readiness reviews, and production-transfer management to keep the NPI program aligned with commercialization goals.

Outcomes

The project validated and prepared approximately $33M in manufacturing assets, enabled an estimated $7.5M in annual revenue through manufacturing readiness, and supported a 10-month engineering services engagement valued at $13.66M MXN.

Metricas clave

• Annual revenue enabled: $7.5M annual revenue enabled (Commercialization supported)
• Capital assets prepared: $33M in manufacturing assets validated (Production assets protected)
• Engineering services program: $13.66M MXN project value (Dedicated engineering execution model)

Evidencia visual (descripcion)

• Medical-device line-conversion visual representing NPI production readiness.
• Validation readiness visual representing equipment qualification and documentation governance.

Trust & References

Eleven BEPC engineers carried the Varipulse-to-Isopulse conversion through a ten-month NPI without losing momentum. They readied $33M in manufacturing assets and put us in position to capture the revenue the new platform was built for.

Ultima revision: July 2026