Case studyMedTech

Program Management for a Patient Interface Redesign

Medical device manufacturer with rising demand

A medical device manufacturer faced quality and production issues with its patient interface, compounded by a strained supplier relationship and demand that exceeded existing capacity.

The challenge

The situation

A medical device manufacturer experienced significant quality and production issues with its patient interface, compounded by a strained supplier relationship and rising demand that exceeded existing capacity. Without structured program management, tackling these challenges became even more difficult.

Our approach

What we delivered

Redesign of the patient interface with a production ramp-up and a new production line at a new supplier

Build-up of a standardized PMO structure with a trending and dashboard system for action tracking

Reliable project planning with integrated risk, quality and communication management

The outcome

Results & impact

5 program levers implemented

Reliable, on-schedule project plans with binding project owners across all program levers.

1 standardized PMO structure

PMO structure with trending and dashboard system implemented for ongoing governance.

0 open quality issues

Quality and production issues with the new supplier and the new production line resolved.

In summary

The manufacturer established a standardized PMO structure and fully resolved the quality and production issues with the patient interface, with reliable project planning across all five program levers.

Related expertise

Supplier Development & Qualification →

Qualification and surveillance audits, plus alternate-source qualification

Manufacturing & Supply Chain Management →

Production planning and scale-up with GMP-compliant quality assurance across the chain

Reporting & Dashboards →

Metrics with defined thresholds and validated dashboards

Risk Management →

Hazard and risk analysis under ISO 14971:2019, with the risk management file

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Sources

Entourage project experience (anonymized)

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