When time, not efficiency, is the constraint
In clinical diagnostics and regulated life sciences manufacturing, time is often the limiting factor. Late-stage specification changes, strict documentation requirements, and volatile demand can expose the weaknesses of traditional efficiency-driven models, which tend to hide waiting time inside queues, handoffs, and replanning cycles.
Quick Response Manufacturing (QRM) takes a different approach by treating time as the primary performance metric. By focusing on the reduction of Manufacturing Critical-path Time (MCT) across both production and office operations, QRM improves responsiveness without compromising quality or compliance.
A long-standing collaboration between the University of Wisconsin–Madison’s Center for Quick Response Manufacturing and Promega Corporation illustrates how this time-based approach can be applied effectively in a clinical-grade manufacturing environment.
Why QRM fits regulated manufacturing
Speed and compliance are often framed as competing priorities, but long lead times frequently introduce more risk, not less. Extended queues and delayed decisions increase handoffs, obscure constraints, and make change harder to manage.
QRM addresses these challenges by emphasizing:
- Focused product families
- Dedicated, cross-functional teams
- Time-based planning and control
- Early visibility into capacity constraints
For regulated manufacturers, this structure improves predictability while reinforcing disciplined execution.
Applying QRM at Promega: from principles to practice
Promega adopted QRM to support its growing clinical and custom manufacturing business, embedding time-based thinking across both shop-floor and office workflows in partnership with UW–Madison’s QRM Center.
Key elements include:
Quick Response Cells (QRCs)
Each QRC owns a defined product family, from early research batches through IVD-scale production. In this context, in vitro diagnostic (IVD) manufacturing operates under current Good Manufacturing Practice (cGMP) requirements, which govern quality systems, documentation, and process control for regulated clinical products. Process knowledge stays with the same teams as volumes grow, reducing revalidation effort and coordination delays when changes occur.
Manufacturing Critical-path Time mapping
System-wide MCT analysis revealed waiting time hidden in queues, approvals, and scheduling. This enabled workflow redesigns focused on lead-time reduction rather than local efficiency gains.
A colocated Quick Response Office Cell (Q-ROC)
Quoting, planning, and data review functions operate within a dedicated office cell, cutting administrative lead time and resolving technical questions in hours instead of days.
Time-based planning and capacity buffers
Time-based controls replace utilization-driven planning, surfacing capacity constraints early and supporting reliable delivery against committed dates.
In urgent situations, this approach enables delivery of customized clinical-grade components in as few as five business days, compared to industry norms of several weeks. UW–Madison research shows that QRM implementations commonly achieve 50–80% lead-time reductions in custom manufacturing environments, a range consistent with Promega’s experience.
Speed with rigor
All QRC activities operate under ISO-certified, cGMP-aligned quality systems. By reducing waiting time and simplifying handoffs, QRM helps maintain momentum while preserving documentation integrity and regulatory rigor.
During periods of extreme demand volatility, including the early stages of the COVID-19 pandemic, this approach supported rapid response to urgent diagnostic needs without sacrificing compliance or reliability.
The role of the university–industry partnership
The collaboration between Promega and UW–Madison’s Center for Quick Response Manufacturing demonstrates how academic research can translate directly into operational impact. The QRM Center contributes research-backed frameworks, MCT analysis methods, and performance metrics, while Promega’s manufacturing environment provides a real-world testbed that informs continued learning.
As Dr. James Rink, Director of the Center for Quick Response Manufacturing, has noted, time-based strategies like QRM can drive both speed and precision when applied thoughtfully.
Transferable lessons
Several insights from this case apply broadly:
- Lead-time reduction often begins in office processes
- Product-focused teams reduce coordination delays
- Time-based planning improves predictability under uncertainty
- Shorter lead times can strengthen quality outcomes
For organizations facing frequent change, customization, or regulatory complexity, QRM offers a structured way to align speed, reliability, and compliance.
From theory to execution
Quick Response Manufacturing brings teams together to accelerate decision-making and improve flow. The Promega example shows how time-based thinking can be embedded across an organization to deliver faster, more predictable outcomes in environments where quality is non-negotiable.
Read the full article at: https://promega.widen.net/s/5bbgkmgwb7/custom-clinical-quick-response-manufacturing-flyer-fl701