In medical device manufacturing, data is everywhere. Machine outputs, inspection reports, validation results, capability indices, and process qualification studies generate thousands of data points on every program. But data alone doesn’t create confidence. Clear, actionable insight does.
In medical device manufacturing, data is everywhere. Machine outputs, inspection reports, validation results, capability indices, and process qualification studies generate thousands of data points on every program. But data alone doesn’t create confidence. Clear, actionable insight does.
As device complexity increases and regulatory expectations tighten, manufacturers are under pressure to move faster without sacrificing quality. That’s where automation and statistical analysis become essential, not as nice-to-have tools, but as core drivers of smarter decisions.
At Lowell, we’ve spent years bridging the gap between raw data and meaningful action, using automation and statistical rigor to improve outcomes across development, validation, and production.
The Problem with Data-Heavy, Insight-Light Processes
Traditional manufacturing environments often rely on manual data handling during process qualification and validation. Spreadsheets are copied and pasted. Charts are generated one feature at a time. Results are reviewed late in the process, sometimes after issues have already compounded into delays or rework.
This approach creates three major risks:
- Slower decision-making, especially during NPI and validation
- Higher chance of transcription or interpretation errors
- Limited visibility into true process capability
When timelines are tight and tolerances are unforgiving, these inefficiencies can quickly derail a program.
Automation as a Decision Accelerator
Automation changes the role of data from a reporting requirement to a decision-making asset.
At Lowell, automation begins on the shop floor and carries through to inspection and further to statistical analysis. Advanced CMMs, vision systems, and multi-sensor inspection platforms collect high-resolution data consistently and repeatably. But the real advantage comes from what happens next.
Instead of manually processing that data, Lowell applies automated statistical analysis to accelerate insight and eliminate guesswork.
PQ-it™: Turning Statistical Rigor into Practical Speed
Lowell’s proprietary PQ-it™ macro for Minitab was developed to solve a common industry problem: process qualification takes too long and consumes too many resources.
PQ-it™ automates the analysis of large inspection datasets, applying standardized statistical tests, generating capability charts, and presenting results in a consistent, review-ready format. What once took hours, or days, can now be completed in minutes.
The impact is measurable:
- Up to 90% reduction in data analysis time
- Improved consistency across validation reports
- Faster feedback loops during process development and optimization
- Greater confidence for OEMs reviewing qualification data
Most importantly, PQ-it™ allows engineers and quality teams to focus on interpreting results, not assembling them.
Better Decisions, Earlier in the Process
Automation doesn’t just speed up reporting, it enables better decisions earlier.
With faster access to capability data, Lowell teams can:
- Identify unstable features before full-scale validation
- Adjust processes proactively instead of reactively
- Support Critical Feature Confirmation (CFC) by focusing attention on what truly affects device performance
- Provide clean, objective evidence for regulatory submissions
This data-driven approach reduces unnecessary iteration and helps programs move forward with confidence.
Automation as a Partnership Advantage
For OEMs, working with a manufacturer that invests in automated analysis and statistical expertise means fewer surprises and more transparency.
Lowell’s customers gain:
- Faster qualification timelines
- Clear, defensible validation data
- A shared statistical language between engineering, quality, and manufacturing teams
- Confidence that decisions are backed by evidence, not assumptions
In an industry where precision and proof matter, automation isn’t about replacing expertise, it’s about amplifying it.
From Numbers to Outcomes
Data will continue to grow in volume and importance across medical device manufacturing. The manufacturers who succeed will be those who can transform that data into insight, and insight into action.
At Lowell, automation and statistical analysis are not side projects. They’re embedded in how we manufacture, validate, and continuously improve. Because better data doesn’t just tell you what happened. It helps you decide what to do next.