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Medical Devices Design of Experiment (DoE)

How Medical Device Manufacturers Simplify Design of Experiments with Cornerstone?

Michael NaegeleJune 9, 20253 min read
How Medical Device Manufacturers Simplify Design of Experiments
5:25

In a manufacturing landscape shaped by AI and automation, statistical Design of Experiments (DoE) continues to prove its value, especially in medical technology development. While some may view DoE as a method of the past, it remains critical for driving innovation, maintaining compliance, and optimizing processes.

As an advanced statistical analysis platform, Cornerstone enables engineers and process specialists to implement DoE without programming expertise. With a guided interface and scalable performance, the software simplifies statistical analysis for teams aiming to improve quality and efficiency in regulated manufacturing environments.


The Real-World Challenge in Medical Device Manufacturing: Process Optimization Under Regulatory Pressure

Medical device manufacturers face high expectations for quality, traceability, and regulatory compliance. Development cycles must remain efficient, yet experimentation and documentation often require significant effort.

Robotic arm operating in a high-tech medical manufacturing environment, demonstrating advanced automation and precision.

Robotic arm operating in a high-tech medical manufacturing environment, demonstrating advanced automation and precision.

Many teams lack the time, resources, or programming knowledge to fully utilize advanced data analysis methods. This is where Cornerstone supports organizations—providing a solution that makes statistical methods more approachable without compromising reliability.

Explore challenges in medical device manufacturing.


Why Traditional Design of Experiments (DoE) Is Still a Competitive Advantage

DoE offers structured, evidence-based insight into process behavior. Unlike AI tools that depend on large volumes of historical data, DoE allows users to uncover new relationships through controlled experimentation.

By systematically varying the influencing factors and analyzing the results with Cornerstone's powerful statistical tools, processes are optimized in a targeted and sustainable manner.

With Cornerstone, the number of experiments that need to be conducted can be minimized without compromising statistical significance. This saves time, costs, and resources in development.

How Cornerstone 8.1 Makes DoE Accessible for Medical Device Engineers

Cornerstone 8.1 is designed to guide users through the statistical analysis process step by step. The intuitive graphical interface incorporates the expertise of professional statisticians, ensuring users apply appropriate methods and receive meaningful, traceable outcomes.

Cornerstone 8.1 enables intuitive, step-by-step statistical analysis through a graphical interface.Cornerstone 8.1 enables intuitive, step-by-step statistical analysis through a graphical interface—supporting DoE workflows, visualizations, and data modeling.

Key Strength of Cornerstone 8.1

  • Intuitive Graphical User Interface: Cornerstone’s interface is designed to be visually structured and easy to navigate. Engineers can manage data, configure analyses, and interpret results within a clean and consistent environment—minimizing the learning curve and reducing the risk of user error.
  • Step-by-Step Guidance: Each analysis in Cornerstone is supported by a guided process that helps users apply the right statistical methods. This structured approach ensures consistency and quality in experimental planning, even for those without formal training in statistics.
  • No Programming Skills Required: Cornerstone allows users to perform complex statistical analysis and DoE without writing a single line of code. The software eliminates technical barriers, making it accessible to engineers and technicians who need data insights but don't have a background in programming or scripting.
  • Fast Learning Curve: Designed with usability in mind, Cornerstone enables users to become productive quickly. Built-in templates, logical workflows, and immediate visual feedback support rapid onboarding—so teams can focus on solving real engineering challenges instead of learning a complex tool.

Explore Cornerstone's Core functions and advanced capabilties.


Key Benefits of Cornerstone 8.1 for Medical Device Manufacturers

Cornerstone 8.1 supports medical manufacturing teams by offering:
  • A reduction in the number of required experiments without sacrificing statistical validity
  • Time and cost savings during development
  • Meaningful process insights for continuous quality improvement
  • Reliable data that supports regulatory audits and traceability

Future-Ready Statistical Analysis for Medical Device Manufacturing Data

cornerstone statistical analysis banner

The latest version of Cornerstone is capable of handling large data volumes typical in today’s digitalized production environments. Developed over decades of continuous improvement, it delivers the performance needed for increasingly complex analyses, making it a strong fit for manufacturers undergoing digital transformation.

Explore Cornerstone in more detail.


Get Started with Cornerstone 8.1: A Practical Fit for Medium-Sized Enterprises

Cornerstone is tailored to meet the needs of medium-sized companies seeking effective solutions. The software offers a cost-efficient alternative to hiring an in-house statistician, and teams can benefit from training and consultation services provided by camLine’s experts. Join a statistical analysis training program.



Let’s Discuss Solutions Together

Our team is ready to deliver tailored solutions that streamline your production, improve product quality, and maximize efficiency across your operations. Tap into camLine’s decades of expertise in digital transformation to overcome your manufacturing challenges.