Designed Experiments for Medical Devices

Designed Experiments for Medical Devices

In this one-of-a-kind workshop, learn how to apply DOE to medical device testing and manufacturing problems. We welcome scientists, engineers, and technical professionals working in this field. The design of experiments topics range from modernized factorial and fractional-factorial designs for screening and characterization, to state-of-the-art response surface methods for process optimization. Throughout this course you will explore cases that come directly from the medical device industry!

On-site (private) workshop only. Email for a quote.


Designed Experiments for Medical Devices (DEMD), On-site only

Customized DOE applications for the medical device industry (developed due to popular demand!)

Optimize your Product or Process

In this one-of-a-kind workshop, learn how to apply DOE to medical device problems. We welcome scientists, engineers, and technical professionals working in this field, as well as organizations and institutions that devote the majority of their efforts to research, development, technology transfer, or commercialization of medical devices. Throughout this course you will explore cases that come directly from this industry!

During a fast-paced two days explore the use of fractional factorial designs for the screening and characterization of products or processes. Also see how to achieve top performance via response surface designs and multiple response optimization.  Practice applying all of these DOE tools while working through cases involving medical device design, pacemaker lead stress testing, and typical processes that may be used in the testing or production of these devices such as seal strength, soldering, dimensional analysis, and more.

Stat-Ease's highly experienced DOE experts will provide you with individualized guidance and support after class to help you get started on your next project—at no extra cost!

Two optional fun and easy-to-read texts, DOE Simplified and RSM Simplified, authored by Mark Anderson and Pat Whitcomb, provide supplemental background reading for all DOE topics covered.

Simulations Provide Practice

Use Design-Expert® software to practice designing and analyzing experiments throughout the workshop. The software provides easy-to-use graphical tools to find key variables and view results. You will be given USB flash drive containing all simulation and data files used in class, as well as a free fully-functional, but time-limited, copy of Design-Expert software for use during and after class.

"Nice mix of computer time and lecture with good real-life examples." 
—Applied mathematician and quality scientist for a medical-diagnostics manufacturer

Course Outline



Day 1

Section 1—Introduction to Factorial Design

  • Background and motivation for factorial designs
  • Factorial design planning process
  • Factorial design case study (microwave popcorn)
    • Selecting effects - Half-Normal plot & Pareto chart
    • ANOVA & residual diagnostics
    • Main effects, interaction, contour & 3D surface plots
    • Intro to multiple-response optimization

Section 2—Enhancements for Full Factorials

  • Replicated full factorial (seal strength)
    • Explanation of power
  • 25 full factorial (reflow soldering)
    • Blocking


Section 3—Fractional Factorials

  • Fractional factorials
    • 25-1 fractional factorial (reflow soldering)
    • Setup and aliases
  • Minimum-run resolution V (MR5) designs (stent delivery)
    • Response transformation
Day 2 Multilevel Factorials
  • Full factorial (pacemaker lead stress testing)
  • Fractionating via optimal design

Section 4—Introduction to Response Surface Design

  • Factorial with center points (bench reaction)
  • Introducing Response Surface Methods “RSM”
  • Augmenting to central composite design “CCD”
  • “Good” response surface designs
  • Sizing for precision

Section 5—Response Surface Methodology

  • Instructor-led exercise (fluid bed coating)
    • Building the design
    • Details of analysis
    • Optimization
 Lunch Section 6—Constrained Response Surface
  • Constrained design space
    • Optimal design
    • Stent spray coating
  • Categoric factors (catheter)
  • RSM design summary
   Section 7—Quality by Design "QbD"
  • Quality by Design
  • Illustrative example (critical dimensions)
  Section 8—Mixture Overview and Next Steps
  • Mixture design overview & case study (rocket-fuel)
  • Exercise: Optimize your process
  • Next steps


Math skills, knowledge of basic statistics, and exposure to simple comparative experiments (e.g. two-sample t-test) are recommended. As a prerequisite, take the online PreDOE course first (a $95 value you get for free! It takes 2-3 hours to complete. You can work at your own pace). Access the PreDOE here.

Before attending class, please download a trial of DX11 (if you do not already have access to it) and work through the General Multilevel-Categoric One-Factor tutorial.

Additional Information

PDHs 16 (equals 1.6 CEUs)
Additional Information No
Recommended Texts and Software

Recommended Texts and Software

Purchase the recommended text or software at the time of registration to receive a 20% discount.