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Statistics Conference Day Zero - Sample Size Calculations for Statistical Testing

April 25, 2017
Washington, DC

This workshop is considered "Day 0" to the 10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference. Professionals often attend both the workshop and the conference. The conference will be held the day after the workshop. You can learn more and register for the conference here.

AdvaMed and the American Statistical Association (ASA) Medical Device and Diagnostic Section are co-hosting the "Day 0" of this year's Statistical Issues Conference.  Statisticians are often inundated with sample size requests that span the gamut of early research and development to manufacturing and marketing.  Different stages of a product’s lifecycle have varying requirements that need to be translated into meaningful objectives and actions.  These objectives drive the determination of sample sizes based on assumptions about the population and inherent to the methods used for sample size calculations. 

This course will discuss concepts in sample size determination.  It will share strategies, tools, methods, procedures, and examples for immediate implementation as needed.  Specific topics to be covered include Acceptance Sampling, Statistical Hypothesis Testing, and an overview of Bayesian sample size determination.  The course will not focus on mathematical detail but rather emphasize practical scenarios and applications.


Poster Session at the Statistics Conference:
The reception following the first day of the conference will feature a poster session, co-hosted by AdvaMed and the American Statistical Association (ASA) Medical Device and Diagnostics Section:

  • Posters due April 10 at 11:59 p.m. EST.  Submit posters to
  • Submit an electronic version of the poster (eg as .ppt or .pdf file)
  • Posters will be judged on statistical innovation, applicability to medical devices and diagnostics, clarity of presentation, effective use of graphics, appropriate example(s) used, and overall impression 

Click here for more information on the poster session.

To view the agenda, click here.

Agenda topics include:

  • Same sizes in acceptace sampling
  • Sample size calculations in quality and reliability engineering
  • Sample size requirements for hypothesis tests


Dan P. Johnson, M.S., Abbott 
Dan Johnson is a principal statistician at Abbott Laboratories with over 25 years industry experience.  He has taught at several universities and industries.  He is a graduate of Kansas State University where he received an MBA and a Master’s degree in Statistics.   

Paul Mathews, M.S., Mathews Malnar and Bailey, Inc.
Paul Mathews is president of Mathews Malnar and Bailey, Inc., a provider of quality engineering and applied statistical consulting and training services for R&D, product, process, and manufacturing engineering organizations. Paul has over 30 years of experience as an engineer, scientist, professor, and consultant. He holds B.S. and M.S. degrees in physics from Miami University and Case Western Reserve University, respectively, and is certified by ASQ as a Quality Engineer and Six Sigma Black Belt. Paul holds ten patents and is the author of Design of Experiments with MINITAB (2004, ASQ Quality Press) and Sample Size Calculations: Practical Methods for Engineers and Scientists (2010, Mathews Malnar and Bailey, Inc). Paul is a member of the American Statistical Association and a senior member of the American Society for Quality. In his free time, Paul races and cruises his sailboat Whitehawk on Lake Erie with his wife Kathy.

Peter Costa, Ph.D., Hologic
Peter J. Costa, is a Senior Applied Mathematician at Hologic Incorporated in Marlborough, MA. Dr. Costa is the co-creator of MATLAB's Symbolic Math Toolbox. He has developed mathematical models for the spread of HIV, the outbreak of AIDS, the transmission of an infectious respiratory disease throughout a population, and the diagnosis of cervical cancer.  Dr. Costa has been awarded four patents.  His research interests include scientific computing and mathematical biology. He received the PhD in Applied Mathematics from the University of Massachusetts at Amherst and is the author of Bridging Mind and Model: Papers in Applied Mathematics (St. Thomas Technology Press 1994) and Applied Mathematics for the Analysis of Biomedical Data: Models, Methods, and MATLAB® (Wiley, 2017).


  • Angel DeGuzman, Abbott
  • Vicki Petrides, Abbott          

April 25, 2017
9:00 a.m. until 5:00 p.m.

Washington Marriott at Metro Center
775 12th Street NW, Washington, DC 20005

Registration Fees

AdvaMed Accel Member Registration: $400.00

AdvaMed Member Registration: $500.00

ASA Member Registration: $500.00
*Please contact us at for pricing adjustments after checkout

ASA MDD Registration: $400.00
*Please contact us at for pricing adjustments after checkout

Non-Member Registration: $600

Government and Non-Profit Registration: $400.00

Cancellation and Refund Policy
All cancellations must be received via email to Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows". 

We welcome substitutions in lieu of cancellations at any time. Please contact us at with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.