Presentations and Publications
Contents of presentations and articles below are the intellectual property of the author(s) and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. All logos and other trademarks are the property of their respective owners.
(Linked titles: click link to download PDF.)
(Linked titles: click link to download PDF.)
"Agile: Quality, Safety, and Compliance," Software Quality Group of New England, 13. March 2019, Bedford MA.
Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples, with co-author Nancy Van Schooenderwoert (Lean-Agile Partners), June 2019 (available thorugh Amazon)
"Risk Management and the Agile Approach," Software Design for Medical Devices Global, 11.-14. February 2019, Berlin Germany.
"Agile for Medical Devices: A New Day Dawns," Medical Device Playbook, 8. May 2018, Toronto ON Canada.
"Revisit: Agile Adoption for Regulated Medical Software," (with Nancy Van Schooenderwoert, Lean-Agile Partners), Software Design for Medical Devices, 22.-24. January, 2018, Boston, MA.
"Documentation for Agile Development: Shared Understanding, Vacation Photos, and Compliance," 3rd Annual ComplianceOnline Medical Device Summit, 8.-9. June 2017, Boston MA.
"Agile for Medical Device Software Development: Where Competitiveness, Compliance, and Quality Meet," MedTechIntelligence Medical Device Software for Regulatory, Quality, Product Development, & Compliance, 21.-22. March, 2017, Washington, DC.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," 2nd Annual ComplianceOnline Medical Device Summit, 15.-16. September 2016, San Diego CA.
"Agile is More Than Software," with Nancy Van Schooenderwoert (Lean-Agile Partners), 6th Software Design for Medical Devices Europe, 22. February 2016, Munich Germany.
"AAMI TIR45 - Agile Meets Software Standards, and We all Win", 4th Software Design for Medical Devices Europe, 28. January 2014, Munich, Germany.
"Agile for Regulated Medical Software - Real-World Productivity, Quality, and Compliance," with Nancy Van Schooenderwoert (Lean-Agile Partners), 4th Software Design for Medical Devices Europe, 30. January 2014, Munich, Germany.
"Agile 4 IEC 62304 (Fast Can Be Safe)," with Nancy Van Schooenderwoert (Lean-Agile Partners), XP2013 7. June, 2013 Vienna, Austria.
"What is Validation? Covering the Basics and Beyond," 16th Software Design for Medical Devices Conference (US), 20. May 2013, San Diego, CA.
"On Being Nimble: Lean Development Principles in Medical Device Software Development," Medical Devices Conference™: Tools, Technologies, and Strategies to Accelerate Your Time to Market™, 5. November 2012, San Francisco, CA.
"Look Before You Leap, or Leap Before You Look? Agile Mini-Plays from Regulated Life-Science Software," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile Software Development for Healthcare Conference, 15. October 2012, Berlin, Germany.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," Agile Software Development for Healthcare Conference, 17. October 2012, Berlin, Germany.
"Agile FDA Mini- Plays, Mosh Pit Style," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile 2012 Conference, 16. August 2012.
"Jump Out of the Waterfall: Applying Lean Development Principles in Medical Device Software Development," with Nancy Van Schooenderwoert (Lean-Agile Partners), 2nd Software Design for Medical Devices Conference, Europe, 2. February 2012, Munich Germany.
"The Shifting Landscape of Software Compliance," , 2nd Software Design for Medical Devices Conference, Europe, 31. January 2012, Munich Germany.
"The Shifting Picture of Software Compliance, at Home and Abroad," with Dan Sterling (Sterling Medical Devices), 14th Software Design for Medical Devices Conference (US), 23. May 2011.
"When it Just HAS to Work: Agile Development in Safety-Critical Environments," with Nancy Van Schooenderwoert (Lean-Agile Partners), ICSQ 2011 (International Conference on Software Quality), 10. February 2011.
"Software Validation Tools: Discovering Hidden Quality Problems," (originially developed by David James, Precision V&V Services), presented at MD&M Midwest, Chicago, IL, 29. September 2010.
Workshop: "Jump out of the Waterfall: Applying Lean Development Principles in Medical Device Software Development," with Nancy Van Schooenderwoert (Lean-Agile Partners), 13th Software Design for Medical Devices Conference (US), 24. May 2010.
"When It Just Has to Work: Agile Development in Safety-Critical Environments," (co-author Nancy Van Schooenderwoert, Lean-Agile Partners), Boston SPIN (Software Process Improvement Network), 18. May 2010.
"When It Just Has to Work: Agile Development in Safety-Critical Environments," presented with Nancy Van Schooenderwoert (Lean-Agile Partners) at Agile 2009 (Agile Alliance National Meeting, Chicago, IL), 24. August 2009.
"IQ and PQ for Commercial GCP Systems," Presented as part of Town Meeting: The Three Validation "Doctors" Respond to Your Questions and Concerns – OQ, IQ, PQ, and Testing Practices, Drug Information Association 45th Annual Meeting, San Diego, CA, 23. June 2009.
Panel Discussion: "Exploring Global Collaboration and Standardization Initiatives," with Sherman Eagles (Partner, SoftwareCPR) and David James (Process Development, Precision V&V), 12th Software Design for Medical Devices conference, 28. April 2009.
Workshop: "Requirements Change Management for Medical Device Safety," with Tony Raymond (New Harbor SQA) and Charles Gropper (CardioNet, Inc.), 11th Software Design for Medical Devices conference, 27. Oct. 2008.
“Validation and Quality Concepts in Open Source Clinical Software: Not an Oxymoron,” presented at DIA (Drug Information Association) 44th Annual Meeting, Boston, MA, 24. Jun. 2008.
Shoemaker, B., “Lessons Learned in a Non-Regulated Validation Project,” J. Validation Technol. 14 (1), Nov. 2007.
“Test-first Practices for Safety-Critical Development: an Agile Approach,” presented at QA&Test 2007 (International Conference on Embedded Software Testing, Bilbao, Spain), 18. Oct. 2007.
“Test-first Practices in Regulated, Safety-critical Environments: an Agile Approach,” presented (with co-author Ron Morsicato) at Agile 2007 (Agile Alliance National Meeting, Washington DC), 15. Aug. 2007.
“Software Development in the FDA-Regulated World: Why Test Only When We’re ‘Done’?” presented (with co-author Ron Morsicato) at Agile Vancouver (Vancouver B.C., Canada), 17. Nov. 2006.
Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples, with co-author Nancy Van Schooenderwoert (Lean-Agile Partners), June 2019 (available thorugh Amazon)
"Risk Management and the Agile Approach," Software Design for Medical Devices Global, 11.-14. February 2019, Berlin Germany.
"Agile for Medical Devices: A New Day Dawns," Medical Device Playbook, 8. May 2018, Toronto ON Canada.
"Revisit: Agile Adoption for Regulated Medical Software," (with Nancy Van Schooenderwoert, Lean-Agile Partners), Software Design for Medical Devices, 22.-24. January, 2018, Boston, MA.
"Documentation for Agile Development: Shared Understanding, Vacation Photos, and Compliance," 3rd Annual ComplianceOnline Medical Device Summit, 8.-9. June 2017, Boston MA.
"Agile for Medical Device Software Development: Where Competitiveness, Compliance, and Quality Meet," MedTechIntelligence Medical Device Software for Regulatory, Quality, Product Development, & Compliance, 21.-22. March, 2017, Washington, DC.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," 2nd Annual ComplianceOnline Medical Device Summit, 15.-16. September 2016, San Diego CA.
"Agile is More Than Software," with Nancy Van Schooenderwoert (Lean-Agile Partners), 6th Software Design for Medical Devices Europe, 22. February 2016, Munich Germany.
"AAMI TIR45 - Agile Meets Software Standards, and We all Win", 4th Software Design for Medical Devices Europe, 28. January 2014, Munich, Germany.
"Agile for Regulated Medical Software - Real-World Productivity, Quality, and Compliance," with Nancy Van Schooenderwoert (Lean-Agile Partners), 4th Software Design for Medical Devices Europe, 30. January 2014, Munich, Germany.
"Agile 4 IEC 62304 (Fast Can Be Safe)," with Nancy Van Schooenderwoert (Lean-Agile Partners), XP2013 7. June, 2013 Vienna, Austria.
"What is Validation? Covering the Basics and Beyond," 16th Software Design for Medical Devices Conference (US), 20. May 2013, San Diego, CA.
"On Being Nimble: Lean Development Principles in Medical Device Software Development," Medical Devices Conference™: Tools, Technologies, and Strategies to Accelerate Your Time to Market™, 5. November 2012, San Francisco, CA.
"Look Before You Leap, or Leap Before You Look? Agile Mini-Plays from Regulated Life-Science Software," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile Software Development for Healthcare Conference, 15. October 2012, Berlin, Germany.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," Agile Software Development for Healthcare Conference, 17. October 2012, Berlin, Germany.
"Agile FDA Mini- Plays, Mosh Pit Style," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile 2012 Conference, 16. August 2012.
"Jump Out of the Waterfall: Applying Lean Development Principles in Medical Device Software Development," with Nancy Van Schooenderwoert (Lean-Agile Partners), 2nd Software Design for Medical Devices Conference, Europe, 2. February 2012, Munich Germany.
"The Shifting Landscape of Software Compliance," , 2nd Software Design for Medical Devices Conference, Europe, 31. January 2012, Munich Germany.
"The Shifting Picture of Software Compliance, at Home and Abroad," with Dan Sterling (Sterling Medical Devices), 14th Software Design for Medical Devices Conference (US), 23. May 2011.
"When it Just HAS to Work: Agile Development in Safety-Critical Environments," with Nancy Van Schooenderwoert (Lean-Agile Partners), ICSQ 2011 (International Conference on Software Quality), 10. February 2011.
"Software Validation Tools: Discovering Hidden Quality Problems," (originially developed by David James, Precision V&V Services), presented at MD&M Midwest, Chicago, IL, 29. September 2010.
Workshop: "Jump out of the Waterfall: Applying Lean Development Principles in Medical Device Software Development," with Nancy Van Schooenderwoert (Lean-Agile Partners), 13th Software Design for Medical Devices Conference (US), 24. May 2010.
"When It Just Has to Work: Agile Development in Safety-Critical Environments," (co-author Nancy Van Schooenderwoert, Lean-Agile Partners), Boston SPIN (Software Process Improvement Network), 18. May 2010.
"When It Just Has to Work: Agile Development in Safety-Critical Environments," presented with Nancy Van Schooenderwoert (Lean-Agile Partners) at Agile 2009 (Agile Alliance National Meeting, Chicago, IL), 24. August 2009.
"IQ and PQ for Commercial GCP Systems," Presented as part of Town Meeting: The Three Validation "Doctors" Respond to Your Questions and Concerns – OQ, IQ, PQ, and Testing Practices, Drug Information Association 45th Annual Meeting, San Diego, CA, 23. June 2009.
Panel Discussion: "Exploring Global Collaboration and Standardization Initiatives," with Sherman Eagles (Partner, SoftwareCPR) and David James (Process Development, Precision V&V), 12th Software Design for Medical Devices conference, 28. April 2009.
Workshop: "Requirements Change Management for Medical Device Safety," with Tony Raymond (New Harbor SQA) and Charles Gropper (CardioNet, Inc.), 11th Software Design for Medical Devices conference, 27. Oct. 2008.
“Validation and Quality Concepts in Open Source Clinical Software: Not an Oxymoron,” presented at DIA (Drug Information Association) 44th Annual Meeting, Boston, MA, 24. Jun. 2008.
Shoemaker, B., “Lessons Learned in a Non-Regulated Validation Project,” J. Validation Technol. 14 (1), Nov. 2007.
“Test-first Practices for Safety-Critical Development: an Agile Approach,” presented at QA&Test 2007 (International Conference on Embedded Software Testing, Bilbao, Spain), 18. Oct. 2007.
“Test-first Practices in Regulated, Safety-critical Environments: an Agile Approach,” presented (with co-author Ron Morsicato) at Agile 2007 (Agile Alliance National Meeting, Washington DC), 15. Aug. 2007.
“Software Development in the FDA-Regulated World: Why Test Only When We’re ‘Done’?” presented (with co-author Ron Morsicato) at Agile Vancouver (Vancouver B.C., Canada), 17. Nov. 2006.
White Papers
Q&A - Adopting Agile for Medical Device Development
by Brian Shoemaker and Nancy Van Schooenderwoert.
This white paper collects the most frequently asked questions we receive from medical device companies interested in knowing how Agile methods support modern high-assurance product development. Click here to download your copy.
Guide for Software SOPs
Are you working to create a compliant quality system for your software development work, but unsure what topics to cover or what to incorporate in each procedure?
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
To obtain a copy of this no-cost resource, click here.
by Brian Shoemaker and Nancy Van Schooenderwoert.
This white paper collects the most frequently asked questions we receive from medical device companies interested in knowing how Agile methods support modern high-assurance product development. Click here to download your copy.
Guide for Software SOPs
Are you working to create a compliant quality system for your software development work, but unsure what topics to cover or what to incorporate in each procedure?
ShoeBar Associates has developed and refined these procedures many times, and has distilled that knowledge into a set of thoughts and questions to help you generate the SOPs you need.
To obtain a copy of this no-cost resource, click here.
Webinar: The Regulators Want You to be Agile! |
(with Nancy Van Schooenderwoert, Lean-Agile Partners)
How do Lean / Agile product development approaches work in the highly regulated, high cost-of-failure medical device environment? How can you use Lean / Agile approaches in developing medical devices and satisfy FDA requirements? This webinar, tailored for companies interested in overcoming these challenges and seeking advantage, is presented by Lean-Agile Partners and ShoeBar Associates - leading specialists in implementing Agile for medical device development. Areas covered:
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Podcasts |
Conception to Completion: Why Agile Development for Healthcare? (with Nancy Van Schooenderwoert, Lean-Agile Partners )
Agile methodologies implemented into software development projects in healthcare are fast becoming more popular, but how can you achieve a successful agile project from conception to completion? In Part 1 of this two-part series, Brian Shoemaker, Principal Consultant at Shoebar Associates and Nancy Van Shoenderwoert, Consultant at Lean Agile Partners, discuss the main reasons for changing the approach to software development, give best practice tips on the agile techniques for a project and address the regulatory challenges of developing a medical device with respect to software development pitfalls encountered. (Click title to download podcast.) Conception to Completion: Why Agile Development for Healthcare (Part 2)(with Nancy Van Schooenderwoert, Lean-Agile Partners )
In part 1, we learned how agile methodologies implemented into software development projects in healthcare are becoming more popular, but how can you achieve a successful agile project from conception to completion? In part 2, Brian Shoemaker, Principal Consultant at Shoebar Associates and Nancy Van Shoenderwoert, Consultant at Lean Agile Partners, discuss how an organisation can best document for design control and how to fit hazard analysis into the iterative development model, while demonstrating practical examples that bring results. (Click title to download podcast.) |