Commentary
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:
(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:
- Regulatory documentation in an Agile environment
- Fitting hazard analysis into the Agile context
- "Inspect and Adapt" as a way to scale Agile
- Considerations for Agile team composition
Podcast: 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.
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.
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.
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.
Presentations & 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.
"Agile is More Than Software," with Nancy Van Schooenderwoert (Lean-Agile Partners), 6th Software Design for Medical Devices Europe, 22. February 2016, Munich Germany.
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.
"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 June 7, 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™, November 5 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, October 15 2012, Berlin, Germany.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," Agile Software Development for Healthcare Conference, October 17 2012, Berlin, Germany.
"Agile FDA Mini- Plays, Mosh Pit Style," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile 2012 Conference, August 16 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), American Society for Quality, International Conference on Software Quality, 10 February 2011.
"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, 24 May 2010.
"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.
“Software Development in the FDA-Regulated World: Why Test Only When We’re ‘Done’?” presented (with co-author Ron Morsicato) at the North East Quality Conference, Mansfield MA, 18. Oct. 2006.
“Why is the FDA Interested in Software Process?” presented at Boston ASQ meeting, 20. Sept. 2006.
“How Do We Capture Software Requirements?” workshop presented at Boston ASQ meeting, 31. May 2006.
“Good Software Requirements: Foundation for Predicate Rule and Part 11 Compliance,” presented at the Drug Information Association 10th Annual Computer Validation and 3rd Annual IT Conference, 12.-14. September 2005.
“Why is the FDA interested in Software Process?” presented (with co-author Christine M. Shoemaker) at the inaugural meeting of Cambridge IT Pro, 24. February 2004.
Shoemaker, B., “Implementing Electronic Records and Signatures and Capturing Process Data,” J. cGMP Compliance 4(3), April 2000, pp. 59-66.
“From Clipboard to Database: Quality Improvement, EDR, and the Bottom Line,” presented at BOSCON (20th Boston Quality Conference) – Boston Section, American Society for Quality, 23. March 2000.
“Replace Your Clipboards: Integrating Mobile Data Capture, Electonic Records and Signatures and Electronic Forms Management,” presented at INTERPHEX 2000 Conference, 21-23 March 2000.
“Implementing 21 CFR Part 11. A new approach to improving document control efficiency and reducing costs with electronic documentation management, electronic records and electronic signatures,” presented at 1999 PDA (Parenteral Drug Association) Annual Meeting, 30. Nov – 3. Dec 1999.
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.
"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 June 7, 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™, November 5 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, October 15 2012, Berlin, Germany.
"Onward to Approval: Documenting Agile Development for Regulatory Compliance," Agile Software Development for Healthcare Conference, October 17 2012, Berlin, Germany.
"Agile FDA Mini- Plays, Mosh Pit Style," with Nancy Van Schooenderwoert (Lean-Agile Partners), Agile 2012 Conference, August 16 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), American Society for Quality, International Conference on Software Quality, 10 February 2011.
"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, 24 May 2010.
"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.
“Software Development in the FDA-Regulated World: Why Test Only When We’re ‘Done’?” presented (with co-author Ron Morsicato) at the North East Quality Conference, Mansfield MA, 18. Oct. 2006.
“Why is the FDA Interested in Software Process?” presented at Boston ASQ meeting, 20. Sept. 2006.
“How Do We Capture Software Requirements?” workshop presented at Boston ASQ meeting, 31. May 2006.
“Good Software Requirements: Foundation for Predicate Rule and Part 11 Compliance,” presented at the Drug Information Association 10th Annual Computer Validation and 3rd Annual IT Conference, 12.-14. September 2005.
“Why is the FDA interested in Software Process?” presented (with co-author Christine M. Shoemaker) at the inaugural meeting of Cambridge IT Pro, 24. February 2004.
Shoemaker, B., “Implementing Electronic Records and Signatures and Capturing Process Data,” J. cGMP Compliance 4(3), April 2000, pp. 59-66.
“From Clipboard to Database: Quality Improvement, EDR, and the Bottom Line,” presented at BOSCON (20th Boston Quality Conference) – Boston Section, American Society for Quality, 23. March 2000.
“Replace Your Clipboards: Integrating Mobile Data Capture, Electonic Records and Signatures and Electronic Forms Management,” presented at INTERPHEX 2000 Conference, 21-23 March 2000.
“Implementing 21 CFR Part 11. A new approach to improving document control efficiency and reducing costs with electronic documentation management, electronic records and electronic signatures,” presented at 1999 PDA (Parenteral Drug Association) Annual Meeting, 30. Nov – 3. Dec 1999.
