Welcome!
If you have a safety-critical application and / or an absolutely fixed deadline for your project, and you want to know if Agile methods can help - you've come to the right place.
Buy on Amazon here(Opens in new window)
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This new book augments the introductory discussion in our earlier book with practical case studies from companies that have employed an Agile approach for regulated medical product development. The cases we examine provide a variety of lessons for businesses looking to gain the benefits of Agile while staying compliant. Taken together, the stories also suggest the breadth of applications of Agile when you start to think outside the box of software development.
Our audience is business and technical leaders in medical product companies. Our goal is to provide inspiration in the form of creative, successful examples of Agile principles applied skillfully. We also provide commentary on each case study to help our readers see how the underlying principles from Lean, Agile, and systems thinking were leveraged. In this way we aim to help our readers become more effective change agents in their workplaces. |
What the experts are saying:
For many years, Nancy Van Schooenderwoert has been my go-to resource for companies facing the thorny challenge of building safety-critical systems with an agile approach. In this new book, she and Brian Shoemaker share advice through case studies of companies that applied Agile successfully in the medical product world. The book goes beyond advice just for those building safety-critical systems and includes lessons for any organization seeking to become more agile.
Mike Cohn, Mountain Goat Software, Co-Founder of Scrum Alliance and Agile Alliance; author of Succeeding with Agile, among others
Brian and Nancy have hit the mark again with a concise and relevant sequel to their previous book. The case study approach adds the right “real-world” perspective, and the diversity of examples invite the reader to see themselves in the examples. Through the lens of being an effective change agent, I believe this book finally lays to rest misconceptions about the mismatch between regulated software development and agile methodology. Grab it, read it, and show it to your colleagues!
Anthony D. Watson, FDA Veteran and Industry Regulatory Affairs Executive
This book is an invaluable collection of practical cases on the adoption of Agile methods specifically in regulated, safety-critical settings where compliance is indisputable. The cases convey both fundamental and practical knowledge, inspiring those who are considering to embrace the Agile principles. At the same time, companies already well ahead into Agile can benefit from the case studies to contrast and compare their own implementation and experiences to continue leveraging the powers of Agile methods for their own benefits!!
Jan van Moll, Head of Quality & Regulatory Affairs – Advanced Development, Philips Healthcare
Whether or not you think your company or team is different, you'd be right to read this book - not for process improvement or quick fixes, but to help you further a culture of quality and transform your software ecosystem. Nancy and Brian hit several key issues related to team culture, a major force in developing an agile mindset, which could impede or precipitate how agility is nurtured long-term. As a software professional, you play a major role in how to apply that force. The authors make refreshingly clear the benefits of Agile principles and frameworks, along with systems thinking, in safety critical, regulated product development environments. Through practical, real world case studies they provide solid grounding that also emphasize critical cultural values necessary for Agile to flourish.
Nivaldo Diaz, Vice president and General Manager, Software Technology Solutions, Becton Dickinson & Co.
This book goes beyond introducing agile concepts, goes beyond 'recipe following', and shares great real-world examples of the challenges and successes that the medical device industry has in adopting agile for medical device software development.
Pat Baird, Sr. Regulatory Specialist, Philips
Agile is not impossible for safety-critical medical systems! Not even when it involves complex mixes of hardware platforms. Nancy and Brian remind us that Agile approach does not mean “throwing off all discipline”, rather it is “a discipline which allows for flexibility.” Who doesn’t need flexibility in this world? These stories may help you see the way for more flexibility in delivering your safety critical system.
James Grenning, Author of Test Driven Development for Embedded C and Contributor to the Manifesto for Agile Software Development
For many years, Nancy Van Schooenderwoert has been my go-to resource for companies facing the thorny challenge of building safety-critical systems with an agile approach. In this new book, she and Brian Shoemaker share advice through case studies of companies that applied Agile successfully in the medical product world. The book goes beyond advice just for those building safety-critical systems and includes lessons for any organization seeking to become more agile.
Mike Cohn, Mountain Goat Software, Co-Founder of Scrum Alliance and Agile Alliance; author of Succeeding with Agile, among others
Brian and Nancy have hit the mark again with a concise and relevant sequel to their previous book. The case study approach adds the right “real-world” perspective, and the diversity of examples invite the reader to see themselves in the examples. Through the lens of being an effective change agent, I believe this book finally lays to rest misconceptions about the mismatch between regulated software development and agile methodology. Grab it, read it, and show it to your colleagues!
Anthony D. Watson, FDA Veteran and Industry Regulatory Affairs Executive
This book is an invaluable collection of practical cases on the adoption of Agile methods specifically in regulated, safety-critical settings where compliance is indisputable. The cases convey both fundamental and practical knowledge, inspiring those who are considering to embrace the Agile principles. At the same time, companies already well ahead into Agile can benefit from the case studies to contrast and compare their own implementation and experiences to continue leveraging the powers of Agile methods for their own benefits!!
Jan van Moll, Head of Quality & Regulatory Affairs – Advanced Development, Philips Healthcare
Whether or not you think your company or team is different, you'd be right to read this book - not for process improvement or quick fixes, but to help you further a culture of quality and transform your software ecosystem. Nancy and Brian hit several key issues related to team culture, a major force in developing an agile mindset, which could impede or precipitate how agility is nurtured long-term. As a software professional, you play a major role in how to apply that force. The authors make refreshingly clear the benefits of Agile principles and frameworks, along with systems thinking, in safety critical, regulated product development environments. Through practical, real world case studies they provide solid grounding that also emphasize critical cultural values necessary for Agile to flourish.
Nivaldo Diaz, Vice president and General Manager, Software Technology Solutions, Becton Dickinson & Co.
This book goes beyond introducing agile concepts, goes beyond 'recipe following', and shares great real-world examples of the challenges and successes that the medical device industry has in adopting agile for medical device software development.
Pat Baird, Sr. Regulatory Specialist, Philips
Agile is not impossible for safety-critical medical systems! Not even when it involves complex mixes of hardware platforms. Nancy and Brian remind us that Agile approach does not mean “throwing off all discipline”, rather it is “a discipline which allows for flexibility.” Who doesn’t need flexibility in this world? These stories may help you see the way for more flexibility in delivering your safety critical system.
James Grenning, Author of Test Driven Development for Embedded C and Contributor to the Manifesto for Agile Software Development
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This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition.
Our book "Agile Methods for Safety-Critical Systems" is now available through Amazon. Click on the link or the book image to go directly to the Amazon page. - Nancy Van Schooenderwoert and Brian Shoemaker |
What the experts are saying:
I heartily recommend the timely and provocative new book, Agile Methods for Safety Critical Systems, by Nancy Schooenderwoert and Brian Shoemaker for next-generation software developers and innovators. Using examples around safety critical medical devices, the authors reveal counter-intuitive means of moving beyond older software methods to be able to consistently produce previously unachievable levels of quality, while simultaneously increasing the speed of production! If that seems impossible, you need to pick up this book!
Jack Lewin MD, Founder and Principal, Lewin and Associates LLC
Brian and Nancy have written a primer on Agile programming that emphasizes quality. This is just the sort of message that should be appreciated by software professionals using Agile in safety-critical domains. Well done!
Rick Chapman, former FDA Branch Chief
This book describes very proven and pragmatic approaches to agile, and does so in plain language.
Agile methods deliver value. This primer addresses the many challenges that medical device organizations might face in adopting Agile, and provides good recommendations for things to consider and solutions to pursue. I hope this primer helps encourage anyone in a safety-critical environment to realize the benefits that Agile methods can provide.
Kelly Weyrauch, Principal at Agile Quality Systems, Lead author of AAMI TIR45
Nancy and Brian answer an emphatic “YES!" to one of the most common concerns about use of Agile methods, whether they can be used in safety-critical questions. In doing so, they provide an excellent introduction to Agile ideas, combined with advice specifically useful for Agile projects with higher need for reliability and quality. In this short and readable book, they give a look at all the key ideas you need to know, plus a host of references for gaining deeper knowledge. Highly recommended!
Ron Jeffries, Agile Manifesto Author, ronjeffries.com
Who says you cannot use agile for regulated medical device development? Nancy and Brian not only show you that you can, they make a compelling case for Agile and its approach of building in quality from day one. This book will help you see how to meet FDA process and documentation demands with Agile's iterative and incremental approach.
James Grenning, author Test-Driven Development for Embedded C and Founder of Wingman Software.
I heartily recommend the timely and provocative new book, Agile Methods for Safety Critical Systems, by Nancy Schooenderwoert and Brian Shoemaker for next-generation software developers and innovators. Using examples around safety critical medical devices, the authors reveal counter-intuitive means of moving beyond older software methods to be able to consistently produce previously unachievable levels of quality, while simultaneously increasing the speed of production! If that seems impossible, you need to pick up this book!
Jack Lewin MD, Founder and Principal, Lewin and Associates LLC
Brian and Nancy have written a primer on Agile programming that emphasizes quality. This is just the sort of message that should be appreciated by software professionals using Agile in safety-critical domains. Well done!
Rick Chapman, former FDA Branch Chief
This book describes very proven and pragmatic approaches to agile, and does so in plain language.
- This book is the facilitator as you start your agile journey
- Pragmatic and plain spoken
- The best introduction to agile I’ve read, and it is written for medical devices.
- Provides a rare, holistic view of agile – for developers, for managers, for Regulatory, for Compliance
Agile methods deliver value. This primer addresses the many challenges that medical device organizations might face in adopting Agile, and provides good recommendations for things to consider and solutions to pursue. I hope this primer helps encourage anyone in a safety-critical environment to realize the benefits that Agile methods can provide.
Kelly Weyrauch, Principal at Agile Quality Systems, Lead author of AAMI TIR45
Nancy and Brian answer an emphatic “YES!" to one of the most common concerns about use of Agile methods, whether they can be used in safety-critical questions. In doing so, they provide an excellent introduction to Agile ideas, combined with advice specifically useful for Agile projects with higher need for reliability and quality. In this short and readable book, they give a look at all the key ideas you need to know, plus a host of references for gaining deeper knowledge. Highly recommended!
Ron Jeffries, Agile Manifesto Author, ronjeffries.com
Who says you cannot use agile for regulated medical device development? Nancy and Brian not only show you that you can, they make a compelling case for Agile and its approach of building in quality from day one. This book will help you see how to meet FDA process and documentation demands with Agile's iterative and incremental approach.
James Grenning, author Test-Driven Development for Embedded C and Founder of Wingman Software.
Training |
Coaching |
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We offer training courses and workshops in Agile topics, and Regulatory topics - all with an understanding of how companies can get the full benefits of Agile while staying fully compliant! You don't have to "water down" Agile's power at all.
Ongoing SupportEven clients who've mastered the basics still have a desire to keep pace with new developments in Agile and in the regulatory world. We develop new training all the time. They say a picture is worth a thousand words. We think an experience is worth a thousand pictures! So we like to design our training around experiences. These give an "Aha! moment" and really stick!
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Coaching bridges the gap between training and actually making the new ideas work inside your company. We coach from experience of having actually used Agile practices to deliver.
Customized assistanceWe offer specific help such as review of FDA documentation prior to submission, review of SOPs, review of Agile Story backlogs, etc. Our custom services were created to serve the needs of medical device companies that needed reviews done with an awareness of how Agile practices fit in.
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We have deep experience in both
the medical devices industry and in Agile practices.
This gives us the ability to address your needs
from a variety of management and technical roles.