Kelly Weyrauch
– Medtronic
- AAMI Agile TIR Committee
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AAMI Technical Information Report
Align Agile Values with regulated Values
Add Agile to an existing, robust, effective Quality
Management System
Align Agile's Incremental/Evolutionary lifecycle
with (mis)expectations of more Linear models
What does the FDA think of Agile?
Challenges unique to Medical Device Software
◦ Continuous Release
◦ Myths, misperception, miscommunication, and mistakes
◦ Others?
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You Can
◦ Agile TIR
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You Should
◦ Benefits not unique to Medical Device Software
 Productivity, Predictability, Team Intangibles
◦ Benefits for Medical Device Software
 Emphasis on User Needs and Intended Use
 Test-Driven Development
 Team discipline, responsibility for continuous improvement
of the development process
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We are uncovering better ways of developing software by
doing it and helping others do it.
Through this work we have come to value:
Individuals and interactions over processes and tools
Working software over comprehensive documentation
Customer collaboration over contract negotiation
Responding to change over following a plan
That is, while there is value in the items on the right, we
value the items on the left more.
Manifesto for Agile Software Development, www.agilemanifesto.org
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FDA Design Control Guidance For Medical Device Manufacturers
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Add Agile to an existing
Quality Management System
◦ Agile by itself is insufficient
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Don’t disrupt the existing system
◦ Avoid raising undue concerns
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“Don’t tell us you are using Agile, we don’t
need to know”
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7 Software Risk Management
8 Software Configuration Management
5.1 SW
Development
Planning
5.1 SW
Requirements
Analysis
5.1 SW
Architectural
Design
5.1 SW
Detailed
Design
5.1 SW Unit
Implement. &
Verification
5.1 SW
System
Testing
5.1 SW
Release
9 Software Problem Resolution
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Mapping 62304’s activities…
5.1 SW
5.1Development
5.1
SWSW
Development
Development
Planning
Planning
Planning
5.1 SW Development Planning
5.2 SW
5.2
SW
5.2 SW
Requirements
Requirements
Requirements
Analysis
Analysis
Analysis
5.3 SW
5.3Architectural
SW
5.3 SW
Architectural
Design
Design
Architectural
Design
5.4 SW
5.4
SW
Detailed Design
5.6 SW
5.6Integration
SW
and Integr. Testing
5.5SW
SW Unit
5.5
Unit
Implement. & Verif
Detailed
Design
Implement. &
Verification
Integration and
Integr. Testing
5.7 SW
5.7 SW
System
System Testing
Testing
5.8SW
SW
5.8
Release
Release
…into Agile’s Incremental/Evolutionary life cycle
For Each Project
5.1 SW Development Planning - Project
5.2 SW Requirements Analysis – High-Level, Backlog Management
5.3 SW Architectural Design – Infrastructure, Spikes
For Each Release
5.1 SW Development Planning - Increment
5.1 SW Development Planning - Story
5.2 SW Requirements Analysis – Story Details
5.3 SW Architectural Design - Emergent
5.4 SW Detailed Design
5.5 SW Unit Implementation and Verification
5.6 SW Integration and Integration Testing
5.7 SW System Testing
More stories …
For Each Story
5.6 SW
Integration
and
Integration
Testing
5.7 SW
System
Testing &
Regression
Testing
More Increments …
For Each Increment
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5.6 SW
Integration
and
Integration
Testing
5.7 SW
System
Testing &
Regression
Testing
5.8 SW
Release
More Releases …
5.1 SW Development Planning - Release
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The FDA does not prohibit or encourage the use of
any specific software development methodology
◦ Based on the intended use of the safety risk associated
with the software to be developed, the software developer
should determine the specific approach, the combination of
techniques to be used, and the level of effort to be applied.
While this guidance does not recommend any specific life
cycle model or any specific technique or method, it does
recommend that software validation and verification
activities be conducted throughout the entire software
lifecycle.
[GPSV: Page 1 General Principles of Software Validation:
Final Guidance for Industry and FDA Staff]
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The FDA does not prohibit the use of Agile
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They have indicated some expected
characteristics of the selected software lifecycle
◦ The quality system requirements do not dictate the types of
design process that a manufacturer must use. Manufacturers
should use processes best suited to their needs. However,
whatever the processes may be, it is important that the design
controls are applied in an appropriate manner.
[Design Control Guidance for Medical Device Manufacturers]
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FDA believes that Agile Methods can be tailored for use
in a regulated environment
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Demonstrate that you satisfy Design Controls,
be in control
Explain what you do
Demonstrate that you do it
Don’t use Agile as an excuse to not do
something
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Frequent Releases
◦ When software is part of a larger system
◦ Regulatory cycles
◦ Field updates
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Myths, misperception, miscommunication,
and mistakes
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“Doctor, it hurts when I go like this…”
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Kelly Weyrauch
kelly.weyrauch@medtronic.com
763-688-0980 kdccf@comcast.net
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