TwinSpin on Agile Jan2012x

offbeatnothingSoftware and s/w Development

Dec 2, 2013 (3 years and 4 months ago)

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Kelly
Weyrauch




Medtronic

-

AAMI Agile TIR Committee

1


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?


2


You Can


Agile TIR



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


3

4

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

5

6

FDA

Design

Control

Guidance

For

Medical

Device

Manufacturers


Add Agile to an existing

Quality Management System


Agile by itself is insufficient


Don’t disrupt the existing system


Avoid raising undue concerns



“Don’t tell us you are using Agile, we don’t
need to know”


7

8

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


8 Software Configuration Management

9 Software Problem Resolution

7 Software Risk Management


9


For Each Story








More stories …

For Each Increment








For Each Release











For Each Project













Mapping 62304’s activities…

5.2 SW Requirements Analysis


High
-
Level, Backlog Management

5.3 SW Architectural Design


Infrastructure, Spikes

5.3 SW Architectural Design
-

Emergent

5.4 SW Detailed Design

5.5 SW Unit Implementation and Verification

5.2 SW Requirements Analysis


Story Details

5.7 SW System Testing

5.6 SW Integration and Integration Testing

5.6 SW
Integration
and
Integration
Testing

5.7 SW
System

Testing &
Regression
Testing

5.6 SW
Integration
and
Integration
Testing

5.7 SW
System

Testing &
Regression
Testing

5.8 SW

Release

…into Agile’s Incremental/Evolutionary life cycle

5.1 SW Development Planning
-

Project

5.1 SW Development Planning
-

Story

5.1 SW Development Planning

5.1 SW Development Planning

5.1 SW Development Planning

5.1 SW Development Planning

5.1 SW Development Planning

More Releases …

More Increments …

5.1 SW Development Planning
-

Increment

5.1 SW Development Planning
-

Release

5.7 SW

System

Testing

5.7 SW

System

Testing

5.6 SW
Integration and
Integr. Testing

5.6 SW
Integration and
Integr. Testing

5.2 SW
Requirements
Analysis

5.3 SW Architectural
Design

5.4 SW

Detailed Design

5.5 SW Unit
Implement. & Verif

5.6 SW Integration
and Integr. Testing

5.7 SW

System Testing

5.8 SW

Release

5.2 SW
Requirements
Analysis

5.3 SW Architectural
Design

5.8 SW

Release


5.7 SW

System

Testing

5.3 SW
Architectural
Design

5.4 SW

Detailed

Design

5.5 SW Unit
Implement. &
Verification

5.6 SW
Integration and
Integr. Testing

5.2 SW
Requirements
Analysis


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]



The FDA does not prohibit the use of Agile

10


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]



FDA believes that Agile Methods can be tailored for use
in a regulated environment

11


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

12


Frequent Releases


When software is part of a larger system


Regulatory cycles


Field updates


13


Myths, misperception, miscommunication,
and mistakes


“Doctor, it hurts when I go like this…”


14

Kelly
Weyrauch


kelly.weyrauch@medtronic.com

763
-
688
-
0980 kdccf@comcast.net


15