1 Release Retrospective on 29.10.2015 „painle ss release “ „few bugs“ 2-3 weeks release phase Potenti ally shippab le Shipped
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Release Retrospective on 29.10.2015
„painless release“
„few bugs“
2-3 weeks release phase
Potentially shippable Shipped
MeVis Medical Solutions AGAgile Adoption and Transformation in a regulated environment
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• Dr. Christian Beck• Manager Agile
Processes • Agile Coach @ MeVis
Medical Solutions
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Feb 07
Sep 07
Apr 08
Nov 08Jun 09
Jan 10
Aug 10
Mar 11
Oct 11
May 12
Dec 12Jul 1
3Fe
b 14Se
p 14Apr 1
50
100
200
300
400
500
600
700
800
Open Bugs in Release Notes
Started experimenting with
Scrum
November 5, 2015 Agile42-Connect
Training and Coaching by Agile42
Training and Coaching by Agile42
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Indicators and examples of organizational and cultural changes
November 5, 2015 Agile42-Connect
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Transparency
8Ersteller oder VeranstaltungstitelAugust 8, 2013
Transparency - at least on operational level
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Focus on Teams
November 5, 2015 Agile42-Connect
10November 5, 2015 Agile42-Connect
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Self-Organized Team Selection
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Meeting Culture
November 5, 2015 Agile42-Connect
13Ersteller oder VeranstaltungstitelAugust 8, 2013
„To be on time is already late“November 5, 2015 Agile42-Connect
14Ersteller oder VeranstaltungstitelAugust 8, 2013
Facilitator, Goal, Agenda, Chartwriting
November 5, 2015 Agile42-Connect
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I support the suggestion
Not my favourite, but I go with the majority
I oppose the suggestion, and here‘s why
Consensus Opinion check
November 5, 2015 Agile42-Connect
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“You don’t think yourself into a new way of acting, you act yourself into a new way of thinking.”
November 5, 2015 Agile42-Connect
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Focus on the system
November 5, 2015 Agile42-Connect
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A (rare) example of methodological alignment between AGILE and regulatory requirements
November 5, 2015 Agile42-Connect
19November 5, 2015 Agile42-Connect
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Team Collaboration
November 5, 2015 Agile42-Connect
21Ersteller oder VeranstaltungstitelAugust 8, 2013
Pairing has become a standard way of work (not just for programmers!)
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Challenges of doing being becoming Agile in a regulated environment
November 5, 2015 Agile42-Connect
EN ISO 13485:2003Quality Management
ISO 60601-1-4Programmable
electrical medical devices
ISO 14971Risk Management
EN 62366:2007Usability
ISO 62304 Medical Device Software
Lifecycle
CE Compliance requires compliance to multiple standards
ISO 62304 closely guides / determines
development of medical software
Comparing the goals
Patient SafetyEffectiveness
Governance throughout product lifecycle
123456
Goals are Product Oriented
ProductivityPredictability
Business ValueQuality
Adaptability& Resilience
Comparing the methods
Defined Process
Plan › Analyze › Develop › Test › CorrectTraceability
CommunicationEmporwerment
TransparencyAdaptability
Formal review and approvalUsabilityConfiguration Management
Iterative & Incremental
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Aligning on Values?
AAMI Medical Device Software Commitee:
Guidance on the use of AGILE practices in the development of medical device software
November 5, 2015 Agile42-Connect
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Aligning on values?
„The values of AGILE and regulatory perspectives actually aligh rather well, although it might be hard to recognize that at first.“
(AAMI TIR 45)
November 5, 2015 Agile42-Connect
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Aligning on values?
Values
Principles
Practices
Individuals and Interactions
Processes and Tools
Comprehensive DocumentationWorking Software
Customer Collaboration Contract Negotiation
Responding to change
Following a plan
Compliance
PredictabilityControl
Stability
Order
November 5, 2015 Agile42-Connect
CourageRespec
t
FocusCommittmentTrust Openness
Adaptability
29 Agile42-Connect
Schneider Culture Model
November 5, 2015
Schneider-Culture-Model by M. Sahota (www.agilitrix.com)
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