agile adoption and transformation in a regulated environment
TRANSCRIPT
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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
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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
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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
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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
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“You don’t think yourself into a new way of acting, you act yourself into a new way of thinking.”
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Focus on the system
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A (rare) example of methodological alignment between AGILE and regulatory requirements
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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
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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)
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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
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CourageRespec
t
FocusCommittmentTrust Openness
Adaptability
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Schneider Culture Model
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Schneider-Culture-Model by M. Sahota (www.agilitrix.com)