The document details a retrospective on agile transformation at Mevis Medical Solutions, highlighting their experience with implementing agile practices in a regulated environment. It discusses the alignment of agile values with regulatory requirements, the challenges faced, and the benefits realized, such as improved team collaboration and reduced bugs in releases. Lastly, it presents the importance of cultural changes and transparency within the organization to foster a successful agile framework.

1. 1
Release Retrospective on 29.10.2015
„painless
release“
„few
bugs“
Potentially
shippable Shipped

2. MeVis Medical Solutions AG
Agile Adoption and Transformation in a regulated
environment

3. 3
• Dr. Christian Beck
• Manager Agile
Processes
• Agile Coach @ MeVis
Medical Solutions

4. 4

5. 5
0
100
200
300
400
500
600
700
800
Feb07
Sep07
Apr08
Nov08
Jun09
Jan10
Aug10
Mar11
Oct11
May12
Dec12
Jul13
Feb14
Sep14
Apr15
Open Bugs in Release Notes
Started
experimenting with
Scrum
November 5, 2015Agile42-Connect
Training and
Coaching by Agile42
Training and
Coaching by Agile42

6. 6
Indicators and examples of
organizational and cultural
changes
November 5, 2015 Agile42-Connect

7. Transparency
7

8. August 8, 2013 8Ersteller oder Veranstaltungstitel
Transparency - at least on operational level

9. Focus on Teams
9November 5, 2015 Agile42-Connect

10. 10November 5, 2015 Agile42-Connect

11. 11
Self-Organized Team Selection

12. Meeting Culture
12November 5, 2015 Agile42-Connect

13. August 8, 2013 13Ersteller oder Veranstaltungstitel
„To be on time is already late“
November 5, 2015 Agile42-Connect

14. August 8, 2013 14Ersteller oder Veranstaltungstitel
Facilitator, Goal, Agenda, Chartwriting
November 5, 2015 Agile42-Connect

15. 15
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

16. 16
“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

17. Focus on the system
17November 5, 2015 Agile42-Connect

18. A (rare) example of methodological alignment
between AGILE and regulatory requirements
18November 5, 2015 Agile42-Connect

19. 19November 5, 2015 Agile42-Connect

20. Team Collaboration
20November 5, 2015 Agile42-Connect

21. August 8, 2013 21Ersteller oder Veranstaltungstitel
Pairing has become a standard way of work (not
just for programmers!)

22. Challenges of doing being
becoming Agile in a
regulated environment
22November 5, 2015 Agile42-Connect

23. EN ISO 13485:2003
Quality Management
ISO 60601-1-4
Programmable
electrical medical
devices
ISO 14971
Risk Management
EN 62366:2007
Usability
ISO 62304 Medical
Device Software
Lifecycle
CE Compliance requires compliance to
multiple standards
ISO 62304 closely
guides / determines
development of
medical software

24. Comparing the goals
Patient Safety
Effectiveness
Governance throughout
product lifecycle
1
2
3
4
5
6
Goals are
Product
Oriented
Productivity
Predictability
Business Value
Quality
Adaptability
& Resilience

25. Comparing the methods
Defined Process
Plan › Analyze › Develop › Test › Correct
Traceability
Communication
Emporwerment
Transparency
Adaptability
Formal review and approval
Usability
Configuration Management
Iterative & Incremental

26. Aligning on Values?
26
AAMI Medical Device Software Commitee:
Guidance on the use of AGILE practices in the
development of medical device software
November 5, 2015 Agile42-Connect

27. Aligning on values?
27
„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

28. Aligning on values?
28
Values
Principles
Practices
Individuals and
Interactions
Processes and Tools
Comprehensive
DocumentationWorking Software
Customer Collaboration Contract Negotiation
Responding to change
Following a plan
Compliance
Predictability
Control
Stability
Order
November 5, 2015 Agile42-Connect
Courage
Respect
Focus
Committment
Trust
Openness
Adaptability

29. Schneider Culture Model
November 5, 2015 29Agile42-Connect
Schneider-Culture-Model by M.
Sahota (www.agilitrix.com)