The document discusses applying agile practices to medical device development while maintaining regulatory compliance. It recommends building compliance incrementally by including more criteria in the Definition of Done for each iteration. This reduces "undone" work over time as agile teams integrate compliance work into their daily routines. Establishing an Agile Quality Management System and collaborating between compliance managers and agile teams can help infuse compliance practices into development.

1. Agile Practicesfor
MedicalDeviceDevelopment
Dr. Andreas Birk, Software.Process.Management
29 April 2021, Webinar for Intland Software
Provided in collaboration
with Intland Software

2. 2
Dr. Andreas Birk
Founder & Principal Consultant, Software.Process.Management
#software_requirements
#software_process_improvement
#communities_of_practice
29 Apr 2021 Copyright © 2021, Software.Process.Management

3. Contents
3
Building up compliance incrementally &
with Agile QMS
Challenges of applying Agile in medical
device development
Important agile practices for medical device
development
Successfully establishing
Agile practices in MedTech
29 Apr 2021 Copyright © 2021, Software.Process.Management

4. BuildingUp ComplianceIncrementally
4
Develop
Achieve
Compliance
Develop
Develop
Compliance after Development
Incremental Compliance
Continuous Compliance
29 Apr 2021 Copyright © 2021, Software.Process.Management

5. Agile QMS
5
QMS
Organization
Agile
QMS
Team
Agile can integrate quality matters better into development than plan-based approaches
Characteristics of Agile QMS
 QMS integrated throughout organization
 Quality rooted in development teams
 Lean/agile practices instead of process control
29 Apr 2021 Copyright © 2021, Software.Process.Management

6. Contents
6
Building up compliance incrementally &
Agile QMS
Challenges of applying Agile in medical
device development
Important agile practices for medical device
development
Successfully establishing
Agile practices in MedTech
29 Apr 2021 Copyright © 2021, Software.Process.Management

7. Regulatory ComplianceRequirements
7
Manage Compliance
Manage Quality
Quality
Management
Plan
Quality
Management
System (QMS)
Regulatory
Requirements
STD
Functional Product
Requirements
Nonfunctional / Quality
Product Requirements
Product Constraints
Process Requirements
 Organization Level
 Project / Team Level
Examples
Emergency power-off, on-screen instructions, …
Measurement accuracy, usability, …
Development process, quality and risk management
procedures, documentation and traceability, …
ISO 13485
IEC 62304
IEC 60601
CFR Title 21
FDA (800)
EU Reg.
2017/745
etc.
Development
Radiation dose limit, operating conditions, …
29 Apr 2021 Copyright © 2021, Software.Process.Management

8. User Story: Template& Example
8
< title >
As a < customer / user >
I want < functionality / property >
so that < business value / goal >
User Story Template
Provide on-screen setup guide
As a Nurse
I want to have a help function with setup
instructions available on the screen
so that I can activate the device fast and reliably.
Example User Story
Source: The Connextra Team, Rachel Davies, Tim Mackinnon, and others; see: http://agilecoach.typepad.com/photos/connextra_user_story_2001/connextrastorycard.html
29 Apr 2021 Copyright © 2021, Software.Process.Management

9. ExtendedStory Template & NonfunctionalAspects
9
< title >
As a < customer / user >
I want < functionality / property >
so that < business value / goal >
< notes >
< test criteria >
Recommended User Story Template
Never exceed max. radiation dose
As a Safety Engineer
I want the radiation dose to never exceed the
value of …
so that the patient’s safety is ensured and the
product complies with …
Notes: … high risk …
Test criteria: …
 Good usability by medical staff …
Example User Story showing nonfunctional aspects
29 Apr 2021 Copyright © 2021, Software.Process.Management

10. Regulatory ComplianceRequirements: Agile Practices
10
Manage Compliance
Manage Quality
Quality
Management
Plan
Quality
Management
System (QMS)
Regulatory
Requirements
STD
Functional Product
Requirements
Nonfunctional / Quality
Product Requirements
Product Constraints
Process Requirements
 Organization Level
 Project / Team Level
Agile Requirements Practices
User Story, Epic, Product Vision, Sprint Goal, Test
Automation, …
Definition of Done, Backlog Constraints, Solution Intent,
Test Automation, …
Selection of agile method & practices, Agile Coaching,
Sprint Retrospective, Scrum Master, …
ISO 13485
IEC 62304
IEC 60601
CFR Title 21
FDA (800)
EU Reg.
2017/745
etc.
Development
29 Apr 2021 Copyright © 2021, Software.Process.Management

11. Scrum: The No. 1 Agile Method
11
Sprint Planning
Increment
Sprint
1-4 Weeks
Agile Iteration
Cycle (Sprint)
Sprint Review &
Retrospective
Daily Scrum
Sprint
Backlog
Product
Backlog
Source: J. Sutherland and K. Schwaber, “The Scrum GuideTM: The definitive guide to Scrum: The rules of the game,” Scrum.org and ScumInc., Nov. 2020.
29 Apr 2021 Copyright © 2021, Software.Process.Management

12. Contents
12
Building up compliance incrementally &
Agile QMS
Challenges of applying Agile in medical
device development
Important agile practices for medical device
development
Successfully establishing
Agile practices in MedTech
29 Apr 2021 Copyright © 2021, Software.Process.Management

13. Definitionof Done
The Definition of Done is …
a set of criteria
that each piece of work within an agile iteration must fulfill
in order to become part of the iteration's product release
13
29 Apr 2021 Copyright © 2021, Software.Process.Management

14. To Do Doing Done
Definitionof Done
14
Agile Iteration
Potentially
Shippable
Product
(PSI)
Definition of Done
Story Story Story
Definition of Done
 Code & tests checked in
 Unit tests complete & pass
 Integration succeeds
 …
Example Definition of Done
29 Apr 2021 Copyright © 2021, Software.Process.Management

15. To Do Doing Done
Definitionof Done: BacklogItem vs. Iteration
15
Agile Iteration
Potentially
Shippable
Product
(PSI)
Definition of Done
(Backlog Item)
Story Story Story
Definition of Done
(Iteration)
Task
Definition of Done (Iteration)
 Installation packages available
 User documentation complete
 …
Example Definition of Done
29 Apr 2021 Copyright © 2021, Software.Process.Management

16. Definitionof Done: Identify Criteria & “Undone” Work
16
Definition of Done (Backlog Item)
 Code & tests checked in
 Unit tests complete & pass
 Integration succeeds
 …
Definition of Done (Increment)
 Installation packages available
 User documentation complete
 …
“Potentially Shippable” Criteria
 Code & tests checked in
 Unit tests complete & pass
 Code documentation complete+
 Integration succeeds
 …
 Installation packages available
 User documentation complete
 Marketing material complete+
 …
Identify Criteria for
“Potentially Shippable”
1
2 Derive Criteria of
Definition of Done
3 Remaining criteria (+) represent “undone”
work
29 Apr 2021 Copyright © 2021, Software.Process.Management

18. Definitionof Done: How to Implement It
18
Task
Separate Tasks in
Iteration Backlog
Written & Printed
Lists
Central Online List &
Documentation
Tasks & Checklists for
Each Backlog Item
Story
29 Apr 2021 Copyright © 2021, Software.Process.Management

19. Definitionof Done: Identify Criteria & “Undone” Work
19
Definition of Done (Backlog Item)
 Code & tests checked in
 Unit tests complete & pass
 Integration succeeds
 …
Definition of Done (Increment)
 Installation packages available
 User documentation complete
 …
“Potentially Shippable” Criteria
 Code & tests checked in
 Unit tests complete & pass
 Code documentation complete+
 Integration succeeds
 …
 Installation packages available
 User documentation complete
 Marketing material complete+
 …
Identify Criteria for
“Potentially Shippable”
1
2 Derive Criteria of
Definition of Done
3 Remaining criteria (+) represent “undone”
work
29 Apr 2021 Copyright © 2021, Software.Process.Management

20. Definitionof Done: Reducing “Undone” Work
20
Agile Iteration
Potentially
Shippable
Product (PSI)
Accomplish Undone Work
Potentially
Shippable
Product (PSI)
Techniques for reducing the amount
of undone work:
 Automation
 Harmonization
 Environment
 Parallelization
 Cross-functionality
(Larman & Vodde, 2016)
29 Apr 2021 Copyright © 2021, Software.Process.Management

21. Definitionof Done: Include ”Undone” Work
21
Definition of Done (Backlog Item)
 Code & tests checked in
 Unit tests complete & pass
 Code documentation complete
 Integration succeeds
 …
Definition of Done (Increment)
 Installation packages available
 User documentation complete
 Marketing material complete
 …
“Potentially Shippable” Criteria
 Code & tests checked in
 Unit tests complete & pass
 Code documentation complete
 Integration succeeds
 …
 Installation packages available
 User documentation complete
 Marketing material complete
 …
Move Criteria to
Definition of Done
29 Apr 2021 Copyright © 2021, Software.Process.Management

22. BuildingUp ComplianceIncrementally
22
Develop
Achieve
Compliance
Develop
Build up compliance
incrementally:
Move more and more “undone”
work into the Definition of Done
Grow development capabilities to
enable this
29 Apr 2021 Copyright © 2021, Software.Process.Management

23. Scrum Teams Create the Definitionof Done
23
Product
Owner
Developers
Scrum
Master
Compliance
Manager
Definition of
Done
Scrum Team Compliance Management collaborates
with the Scrum Team(s) to ensure the
Definition of Done is appropriate for
regulatory compliance
29 Apr 2021 Copyright © 2021, Software.Process.Management

24. Types & Examplesof Definitionof Done Criteria
24
 Measurement data transmitted only via
secured channel
 Patient data kept separate from customer
record
 …
 Information security audit conducted
successfully
 Automated security tests passed
 …
 Data security checklist passed and
documented
 Data security tests passed
 …
Individual Nonfunctional Requirements
Statements
Institutionalized Procedures and Automated
Testing
Groups of Nonfunctional Requirements
(Checklists, Test Suites, etc.)
There are three basic types of criteria that a Definition of Done can contain, related to nonfunctional requirements
Examples: (Data Security & Privacy)
29 Apr 2021 Copyright © 2021, Software.Process.Management

25. BuildingUp ComplianceIncrementally
25
Develop
Achieve
Compliance
Develop
Develop
Definition of Done brings
compliance requirements and
associated work into agile
iterations
Eventually, the agile teams
integrate regulatory compliance
seamlessly into their daily work
routine
29 Apr 2021 Copyright © 2021, Software.Process.Management

26. Landscape of Practices:Compliance & Agile QMS
26
Agile Development
Test
Automation
Acceptance Testing
Definition of Done
Agile Improvement
Agile Release Train
(ART)
Requirements Tracing
Supplemental
Documentation
Solution
Intent
Backlog Constraints
29 Apr 2021 Copyright © 2021, Software.Process.Management

27. Contents
27
Building up compliance incrementally &
Agile QMS
Challenges of applying Agile in medical
device development
Important agile practices for medical device
development
Successfully establishing
Agile practices in MedTech
29 Apr 2021 Copyright © 2021, Software.Process.Management

28. EstablishPractices & ContinuousImprovement
28
Connect & collaborate with agile teams
Start with picking low-hanging fruit from where you stand
 Definition of Done is a good candidate
Improve continuously
 Conduct PDCA cycles (Plan – Do – Check – Act)
 Drive improvement by agile retrospectives
29 Apr 2021 Copyright © 2021, Software.Process.Management

29. 29
Summary

30. Summary
30
Infuse compliance into the work practices of agile teams
Build compliance incrementally based on
Definition of Done & reducing “undone” work
Instead of predefined work instructions:
Demonstrate compliance with traceable work products
and results
Develop
Achieve
Compliance
Develop
Develop
29 Apr 2021 Copyright © 2021, Software.Process.Management

31. Get Further Information
Associated White Paper
Agile Best Practices
for Medical Device
Development
EstablishAgile QMSand
Compliance
Download from Intland’s website
Follow-Up Webinar
Patterns of Agile Success in
Medical Device Development
Thursday 17 June 2021
3:00 PM (CEST) / 9:00 AM (EDT)
Sign up at Intland’s website
31
29 Apr 2021 Copyright © 2021, Software.Process.Management

32. Thank You!
32
Contact
Dr. Andreas Birk
Software.Process.Management
info@swpm.de
LinkedIn, XING
www.swpm.de
Blog & Resources: MakingOfSoftware.com
29 Apr 2021 Copyright © 2021, Software.Process.Management