Dr. Andreas Birk: Patterns of Agile Success in Medical Device Development

Patternsof AgileSuccessin
MedicalDeviceDevelopment
Dr. Andreas Birk, Software.Process.Management
17 June 2021, Webinar for Intland Software
Provided in collaboration
with Intland Software

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

Key Questionsof ThisWebinar
3
What benefits does Agile provide to healthcare product development?
What proven best practices contribute to successful implementation of Agile?
What important experiences do healthcare companies report?

Contents
4
Benefits of Agile in Healthcare
Key Agile Success Strategies
Overcoming
Regulatory Challenges
Agile Perspectives for MedTech

MedicalDevices
5
+++ Components +++ Components +++ Components +++ Components +++ Components +++
+++ Interconnected Systems +++ Interconnected Systems +++ Interconnected Systems +++
+++ Value-Added Services +++ Value-Added Services +++ Value-Added Services +++

Development of MedicalDevices: Unique Challenges
6
Regulatory compliance Increasingly important role of
software
Combined hardware/software
development

Scrum: The No. 1 Agile Method
7
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.

Agile Maturityacross Companies
8
4%
No Agile initiatives
6%
Considering an Agile
initiative
20%
Experimenting with
Agile in pockets
5%
Agile practices are
enabling greater
adaptability
54%
Use Agile practices
but still maturing
11%
High level of
competency with
Agile practices across
the organization
84% Journey to Agile not yet started or still ongoing
Levels of competency with Agile practices in organization.
Source: 14th Annual State of Agile™ Report, Digital.ai, 2020. (https://stateofagile.com)

Case Studiesof Agile Introductionin Healthcare
9
Abbott Laboratories
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
GE Healthcare
Siemens
Healthineers
Philips
[1]
[3]
[5]
[4]
[6] [7][8]
New product generation development
project
Product development organization
Product line development organization
Global development organization across
various business areas
Scope of Agile Initiative
Legend: Reported core phase of agile initiative
Reported agile development preceding the agile initiative, or
its continuation
[n] Case study publication date with ID of literature references
(see presentation handout)

10
“While we've only just begun our journey, we've seen positive results
already.
Getting feedback early and frequently from customers has let us prioritize
features correctly [...]
We've seen much more transparency and accountability among our teams.”
GE case study [3]
Early customer feedback
Customer mindset
Transparency
Accountability
Speed
Time savings
Cost savings
Predictability
Quality
Team morale
Benefit statements from the case studies

11
“Progress within the project was highly transparent from an early stage and
we [reached] our planned milestones.”
Siemens case study [5]
“Average release cycle time down from 18 months to
6 months”
“Feature cycle time reduced from >240 to <100 days”
Philips case study [7]
Customer mindset
Transparency
Accountability
Speed
Time savings
Cost savings
Predictability
Quality
Team morale

12
“Better work-life balance and team morale”
Abbott case study [2]
“more interesting work [… , higher] team spirit [… , and] over hours
decreased”
Customer mindset
Transparency
Accountability
Speed
Time savings
Cost savings
Predictability
Quality
Team morale

Benefits of Agile across Industries
13
1. Ability to manage changing priorities 70 % [G] [S]
2. Project visibility 64 % [G] [S]
Delivery speed / time to market 60 %
4. [A] [P]
Team morale 59 %
5. [A] [S]
Increased team productivity 58 %
6. [S]
Project predictability 50 %
8. [P] [S]
Software quality 46 %
9. [A] [P]
Project cost reduction 26 %
13. [A]
Benefits realized by companies adopting Agile, their rank and percentage of answers (multiple answers possible; selected results)
Source: 14th Annual State of Agile™ Report, Digital.ai, 2020. (https://stateofagile.com)
Case study companies that have
reported the respective benefit
…
…
…

Contents
14
Overcoming

Continuously
Improve & Evolve
Conduct Rollout
Plan & Prepare
Rollout
Agile AdoptionPhased Approach
15
Conduct Pilot
Project
Collect & Analyze
Available Agile
Experience
Important Activities:
 Attain management commitment & support
 Plan & prepare rollout activities
 Establish roles & organizational structures
 Train the organization affected by rollout

Agile AdoptionTimeline
16
Minimum and maximum durations of the core agile adoption phases at the case study companies
Durations depend on complexity and timeline of development projects, size and context of development organization, intensity of
preparation measures like training, and scope of agile initiative
1
9 months
6 months 6 months
18 months
9 months
Pilot Rollout Preparation Rollout
Total: 11 months
Total: 36 months
t

Agile Teamwork
Team-level approach most widespread: Scrum – other prominent approach: Kanban
Key: Cross-functional feature teams
Implementation of agile teams: Establish new roles and adapt organization
Embed agile teams into suitable organizational structures and processes: SAFe®, LeSS etc.
17

Scrum: The No. 1 Agile Method
18
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.
Scrum Focus
 Team-Level
 Coordination within Self-
Organizing Team

Cross-Functional Feature Teams
19
Product
Backlog
Product Owner
Feature Team
Cross-Functional Cross-Component
Stable & Long-Lived
Potentially
Shippable
Increment
(PSI)
Customer-
Centric
Feature
The team has the necessary knowledge and skills to complete a customer-centric feature end-to-end.
If not, the team is expected to acquire the needed knowledge and skills.
Source: C. Larman and B. Vodde, Large-scale Scrum: More with LeSS. Upper Saddle River, NJ: Addison-Wesley, 2016.

Component Teams vs. Feature Teams
20
Source: C. Larman and B. Vodde, Large-scale Scrum: More with LeSS. Upper Saddle River, NJ: Addison-Wesley, 2016.
Product
Owner
Product
Backlog
Item 1
Item 2
Item 3
Item 4
…
Component A
Team
Component B
Team
Component C
Team
Component A
Component B
Component C
System
Component Teams
Product
Owner
Product
Backlog
Item 1
Item 2
Item 3
Item 4
…
Red
Team
Green
Team
Blue
Team
Component A
Component B
Component C
System
Feature Teams

Agile Testing & Test Automation
21
Unit Tests
Components Tests
Functional Tests
Examples
Story Tests
Prototypes
Simulations
Exploratory
Scenarios
Usability Testing
User Acceptance Testing
Alpha/Beta
Performance Testing
Load Testing
Security Testing
“-ility” Testing
Q3
Q2
Q1 Q4
Business Facing
Technology Facing
Supporting
the
Team
Critiquing
the
Product
Manual
+ Automation
Automation
+ Manual
Automation Specialized Tools
Based on: L. Crispin and J. Gregory, Agile testing: A practical guide for testers and agile teams. Amsterdam: Addison-Wesley Longman, 2008.
And based on suggestions by Brian Marick: B. Marick, “My Agile testing project,” Exampler, Aug 21, 2003. http://www.exampler.com/old-blog/2003/08/21/

Requirements & Traceability
22
Market Requirement
User Story
Test Case
Test Run &
Test Result
derive
derive
derive
Capture how requirements are implemented
Track development status & progress
Integrate development information & assets
Meet regulatory compliance requirements
Objectives of Requirements Traceability

ToolSupport
Agile ALM tool bridges artifacts from product requirements via software requirements to
user stories, each with associated test cases
Omnyx case study [9]
Automated integration, testing and deployment provide rapid feedback on system quality
“improve processes and tools that have too many interfaces or too much overhead”
23

Contents
24
Overcoming

Agile Practices That SupportRegulatory Compliance
25
Definition of Done
Hybrid development
Testing
Important Practices
GE [3], Siemens [4]
GE [3], Siemens [4]
Abbott [1], GE [3], Philips [6], Siemens [4]
Emphasized in Case Studies …

Definitionof Done
26
Agile Iteration
Potentially
Shippable
Product (PSI)
To Do Doing Done
Definition of Done
Story Story Story
Definition of Done
 Code & tests checked in
 Unit tests complete & pass
 Integration succeeds
 …
Example Definition of Done

Hybrid Development
27
Non-Agile Agile
&
combined
Non-Agile Agile
Interact & Coordinate
Obtain Input
Use & Maintain
Non-Agile Work Products
Deliver Output
Hybrid development can offer more advantages than Agile
alone
This is particularly true for complex domains like MedTech

Contents
28
Overcoming

Philips [6]
Agile initiative involving …
 28 Businesses
 50 locations
 4000+ Engineers
Agile is for Everyone
29
Organizations of all sizes Combined hardware/software development
Omnyx [9]
 Founded in 2008
 Scrum from ground up
 Tripled staff in 2009
Abbott Laboratories Case Study [1]
Software for medical devices
Trend: Agile Hardware Development
E.g., see Scrum in Hardware Guide [10]
Internet of Things (IoT) / Networked Devices
New software functionality for traditional hardware
product categories

DevOps & ContinuousDelivery
30
Production Environment
or Customer Site
Development Environment
Code
Repository
Code
Change
Trigger
Continuous Integration
Integrate – Build – Test
Continuous
Delivery
Continuous Deployment
Automate / Speed up / Increase Frequency of Releases
Developer Customer
or User
The advantages of this approach are that one has faster time-to market, higher quality, lower risk, better
predictability, less manual effort (through more automation and fewer variants), and more flexibility to
changes.
(Giorgi & Paulisch, 2019)

Agile QMS
31
QMS
Organization
Agile
QMS
Team
Agile can integrate quality matters better into development
than plan-based approaches
Cornerstones of Agile QMS
 Pervasive focus on customer and business value
 Personal engagement for quality
 Early testing for fast learning
 Real-time data and open systems
 Prevention, risk management, and systematic
improvement
 Quality competence throughout the organization
(Stelzhammer & Wolter, 2017)

32
Summary

Summary
33
Agile has significant advantages over
plan-based approaches
The path to Agile is well-explored and safe
Established agile practices comply with healthcare
regulations

Get Further Information
Associated White Paper
Agile Success Stories
in Healthcare
Build onExperiences and
LessonsLearnt
Download from Intland’s website
Related Webinar
Approaches to Agilein
Medical Device Development
Thursday 8 July 2021
3:00 PM (CEST) / 9:00 AM (EDT)
Sign up at Intland’s website
34

Thank You!
35
Contact
Dr. Andreas Birk
Software.Process.Management
info@swpm.de
LinkedIn, XING
www.swpm.de
Blog & Resources: MakingOfSoftware.com

Literature References (1/2)
Abbott Laboratories Case Study
[1] R. Rasmussen, T. Hughes, J. R. Jenks, and J. Skach,
FDA Regulated Environment,” in Proceedings of the 2009 AGILE
pp. 151–155.
[2] R. Rasmussen, T. Hughes, J. R. Jenks, and J. Skach,
FDA Environment: An Experience Report,” presented at the
Aug 24-28, 2009, Chicago, IL.
GE Case Study
[3] A. Deitsch and R. Hughes, “GE Healthcare Goes Agile,”
Dec 02, 2010.
Siemens Healthineers Case Study
[4] A. Heck, “Big and distributed agile product development in
industry: Learnings from the first project,” presented at the 13th
Conference, XP 2012, Malmö, Sweden, May 21-25, 2012.
[5] A. Heck, “Scrum in a medical technology environment,” in
guide for software quality assurance in the agile world, Santa
Nook, 2014.
Philips Case Study
[6] S. Venkatasubramaniam, “Agile: A peek into Philips agile
transformation,” presented at the Regional Scrum Gathering
South Asia 2015, Jun 5-6, 2015, Bengaluru, India.
[7] S. Jagadeesan, “Scaled Agile transformation journey in
PHILIPS,” Oct 14, 2016.
https://www.linkedin.com/pulse/scaled-agile-transformation-
journey-philips-sundaresan-jagadeeesan/ (accessed May 27,
2021).
[8] Scaled Agile, “Case Study - Royal Phillips,” Scaled Agile
Framework. https://www.scaledagileframework.com/royal-
phillips-case-study/ (accessed May 27, 2021).
Omnyx Case Study
[9] M. Meissner, “Building an Agile Culture in a Regulated
Environment,” Agile Alliance Experience Report, 2011.
https://www.agilealliance.org/resources/experience-
reports/building-an-agile-culture-in-a-regulated-
environment/ (accessed May 09, 2021).
36

Literature References (2/2)
Other References
[10] Scrum Inc., “Scrum in Hardware Guide.”
hardware-guide/ (accessed May 27, 2021).
[11] F. Giorgi and F. Paulisch, “Transition towards Continuous
Healthcare Domain,” in Proceedings of the 41st International
Engineering: Software Engineering in Practice, Montreal,
253–254.
[12] M. Stelzhammer and O. Wolter, “Agiles
Wie wir künftig Qualität managen,” in
Handlungsempfehlungen, Best Practices, 2nd Ed., Wiesbaden,
Fachmedien, 2017, pp. 463–474.
37

Dr. Andreas Birk: Patterns of Agile Success in Medical Device Development

Dr. Andreas Birk: Patterns of Agile Success in Medical Device Development

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