Agile in MedTech: Essential Best Practices, and How to Support Them

Agilein MedTech:
Essentialbest practices,and howto supportthem
Atef Ghribi (Intland) & Dr. Andreas Birk (Software.Process.Management)
20 October 2021, MedConf 2021, Munich

Your Presenters & Authors
2
Atef Ghribi – Presenter
Solution Engineer & Technical Consultant
Intland Software GmbH
atef.ghribi@intland.com
Dr. Andreas Birk
Founder & Principal Consultant
Software.Process.Management
andreas.birk@swpm.de
Contact us via email, Xing, or LinkedIn

Contents
Challenges of Agile in MedTech
Best Practices for Agile in MedTech
 Definition of Done
 Building up Compliance Incrementally
 Requirements Traceability
 Hybrid Development
Landscape of Practices: Compliance & Agile QMS
Summary
3

MedicalDevices Today
4
+++ 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
5
Regulatory compliance Increasingly important role of
software
Combined hardware/software
development

Benefits of Adopting Agile
6
Ability to manage changing priorities 70 %
Business/IT alignment 65 %
Delivery speed / time to market 60 %
Project risk reduction 51 %
Software quality 46 %
Increased team productivity 58 %
Engineering discipline 44 %
Benefits realized by companies adopting Agile. (Multiple selections possible)
Source: 14th Annual State of Agile™ Report, Digital.ai, 2020. (https://stateofagile.com)

ExperienceReports of Agile Introductionin Healthcare
7
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] Publication date of case study / experience report with ID of
literature references (see presentation handout)

Best Practices for Agile in MedTech
8
Definition of Done Requirements Tracing
Hybrid Development
&
Incremental
Compliance among others …

Regulatory ComplianceRequirements
9
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, …

Requirements & Traceability
10
Market Requirement
User Story
Test Case
Test Run &
Test Result
Derived from
Derived from
Derived from
Capture how requirements are implemented
Track development status & progress
Integrate development information & assets
Meet regulatory compliance requirements
Objectives of Requirements Traceability
19 Oct 2021 Copyright © 2021, Software.Process.Management

11
Example for Requirements Decomposition
Leap to Test Management
11
19 Oct 2021 Screenshots from the tool codebeamerX by Intland Software

Definitionof Done
12
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
 Risk Evaluation conducted
 Tests confirm that radiation doses cannot
be exceeded
 …
Example Definition of Done
19 Oct 2021 Copyright © 2021, Software.Process.Management

Definitionof Done: How to Implement It
13
Task
Separate Tasks in
Iteration Backlog
Written & Printed
Lists
Central Online List &
Documentation
Tasks & Checklists for
Each Backlog Item
Story

Buildingup ComplianceIncrementally
14
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

Hybrid Development
15
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

Hybrid Development
16
16

Hybrid Development
17
17

Agile Practices That SupportRegulatory Compliance
18
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 Experience Reports from …

Landscape of Practices:Compliance & Agile QMS
19
Agile Development
Test
Automation
Acceptance Testing
Definition of Done
Agile Improvement
Agile Release Train
(ART)
Requirements Tracing
Supplemental
Documentation
Solution
Intent
Backlog Constraints

Summary
21
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 on Experiences and
Lessons Learnt
22
Download from Intland’s website
Additional Information
Unlocking the Power of Agile in
Medical Device Development
intland.com/agile-medical-development/
Access insights

Thank You!
23
Atef Ghribi
Solution Engineer & Technical Consultant
Intland Software GmbH
atef.ghribi@intland.com
Dr. Andreas Birk
Founder & Principal Consultant
Software.Process.Management
andreas.birk@swpm.de
Contact us via email, Xing, or LinkedIn

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).
28

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.
29
Whitepaper with Additional Details
intland.com/agile-medical-development/
Download from Intland’s website

Challenges ExperiencedWhen Adopting Agile
31
General organization resistance to change 48%
Not enough leadership participation 46%
Inconsistent processes and practices across teams 45%
Organizational culture at odds with Agile values 44%
Inadequate management support and sponsorship 43%
Lack of skills / experience with Agile methods 41%
Insufficient training and education 39%
Lack of business / customer / product owner availability 36%
Pervasiveness of traditional development methods 30%
Fragmented tooling and project-related data / measurements 29%
Minimal collaboration and knowledge sharing 22%
Regulatory compliance 16%
Challenges/barriers experienced when adopting and scaling Agile. (Multiple selections possible)

Agile Methods Used
32
Agile methodologies used. / Scaling methods and approaches applied in organizations.
Agile Methods Agile Scaling Approaches

Agile Maturityacross Companies
33
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.

Percentage of Teams Using Agile
34
Percentage of teams within company that have adopted Agile practices.
None of our teams
are Agile
Less than 1/2 of our
teams are Agile
More than 1/2 of our
teams are Agile
All our teams are
Agile

Details: Hybrid Development & Agile
QMS
35

Hybrid Development Capability
Hybrid development can offer more advantages than Agile alone
This is particularly true for complex domains like MedTech
Actively build and improve your capabilities to perform hybrid
development
Use agile practices that help managing hybrid development
constellations
e.g., Agile Release Train, Product Definition, Solution Intent
36
Non-Agile Agile
Interact & Coordinate
Obtain Input
Use & Maintain
Non-Agile Work Products
Deliver Output

Agile QMS
37
QMS
Organization
Agile
QMS
Team
Agile can integrate quality matters better into development than do plan-based QMS
Several agile practices support quality and regulatory compliance, for instance ...
Built-In Quality &
Compliance
Concepts from the Scaled Agile Framework (SAFe®)
Can provide a blueprint for agile QMS
Principle: Build solution & compliance incrementally
Agile Testing Many novel techniques & strategies for testing & QA
Brings many benefits for Agile product organizations
Examples: Test-First, Test Automation, Test-Driven Development
Definition of Done Quality criteria for work items & product increments
Agile teams define & evolve their Definition of Done
Leads to quality attitude & toolset that are rooted deeply in development team

Agile QMS
38
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)

Details: Building Compliance
Incrementally
39

BuildingUp ComplianceIncrementally
40
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

BuildingUp ComplianceIncrementally
41
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

Details: Agile Requirements
42

Scrum: The No. 1 Agile Method
43
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.

Regulatory ComplianceRequirements
44
Manage Compliance
Manage Quality
Quality
Management
Plan
Quality
Management
System (QMS)
Regulatory
Requirements
STD
Functional Product
Requirements
Product Constraints
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, …

Regulatory ComplianceRequirements: Agile Practices
45
Manage Compliance
Manage Quality
Quality
Management
Plan
Quality
Management
System (QMS)
Regulatory
Requirements
STD
Functional Product
Requirements
Product Constraints
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

User Story: Template& Example
46
< 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

ExtendedStory Template & NonfunctionalAspects
47
< 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

Details: Definition of Done
48

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
49

To Do Doing Done
Definitionof Done
50
Agile Iteration
Potentially
Shippable
Product
(PSI)
Definition of Done
Story Story Story
Definition of Done
 …

To Do Doing Done
Definitionof Done: BacklogItem vs. Iteration
51
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
 …

Definitionof Done: Identify Criteria & “Undone” Work
52
Definition of Done (Backlog Item)
 …
Definition of Done (Increment)
 …
“Potentially Shippable” Criteria
 Code documentation complete+
 …
 Marketing material complete+
 …
Identify Criteria for
“Potentially Shippable”
1
2 Derive Criteria of
Definition of Done
3 Remaining criteria (+) represent “undone”
work

Definitionof Done: Identify Criteria & “Undone” Work
53
 …
 …
 Code documentation complete+
 …
 Marketing material complete+
 …
Identify Criteria for
“Potentially Shippable”
1
2 Derive Criteria of
Definition of Done
3 Remaining criteria (+) represent “undone”
work

Definitionof Done: Reducing “Undone” Work
54
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)

Definitionof Done: Include ”Undone” Work
55
 Code documentation complete
 …
 Marketing material complete
 …
 Code documentation complete
 …
 Marketing material complete
 …
Move Criteria to
Definition of Done

Scrum Teams Create the Definitionof Done
56
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

Types & Examplesof Definitionof Done Criteria
57
 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)

Details: Findings from Case Studies &
Experience Reports
58

Case Studiesof Agile Introductionin Healthcare
59
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)

Benefits of Agile in Healthcare
60
“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

61
“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

62
“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
63
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)
Case study companies that have
reported the respective benefit
…
…
…

Agile AdoptionTimeline
64
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 Practices That SupportRegulatory Compliance
65
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 …

Philips [6]
Agile initiative involving …
 28 Businesses
 50 locations
 4000+ Engineers
Agile is for Everyone
66
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
67
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
68
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)

Details: Requirements Tracing, Agile
Testing & Tool Support
69

70
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

Agile Testing & Test Automation
71
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/

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”
72

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