Dr. Andreas Birk: Approaches to Agile in Medical Device Development

Approachesto Agilein
MedicalDeviceDevelopment
Dr. Andreas Birk, Software.Process.Management
4 March 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
04 Mar 2021 Copyright © 2021, Software.Process.Management

Contents
3
Does Agile contradict regulated
product development?
Advantages of Agile for medical
device development
Challenges of Agile adoption in
MedTech environments
Agile success strategies for medical
device development

MedicalDevices
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

Cornerstones of Regulatory Compliance
6
Many different constraints & requirements
Each organization must define its own specific response
Foundation: Quality Management Systems & risk management

Common Conceptionsof Agile: Scrum
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 Manifesto
… we have come to value:
8
Source: https://agilemanifesto.org
Individuals and interactions over processes and tools
Working software over comprehensive documentation
Customer collaboration over contract negotiation
Responding to change over following a plan

Agile Principles
Principles behind the Agile Manifesto
Our highest priority is to satisfy the
valuable software
Agile processes promote sustainable
Continuous attention to technical excellence
design [...]
"At regular intervals, the team reflects on
more effective, then tunes and adjusts its
accordingly"
SAFe® Lean-Agile Principles
Build incrementally with fast, integrated
learning cycles (Principle #4)
Base milestones on objective evaluation of
working systems (#5)
Apply cadence, synchronize with cross-
domain planning (#7)
9
Source: https://agilemanifesto.org/principles.html
Source: https://www.scaledagileframework.com/safe-lean-agile-
principles/

Contents
10
device development
device development

Benefits of Adopting Agile
11
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)

Contents
12
device development
device development

Challenges ExperiencedWhen Adopting Agile
13
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)

Challenges of Agile Adoptionin MedTech
Regulatory compliance
Combined hardware/software development
The agile adoption itself: “journey to agile”
14

Contents
15
device development
device development

Agile Success Strategies
Manage your transition to Agile
Acquire the ability for hybrid development
Build an agile QMS
16

Agile Methods Used
17
Agile methodologies used. / Scaling methods and approaches applied in organizations.
Agile Methods Agile Scaling Approaches

Agile Maturityacross Companies
18
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.

Transitionto Agile
19
Two Fundamental Approaches for Starting with
Agile
Start with baseline
setup
Start from where you
are
e.g., Kanban, LeSS
e.g., Scrum, SAFe®
Self-organizing teams / organizations
Continuous optimization & improvement
Use improvement practices
built into agile methods
e.g., retrospectives, systems thinking
General Principles for
Applying & Evolving Agile

Percentage of Teams Using Agile
20
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

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
21
Non-Agile Agile
Interact & Coordinate
Obtain Input
Use & Maintain
Non-Agile Work Products
Deliver Output

Agile QMS
22
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

Unlock the Power of Agile
24
Agile can significantly advance medical device development
Agile must be actively managed to satisfy compliance requirements
Transition to Agile Agile QMS
Hybrid Development

Get Further Information
Associated White Paper
Approaching Agile in
Medical Device
Development
Unlock thePowerof Agile in
RegulatedEnvironments
Download from Intland’s website
Follow-Up Webinar
Agile Practices for
Medical Device Development
Thursday 29 April 2021
3:00 PM (CEST) / 9:00 AM (EDT)
Sign up at Intland’s website
25

Thank You!
26
Contact
Dr. Andreas Birk
Software.Process.Management
info@swpm.de
LinkedIn, XING
www.swpm.de
Blog & Resources: MakingOfSoftware.com

Dr. Andreas Birk: Approaches to Agile in Medical Device Development

Dr. Andreas Birk: Approaches to Agile in Medical Device Development

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Dr. Andreas Birk: Approaches to Agile in Medical Device Development