Medical device companies need to be adept at managing product changes to meet the increasing challenges of software-intensive, connected medical devices, including dealing with greater complexity, frequent changes, and cybersecurity issues.

1. Embracing Change:
Modern Management of
Connected Medical Devices
Aaron Joseph
Principal Consultant - Sunstone Pilot, Inc.
sunstonepilot.com
Presented to MedTech Fron4ers – March 7, 2019
h@p://www.tripleringtech.com/category/medtechfronHers/
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2. Aaron Joseph
Principal Consultant – Sunstone Pilot, Inc.
• 20+ years medical device development over a wide range of products:
• surgical roboHcs system, digital x-ray fluoroscopy system, drug inhaler devices, roboHc
catheter system, x-ray catheter for brachytherapy, laser eye surgery system, and heart-lung
bypass machine, mulHple IOT products
• >50 product development projects and >25 quality systems
• Assist clients with all aspects of design controls: risk management,
requirements management, V&V tesHng, refining design controls procedures,
and training R&D staff
• Implement requirements management tools to streamline DHF documentaHon
• Avid promoter of lean and agile methods for medical device development
• BSEE - Rice University and MS Bioengineering - University of Washington
2 Copyright 2019 Sunstone Pilot, Inc. 7-MAR-2019

3. Outline
1. Challenge of SW-intensive, connected medical devices
2. Design controls and tradiHonal product development process
3. Changes aber product launch
4. Minimizing cost of design changes
5. Sobware patching and cybersecurity
6. Q&A
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4. New CapabiliFes à New Challenges
• More features à greater complexity, more
sobware components, more 3rd party sobware
• Connected à cybersecurity risks, privacy risks,
interoperability challenges
+ Greater regulatory scruHny!
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5. Example Connected Medical Device
Firmware on
watch
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• Wearable device + mobile app + cloud
• Heart monitor + analysis of other paHent data
• Distributed architecture with mulHple sobware plaiorms
Mobile app on
smart phone
Data analysis and storage on
cloud plaiorm
Browser or client app
on laptop

6. EscalaFng Cost of Change
Cost of Change
Product Launch
Product Development Timeline
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Concept Pre-Produc4on Produc4on
?
Where is the design freeze?
How are changes handled aber design freeze?
Or aber product launch?

7. Design Controls and
Product Development
Developing products in a highly regulated environment
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8. Design Controls
Establish and maintain procedures for…
1. Design and Development Planning – selng up for success
2. Design Input – what does the product need to do?
3. Design Output – what the product is
4. Design Verifica4on – does output conform to input?
5. Design Valida4on – does product meet user needs?
6. Design Review – are we on the right path?
7. Design Changes – improving product
8. Design Transfer – gelng new product into manufacturing
9. Design History File – how we ended up with the current product (also: shows
we did all of the above)
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ß Involves all the other aspects of design controls

9. Product Development in Phases
3
Verifica4on
4
Pre-Produc4on
5
Produc4on
0
Concept
510k submission
Product Launch
GATE
GATE
1
Planning
2
Development
GATE
GATE
-Product
development
planning,
-Hazard Analysis,
-Requirements &
architecture
-Regulatory
strategy
Mfg
Process
valida4on
+
Launch
readiness
-HW & SW design,
-Detailed Risk Analysis,
-Prototyping
-Test method
development
-Mfg process development
-Design freeze
-Design verifica4on
-Mfg process
development
-Clinical tes4ng,
-Human factors
tes4ng
-Prepare
submission
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DHF documents

10. Product Development Finished (?)
3
Verifica4on
4
Pre-Produc4on
5
Produc4on
0
Concept
Product Launch
1
Planning
2
Development
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What does “Product Launch” really mean?
• product development team view = “All done!”
• company view = How can we lower mfg costs and increase sales?
• customer view = “just the baseline product that needs improvement”
à New set of challenges aber launch

11. Changes aLer Product Launch
Wait, I thought we were done!
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12. Hardware vs. SoLware
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What are typical changes
aber product launch?
Hardware-Only Device So[ware-Intensive Device
• Changes to packaging / labeling
• Changes to component suppliers
• Refinements to mfg process steps
(same)
• SW changes due to updated OS or 3rd party library
• SW changes to maintain interoperability
• SW changes to address security vulnerability
• Changes to GUI or other funcHons
• AddiHonal features
Ex: intravascular
catheter
VS
Not
planned

13. Product Design Changes
• How does a medical device company manage changes to a released
product?
• Changes can be internally driven (planned enhancements) or externally
driven (customer complaints, security issues, interoperability issues, etc.)
• Changes can be urgent or non-urgent
• Changes to product can be small or big
• What’s the best way to handle a wide variety of possible changes?
• Is the company even set up to handle changes?
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14. Example Triage of Design Changes
Process scaled appropriately to different types of changes
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Sobware Patch
Small?
Manage through rouHne
change process (ECO)
No
Yes
Big ?
No
SW
only?
Major Project: repeat all design controls
Yes
Change Needed*
Yes
3
Verifica4on
1
Planning
2
Development
4
Pre-Produc4on
Product Re-Release
Criteria to evaluate design changes (not exhausHve):
• New product feature?
• New hazards or risks?
• New regulatory filing?
• Large performance change?
• Major or minor change to requirements?
Minor Sobware Project
(SW design controls)
Minor Project (HW & SW):
repeat some design controls
No
No change to SW reqts
SW Release
*part of a larger change review process (i.e. involving a Change Review Board)

15. ImplemenFng Changes & UpdaFng DHF
• Problem: users repeatedly press wrong bu@on on watch
• SoluHon: change GUI on watch and GUI on phone (minor SW Project)
• New SW Project:
• Update DHF docs: SW Dev Plan, Risk analysis, SW reqts, SW design, SW test cases
• Revise sobware (in watch, in mobile app)
• Perform tesHng of modified sobware + regression tesHng
• Update DHF docs: SW reports, SW trace matrix, SW release docs
• Sobware release
• SW release candidate à SW release à product release
NOTE: Any change to the product SW is a new SW release, including small patches
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Key Tools: task mgmt / defect tracking tool, requirements mgmt tool, test mgmt tool, SW configuraHon mgmt tool

16. Minimizing cost of design
changes
Corollary: prepare for change!
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17. Minimize Cost of Design Changes
• Flexible development processes (scale to size and type of changes)
• Short review/approval cycles (days not weeks)
• Well-defined SW configuraHon and release process (“turn the crank”)
• Product designed for upgradeability (modular architecture, well-
defined interfaces, secure SW patching, etc.)
• Automated sobware tesHng
• Automated documentaHon (via requirements mgmt / ALM tool)
NOTE: These measures apply primarily to sobware changes (more difficult to minimize cost of
hardware changes)
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18. Agile Cycles and Design Planning
Sprint Plan
Release Plan
Project Plan
• Design controls are organized around mulHple
cycles (layers)
• Project = one or more Releases
• Release = one or more Sprints
• Planning performed at all layers
• Regular updates to DHF documentaHon
18
SW Projects are controlled by a Sobware Development Plan:
• Defines all acHviHes and deliverables for project compleHon
• IdenHfies dependencies with other funcHons for product
release (Regulatory, Mfg, Clinical Training, Service, etc.)
• Enables team to scale to small or big SW projects
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19. Managing SW Development by Project
19
R1 Release
SW Development Plan SW Maintenance
3 key acHviHes:
• SW verificaHon
• Document updates
• Design review
R1 candidate
S6 S7 S8
sprints
Working SW
from each sprint
S9 S10
R2 Release
R2 candidate
. . .
S13
R3 Release
R3 candidate
. . .
Commercial Release
V1.0 V1.1 V1.2
P1
P1 Release
P1 patch
V1.2.1
. . .
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20. SoLware Patching and
Cybersecurity
Product End-of-Life may be determined by security vulnerabiliHes
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21. Monitoring (Product Surveillance)
• Customer complaint handling
• Incident response
• Bug fixes
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What to look for?

22. Inputs to SoLware Defect Tracking – Post Release
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Evaluate
SW Issue
Engineering Test
Clinical Test
Product Logs
Customer Feedback
Changes in SOUP
SQA
SW
change needed
now?
Keep issue for
next SW release
Evaluate SW
Change
• Safety impact?
• Regulatory impact?
• Fits within a maintenance patch?
Implement SW Change:
• Revise SW
• Test SW change + regression tests
• Other tests
• Update DHF/RMF
• Release SW
No
Yes
Changes to environment
(interoperability)
Cybersecurity Vulnerability

23. SoLware Patches
• Patches released in response to:
• Minor bug fixes
• Security issues
• OS / 3rd Party sobware upgrades
• Design new products for patching
• Secure, remote (over-the-air) sobware upgrades
• Consider designing 2 means of patching in case one
becomes vulnerable in the future
• Establish a cadence of SW patches to manage all
non-urgent changes
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24. Cybersecurity VulnerabiliFes Discovered Frequently in Medical Devices
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h@ps://mdviper.org/ics-cert-vulnerability-alerts-advisories/ (from MDISS website)

25. Security Management
• Support security across the full product life cycle:
secure by design + patching + monitoring + replacement
• Monitoring of cybersecurity threats (reports)
• Customer complaint handling
• Incident response
• Define responsibiliHes for product maintenance before product
launch
• Patch management
• Well-defined process with trained individuals to be able to execute
rapidly when needed
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26. Security Management
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3
Verifica4on
4
Pre-Produc4on
5
Produc4on
0
Concept
Product Launch
1
Planning
2
Development
Secure by design
• SW coding standards
• Vulnerability scanning
• SW upgradeability
• PenetraHon tesHng
Secure in use
• Monitoring
• Complaint handling
• Incident response & evaluaHon
• SW patching

27. Summary
“A bad system will beat a good person every Hme.” – W. Edwards Deming
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28. Managing Cost of Change
Cost of Change
Product Launch
Product Development Timeline
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Concept Pre-Produc4on Produc4on
Avoid inflaHng cost of change due to
inappropriate design control procedures
Set up processes and tools to:
(1) minimize cost of change* aber launch and
(2) get benefits before launch
*SW changes only

29. Slow Can Be Dangerous!
• The risks of responding slowly to a needed change (heart monitor):
• Unhappy customers ($)
• CommunicaHon failure—delayed diagnosis
• Malicious a@ack—incorrect data leading to incorrect prescripHon leading to
paHent harm
• For other devices, the risks can be even greater!
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30. Processes Prepared for Change
• Agile methods for product development
• Design iteraHons are expected during development (and aber product launch)
• Design controls are not forced to be sequenHal (don’t create a “waterfall” framework)
• MulHple iteraHons of risk management, design inputs, design outputs, V&V tesHng
• ConHnuum of product knowledge: development à sustaining
• Streamlined compliance
• Minimize delays in review, approval, and release
• Eliminate redundant records
• Centralized issue tracking (not compartmentalized)
• Test automaHon
• DocumentaHon automaHon
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31. Summary
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• Companies that are adept at managing product design changes:
• faster at product development
• be@er at post-market maintenance
• => longer product life!
• MulHple external factors can drive SW changes aber product launch
• Ensuring product safety and effecHveness:
• Old paradigm: prevenHng change
• New paradigm: responding to change

32. Suggested Online Resources
Background on managing highly iteraHve product development:
• h@ps://www.youtube.com/watch?v=502ILHjX9EE - Agile Product Ownership in a Nutshell – a short, animated descripHon of
scrum in operaHon by Henrik Kniberg
• h@ps://less.works/ - Large Scale Scrum (LeSS) framework for large scale projects
• h@p://www.scaledagileframework.com/ - a management system for large scale projects (SaFE)
• h@p://www.leanprimer.com/downloads/lean_primer.pdf - good overview of lean principles wri@en by two sobware
management consultants (Craig Larman and Bas Vodde) who include aspects of sobware agile methods as well.
Cybersecurity for connected medical devices:
• FDA Cybersecurity Guidances
• h@ps://www.fda.gov/medicaldevices/digitalhealth/ucm373213.htm
• h@ps://www.fda.gov/downloads/medicaldevice/deviceregulaHonandguidance/guidancedocuments/ucm482022.pdf
• Product Security Framework and security templates from the BD company website:
• h@p://www.bd.com/en-us/support/product-security-and-privacy
• NIST Cybersecurity Home Page with “Cybersecurity Framework”
• h@ps://www.nist.gov/topics/cybersecurity
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33. Q & A
Aaron Joseph
• Streamlined compliance for medical device development
• Assist clients with all aspects of design controls: risk management, requirements
management, V&V tesHng, refining procedures
• Contact me to schedule a Lunch & Learn or training session for your team:
• aaronanswers@gmail.com
• 408-529-2490
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