Strategies to limit project timeline and cost in medical devices

Integrated Computer Solutions Inc. www.ics.com
Strategies to Limit Project Timeline
and Cost in Medical Devices
Milton Yarberry
Director of Medical Devices
1

Context
Perspective
● Software consulting for medical devices
● Medical device manufacturer
● Startups and major medical
manufacturers
● Class II, Class III
● ICS collective experiences
Assumes
● The basics
● Design Controls
● SDLC
● Risk Management
Optimization
● Software Development
● Project management
● Design Controls
2

Medical Device Development – Budget & Schedule
● Design Controls & Quality – 21 CFR 820.30, ISO 13485
● Design risks  Budget and Schedule
● ASSERTION: Biggest risk to budget & schedule in MD development is managing change
3

Development Change Categories
What is changed
● Product Requirements (what)
The device shall provide a means to silence an alarm temporarily
without disabling the alarm.
● Design Requirements (how)
When an alarm is triggered, the device shall show a pop-up with
alarm description and an alarm pause button
When an alarm is paused, a 2 minute countdown timer will start to
resume the alarm
● Technology (implementation)
APIs
Component threading
Audio driver
UI layer behaviors
Who changes it
● User related change
● End user (clinicians)
● Customer stakeholders (IT, Finance,
Service, Quality)
● Environment related change
● Competition
● Financial
● Regulatory
4

Medical Device Development – Budget & Schedule
● Design Controls & Quality – 21 CFR 820.30, ISO 13485
● Design risks  Budget and Schedule
● ASSERTION: Biggest impact to budget & schedule in MD development is managing change
5

The Cost of Change
6

Seven Strategies to Reduce Budget and Schedule
1) Design changes early
2) MVP & Roadmap
3) Front-load systemic change
4) Accelerate schedule at the start
5) Tune you QMS to support your development process
6) Avoid design procrastination
7) Take credit for design evolution
7

Design Changes Early – FAIL FAST
● Iterate on prototypes before design controls
● Controversial features
● Workflow validation
● Much harder to change later  leads to compromises
● Design Usability First
● Use Errors are upstream almost everything else
● Can impact: database, control systems software, communication rates, sensor accuracy
requirements, system processing power
8

Using UX to Feed Development
9
21 CFR 820, ISO 13485 - Design Control and QMS
DEFINE & ANALYZE
RAPID SOFTWARE
PROTOTYPING
IEC 62366 - Human Factors and Usability Standard
FORMATIVE STUDIES
CONVERT TO FRONT END
APPLICATION
FRAMEWORK
DEVELOP BACK END
SOFTWARE
● User research
● Functional analysis
● Task analysis
● Hazard analysis
● Design specifications
● User interface design with
Industry leading tools
● Quick, efficient product
realization
● UX Specification
● High Fidelity Prototyping
● Early, inexpensive, design
modification
● UI Definition, Summative
Criteria
● Documented support for
FDA’s HFE/UE report
● Application Framework
● Built in software
architecture
● Framework Unit Tests
Product Requirements
Software and System
Specifications
Verification and
Validation
FDA Submission

MVP & Roadmap
● Minimum Viable Product (MVP)
● Minimally cover the intended use / indications for use
● Post submission and waiting for clearance,…
● Roadmap non-MVP features
● !! but account for with front-loaded preliminary evaluation
● V1.1 - Non-critical features  Letters to file
10

But, Front-Load Systemic Change
Do preliminary evaluation of key areas that can cause system change
• Usability
• Workflow
• Use Errors
• Cybersecurity
• TPM
• Hardware acceleration
• Hidden keys
• Compartmentalization
• Cyber-MVP
• Safety
• Fail safely
• Fail conditions
• Recovery
11

Accelerate schedule at the start
● Artificial deadline concept
● More than just a hedge – risk management and execution dynamics
● Easier to slow down than speed up
● Discover risks earlier  more reaction time
● More effective than accelerating at the end
● Hard areas – swarm early or use a specialist
12

3 Person-Year Project Estimated to be 2 Years
13
Burndown Chart

Tune Your QMS to Support Your Development Process
● Deliberate timing of Design Controls
● Isolate exploring from designing
● Testing internal interfaces
● Big Bang engineering
● Use your requirements (don't review them frequently)
● Use design reviews
● Put your processes in your tools
14

Avoid design procrastination
● Why?
● Design ambiguity is expensive
● Undermines organizational focus
● Engineering uncertainty
● “Leaving a hole” – staring at the hole.
● Adjacent areas affected.
● Uncertainty about the size of the hole
● Are we done? When is the decision official?
● Software and system engineering  tightly coupled dependencies
● Agile ‘defer decisions till the last responsible minute’
● Schedule and budget variability strongly correlate with ambiguity
● How?
● Early and extensive prototyping
● Road-mapping changes if needed
● Evaluate deferral vs. remediation
15

Usability Detailed Workflow
● User workflow by screen
● Six moderately complex screens
16

Detailed UI Prototype – Impact on Schedule
17
Prototype Design/development V&V
Redesign Bug fix
Estimated
Typical
Detailed Prototype
Draft
• MVP
• Use cases
• Workflows
Early draft
• Exception cases
• Error handling/recovery
• Hazard Analysis

Detailed Prototypes – Fringe Benefits
● Shortened: design, redesign, defects
● UI design documents
● HFE/UE collateral
● Better project estimation
● Organizational focus
● Jumpstart on development
● Enable V&V earlier (smaller team)
● Fund raising collateral
18

Take Credit for Design Evolution
● Standardizing design process early  less ‘rework’ design artifacts
● Reviews happen, decisions are made  lightweight capture
● Design Controls as an asset not overhead
19

Using UX to Feed Development
20
21 CFR 820, ISO 13485 - Design Control and QMS
DEFINE & ANALYZE
RAPID SOFTWARE
PROTOTYPING
IEC 62366 - Human Factors and Usability Standard
FORMATIVE STUDIES
CONVERT TO FRONT END
APPLICATION
FRAMEWORK
DEVELOP BACK END
SOFTWARE
● User research
● Functional analysis
● Task analysis
● Hazard analysis
● Design specifications
● User interface design with
industry standard tools
● Workflows  usage
● Quick, efficient product
realization
● UX Specification
● High Fidelity Prototyping
● Early, inexpensive, design
modification
● UI Definition, Summative
Criteria
● Documented support for
FDA’s HFE/UE report
● Application Framework
● Built in software
architecture
● Framework Unit Tests
Product Requirements
Software and System
Specifications
Verification and
Validation
FDA Submission

Seven Strategies to Reduce Budget and Schedule
1) Design changes early
2) MVP & Roadmap
3) Front-load systemic change
4) Accelerate schedule at the start
5) Tune you QMS to support your development process
6) Avoid design procrastination
7) Take credit for design evolution
21

Thank you.
22

Strategies to limit project timeline and cost in medical devices

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