This document discusses balancing feasibility and design control phases of medical device development. It provides strategies to reduce regulatory, technical, and safety risks, including employing tools like risk signal charts during feasibility to identify issues before design controls. Examples are given of when design controls may be started too early or late. Best practices are discussed for optimizing budgets and schedules by strategically initiating design controls at the right time.

1. FLIPPING THE SWITCH
Balancing Late Feasibility and Early Design Controls

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3. Flipping the Switch
ChadGibson JamisonFloat
Introductions

4. Flipping the Switch
Topics
Traditional motivators for Design Controls
Balancing act between Feasibility and Design Controls phases
Tools to get the most out of Feasibility and Design Controls Phases
What Happens when Things Go Bad (or Good)
Recommended Strategies
ChadGibson
JamisonFloat
When to ‘Flip the Switch’ for Design Controls

5. Flipping the Switch
Scope and Definitions
US-Centric Approach
Medical Devices (not pharma)
Feasibility = Research
Design Controls = Development

6. Flipping the Switch
Design Controls
Business Milestones
(Gates / SOPs)
Project Costs Time-to-Market Internal Department
Domains
Company Valuation
(e.g., Start-Ups)
Risk / Benefit
Assessments
Commonly used drivers to determine when to initiate design
controls.

7. Flipping the Switch
The Balancing Act
- Minimize regulatory & compliance risk
- Minimize safety risk
- Maximize clinical benefit / effectiveness
- Minimize costs
- Minimize time-to-market
- Maximize product income
- Meet other internal goals
Maximize the value of Feasibility and
Design Controls Phases.

8. Flipping the Switch
The Right Work at the Right Time

9. Flipping the Switch
Risk Signal Chart
Key Risk Item
3/19/2020
Status
Rationale for Rating
(if Yellow or Red)
Minimum Target Status (before
entering design controls)
Acceptance Criteria: What Minimum Target Status Means
Regulatory / Compliance
Product code /
classification is defined
and accurate
Y
Product codes are identified, but "grey areas"
exist because of the nature of the technology
being used.
G
A 513(g) request comes back with a product code(s) that fall
under the 510(k) pathway.
Technical
The laser subsystem can
last 5 years without
repair or replacement.
R
No data exist for the reliability of the laser
subsystem. Because of the costs of this
subsystem, this
Y
Informal testing and analysis supports a 5-year life (90/90)
without degradation to the key parameters (power output,
wavelength)
Business
Launch the product in
the US no later than
December 2021.
R
Current estimates show a longer lead-time.
Further assessment is required to adjust user
and business needs AND/OR the timeline.
Y
Updated user / business needs to hit the December 2021
goal, or the launch date is adjusted.
Safety and Effectiveness
Safety risks are not fully
assessed or understood.
R
No safety risk assessments have occurred.
Y
Perform a top-down preliminary risk assessment to identify
potential hazards and mitigation options, focusing primarily
on optical, thermal, and electrical hazards. Assess if the risks
can be adequately mitigated in a final production
embodiment.
G
Y
R Item has issues that must be addressed to complete design, testing, or clearance of the product..
Item is well-understood and reflective of industry and FDA expectation. Green DOES NOT imply ZERO
risk.
Item has unresolved issues or risk of delay (e.g., unexpected test results).
Use the Risk Signal Chart to identify and track project risk.
Sample Risk Signal Chart

10. Flipping the Switch
Reduce Project Risk
Use the Risk Signal Chart to identify and track
project risk.
Key Risk Item
3/19/2020
Status
Rationale for Rating
(if Yellow or Red)
Minimum Target Status (before
entering design controls)
Accepta
Regulatory / Compliance
Product code /
classification is defined and
accurate
Y
Product codes are identified, but "grey areas" exist
because of the nature of the technology being used. G
A 513(g) req
fall under th
Technical
The laser subsystem can
last 5 years without repair
or replacement.
R
No data exist for the reliability of the laser subsystem.
Because of the costs of this subsystem, this Y
Informal tes
(90/90) with
(power outp
Business
Launch the product in the
US no later than December
2021.
R
Current estimates show a longer lead-time. Further
assessment is required to adjust user and business needs
AND/OR the timeline.
Y
Updated us
goal, or the
Safety and Effectiveness
Safety risks are not fully
assessed or understood.
R
No safety risk assessments have occurred.
Y
Perform a t
identify pot
focusing pri
hazards. Ass
in a final pro
Sample Risk Signal Chart

11. CLIENT | PROJECT | PHASE 1 | PHASE TITLE | 3
Flipping the Switch
Regulatory & Compliance Risk
• Regulatory Strategies
• Read and Understand FDA Regulation
• Read and Understand FDA Guidance
• Read and Understand Consensus Standards
• Predicate Device Research
• Q-Submission Process
• 513(g) Requests
Key Risk Item
3/19/2020
Status
Rationale for Rating
(if Yellow or Red)
Minimum Target Status (befo
entering design controls)
Regulatory / Compliance
Product code /
classification is defined
and accurate
Y
Product codes are identified, but "grey areas"
exist because of the nature of the technology
being used.
G
Technical
The laser subsystem can
last 5 years without
repair or replacement.
R
No data exist for the reliability of the laser
subsystem. Because of the costs of this
subsystem, this
Y
Business
Launch the product in
the US no later than
December 2021.
R
Current estimates show a longer lead-time.
Further assessment is required to adjust user
and business needs AND/OR the timeline.
Y
Safety and Effectiveness
Safety risks are not fully
assessed or understood.
R
No safety risk assessments have occurred.
Y
Employ strategies for reducing regulatory risk.

12. CLIENT | PROJECT | PHASE 1 | PHASE TITLE | 3
Flipping the Switch
Technical & Business
• User Research
• Requirements / Needs Definition
• Early Architecture Development
• House of Quality / Quality Function Deployment
• Reliability Estimation
• Simulations
• Prototyping
• Engineering (“Informal”) Testing
• Project Plan / Planning
Key Risk Item
3/19/2020
Status
Rationale for Rating
(if Yellow or Red)
Minimum Target Status (befo
entering design controls)
Regulatory / Compliance
Product code /
classification is defined
and accurate
Y
Product codes are identified, but "grey areas"
exist because of the nature of the technology
being used.
G
Technical
The laser subsystem can
last 5 years without
repair or replacement.
R
No data exist for the reliability of the laser
subsystem. Because of the costs of this
subsystem, this
Y
Business
Launch the product in
the US no later than
December 2021.
R
Current estimates show a longer lead-time.
Further assessment is required to adjust user
and business needs AND/OR the timeline.
Y
Safety and Effectiveness
Safety risks are not fully
assessed or understood.
R
No safety risk assessments have occurred.
Y
Employ strategies for reducing technical risk.

13. CLIENT | PROJECT | PHASE 1 | PHASE TITLE | 3
Flipping the Switch
Patient and Operator Safety
• ISO 14971
• ISO 60601-1 (references IEC 62366-1, IEC 62304)
• Preliminary Hazard Analyses
• Master Harms Lists
• User Research & Early Usability Engineering
Employ strategies for reducing safety risk.
Key Risk Item
3/19/2020
Status
Rationale for Rating
(if Yellow or Red)
Minimum Target Status (befo
entering design controls)
Regulatory / Compliance
Product code /
classification is defined
and accurate
Y
Product codes are identified, but "grey areas"
exist because of the nature of the technology
being used.
G
Technical
The laser subsystem can
last 5 years without
repair or replacement.
R
No data exist for the reliability of the laser
subsystem. Because of the costs of this
subsystem, this
Y
Business
Launch the product in
the US no later than
December 2021.
R
Current estimates show a longer lead-time.
Further assessment is required to adjust user
and business needs AND/OR the timeline.
Y
Safety and Effectiveness
Safety risks are not fully
assessed or understood.
R
No safety risk assessments have occurred.
Y

14. Flipping the Switch
Feasibility vs. Design Controls
How to optimize project budget and schedule via strategic
initiation of design controls.

15. Flipping the Switch
Examples
Started Too Soon?
• Major technical issues are discovered right
before verification.
• You discover technicians are the primary users
of this device, not doctors.
• Your 510(k) reviewer indicates there’s no viable
predicate.
• Launch dates were set in stone before
considering sterility validation timelines.
Started Too Late?
• “We just started selling this, but our CFO thinks it
might be a medical device.”
• Document Releases / Change Orders are “catching
up” to work already done.
• Final designs are ahead of safety risk management
and requirements work.

16. Flipping the Switch
Best Practices Discussion
ChadGibson JamisonFloat
Chad and Jamison’s Favorite Approaches

17. Flipping the Switch
Q&A
ChadGibson JamisonFloat

18. THANK YOU!
Balancing Late Feasibility and Early Design Controls