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Verification vs. Validation
Verification Validation
Does the design output Does the design
satisfy the design output satisfy the
inputs: intended use:
Performance Efficacy: does it
Functional actually work?
Safety Stakeholder
Regulatory Requirements
Aesthetic Are people going
to buy it?
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Initial Steps
Validate the problem.
Is this a problem worth solving? If users don’t
think this is a major problem, your solution won’t
be appealing.
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Initial Steps
Validate the product.
The problem might exist, but does your product
actually solve it?
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Product Validation
Validation should be performed at many points
during the Product Development Process:
1. Early Stage: Proof of Concept
• Product Feasibility
2. Preliminary Evaluation
• Confirmation of Design Requirements
3. Pivotal Evaluation
• Pre-commercial Product Validation
Feeding Information Back into the Development
Process is Critical!
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Prototype Development
Design Requirements
Validate the Key Product Requirements
(MVP)
Concept Development
Validate Use Case Assumptions
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Prototype Development
Detailed Design
Verify dimensions and performance
Prototype Fabrication
Verify actual vs. designed
Product Validation
Validate Product Suitability
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Performance Validation
Functional Areas to be Evaluated:
1. Hardware Validation
• Electronic
• Mechanical
2. Software Validation
• Functional Performance
3. User Validation
• Use Case Scenarios
4. Execution Validation
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Product Validation
Important things to Research:
1. Use Case Scenarios
• Stakeholder Requirements
• Product Lifecycle
• Real Scenarios
• Work flows
• Real Users
• Unbiased
• Negative Feedback can be good
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Product Validation Methods
• Computer Modelling
• Bench Tests
• Animal Models
• Human Models
• Focus Groups
• Clinical Trials
• Offering for Sale
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Risk Management
1. Feedback for Stakeholders
2. Product Safety Risk
3. Product Development Risk:
• What to spend and when to spend it?
4. Organizational Risk
• Human Resource Management
5. Competitor Risk
• What’s happening in the Industry
6. Regulatory Risk
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Product Validation
Questions?
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