Product Validation

Nigel Halsted, Dipl. T., B.Tech, MBA

Project Leader, Health Technology
Research Group
 Presentation Outline
1. What is Validation?
2. Verification vs. Validation
3. Validation During Product Development
• When to Validate during Prototype Development
• Types of Validation
• Important things to Research
• Validation Methods
4. Risk Management
5. Questions
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 What is Validation?
Validation: the action of checking or proving the
validity or accuracy of something.
"the technique requires validation in controlled
trials"

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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.

Validate the market.

Some users might agree that this is a problem
worth solving. But are there enough of them to
make up a market for your product?

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 Initial Steps
Validate the product.
The problem might exist, but does your product
actually solve it?

Validate willingness to pay.

There might be market demand and a great
product. But will people actually be willing to
reach into their wallets and pay for 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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