How can you validate and test high-risk products?

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High-risk products are those that involve significant uncertainty, complexity, or novelty, and that have the potential to create a huge impact or a huge failure. Developing and launching such products can be challenging, costly, and risky. How can you validate and test high-risk products to reduce the chances of wasting time, money, and resources, and to increase the chances of creating value for your customers and your business? Here are some tips and tools to help you.

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1 Define your assumptions

Before you start building or testing anything, you need to clearly define your assumptions about your product, your customers, your market, and your business model. These are the hypotheses that you need to validate or invalidate with evidence. You can use tools like the Lean Canvas, the Value Proposition Canvas, or the Business Model Canvas to help you articulate your assumptions and identify the most critical ones.

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David E. Lally

Semi-retired but open to projects
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Regulatory Compliance: Understand the regulatory requirements specific to your industry and product. Ensure you have a deep knowledge of the relevant standards and guidelines (e.g., FDA regulations, ISO standards). Establish a regulatory strategy and documentation plan that outlines how you will meet these requirements throughout development and testing. Risk Assessment: Use methods like Failure Modes and Effects Analysis (FMEA) to prioritize and address high-risk areas. Design and Development: Follow industry best practices for product development, including design control processes. Create detailed design documentation, including design specifications, drawings, and design verification plans.

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2 Prioritize your risks

Not all assumptions are equally risky. Some are more likely to be true or false, and some have more impact on your product's success or failure. You need to prioritize your risks based on their importance and uncertainty, and focus on testing the ones that are both high-impact and high-uncertainty. You can use tools like the Riskiest Assumption Test (RAT) or the Assumption Mapping to help you prioritize your risks and plan your experiments.

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David E. Lally

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Verification and Validation (V&V): Verification: Ensure that the product is being built correctly according to the design specifications. This may involve component testing and analysis. Validation: Demonstrate that the product meets its intended use and user needs. This often includes testing the product in a real-world environment or simulating actual usage conditions. Testing Methods: Choose appropriate testing methods, such as: Physical testing (e.g., stress testing, load testing, environmental testing) Software testing (e.g., unit testing, integration testing, system testing) Usability testing Human factors testing Clinical trials (medical devices/pharmaceuticals) Use statistically valid sample sizes to ensure testing is reproducible.

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3 Design your experiments

Once you have identified and prioritized your risks, you need to design your experiments to test them. An experiment is a method of collecting data and feedback from your customers or potential customers to validate or invalidate your assumptions. You can use various types of experiments, such as interviews, surveys, landing pages, prototypes, MVPs, or pilots, depending on your stage of development, your resources, and your goals. You can use tools like the Experiment Canvas or the Test Card to help you design your experiments and define your metrics and criteria.

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David E. Lally

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Prepare for regulatory audits and inspections by maintaining comprehensive documentation and demonstrating compliance with relevant standards. Remember that the specific testing and validation procedures will vary depending on the nature of the high-risk product and the applicable regulations. Consulting with experts in your industry and engaging regulatory authorities early in the development process is often essential to success.

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4 Run your experiments

After you have designed your experiments, you need to run them and collect the data and feedback. You need to make sure that you run your experiments in a reliable, ethical, and rigorous way, and that you reach enough customers or potential customers to get valid results. You also need to be aware of the potential biases and pitfalls that can affect your experiments, such as confirmation bias, false positives, false negatives, or vanity metrics. You can use tools like the Experiment Report or the Learning Card to help you document and analyze your experiments and results.

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5 Learn and iterate

The final step of validating and testing high-risk products is to learn from your experiments and iterate on your product, your assumptions, or your experiments. You need to compare your results with your metrics and criteria, and draw conclusions about whether your assumptions are validated or invalidated, and whether your product is viable, desirable, or feasible. You also need to decide what to do next based on your learnings, such as pivot, persevere, or kill your product idea, or run new or different experiments. You can use tools like the Pivot or Persevere Canvas or the Validation Board to help you learn and iterate.

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Venkatesh V.
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Do remember the steps mentioned are not linear. One should also create a research backlog that the product trio works on.The best enabler for this trio is a dedicated engineer who is in charge of creating experiments

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can you validate and test high-risk products?

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3

4

5

6

1 Define your assumptions

2 Prioritize your risks

3 Design your experiments

4 Run your experiments

5 Learn and iterate

6 Here’s what else to consider

Product Development

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How can you validate and test high-risk products?

1

2

3

4

5

6

1 Define your assumptions

2 Prioritize your risks

3 Design your experiments

4 Run your experiments

5 Learn and iterate

6 Here’s what else to consider

Product Development

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