Every efficient preclinical development plan involves tradeoffs. Studies may be combined, endpoints reduced, existing evidence leveraged, or testing deferred to make the program more efficient. Each of those decisions also carries assumptions about what the study will accomplish, what regulators will accept, and what happens if those assumptions prove incorrect.

This worksheet is a discussion guide designed to help cross-functional medical device teams make those assumptions visible before committing to a study plan. It provides a structured process for comparing the proposed strategy against the strongest possible evidence plan, identifying where the strategy has been streamlined, and evaluating whether the resulting tradeoffs are understood and defensible.

Whether you’re developing an initial preclinical strategy or preparing to finalize a protocol, this resource can help your team challenge key assumptions, identify potential downstream consequences, and make more informed decisions before significant time and resources are committed.

What You’ll Find

This discussion guide walks teams through a structured review of their preclinical strategy, including:

• Defining the strongest possible evidence plan
• Identifying where the proposed strategy has been streamlined
• Surfacing the assumptions behind key strategic decisions
• Stress-testing the consequences if those assumptions prove incorrect
• Evaluating the potential cost and impact of recovery
• Determining whether to accept, mitigate, clarify, or redesign