Requirements Debt: A Medical Product Program Risk

Most organizations do not identify requirement clarity and management as a high effort, high impact to the product item, if it is even identified at all. Some organizations believe requirements do not pose a traditional existential threat to the program because the cost of poorly defined or missed requirements is not immediately measurable.

However, as you’ll see in this whitepaper, Requirement Debt™ has a major impact on time, scope, and budget. In this paper, we’ll cover:

• The impact of requirements debt on medical device development
• The value of proactively writing traceable, testable requirements
• Mitigating costly, late-stage change with proactive requirements management