The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. However ineffective and inefficient, the industry still relies overwhelmingly on static documents housed in Excel/Word and relies on manual processes that add significant risk to the development process.

Axendia conducted a research study focusing on the medical device industry’s approach to requirements management with a goal to identify and analyze the drivers, barriers, trends, and value of requirements management across the product development lifecycle.

9 out of 10 (87%) Executives surveyed for this report admitted to having a ‘not effective or somewhat effective’ requirements management process.

In this webinar, Axendia’s Senior Industry Analyst, Sandra K. Rodriguez will share the outcomes of the research including:

• The impact of having an ineffective requirements management process
• The critical importance of requirements management to achieve improved patient outcomes, product quality, and time to market
• The negative impact on budgets, verification and validation activities when relying on manual processes

Sandra will be joined by Jama’s medical and life science principal solutions lead, Steven Meadows, who will be sharing his experience and unique perspective on the above.