New Market Research:  The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

An Axendia Market Research Report

Medical device organizations are continuing to sharpen their focus on developing high-quality medical devices aimed at improving patient outcomes. However, many struggle with effectively managing requirements and traceability across the product development lifecycle. This can be costly, risky, and lead to delays in new product introductions when considering the increased complexity in medical products, competition, and a shifting regulatory landscape.

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 business value of requirements management across the product development lifecycle

9 out of 10 executives surveyed for this report admitted to having a ‘not effective or somewhat effective’ requirements management process. This acknowledgement shows that executive management needs to think holistically about the product development lifecycle and invest in the proper tools that will enable getting requirements management right – the first time.

This report also highlights the outcomes of our research including:

  • The impact of having an ineffective closed-loop 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, traceability, verification and validation activities when relying on manual processes.

In support of this research, we surveyed 96 medical device professionals representing a wide range of medical device manufacturers that market and sell products world-wide.

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The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.

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