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Successfully managing change through integrated manufacturing operations management

How would you rate your Medical Device company’s ability to assess the financial impact of product changes?


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In a recent survey conducted by analyst firm Axendia, a group of medical device manufacturers were asked about the characteristics of their change management processes and systems.

Surprisingly, most companies are not able to clearly quantify the financial impact of potential product changes. Only 2% of the companies said their ability to estimate the costs of product changes was excellent. 10% assessed their ability as poor, with the majority of companies rating their ability as average. When those manufacturers were split into the closed-loop and open-loop groups, a dramatic difference surfaced. 80% of the closed-loop manufacturers said their ability to assess the financial impact of change was above average. Only 9% of the open-loop group reported their financial assessment ability was above average.

To support the increased rate of innovation, Med-Tech companies must stop chasing defects and manage product changes as a set of data instead of documents. To succeed in this changing environment, medical device manufacturers must focus on improved product outcomes while simultaneously supporting shorter innovation cycles driven by closed-loop integrated systems that allow for real-time decision making based on real intelligence.