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Why compliance is not good enough.

N Kossovsky, B Brandegee

    Journal of Biomedical Materials Research
    |February 24, 1999
    PubMed
    Summary
    This summary is machine-generated.

    Medical device manufacturers must adopt proactive risk abatement strategies beyond mere compliance. Integrating risk management into operations ensures successful product launches and protects investments in a dynamic market.

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    Area of Science:

    • Medical Device Engineering
    • Risk Management
    • Product Liability

    Background:

    • The medical device industry faces a dynamic operating environment.
    • Product development pipelines are critical for manufacturer success and return on investment.
    • Compliance with regulations is a baseline, not a complete risk solution.

    Discussion:

    • Risk abatement should be an integral part of a medical device manufacturer's core operating strategy.
    • Moving beyond compliance requires a shift towards proactive risk management.
    • This editorial advocates for a strategic approach to minimize risks throughout the product lifecycle.

    Key Insights:

    • A robust risk abatement strategy is essential for medical device manufacturers.
    • Key components include fostering a strong corporate culture around risk, utilizing scenario modeling tools, and establishing effective implementation systems.

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  • Proactive risk management is crucial for ensuring successful product launches and financial viability.

    • Outlook:

    • Future success in the medical device sector hinges on the strategic integration of risk abatement.
    • Manufacturers should prepare for evolving regulatory landscapes and market challenges.
    • Implementing comprehensive risk strategies will be key to sustained growth and innovation.