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Related Experiment Videos

Development phases for medical devices.

D Scott, J G Webster

    Medical Instrumentation
    |January 1, 1986
    PubMed
    Summary
    This summary is machine-generated.

    This study presents a structured process for evaluating new medical devices, ensuring market need and economic viability before commercial development. The procedure involves checklists, design specifications, and reviews to guide projects effectively.

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    Area of Science:

    • Medical device development
    • Product commercialization strategy

    Background:

    • New medical devices require rigorous analysis to ensure successful commercialization.
    • Existing processes may lack a structured approach for evaluating market viability and technical feasibility.

    Purpose of the Study:

    • To present an orderly procedure for analyzing potential new medical devices.
    • To guide decision-making regarding commercial development of innovative medical technologies.

    Main Methods:

    • Implementation of a product checklist for initial screening of market need and economic viability.
    • Development of a design specification for cross-functional team alignment on function and cost.
    • Conducting phased reviews during design, development, pre-production, and production stages.

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    Main Results:

    • The procedure provides a systematic framework for medical device analysis.
    • Ensures alignment between engineering, marketing, and finance teams.
    • Facilitates continuous project management throughout the product lifecycle.

    Conclusions:

    • The presented procedure offers a comprehensive approach to medical device commercialization.
    • A structured analysis enhances the likelihood of successful market introduction and economic viability.
    • Continuous oversight is crucial for managing medical device projects effectively.