Medical Device Design and Regulation

Medical Device Design and Regulation is a critical sub-discipline of biomedical engineering that encompasses the entire lifecycle of creating and commercializing devices used for diagnosing, treating, or monitoring medical conditions. This process involves applying engineering principles to develop innovative, safe, and effective solutions—from simple surgical tools to complex imaging systems and life-sustaining implants like pacemakers. Crucially, this design and development process is rigorously governed by regulatory frameworks, such as those enforced by the U.S. Food and Drug Administration (FDA), which establish stringent requirements for testing, documentation, and quality management to ensure patient safety and device efficacy before a product can be brought to market.

  1. Introduction to Medical Device Engineering
    1. Definition of a Medical Device
      1. Device vs. Drug vs. Biologic
        1. Examples of Medical Devices
        2. Historical Evolution of Medical Devices
          1. Early Medical Devices
            1. Key Innovations and Milestones
              1. Impact of Technology on Device Development
              2. The Role of the Biomedical Engineer
                1. Core Responsibilities
                  1. Interdisciplinary Collaboration
                    1. Ethical Considerations
                      1. Professional Organizations
                      2. The Medical Device Industry Landscape
                        1. Key Market Segments
                          1. Diagnostic Devices
                            1. Therapeutic Devices
                              1. Monitoring Devices
                                1. Assistive Devices
                                2. Major Companies and Start-ups
                                  1. Multinational Corporations
                                    1. Emerging Start-ups
                                      1. Academic and Research Institutions