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Business of Medicine/Practice Management

Design It, Build It, Launch It! Device Innovation for 2023

Sunday, October 1, 2023
3:45 PM - 4:45 PM East Coast USA Time
Location: 106A

    Lead Presenter(s)

  • AD

    Anand K. Devaiah, MD

    Professor of Otolaryngology, Neurological Surgery, and Ophthalmology
    Boston Medical Center
    Boston, MA, United States

    • Co-Presenter(s)

  • SN

    Srinivas Nandkumar, PhD

    Director, Division of Dental and ENT Devices
    Food and Drug Administration, United States

PROGRAM DESCRIPTION: Otolaryngologists -- by the very nature of the profession and problems they address -- are innovative individuals. This is also reflected in the growing number of practitioners who find themselves assessing and developing new devices and technologies. If you are an Otolaryngologist who is interested in being more involved in the device and technology development space, or wish to better understand the pathways that have brought a new device to your practice, then this course is for you. You will be introduced to a practical process for innovation within the medical device space. Participants will have the chance to learn from experts with experience in developing and evaluating devices in academic, private, and government regulatory settings, and who have experience in working with startup and established companies. Updated for 2023, this course is designed to be accessible to people both new and experienced in this aspect of the Business of Medicine. Participants will be introduced to a number of subject areas including: 1) problem-based ideas versus technocentric ideas, 2) building your team, 3) design considerations, 4) funding methods, 5) basics of patents/intellectual property, 6) device considerations for regulatory pathways, and 7) Total Product Lifecycle and innovation impact. The presenters will also introduce concepts specific to health equity and disparities, and how this relates to innovation. New for 2023 is an expanded discussion on the “how-to” for developing and launching a new device.

OUTCOME OBJECTIVE 1: Learn basic concepts inherent to device development which allow translation of ideas to working prototypes

OUTCOME OBJECTIVE 2: Synthesize a basic framework of development in order to execute on a device’s development

OUTCOME OBJECTIVE 3: Understand the key concepts of the regulatory process which are integral to device development

BACKGROUND STATEMENT: This topic integrates a number of important concepts for Otolaryngologists. The course helps address critically important areas in de-novo device development, working with device companies, and evaluating devices being brought into their practice.