Design, build, and use it! A crash course and guide to device innovation (2025)

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 2025, this course is redesigned to be accessible to people both new and experienced in this aspect of the Business of Medicine. A case-based approach with brand new sections to illustrate key learning points will be employed. 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) basics of patents/intellectual property and licensing strategies, 5) basic corporate structure and governance, 6) funding methods, 7) device considerations for regulatory pathways, and 8) Total Product Lifecycle and innovation impact. Concepts specific to health disparities, and how this relates to innovation, will be discussed. Also new for 2025 is an expanded discussion on ways to develop and launch a device, organizational structures (e.g. LLC, C-Corp, and others), and considerations around investors.

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 including business structures 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, business viability, working with device companies, and evaluating devices being brought into their practice.

Comprehensive Otolaryngology Track Statement :