Chairs: Eugene Skalnyi

Faculty: Eugene Skalnyi, Philippe Y. Laberge, Dominique Filloux, Ali Behbahani

Description: Participants will gain a holistic understanding of the diverse professional roles and multidisciplinary contributions that medical experts can assume, contingent on their preferred level of engagement and the developmental phase of the device or enterprise. The curriculum will elucidate the strategic framework for establishing and managing a high-performing clinical research site. This course offers an in-depth exploration of the foundational principles and methodologies underlying the medical device development lifecycle, encompassing the journey from conceptualization to clinical application, emphasizing pivotal components such as intellectual property protection, innovation in research and development, capital acquisition strategies, interdisciplinary team assembly, clinical trial execution, regulatory compliance, and other integral facets of the process.

Learning Objectives: At the end of this course, the participant will be able to:

1. Objective State the number and types of roles medical professionals can be involved in during the process of medical device innovation process. Understand the elements required to be a successful clinical research site and investigator
2. Objective Understand the general philosophy of innovation. When, how, and if to innovate. Design and conduct of clinical research. Understand the mechanism and importance of securing Intellectual Property (patents) to protect the ideas, the product development process and FDA regulatory Clearance/Approval pathways
3. Objective Compare the different types of financing of an idea/company and what investors are looking for

Course Outline

1:30 PM Welcome, Introduction and Course Overview

E. Skalnyi

1:35 PM Beyond the Scalpel: A Deep Dive Into the Multifaceted Roles of Medical Professionals in Innovating, Designing, and Advancing Medical Devices. Philosophy of Medical Device Innovation. Fundamentals for Building a Start-Up Company. Pearls of Design and Condu

E. Skalnyi

2:00 PM How to Become a Clinical Researcher and Build a Top Clinical Research Site: Challenges and Dilemmas

P. Laberge

2:25 PM Medical Device Product Realization From an Engineering Point of View: Intellectual Property, the Product Development Process and FDA Regulatory Clearance/Approval Pathways

D. Filloux

2:50 PM Innovation Financing From the Other Side of the Table. What Investors are Looking for?

A. Behbahani

3:15 PM Discussion Questions & Answers

1:30 PM Adjourn