Project Management in the Medical Device Field

Wednesday, October 25, 2023

4:00 PM-5:30 PM

BIOMED Seminar

CLICK HERE TO ATTEND VIA ZOOM

Title:
Project Management in the Medical Device Field

Speaker:
Michael O’Connor, PhD, MSPM, MSTM, MBA, PE
Senior Research Program Director
Program Management
Medtronic

Details:
The medical device industry is characterized by its stringent regulatory requirements, complex technological innovations, and critical implications for patient safety. Effective project management within this domain is essential to ensure the successful development, manufacturing, and market entry of medical devices. This presentation explores the key aspects of project management in the medical device field, highlighting its unique challenges and the critical role it plays in delivering safe and effective healthcare solutions.

Project management in the medical device sector encompasses various phases, including concept development, design and engineering, regulatory compliance, manufacturing, quality assurance, and post-market surveillance. Each of these phases demands meticulous planning, clear communication, and adherence to regulatory guidelines such as ISO 13485 and FDA requirements. Additionally, medical device project management necessitates cross-functional collaboration among diverse teams, including engineers, regulatory experts, quality assurance professionals, and clinicians.

Biosketch:
Michael O'Connor, PhD, MSPM, MSTM, MBA, PE, is a Senior Research Program Director of Program Management with Medtronic. He has over 37+ years of professional experience and 33+ years of professional experience in the medical device industry. Dr. O'Connor earned his PhD in Civil Engineering, majoring in Project Management, from the University of Maryland, College Park, A. James School of Engineering. He is currently teaching graduate level course at five different colleges and universities, and he has volunteered his time with many professional societies, universities, and colleges over many years. In addition to Medtronic, Dr.  O'Connor's corporate experience includes stints at 3M and Pfizer.

Contact Information

Lisa Williams
ltw22@drexel.edu