Julie’s passion is bringing quality, reliable products to patients and clinicians. She has been in technical and quality roles in the medical device industry for 19 years. Her knowledge spans regulatory classifications and industries, from pressure injury and remote monitoring to spine and active implantables.

Julie is well-versed in quality management systems compliant with ISO13485 and 14971, FDA QSR, as well as EU and international regulations. She’s adept at creating quality systems that meet the specific needs and regulatory goals of an organization. As a certified ISO13485 lead auditor, she can also optimize a quality system for a new strategy or improved performance.

Julie earned her B.S. in Biomedical Engineering from Washington University in St. Louis and an MBA from Christian Brothers University. Julie has been recognized by Crain’s Chicago Business in its 2023 editorial feature, Notable Women in STEM.

Steve holds a B.S. in Materials Science and Engineering from the Massachusetts Institute of Technology (MIT) and has 17 years of experience working cross-functionally to bring complex medical devices to market through challenging regulatory landscapes under demanding timelines. He has worked on a range of medical devices from Class II in-vitro diagnostics (IVDs) to Class III implantables.

Steve is exceptional at implementing systems and processes that produce safe and effective medical devices that withstand regulatory scrutiny across all markets. His expertise is in developing and executing strategies for systems integration, design control, risk management, usability engineering, software development processes, DHF remediation, design and development planning and verification & validation.

Mike brings nearly 20 years of experience in medical device manufacturing and product development. Before joining Ontogen, Mike held key leadership positions in manufacturing and supply chain for Talis Biomedical where he developed and led the manufacturing of their Point-of-Care diagnostics platform.  

Prior to Talis Biomedical, Mike held increasing leadership positions in manufacturing at Endotronix and led the development of their implantable sensor manufacturing.  Mike also held leadership positions in both R&D and Manufacturing at Nanosphere (acquired by Luminex in 2016), after which he led Luminex’s Northbrook-based manufacturing operations for the Verigene product line.

Mike holds a degree in General Engineering from the University of Illinois Urbana-Champaign.