We bring medical devices to life.
We are a core team of seasoned medical device development experts with a combined 70+ years experience bringing med tech products to life. We have proven experience developing and bringing to market products in the areas of orthopedics, cardiac implants, intravascular catheters, neurosurgery, in-vitro diagnostics, women’s health, drug preparation and infusion, and others.
We drive medical technology projects at any stage to success.
Let us know how we can support your project.
Meet Our Leadership Team
Julie Byars - Principal, Co-founder
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 Maltas - Principal, Co-founder
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.
Tyler Panian - Principal, Co-founder
Tyler has over 14 years experience in new product development, filling med tech R&D roles across both startups and large companies leading several products from concept to launch, spanning Class I, II and III. Tyler’s core competency is in front-end innovation, design, and development of medical technology solutions. He holds over 20 patents in the medical device space and is adept at implementing creative solutions to challenging design problems. Tyler holds a B.S. in Mechanical Engineering from Brigham Young University (BYU) and a M.S. in Mechanical Engineering from the University of Southern California (USC). Tyler regularly participates as a Panel Reviewer for SBIR/STTR applications with the NIH.
What is Ontogen?
Our name Ontogen comes from the biological term ‘ontogenesis’, which
describes the development of an organism from the earliest stage to maturity.
This concept summarizes the services we offer and the value we bring to our clients.
We bring medical devices to life from the earliest stage to maturity.
Professional Affiliations & Partnerships
Portal Innovations -
Medical Device Incubator
mHUB - Chicago based
accelerator and incubator