Meet Megan Graham: Driving Regulatory Excellence & Innovation in MedTech

Ben Trombold

Published on: March 11th, 2025

At Orthogonal, we take pride in highlighting the diverse experiences and contributions of our team members. We’re excited to spotlight Megan Graham, our VP of Regulatory & Quality, whose expertise in software engineering, regulatory strategy, and quality management is shaping the future of MedTech. Her passion for bridging the gap between software development best practices and compliance drives her work, ensuring that innovation and patient safety go hand in hand.

A Journey in Healthcare Innovation

Megan Graham’s career in the medical device industry spans over 25 years and is rooted in her passion for building solutions that solve critical problems. Initially pursuing mechanical engineering, Megan soon realized her love for math and switched her major to mathematics and computer science. Having been a programmer since the age of 10, she built a career in algorithmic solutions within the defense industry before transitioning to MedTech. Megan’s journey to Orthogonal began through collaborations with the company’s leadership in the software working group. After years of consulting in regulated software, she joined Orthogonal to leverage her expertise in software architecture, development practices, and regulatory strategy to make a tangible impact in the industry.

Driving Change & Industry Impact

Megan sees the medical device industry as being on the cusp of significant change, driven by new technologies, regulations, and players entering the market. She is particularly passionate about bridging the gap between quality management systems and software engineering best practices to create solutions that meet regulatory requirements and deliver value to patients and clinicians. Megan believes that iterative development is key to accelerating innovation in the healthcare space while maintaining high standards of quality and compliance. She foresees the rise of AI/ML, the expansion of neuro-related technologies, and an increased role for academic healthcare institutions in driving future advancements.

Passions Beyond Work

Outside of work, Megan finds joy in nature, spending time on her property surrounded by wildlife and taking her two dogs for walks, but only when it’s not cold! She and her husband are avid sailors, enjoying the short sailing season in Minnesota. Megan is also passionate about refining processes, whether in the kitchen, cooking, or out on the water. She enjoys hobbies that require skill, risk-taking, and continuous improvement, reflecting her process-oriented mindset and drive for quality in both her personal and professional life. Megan also has a quirky theory that every food in the world goes with either chocolate or mayonnaise, and she’s tested this theory with various teams she’s worked with, classifying foods into one of the two categories.

Vision, Purpose & Patient-First

Megan’s work is driven by a deep sense of empathy for patients and a commitment to delivering high-quality solutions that genuinely make a difference. She believes that balancing speed, quality, and efficiency is key to success, and she aligns closely with Orthogonal’s mission of helping patients more quickly. Looking ahead, Megan hopes to disrupt the regulatory framework to enable more iterative and agile approaches to developing medical devices and healthcare software. Her ultimate goal is to ensure that the products she works on positively impact as many patients as possible while fostering a culture of innovation and teamwork.