Professional Summary

Kristyn holds a Master’s degree in Bioengineering with hands-on experience in tissue engineering, microfluidics, biotechnology, and the medical device industry. She has extensive expertise in FDA-regulated environments, including compliance with 21 CFR 820 and ISO 13485 standards.

Leadership & Experience

Kristyn has been a core member of Energy Delivery Solutions for over 10 years, currently serving as Vice President and Chief Operating Officer (COO) for the past 4 years. Throughout her tenure, she has led and contributed across multiple departments, including Research & Development, Manufacturing, Quality, and Finance.

She co-developed the Quality Management System (QMS) used at Energy Delivery Solutions and has driven continuous improvements in manufacturing processes, resulting in higher production yields and extended shelf life for liposomal-ATP–based products.

Regulatory & Product Development

Kristyn played a critical role in the research and development of CT-STOR®, contributing to its successful FDA clearance as a Class II Medical Device for use in cell and tissue processing applications.

Research & Publications

She has co-authored multiple book chapters focused on the application of Energy Delivery Solutions’ core technology within the field of Hair Restoration Surgery.

Innovation & Funding

In addition to her operational and leadership responsibilities, Kristyn actively works to secure future grants and funding to support the growth and expansion of the company’s core technology platform.