Christie Bergerson

Dr. Bergerson has a wide range of expertise including in vitro diagnostics, artificial intelligence in healthcare, and orthopedic medical devices. She has experience preparing applications and performing gap analyses for FDA, WHO and IVDR submissions, both on the hardware and the software side. 

Dr. Bergerson participated in the development of the Quality Management System, developed verification and validation testing protocols, led Design of Experiment reviews, led verification and validation testing, composed technical reports for compliance with DHR/DMR regulations for FDA submissions, and participated in risk management activities.

Dr. Bergerson is knowledgeable of Software as a Medical Device regulations as well as the process for verification and validation of artificial intelligence/machine learning algorithms for submission to the FDA. She also led cross-functional design reviews for the mechanical, electrical, EMC and software teams and determined whether the path forward was technologically appropriate.

Dr. Bergerson has extensive experience with medical device quality systems and has led failure analysis efforts after a worldwide product launch. She has experience turning the Voice of the Customer into user requirements, then into product requirements down to detailed specifications, as well as performing gap analysis on product requirements and risk management documentation. Dr. Bergerson is well-versed in testing to ASTM standards, as well as developing justifiable modifications to accomplish target testing. As part of her experience in the medical device industry, Dr. Bergerson has designed, developed and implemented various sensing technologies and barcode readers using machine vision/computer learning algorithms for in vitro diagnostic and medical device applications which were ultimately cleared by the FDA, received a CE mark and were marketed worldwide.

Dr. Bergerson also has extensive experience working with proof of concept Total Knee Replacement components and conducting the testing necessary for a 510(k) submission to the FDA. This involved ASTM/ISO based testing of implant components, porous coating characterization based on ASTM standards, and designing a battery of tests with custom testing rigs for range of motion/constraint testing of the knee. In the regenerative medicine and materials characterization space, Dr. Bergerson worked to design and develop a PPF cuff for comminuted fractures of the long bones which had the appropriate mechanical environment for differentiation of stem cells into bone and tuned the degradation profile of the cuff such that it would biodegrade away after reformation of the bone. Dr. Bergerson led the effort to select the optimal nanoparticle concentration/composition for the PPF nanocomposite cuff material through extensive characterization testing, based both on ASTM standards and more customized approaches. The cuff geometry and manufacturing technique were optimized through the same type of characterization and in vivo testing was conducted using a six-camera motion capture system with gait analysis as the data of interest. She also has experience with cell culture, cardiovascular mechanics, tissue harvesting techniques and creating flow systems to mimic in vivo mechanical environments. Her cardiovascular experience is both theoretical (i.e. study and mathematical description of the biomechanics of cardiovascular tissue) and experimental (i.e. setting up a flow system to replicate in vivo conditions experienced at different points in the vasculature, analysis of different strut types for stents).

Dr. Bergerson has experience working on several mechanics and biomechanics projects in microgravity-based applications. She was part of a team selected to develop a hands-free Heads Up Display based speech recognition system for the International Space Station, investigate thermal energy management in two phase flow based systems, analyze the mechanics for Protein Exchange Membrane fuel cells and develop a protein nanopore capable of analyte detection in microgravity in conjunction with NASA. The last project included testing the technology in microgravity aboard the DC-9 (a.k.a. Vomit Comet).

Dr. Bergerson has experience electrospinning nanofibers, including the creation of a custom electrospinning module for parallel fibers, coding in Python, C++, MATLAB and LabVIEW and investigating the constitutive relations of polymers to inform computational models of biodegradation. She developed the Biomechanical Experiential Learning Lab course and was faculty of record for Texas A&M University where she taught undergrads the fundamentals of experimental design their senior year.