Michael Kinzie

Michael has decades of experience in a variety of fast-paced collaborative environments as well as extensive experience in product development of Medical Devices. This requires expertise in Design Controls: 21 CFR 820.30 and ISO 13485; Risk Management ISO14971; Human Factors and Usability Engineering IEC 62366-1; and many other relevant Standards.

With Dark Horse clients, Michael particularly focuses on the degree to which regenerative medicine core capabilities overlap with high-quality medical device design and manufacturing and bioprocessing manufacturing equipment. Medical device development begins with market research and business strategy (identifying and addressing unmet needs and identifying the competitive landscape), followed by product development (requirements and risk management, project management, etc.), and test validation methods, as well as regulatory elements (including strategy and authorship), and quality. To quote Michael, “Quality is everyone’s job,” and the ultimate goal in the design and device development of a medical device is to launch a high-quality, safe and effective product, free from defects. It’s also important to note that device development is not just the system or related consumable, but any related software as well.

Michael is a System Engineer by nature and a degreed Chemical Engineer, which allows him to be efficient and effective in managing Risk and Requirements, System Architect, FMEA’s, FTA, and Reliability specifications, throughout the design cycle. This enables Michael to deliver a high-quality Design History File (DHF) and Technical File for CE Marking. Michael is also an Operations Leader with experience in high volume automated consumable manufacturing, blow and injection molding, vinyl and tubing extrusion, ultrasonic and RF welding, a variety of terminal sterilization processes, aseptic filling, and other secondary operations.

Before joining Dark Horse, Michael most recently served as Chief Operating Officer at Crystal Diagnostics, a startup company launching a novel liquid crystal technology to detect food-borne pathogens. Michael oversaw Product Development, Manufacturing of Equipment and Consumables, Supply Chain Management and implemented the infrastructure to support future growth.

Michael was Director of Process Engineering at Invitae tasked with scaling Patient Cancer Monitoring (PCM) using Patient Specific Primers for In Vitro Diagnostics (IVD) Next-Generation Sequencing (NGS) products. A key success factor was developing and integrating the Syncade Manufacturing Execution System (MES), automating an electronic Batch Record, replacing inefficient paper travelers. Core to the manufacturing process, Michael’s team characterized and qualified a Tecan Automated Fluid and Liquid Handling System both for Manufacturing patient samples and NGS Quality Control Library Sample Preparation.

At Aktiv Pharma Group, Michael led the Technical Development of a novel Combination Product, Emergency Use Auto Injector following Design for Six Sigma (DFSS) principles and utilizing the Concept, Design, Optimize and Verify (CDOV) methodology. Where attention to detail is critical in developing and managing the Critical Parameter Database, by identifying input signals and output responses of product functionality, characterizing Control Factors, and impressing Signal to Noise ratio through Design of Experiments (DOE), to demonstrate by objective evidence, both for the product and process six-sigma capabilities. Being classified as a High Priority Product by the FDA, Michael drove reliability into product design and automated manufacturing processes, by identifying potential Risk Control measures using Fault Tree Analysis and Failure Mode Effect Analysis and fulfilling the requirements of the FDA’s Reliability Guidance. Utilizing CAMEO Systems Modeler, a Model Based System Engineering (MBSE) Tool, a model was generated to analysis and predict the nominal and associated tolerance of product performance.

At Terumo BCT, Michael was the System Engineer on the full product development lifecycle and commercialization of the Quantum Cell Expansion System (CES), an instrumentation platform for the Cell and Gene Therapy space. The Quantum (CES) is a bench-top, medical device, operates continuously, and automates the cell culturing of Mesenchymal Stem Cells and T-cells, in a complex, sterile, single-use, functionally closed consumable. The CES fully automates the manual cell expansion workflow for the Scientist. The Quantum CES utilizes a Hollow Fiber Bioreactor and Gas Transfer technology incorporated into an elegant hydraulic layout that mimics the cell environment. Michael was responsible for generating and managing the system architecture and requirements, User Needs, product and subsystem requirements, interface controls, and design specifications. Michael has substantial experience with centrifugation, filtration, fill and finish products and processes. He was the Product Engineer for the Elutra product line, which among many applications, isolates T-cells from a patient’s leukapheresis collection, by means of a Counterflow Centrifugal Elutriation. Dr. Carl June, from the University of Pennsylvania, utilized the Elutra to isolate patient’s T-cells for the product now known as Kymriah, sold by Novartis.

• Certified Six Sigma Green Belt

Crystal Diagnostics
Chief Operating Officer

Invitae Corp.
Director of Process Engineering

Aktiv Pharma Group
Senior System Engineer/Engineering Manager

Terumo BCT
Senior System Engineer/Engineering Manager

University of Colorado, Boulder
‍B.S. in Chemical Engineering