About Boulder BioLabs
Boulder BioLabs is the contract microbiology testing lab inside the Boulder BioMed family of companies — a vertically integrated medical device services group co-located on a single Boulder, Colorado campus.
Our Mission
Cut weeks out of every medical device validation by putting sterilization, microbiology testing, and regulatory support under one roof.
Quality System
Boulder BioLabs operates under the Boulder BioMed ISO 13485 quality management system. Microbiology testing protocols are aligned with ISO 11737-1, ISO 11737-2, USP <71>, USP <85>, and ISO 10993-7. Lab-level method accreditations (A2LA, ISO 17025) are in progress.
Leadership
Jim Kasic
With more than 30 years of experience in the Class I, II, and III medical device industry, Jim's range of experience spans large multi-national organizations to start-ups with national and international scope. He holds over 40 U.S. and international patents and has authored several dozen scientific publications.
Prior to Boulder iQ, Jim founded and served as president of Boulder BioMed, and president and CEO of Sophono, Inc. (acquired by Medtronic). Earlier in his career, Jim was an engineering manager and senior design engineer at Boston Scientific, and a reliability/process/design engineer at W. L. Gore and Associates. Jim earned a Bachelor of Science degree in physics, and a Master of Science degree in chemical and biological engineering from the University of Colorado. He holds an MBA from the University of Phoenix.
Melissa Brookshier
Melissa is a senior life science and biomedical device professional with more than 25 years of experience in quality, regulatory, research and development. Her expertise and leadership experience range from concept feasibility to product launch and post-market surveillance.
Before joining the Boulder BioMed family, Melissa was director of consulting services of the Denver office at the Azzur Group. She has held the positions of vice president of operations and director of product development at Sharklet Technologies, project manager of R&D at Baxter International, and manager of product evaluations and study director at BDC Labs. Previously, she was the R&D manager at Spectranetics (now Philips Healthcare) and a product specialist at W.L. Gore & Associates.
Mike Daddario
Mike leads day-to-day microbiology operations at Boulder BioLabs and Boulder Sterilization, with hands-on responsibility for sterility, bioburden, method suitability, LAL/BET, EO residuals, and CD residuals programs. He joined the Boulder BioMed family in June 2024.
Before joining Boulder, Mike spent nearly three years as Sterility Laboratory Manager at a national contract sterility lab, where he ran the sterility lab supporting tissue banking and medical device sterility release programs. Prior to that, he spent three and a half years at a Colorado microbiology lab, advancing from Microbiology Technician to Microbiology Lab Supervisor. He ran high-volume USP <85> Kinetic-Turbidimetric BET assays, USP <1113> microbial identification, USP <51>, <61>, <62>, <71>/<1223> product testing, and AAMI VDmax/Method 1 radiation sterilization validations. He was responsible for personnel training and supervision, LOP and method development, equipment maintenance and calibration, and validation of new laboratory procedures.
Mike earned a Bachelor of Science in Biology from the University of Colorado Colorado Springs (2017).
Location
Boulder BioLabs: 5375 Western Avenue, Boulder, CO 80301
Boulder BioMed family operations: 5421 Western Avenue, Boulder, CO 80301
303-531-1238
The Boulder BioMed family operates from two adjacent buildings on Western Avenue in Boulder — one campus, two buildings, five companies. Boulder BioLabs and Boulder Sterilization are co-located, with samples moving between the sterilizer and the microbiology lab without ever leaving the campus.