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Owner - Catstrap: an automotive security products manufacturer of devices to prevent catalytic converter theft and EV Charging cable theft. CatStrap is family-owned and operated business with 10+ years of experience as a manufacturer of market-leading solutions that have protected over 100k vehicles across the US and Canada. Prev: Co-Founder, Revol Snax — an emerging CPG brand that satisfies sweet cravings with high protein, low sugar snacks. We offer better-for-you sweet snacks with best-in-class flavor and clean ingredients. Vertically integrated manufacturing in Washington, DC. Prev: Biomedical Engineer (lead reviewer) at the FDA in the Division of Reproductive, Gastro-Renal, and Urological Devices. I worked in pre-market medical devices at all stages of product development including preclinical/clinical testing, FDA submissions, and post-market compliance. Product experience areas include minimally invasive surgical devices, neuromodulation, HIFU therapy, optical imaging diagnostics, drug delivery devices, ultrasound systems, and information management software.
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Owner And OperatorCatstrapWashington, Dc, Us -
Owner/OperatorCatstrap Feb 2013 - PresentWhitehouse, Ohio, UsCatstrap is the leading manufacturer of anti-theft devices for catalytic converter and EV charging cable theft applications. Since 2014, the CatStrap and CatEye products have been installed on 100,000+ vehicles across the US and Canada with industry-leading success rates (<0.25% lifetime warranty claims). We offer universal solutions including unique mechanical cutting barriers, Blue Dye deterrents, and sonic alarm protection. The EV Cable Shield is a flexible, lightweight sleeve with a steel core that encompasses EV Charging cables and makes them impractical to cut with conventional tools.The CatStrap is a physical cutting barrier made with ultra-hardened strip steel that shields the entire length of the exhaust pipe. The CatEye alarm is a smart motion sensor that activates a 130 dB siren with noise above the threshold of human pain. The DyeDefender is a flexible stainless steel hose pressurized with Blue Dye that sprays when punctured. -
Co-FounderRevol Snax Apr 2018 - Apr 2024Washington, District Of Columbia, UsCo-founder of Revol Snax, a healthy refrigerated snack brand. Revol Snax was a CPG brand in the ketogenic snack space that satisfied sweet cravings without sugar. First full-time entrepreneurial venture. Some of our accomplishments: over 500,000 units sold and $1.9M in lifetime sales, completely bootstrapped. Successfully launched a $50k+ kickstarter, gained over 1000 Amazon reviews, maintained successful Whole Foods distribution for 5 years, and scaled up our own vertically integrated manufacturing process.Our high protein, low carb snacks were made with fresh & simple ingredients. Our origin story came from trying to satisfy our own sweet tooth after reducing sugar from our diets. The lack of options was frustrating. We knew the market needed better low sugar options and started sharing our creations with friends out of our home kitchen. -
Medical Device Consultant - Fda StrategySelf Employed Jul 2019 - Dec 2021Satellite Beach, Florida, UsI worked with medical device companies to streamline pre-/post-market regulatory strategy by leveraging my experience as a former FDA reviewer. • Provide strategy consulting at all stages of product lifecycle, including non-clinical and clinical testing, FDA submissions, and post-market compliance, including design modifications• Develop nonclinical performance testing protocols, as well as early stage clinical protocols, for FDA pre-submissions and marketing applications• product areas of expertise include both therapeutic and diagnostic devices, such as minimally invasive surgical devices, endometrial ablation, neuromodulation and stimulation, machine learning-based imaging diagnostics, therapeutic ultrasound systems, obstetric and postpartum technologies, and information management software. -
Biomedical Engineer - Lead Reviewer (Premarket)Fda Jun 2014 - Jun 2019Silver Spring, Md, UsLed premarket review teams and made official approval recommendations for medical device and drug-device combination products including IDE, 510(k), de novo, and PMA applications. Served as an Early Feasibility Study (EFS) program representative to facilitate collaboration between review teams and early stage sponsors to help guide projects through IDE approval requirements for initial U.S. clinical studies.Responsibilities:• Evaluated preclinical and clinical performance data in accordance with FDA recognized standards and/or performance criteria to assess safety and effectiveness• Identified and developed performance testing requirements and study endpoints for devices in premarket development• Collaborated with cross-disciplinary review teams to develop clinical risk assessments and assisted industry sponsors with clinical protocol development• Reviewed pre/post market clinical data and adverse event reports for safety signals• Conduct engineering/regulatory consulting reviews for drug, device, and biologics submissions -
Graduate Student ResearcherInstitute For Complex Engineering Systems - Carnegie Mellon Feb 2013 - Jun 2014Pittsburgh, Pa, UsBone and Skeletal Muscle Regeneration Project • Built tissue engineered stem cell scaffolds using 3D printing technology for in vivo animal studies• Created printable 'bio-ink' composed of decellularized extracellular matrix (ECM) tissue derived from bone and skeletal muscle to help drive stem cell differentiation• Developed a 3D bioprinting approach to spatially control stem cell differentiation for regenerative medicine applications -
Medical Device Evaluation - Biomedical Engineer InternFda - Center For Devices And Radiological Health Jun 2013 - Aug 2013• Reviewed 510(k) & PMA applications to assign 21 CFR classification and regulatory requirements to a wide range of medical devices • Successfully merged over 100 unclassified medical device applications into existing regulation• Participated in Senior Science Council meetings to discuss appropriate clinical trial, regulatory review, and post-market compliance strategies for high-risk medical products• Primary author of public-facing Wireless Medical Telemetry webpage:http://www.fda.gov/medicaldevices/digitalhealth/wirelessmedicaldevices/ucm364308.htm
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Mse Student InternBayer Materialscience Sep 2012 - Dec 2012Leverkusen, Nrw, DeWind Turbine Blade Project • Worked with research and development department to optimize a material selection process aimed at maximizing material strength properties by determining the statistical significance of multiple test variables -
Research Assistant - Division Of Cardiothoracic SurgeryUpmc May 2011 - Aug 2011Pittsburgh, Pa, Us• Formulated an experimental design to explore the therapeutic potential of stem cells for treating aortic disease• Conducted in vitro experiments to evaluate the effects of stressed cell environments on reactive oxygen species production• Worked collaboratively with research team to draft formal research grant proposals -
Operating Room VolunteerAllegheny General Hospital May 2010 - Aug 2010Pittsburgh, Pennsylvania, Us -
Undergraduate ResearcherBone Tissue Engineering Center - Carnegie Mellon University Jan 2010 - Aug 2010• Analyzed in vitro stem cell experiments and biological protein assays to evaluate bone tissue regeneration
David Birsen Skills
David Birsen Education Details
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Carnegie Mellon UniversityM.S. Biomedical Engineering -
Carnegie Mellon UniversityBiomaterials And Tissue Engineering Track
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Anthony Wayne High School
Frequently Asked Questions about David Birsen
What company does David Birsen work for?
David Birsen works for Catstrap
What is David Birsen's role at the current company?
David Birsen's current role is Owner and Operator.
What is David Birsen's email address?
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What is David Birsen's direct phone number?
David Birsen's direct phone number is +130179*****
What schools did David Birsen attend?
David Birsen attended Carnegie Mellon University, Carnegie Mellon University, Anthony Wayne High School.
What skills is David Birsen known for?
David Birsen has skills like Biomedical Engineering, Medical Devices, Regenerative Medicine, Fda, Biomaterials, Business Development, Matlab, Tissue Engineering, Stem Cell Technology, Cell Signaling, Regulatory Affairs, Technology Commercialization.
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