David Birsen Email & Phone Number

Washington, DC, US

Whitehouse, Ohio, US

Catstrap 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.

Washington, District Of Columbia, US

Co-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.

Satellite Beach, Florida, US

• I 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.

Silver Spring, MD, US

• Led 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.
• 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

Pittsburgh, PA, US

• Bone 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

• 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

Leverkusen, NRW, DE

• Wind 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

Pittsburgh, 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

Pittsburgh, Pennsylvania, US

• Analyzed in vitro stem cell experiments and biological protein assays to evaluate bone tissue regeneration

M.S. Biomedical Engineering

B.S. Materials Science Engineering, Double Major In Biomedical Engineering, Biomaterials And Tissue Engineering Track

Education record