Carlos Michel, PhD

• Led systems integration and assay design for Accelerate Wave™, enhancing direct-from-sample AST for gram-positive pathogens. Partnered with data science team to troubleshoot and analyze machine learning results, enriching assay platform performance.

• Led multidisciplinary team of scientists and engineers in assay design for FDA-cleared Arc™ system.
• Managed end-to-end assay development, achieving FDA 510(k) clearance for Accelerate Arc™ in September 2024.
• Oversaw pre-clinical verification studies and CRO partnership for 510(k) clinical trial, ensuring compliance with regulatory standards.
• Authored clinical trial protocols, reports, and FDA submissions, securing de novo clearance for Pheno® in 2017.

• Established research partnerships with multiple clinical microbiology laboratories in US and Europe through direct training in instrument and assay techniques.
• Collected pre-clinical results from patient samples and user feedback for product design enhancements.
• Delivered impactful presentations as technical ambassador at scientific conferences, simplifying complex assay designs for diverse audiences.
• Hired, trained, and mentored R&D teams of over 10 scientists and research associates, promoting scientific rigor and cross-functional collaboration.
• Maintained a ‘Quality-First’ culture while prioritizing customer-centric approaches across all projects.
• Collaborated with leadership to refine project goals and resources, ensuring alignment with product requirements.
• Presented updates to internal executives and company board to support operational efficiency and resource management.
• Promoted cross-functional collaboration to uphold project timelines and deliver on key objectives.

Led design and validation of assays for FDA-cleared Accelerate Pheno® systems.

Developed and optimized assay reagents for enhanced performance.

Integrated molecular detection assays with software and analysis for automated microbial identification.