Atlanta Metropolitan Area
Seasoned medtech innovator with a proven track record of bringing breakthrough products to market, scaling operations, and driving quality, growth, and profitability in regulated environments. Core strengths: ✅ Full-cycle product innovation – from early concept to commercialization and continuous improvement including market research, product design and development, IP strategy, clinical validation, regulatory approval (PMA, IDE, 510(k), CE), and global commercialization. Start to finish technical leadership on 2 successful original PMA’s that lead to acquisitions. ✅ Executive P&L leadership – across R&D, manufacturing, and operations. Proven ability to build high-performing teams, define vision, and deliver measurable results. ✅ Deep technical domain expertise – Specialized knowledge in sensors and implantable sensing systems, smart surgical tools, and data insights for surgical guidance and management of chronic diseases. ✅ Entrepreneurial experience – founder and builder of startups with expertise in capital raising, M&A due diligence and leading organizational change through growth and transition.
Leading the development of next generation implantable Heart Failure management solutions.
• Led product development and innovation for the Cordella™ HF system, a next generation comprehensive digital health platform for managing heart failure patients, combining an implantable wireless hemodynamic monitor with vitals signs and patient reported symptoms to guide proactive and precise therapeutic interventions that prevent hospitalizations and improve patient’s quality of life. • Brought fresh vision and leadership to the company product roadmap resulting in improved performance, enhanced safety and user experience, and industry-leading innovations. • Demonstrated transformational leadership to bring about a culture change and align department and broader organization to a common patient-centric mission and purpose. • Provided technical and strategic leadership in the success of the PROACTIVE-HF trial showing the benefits of comprehensive HF management using the Cordella™ System. • Ensured expedient remediation of customer issues with a sense of urgency by empowering cross-functional teams and setting clear ownership and accountability. • Led all technical aspects of the PMA approval process including submissions and interaction with the FDA leading to successful PMA approval. • Led clinical science efforts including publications, conference presentations, and KOL interactions. • Transformed software into a high performance center of excellence by investing in people, processes, and infrastructure and delivered continuous rapid software innovation. • Built a data science team from the ground up including setting the department vision, strategy, and foundation for data-driven advanced analytics and AI/ML innovations. • Developed and implemented plans for organizational scale up to support rapid commercial ramp. • Managed and led all aspects of a robust worldwide IP portfolio. • Supported fund-raising and acquisition due diligence leading to company acquisition by Edwards Lifesciences (NYSE: EW)
Co-founded medical robotics IP company developing surgeon-taught, autonomously-executed orthopedic robotic surgery methods. Filed U.S. and international patent applications; built benchtop proof-of-concept prototype demonstrating force-guided autonomous bone preparation.
• Co-founded Polaris Surgical, that later combined with ICON to form MiRus, as a next generation smart surgical systems company focused on improving surgical precision and efficiency and reducing radiation exposure. Led all aspects of product development and commercialization including market research, KOL engagement, design and development, intellectual property, clinical/pre-clinical validation, regulatory approvals, and operations scale-up. • Developed a comprehensive product portfolio for knee, hip, and spine surgeries for dynamic 3D guidance of implant placement and measurement of anatomic alignment, balance, and kinematics. • Invented and led the development and commercialization of the award-winning GALILEO™ Spine Alignment Monitoring System, the first and only FDA-approved product for real-time intra-operative monitoring of spinal alignment. • Invented and led the development of the VITESSE™ pedicle screw placement system, a one-of-a-kind single-instrument spinal screw placement procedural solution for improved patient safety and workflow efficiency. • Led the development and validation of the Polaris Knee System - a real time system for dynamic intra-operative assessment of knee balance/kinetics - and the Polaris Hip System for intra-operative guidance of acetabular cup placement and leg length and offset. • Integrated augmented reality (AR) and multimodal image registration into next generation surgical systems for improved visualization and increased surgical efficiency/accuracy.
• As a key executive and technology expert, commercialized the first permanently implanted sensor for remote monitoring and management of chronic heart failure (HF) leading to acquisition by St. Jude Medical (now Abbott, NYSE:ABT) for more than $450M. • Led the development of the CardioMEMS HF sensor, the world’s first wafer-fabricated permanent implant, from concept to commercial scale manufacturing and sales >$100M. • P&L and site leadership responsibility for a multi-function organization supporting a >$60M a year business consisting of 50+ people. Departmental responsibilities include product development, manufacturing, supply chain, quality control, and product service and repair. • Supported a pivotal HF clinical study involving more than 500 patients across multiple sites by implementing capable manufacturing processes and stringent quality control measures that resulted in zero sensor failures during the study. • Led the rapid scale-up of company operations, including strategic and operational planning, resulting in a rapid increase in manufacturing capacity and foundation for sustainable future growth. • Directed continuous improvement efforts to improve product reliability, manufacturability, and yields resulting in > 50% reduction in product cost. • Directed the design and construction of a $7M 30,000 sq. ft. FDA cGMP compliant manufacturing facility including state-of–the-art cleanrooms and specialized equipment. • Extensively interacted with physicians, investors, board members, potential acquirers, regulatory officials, and auditors - prepared reports, presentations, and due diligence materials as required.
• Directed the development, scale-up, and commercialization of 1st and 2nd generation sensors for monitoring of Abdominal Aortic Aneurysms (AAA). The revolutionary EndoSure sensor was the first wireless, battery-less, permanently implantable pressure sensor for human use to be commercially available in the US. • Executed product validation plans in compliance with FDA/ISO requirements. • Expanded scope and scale of company manufacturing operations to include sensor, catheter and electronics manufacturing resulting in improved quality and reduced cost. • Evaluated, selected, qualified and managed key partners for the production, assembly, packaging, warehousing, and distribution of all company products. • Performed short-term and long-term manufacturing capacity planning by identifying the need for additional capacity, contracting with other manufacturers, and recommending expansion of facilities. • Played a key role in the company developing a culture of quality, acquiring ISO 13485 certification, and maintaining compliance with FDA regulations.
• Lead the development of the core Micro Electro Mechanical Systems (MEMS) technology utilized in CardioMEMS’ portfolio of sensor products. • Transitioned the 1st generation sensor from proof-of-concept lab prototypes to volume production. • Evaluated and selected MEMS foundries for the scale-up and manufacture of the sensor and delivered first functional prototypes for evaluation within 3 months of project initiation. • Managed production to fulfill requirements for clinical trials.