Medical Device Regulatory Consultant | Lucent Clinical

Project Examples

Helping Companies Make a Difference in Healthcare

Thirty years of commercializing novel medical devices with a winning regulatory strategy and clinical trial oversight. Experience in multiple device therapeutic areas covering acute and chronic disease. One consistent outcome: medical devices that make it to market and stay there.

Cardiac conduction system pacing: IDE multi-center trial and regulatory submission for an implantable lumenless cardiac pacing lead system..

Opened new markets: Sacral nerve stimulation landmark multi-center IDE trial and PMA submission for urinary urgency-frequency and retention.

Risk-Based Monitoring: co-authored the foundational industry framework for RBM in medical device clinical trials.

Thought Leadership: Published a foundational, industry-specific framework for applying risk-based monitoring (RBM) to medical device trials.

Collaborating with key clinical experts in advancing healthcare.

Led a landmark prospective, randomized multi-center trial that established sacral nerve stimulation (SNS) as a standard treatment for refractory urinary urge incontinence, demonstrating high success rates and superior efficacy over standard care, providing essential evidence for FDA PMA approval.