Founder, Principal Consultant, Engineer

With over 14 years of expertise in orthopedic New Product Development, I’ve developed strategies that include expert planning to ensure projects stay on time and on budget. I also specialize in navigating the complex landscape of FDA 510(k) clearances, ensuring that innovative medical devices reach the market safely and efficiently. My approach is rooted in realism, conscientiousness, and a solution-focused methodology that has led to the successful clearance of over 27 products, including groundbreaking material technologies and first-in-the-U.S. designs.

I hold a Bachelor of Science in Mechanical Engineering from Rutgers University and bring over 29 years of engineering, quality, and regulatory experience to the table. My background spans capital equipment engineering, materials technology development, and medical device innovation.

I began consulting for medical device companies in August of 2023 with my company, Arthroplasty Regulatory Consulting.

Key Expertise:

• FDA 510(k) Clearance & Regulatory Strategy

• Orthopedic Implant Development (Knees, Hips, Ankles)

• Sterilization & Validation Testing Compliance

• Cross-Functional Team Leadership & Project Management

• Patent Development & Intellectual Property Strategy

I collaborate with orthopedic companies for FDA clearance expertise, universities and labs developing new products, and surgeons pioneering innovative materials and designs. My mission is to ensure product safety and compliance, passing the “Grandma Test”—if it’s not safe enough for my grandmother, it’s not safe enough for the market.

Let’s connect if you’re looking to navigate regulatory challenges, streamline product development, or bring innovative medical devices to market.