Founder, Principal Consultant, Engineer

ARC helps medical device companies bring orthopedic and arthroplasty products from concept toward FDA clearance with practical regulatory strategy, product development, testing, and validation—keeping projects on time, on budget, and hassle free.

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 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 multiple products, including groundbreaking material technologies and first-in-the-U.S. designs.

29+ Years of Engineering, Quality & Regulatory Experience. 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.

Orthopedic Implant & Arthroplasty 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

• Completion of Training Curriculum for FDA Third Party 510(k) Review

27+ Medical Device Clearances. I have supported the successful FDA clearance of more than 27 medical devices, including orthopedic products, innovative material technologies, and first-in-the-U.S. designs.

A First-Time-Right Approach to Medical Device Safety. 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.

Supporting Orthopedic Medical Device Innovators. I collaborate with orthopedic companies for FDA clearance expertise, universities and labs developing new products, and surgeons pioneering innovative materials and designs.

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