Meet Our Experts
Meet the dedicated consultants who bring unparalleled expertise to your projects.
Chris Lotzow
Chris Lotzow is a senior regulatory advisor with extensive experience in medical devices, biomaterials, and global regulatory strategy. He specializes in MDR and FDA pathways, helping companies navigate complex submissions and compliance challenges. Chris combines legal, technical, and regulatory expertise to deliver efficient, science-based solutions across the product lifecycle.
Michelle Chutka
Michelle Chutka is a senior medical device and quality systems consultant with more than 20 years of experience in product development, design controls, risk management, and manufacturing transfer. She specializes in ISO 13485, ISO 14971, process validation, and regulatory compliance, helping organizations successfully develop, scale, and commercialize medical technologies. Michelle combines deep engineering expertise with strong leadership experience to deliver practical, risk-based solutions across the entire product lifecycle.
Simon Lee
Simon Lee is a MedTech commercial leader with 20+ years of experience in product management, sales, and strategic marketing. He has a proven track record of driving growth, launching products globally, and building partnerships. Simon combines clinical insight and commercial expertise to turn innovation into measurable business results
Product Strategy & Market Access, Marketing, Clinical and Medical Education
Elyse Storey
Elyse Storey is a results-driven MedTech commercial leader with 15+ years of experience in product management, sales, and surgical innovation. She has a strong track record of driving growth, launching products, and expanding global markets. Elyse combines clinical insight and commercial expertise to deliver impactful, market-leading solutions.
Product Strategy & Market Access, Marketing, Clinical and Medical Education
Jesper Thyregod
Simon Lee is a MedTech commercial leader with 20+ years of experience in product management, sales, and strategic marketing. He has a proven track record of driving growth, launching products globally, and building partnerships. Simon combines clinical insight and commercial expertise to turn innovation into measurable business results
Change Management & Organizational Development, Corporate & Business Strategy, EU representative & PRRC, Research & Development
Susan Ballegaard
Susan Ballegaard is a senior life science leader and Qualified Person (QP) with 25+ years of experience in quality, GMP, and regulatory compliance. Susan combines deep technical expertise with strong leadership, helping organizations build compliant, scalable quality systems that support both regulatory requirements and business performance
