The Critical Linkage Between Reimbursement And Regulatory Strategies

Barb Atzenhoefer – Product Development Strategist, NAMSA

During her 28+ years in the medical device industry, Barbara has held executive, management and staff positions in regulatory, clinical, quality and product development.  In 2003 she joined NAMSA, specializing in regulatory affairs.  Her regulatory experience includes authoring over 200 hundred global regulatory strategies, clinical and marketing applications. She has particular expertise in FDA strategy and requirements, and interacts frequently with the organisation.

Christopher Salmen – Director, Reimbursement Strategy, NAMSA

Areas of Expertise

• Industries: IVD, Medical Devices, Durable Medical Equipment, Digital Health, and Artificial Intelligence
• Functions: Market Access, Health Policy, Product Development, HEOR, and Stakeholder Advocacy.
• Therapeutic Indications: Epidemiology, Endocrinology, Pulmonology, Oncology,  and Molecular Pathology

Organizational Alumnae - MedTech focus

• Hologic - cervical cancer screening and COVID-19 PCR mDx
• ResMed – Digital health, COPD, Sleep Disorder Breathing
• Metabolic Markets – Endocrinology Medical Devices
• DexCom – Continuous Glucose Monitoring for diabetes
• Alere (known as Abbott Diagnostics) – POC diagnostics
• The Keck Graduate Institute – Masters of Business & Science
• The Colorado College – Pre-Med with Major in Biochemistry