Mark Besser

The program covers medical-device design and development, next-generation technologies, regulatory compliance, cybersecurity, supply-chain resilience, quality, and manufacturing operations. Conference topics include market readiness and adoption of medical devices; scaling miniaturized devices from prototype to production; signal integrity and EMI for medical imaging and AI-driven devices; AI-based demand forecasting; changes to FDA inspections and the Quality Management System Regulation (QMSR); 3D printing of bioabsorbable implants; and robotics and AI in pharmaceutical manufacturing. Show-floor education also addresses digital transformation, AI adoption, workforce transformation, smart manufacturing, automation, packaging, additive manufacturing, and sustainable operations. Workshops address digital lean manufacturing using automation, AI, robotics, and data analytics; OT/IT integration and smart-manufacturing roadmaps; and sterilization technologies including supercritical carbon dioxide, vaporized hydrogen peroxide, chlorine dioxide, nitrogen dioxide, electron beam, and X-ray. Sterilization topics include validation, material compatibility, scalability, regulatory expectations, and lower-emission approaches. The leadership program covers mentorship, leadership credibility, difficult conversations, decision fatigue, and burnout.