Mike Schultz is a MedTech innovator with over 25 years of hands-on experience in developing
and commercializing complex catheters and minimally invasive devices. He offers deep
expertise in catheter construction, Nitinol components, rapid-exchange systems, aspiration
technologies, steerable/deflectable catheters, dilators, ergonomic handles, braid-reinforced
designs, and embolic protection, delivering reliable, FDA-compliant solutions under ISO 13485.

As a fractional consultant, Mike supports MedTech OEMs, CMOs, and startups with targeted
work in complex catheter design, process development/validation, and operational
optimization. He excels at technical due diligence and value creation as an operator, advisor, or
interim leader.

Key achievements include:

• Leading full lifecycle development and 510(k) clearance of a 5Fr rapid-exchange
  aspiration catheter (RIO) for Boston Scientific’s Filterwire EZ embolic protection system,
  handling specs, PFMEA, design controls, tooling, validation, packaging, and launch as
  sole contract manufacturer.
• Establishing precision manufacturing and process transfer for Nitinol loop components
  in Filterwire EZ, securing "Dock to Stock" status, high-volume output (thousands
  monthly), strong controls, and long-term supplier role via continuous improvement and
  CAPA fixes.
• Driving advancements in steerable/deflectable catheters, dilators/sheaths, ergonomic
  handles, and reinforced constructions at Spectrum Plastics Group (VP of Innovation and
  Development – Vascular Technologies) for structural heart, urology, robotic-assisted
  surgery, vascular access, cardiology, and interventional applications; expanding
  capabilities through partnerships and stock configurations while delivering full design-
  to-production transfer services.

Mike is ideal for short-term virtual engagements to solve catheter innovation challenges, scale
manufacturing, ensure regulatory readiness, or accelerate programs to market. His operator
mindset and proven vascular expertise make him a reliable partner for MedTech complexities.