About

 

Distal Solutions provides flexible, attentive consulting services to the medical device industry, with focused expertise in catheter-based R+D. We enjoy being the creative force behind new therapies and are driven by those disruptively elegant solutions that others have yet to find.

 

As Principal, Dave Rezac leads a small, dedicated team with rich and varied technical background in interventional product development. Being well versed in ISO 13485 Design Control practices and Risk Mitigation via ISO 14971, Distal can help address engineering challenges at all phases of the development lifecycle.
 


 

Value-Added Services

 

 

  • Complex part design and sourcing (Solidworks, OnShape)
    • Complete catheter systems
    • Handle components / mechanism design
    • Nitinol implant and delivery system componentry
    • Drawing package development and maintenance
  • Catheter-oriented process development and manufacturing fixture design, documentation
  • Vendor selection, management, and technical oversight (specialty suppliers, CMs, etc.)
  • In-vivo study protocol development, execution, reporting
  • Clinical site initiation, physician training, and case support
  • In-vitro test method design and fixture fabrication

 


 

Prototyping Capabilities

 

 

  • Dedicated catheter development lab, including:
    • Shaft lamination and complex catheter reflow operations (horizontal and vertical arrangements)
    • Tipping stations and assorted secondary ops (skiving, hole punching, etc.)
    • UV curing stations (metal halide and LED sources)
    • Hydrophilic coating application
    • SLA for quick turn handle form evaluation, test fixture componentry, anatomical modeling, etc.
    • Automated tensile / compressive test stand for bond strength analysis and trackability testing
    • Assorted wet lab / vascular model performance testing capabilities
  • Basic machining equipment (mill, lathe) for quick-turn part modification
  • Laser welding (down to 0.1mm spot size)
  • Laser cutter (flat) for rapid fixture and enclosure fabrication
  • Forming furnace and familiarity with NiTi secondary ops / fixture development

 


 

Email us to learn more

info@distalsolutions.com

Location

100 Waverly Street, Suite 3, Ashland, MA 01721