Design & Development

Development partnerships  

• Gather and synthesize clinical feedback to create clear and detailed need specifications
• Translate clinical and marketing needs into successful product designs
• Use rapid iteration and parallel design paths to decrease development time and mitigate risk
• Structure projects and direct incentives to ultimate project goals
• Reduce regulatory uncertainty by defining clear strategies and moving quickly to submission
• Obtaining early clinical feedback
• Consider production related issues early in the design process

• Solve problems and collaborate
  

In-House Technical Resources

• Catheter layup, lamination, reflow, cutting, shaping, tipping, etc.
• Braiding and coiling
• Small part injection molding
• Balloon fabrication
• Laser welding
• Coating application, including proprietary technology to coat catheter inner surfaces
• Custom fixture design and fabrication
• Mechanical and electrical testing
• Controlled environments for component and finished device manufacturing
• Medical image analysis/segmentation and anatomical model construction
• Wet lab, flow models, and Langendorff preparations

Regulatory & Clinical Support

Regulatory services include:

• Global regulatory strategy development
• FDA meeting preparation and attendance
• Preparation of regulatory submissions for medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, de novo applications, HDEs, 513(g) and Request for Designation
• OUS regulatory filings
• Labeling and marketing material review

Clinical services include:

• Clinical Strategy and Protocol Development
• Investigator Brochure Development
• Clinical Procedure On-Site Support

Quality services include:

• Quality System development and implementation
• Training on regulatory and quality processes
• FDA inspection preparation (QSIT & BIMO)

• Post-market support