Design & Development

Your Partner in Possibility 

Expand possibilities and drive innovation as you bring your concept to market with AuST Group as your partner.

We combine our capabilities in medical device design and development with regulatory support and manufacturing expertise. AuST Group will guide your project through development and testing, to design transfer and production. With support through regulatory benchmarks and clinical use.

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Early Development >>> High Volume Production

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

The Medical Device Gold Standard

Your Solution for Design, Development, and Manufactuing