Design & Development

Interface offers a comprehensive array of engineering capabilities ranging from customized mold and end plug design to the design and development of complex balloons and balloon catheters. Our long history in balloon design and development is built upon extensive product and project expertise in the development of more than 2,000 different balloon designs over the last 12 years. Interface is your proven partner from concept development and prototyping to full-scale production.

Our services include:

• Standard and custom balloon designs
• Catheter design
• Material testing and analysis capabilities – DMA, DSC and UTM
• State-of-the-art machine shop for building standard and proprietary tools, dies and molds
• Process development and design validation

5-Phase Development Process

Interface employs a robust 5-phase development approach to bring your product to market quickly while complying with all ISO and GMP requirements.

• PHASE I: PROJECT INITIATION – Evaluation of product concept and customer design input, and determination of project plan requirements.
• PHASE II: FEASIBILITY – Generation of project plan, risk analysis and initial design process, followed by prototype builds and feasibility studies.
• PHASE III: DESIGN DEVELOPMENT – Design and risk analysis developed and completed. Design verification and validation performed, followed by creation of Design History File.
• PHASE IV: PRODUCTION TRANSFER – Process Validation performed and design transferred to manufacturing for pilot or production requirements.
• PHASE V: DELIVERY/MARKET INTRODUCTION – Completion of final Design Review, audit of Design History File, and product released to customer.