PRODUCT DEVELOPMENT

Design &
Development Services

With deep expertise in catheter-based delivery systems and implants, our dedicated team of engineers will work collaboratively with you in order to bring elegant and disruptive medical solutions to life.

 

Resonetics provides complete medical device design and development services from initial concept through product validation and commercial scale up.

Our diverse technical experience and rapid-turn mindset will provide a creative force to drive the development of your next therapy. The Resonetics Design and Development team (formerly Distal Solutions) is well versed in in ISO 13485 Design Control and ISO 14971 Risk Mitigation practices. We support your team while addressing engineering and manufacturing challenges at all phases of the development lifecycle.

We understand the unique challenges of bringing novel therapies to market.

Our goal is to seamlessly collaborate with your team, while striving to be flexible and attentive to the changing demands of your project. As your full-service partner, we can prepare the design documentation your project needs for regulatory approval and increase speed to market.

Our partnership with Lightspeed Application Development Labs will allow you to take advantage of the latest micro manufacturing technology.

Our Design & Development team partners with Lightspeed ADL engineers to seamlessly integrate the latest advancements in processing capabilities and achieve a targeted, efficient, and scalable solution for your product. We take manufacturability and unit cost into account upfront to ensure targets are realized at launch.

 

PRODUCT DESIGN SERVICES

  • Complex part design (Solidworks)
    • Complete catheter delivery systems
    • Handle and mechanism design
    • Nitinol implants and delivery system componentry
    • Drawing package development and design documentation
  • Product and component sourcing utilizing both the broad manufacturing capabilities across the Resonetics platform and external suppliers
  • Expert implementation of laser cut tubes for catheter shaft reinforcement
  • Manufacturing fixture design and documentation
  • Full assignment of product intellectual property

DEVELOPMENT SERVICES

  • Catheter-orientated manufacturing process development
  • Supply chain selection, management, and technical oversight
  • In-vivo study protocol development, execution, reporting
  • Clinical site initiation, physician training, and case support
  • In-vitro test method development and fixture fabrication
 
 

DEDICATED CATHETER RAPID PROTOTYPING LAB

  • Shaft lamination and complex catheter reflow operations (horizontal and vertical arrangements)
  • Dedicated lab and laser welders for pull wire attachment and articulated systems
  • Tipping stations and assorted secondary ops (skiving, hole punching, etc.)
  • UV curing stations (metal halide and LED sources)
  • 3D printing (SLA, FDM) and laser cutting 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 and vascular model performance testing capabilities