PRODUCT DEVELOPMENT

AGILE PRODUCT
DEVELOPMENT

The product development team at Resonetics is driven by the guiding principles of quality, speed, and partnership.  With deep expertise in catheter-based delivery systems, electrophysiology, cryotherapy, and implants, our dedicated team of engineers will work collaboratively with you to bring elegant and disruptive medical solutions to life.

 

Complete medical product development services from initial design and prototyping to 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 AGILE Product Development team is well-versed 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 development.

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 Lightspeed Labs allow you to take advantage of the latest micromanufacturing technology.

Our AGILE Product Development team works directly with Lightspeed 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

  • Medical device conceptual design and evaluations
  • 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 to find the best solution, utilizing both the broad manufacturing capabilities across the Resonetics network and external suppliers
  • Development and design freeze phase
  • Manufacturing fixture design and documentation
  • Complete assignment of product intellectual property
  • Design verification, validation, and preproduction
  • Initiate transfers from R&D to commercial production
 
 

MEDICAL DEVICE DEVELOPMENT SERVICES

  • Minimally invasive therapeutic and diagnostic medical products for:
    • Electrophysiology
    • Cardiology
    • Radiology
    • Cryotherapy
    • Drug Delivery
    • Pulmonology
    • Gastroenterology
    • Pain management
    • Neurology
  • 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

AGILE Product Development Process

  1. Concept Phase: New product ideas are evaluated for their feasibility. Concepts are developed and tested to assess their ability to meet the requirements.
  2. Planning Phase: The project is organized to begin the development of the product.
  3. Development and Design Freeze Phase: Concepts are developed and transformed into designs that are then refined iteratively until all the design inputs are met.
  4. Design Verification Phase: The product is submitted to extensive design verification testing to objectively demonstrate that the design outputs can satisfy the design inputs
  5. Validation and Pre-Production Phase: Design and processes are validated to get the product ready for commercial production. Limited runs may be performed for clinical studies.
  6. Design Transfer to Production Phase: Product design is officially transferred from R&D to commercial production.
 
 

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