Design Services

Proxcath

Medical Design Services

Medical Design Services

ProXCath solves complex engineering designs for medical industry leaders, OEMs and start-up companies. This is achieved by applying our multidisciplinary expertise, collaborative teamwork, off–the-shelf technology and our proven processes (Medical Design Services).

Contract design service allows you to bring products to the market quickly in a very efficient way. The design team is highly specialized in catheters, delivery systems, stents and associated products used in minimally invasive therapies.

As your contract partner for design services, we are committed to delivering all technology and services you require to bring your product concept into life.

Medical Device Design & Development

At ProXCath Medical, many of our sites are involved with the design and development of medical products. Our team uses a multi-phase design process to deliver the best products possible to our customers. This proven approach helps structure the flow of product development and ensures maximum collaboration at every step. Throughout the process we communicate frequently with our customers, provide consistent and timely production schedules, and thoroughly document each development process.

We co-develop breakthrough medical device designs using the latest tools and techniques to create products that are robust, safe, effective, and within budget.  We develop manufacturing processes that ensure effectiveness all the way through to product launch. We also validate processes across the entire spectrum of product development – from bottom-up creation to parallel line-transfer.

  • PTCA & PTA Balloon Catheters
  • Stent Delivery Systems
  • CTO Catheters
  • Vulnerable Plaque Detection Catheter
  • Embolic Filter Device Delivery System
  • Steerable EP Catheters & Sheaths
  • Kyphoplasty Delivery Device
  • Endoscopic Biopsy Device
  • IVUS & Imaging Delivery Systems
  • Laparoscopic Device
  • Valve Repair/Replacement Delivery System

Manufacturing Process & Transfers

  • Determine Project Scope
  • Execute Technical Assessment
  • Perform Financial and Schedule Assessment
  • Customer Review of Project Proposal and Costs
  • Confirm Project Charter
  • Develop a Detailed Project Schedule
  • Assign a Cross-Functional Manufacturing Transfer Team
  • Establish a Communication Plan Between Project Teams
  • Establish Quality System Plan
  • Identify Regulatory Needs and Support
  • Implement a Risk Management Strategy
  • Optimize Supply Chain
  • Establish Tooling and Fixture Strategy
  • Assess Design for Manufacturability (DFM)
  • Customer Review of Project Changes and Improvements
  • Implement Design and Process Improvements
  • Run Prototype and Evaluate Changes
  • Perform and Document Testing to Support
  • Design and Process Change
  • Build or Transfer Tooling
  • Perform Installation Qualification (IQ)
  • Perform Product Equivalency Build
  • Finalize Manufacturing Procedures
  • Initiate Test Method and Validation
  • Execute Operational Qualifications (OQ)
  • Execute Performance Qualifications (PQ)
  • Execute Product Performance Qualifications (PPQ)
  • Finalize Testing Methods and Validations
  • Support Regulatory Needs
  • Release for Commercial Sales
  • Perform Line Audit for Manufacturing Kick Off
  • Build and Manage Safety and Close Out Stock
  • Confirm Capacity Ramp-Up Plan and Metrics
  • Monitor Line Metrics
  • Utilize Continuous Improvement
  • Establish On-Going Quarterly
  • Business Review Meetings

DFM & Phase Gate Process

  • Concept feasibility and market assessment
  • Design requirements/inputs
  • Design drawings/models
  • Tool/mold design, making, and prototyping
  • Design verification and validation
  • Production readiness
  • Commercial transfer
  • Postmarket launch & customer support

Regulatory Support

We can manage the complete approval process for your Class II, Class IIb, or Class III medical device program. Our dedicated team is well-versed in the requirements of regulatory bodies worldwide.

Services include:

  • Regulatory affairs & quality assurance
  • Regulatory & clinical strategy development
  • Design history files/technical files
  • Data management
  • 510(k) and PMA regulatory submission services
  • CE Mark submissions & audit support
  • Approval process management
  • Post approval services – field management

APPLICATIONS