CATHETER RESEARCH INC.
With complete solutions for design, development, and manufacturing processes within the medical devices industry, CRI is a leading medical product developer and manufacturer of medical devices. CRI provides its customers with unbeatable service, excellent quality control and regulatory compliance. Located in Indianapolis, Indiana, CRI is a top Midwest medical device manufacturer and employs 100+ people. In 2008, CRI began the process to become an employee-owned business with a 30% ESOP acquisition. In December 2010, CRI became 100% employee owned company.
Customer Focus
CRI has a dedicated staff focused on being the internal advocates for all of our customers to ensure a high level of satisfaction. The customer service staff follows up on all customer requests for timely action and responses. All customer feedback and questions are entered into a tracking database within hours of receipt. The system includes a follow up loop and closure after the feedback is addressed. The feedback is categorized and trended for improvements and preventive measures to be put in place if needed. CRI has an annual goal of 98% on time delivery, and has met this goal consistently.
Project Management
CRI has an excellent track record with project management. Each new customer is assigned a dedicated project manager, to ensure effective and timely communication. This includes operating to a plan and schedule, with reporting on deliverables and budget attainment. Project Management is used for new design, design changes and manufacturing transfer programs.
- Device Review
- Document Review
- Manufacturing Transfer
- Inventory Transfer
- Inventory Control
- Project Cost Estimates
- Budget & Delivery Tracking
Quality Tools and Regulatory Excellence
CRI has developed and implemented a state of the art Quality Management System, combining both simplicity and regulatory compliance. This system includes a Quality Manual consisting of only 3 pages, which is the road map for all of our employees to follow, to stay on track within the system. You will find this roadmap hanging in all areas, as a quick reference to procedural guidance. The document numbering system is designed to allow for quick retrieval and reference to quality procedures, manufacturing and inspection procedures, work instructions and forms. All new hires at all levels receive FDA QSR (GMP) and ISO13485:2003 training within their first week, ensuring critical requirements are understood. This training is repeated quarterly to re-emphasize critical objectives.
- Fully integrated ERP system
- Risk management
- Fully compliant calibration and preventive maintenance system
- Includes all fixtures and tooling
- Equipment
- Gages
- Scales
- Dispensing apparatus
- Six Sigma and lean methodologies
- Statistical sampling techniques - AQL, C=0, etc.
- Process capability measurement - Cpk, Ppk, etc.
- Process validations (IQ/OQ/PQ)
- Sterilization Validations (ETO / Gamma)
- Cost containment
- Design control & documentation
- Process yield / defect analysis
- Process control (SPC)
- Project Management
- Formal corrective / preventive action
- Material traceability systems
- Precision measuring gages
- Microscopes
- Micrometers (digital / laser)
- Pin gages, block gages
- Calipers
- Profile projector
- Instron tensile and compression tester
- Tubing burst test systems - high pressure
- Pouch burst testers
- Leak testing equipment
- Other various precision gages
CRI’s engineering department offers an extensive and diverse background in all phases of engineering design and development. We specialize in medical device disposables, from concept stage through final Medical Packaging and distribution, with 80% of our business being contract manufacturing of Medical Disposables and other devices. We focus on design for manufacturability, with emphasis on creating repeatable, controlled processes and high functioning devices for our customers. Our internal areas of expertise include:
- Ultrasonic welding
- RF welding
- Plasma treatment
- Pad printing
- Heat forming
- Balloon bonding
- Insert molding
- UV / CA & solvent bonding techniques
- Swaging
- Medical Packaging
- Sterilization validations
- Tooling for high volume throughput
CRI's supply chain management is designed to manage and control the most difficult piece for anyone's business. Controlling quality, delivery and responsiveness at the supplier level is not only critical, but is becoming the primary focus for all regulatory bodies, including FDA and ISO13485:2003. Our innovative process provides for excellence to meet not only the regulatory requirements, but to ensure customer's needs are met consistently. This includes a comprehensive feedback system for suppliers and partnering with suppliers for combined excellence and rewards.
- Focus on economic order quantities based on price, delivery and storage costs.
- Minimal obsolescence with excellent communication to customers.
- Change management agreements including multiple department approvals at critical suppliers.
- Utilizing MRP system for ensuring on time deliveries to meet customers due dates.
Fulfilment and Distribution
- Negotiated tariffs with multiple freight companies
- Goal is 100% fill rate with 98% on time delivery
- Annual re-negotiation process with freight companies to keep costs down
- 99.9% accuracy in shipping and customer documentation
- 99.9% damage free shipments
Extrusion
CRI has implemented an extrusion and tubing line for flexible PVC, single lumen, medical Tubing; with a focus on quality and short lead-times.
CRI is committed to the highest quality medical tubing and strong customer service. We have invested in state-of-the-art extrusion and tubing manufacturing equipment to insure a “robust” extrusion process and we have a highly skilled and dedicated extrusion team.
Let CRI assist you with the production of plastic tubing and extrusion that will meet your exact requirements and exceed your expectations.
Our capabilities include:
- Quality System compliance to: FDA QSR 21 CFR Part 820 and ISO 13485, 2003
- Flexible Polyvinyl Chloride (PVC) Extrusion
- Medical Tubing
- Gas Sampling Lines
- High Volume Extrusion
- Diameter Ranges: .040 ID and .750 OD
- Installation Qualifications (IQ)
- Operational Qualifications (OQ)
- Performance Qualifications (PQ)
- Reeled (coil) Tubing
- Cut-to-Length
- Precision Tolerances
- Short Lead-times
- Closed-looped Measurement System
- In-process & Final Inspection
- Statistical Process Control (SPC)
Manufacturing and Transfers
CRI takes a team approach to transferring manufacturing lines into our facility. We assign a dedicated Program Manager at the start, to ensure all deliverables are documented and tracked. We focus on improving process and product during the transfer, resulting in lower costs and improved quality. CRI also minimizes the effort for our customers, making transfers seamless and smooth.
- Class 8 cleanroom facility
- 1920 square feet
- ISO certified
- Controlled environment
- all production working areas
- Lean manufacturing
- maximizing customer value while minimizing waste
- resulting in lower and controlled costs
- Evaluate all aspects of process
- Eliminate non-value added steps
- Minimize process steps
- Less human efforts, less space, less cue times, less waste, less inventory
- Single piece flow
- Reduces errors and improves visualization of process
- Reduces errors and improves visualization of process
- Visual manufacturing
- Organized work centers and processes
- Indicators at all stages of process for status
- Fully integrated MRP system
- Utilizing M2M software for all aspects of business
- Bar coding
- Automated manufacturing processes and cost analysis by product
- Document Control
- Our document control process includes all regulatory requirements for this critical area of our Quality Management System. This includes lock out of documents pending changes, to ensure implementations are compliant and that errors are prevented. The final stage of document control includes training and effectiveness measurement.
- Fully implemented change control system for all documents for a fully compliant Quality Management System
- Device Master Records (DMR)
- Device History Records (DHR) for all lots manufactured
- Document control process tracked for quick change turn around
- Standards library always kept up-to-date
- Our document control process includes all regulatory requirements for this critical area of our Quality Management System. This includes lock out of documents pending changes, to ensure implementations are compliant and that errors are prevented. The final stage of document control includes training and effectiveness measurement.
