1. Catheter Research, Inc.
Company Overview
2012
Catheter Research, Inc.
5610 W. 82nd Street
Indianapolis, IN 46278
Phone: (317) 872-0074
Fax: (317) 872-0169

2. About CRI
Catheter Research Inc. (CRI) specializes in catheters and tubing, and
has expanded as a developer and manufacturer of medical devices.
Our goal is to provide the most cost-effective product development
combined with quality OEM medical device manufacturing.

3. About CRI
• History: Established in 1987 as • Business Model
an engineering firm focused on 20% 3%
Contract Manufacturing
catheter development. CRI proprietary products
sold directly to end user
Contract design and
design for manufacturing
77%
• Current Status:
• ISO 13485:2003 Certified.
• Thomas Medical
• 100% Medical Portfolio. • Proprietary product line
• 130 Employees. for OB/GYN market.
• 100% ESOP – Employee
Owned.
• Customer Types: Medium to
large medical device
manufacturers.

4. Overview

5. Manufacturing
• Proprietary products: • Custom products:
• Hysterosalpingography • GSL (anesthesia capnography)
Catheters • BPH device
• Uterine Manipulators • Electro-Physiology catheter
• Loop Electrodes • Spinal steerable catheters
• Endometrial Samplers • Guidewires
• Sono-Inject Catheters • Pacing Leads
• Gastrointestinal Devices
• Neurological accessories
• High Pressure Contrast Media Injection
Lines
• Capillary Electrophoresis Cartridges
• Orthopedic Devices
• Custom Kit Packing
• Others that can’t be named

6. Manufacturing
• Assembly Capabilities • Extrusion Sub-Contractors
• Heat Forming • Multi Lumen / Metal Reinforced
• Welding/Bonding Tubing
• Ultrasonic Welding • Bump / Taper Extrusion
• RF Welding • Cleanroom Operations
• Plasma Treatment • ISO Class 8 Cleanroom Facility
• Balloon Bonding
• Packaging and Labeling
• UV / CA & Solvent Bonding
Techniques • Laser Etching/Marking
• Pad Printing • Tooling for high volume
• Insert Molding throughput
• Tipping • Test and Calibration
• Swaging/ Crimping • Tensile Testing
• Accelerated Aging
• Hole Punching / Skiving • Sterilization validations
• Extrusion In-House • Bioburden / Biocompatibility
• Single lumen, high volume • Burst Testing

7. Manufacturing
• Manufacturing Principals: • Made to Manage ERP System:
• Lean Manufacturing: • Fully integrated sales,
• Maximizes customer value while engineering and production
minimizing waste .
• Results in lower and controlled costs. modules with financial reporting.
• Visual Manufacturing:
• Organized work centers and • Team Approach for
processes .
• Indicators at all stages of process.
manufacturing transfers:
• Assign dedicated Project
• Document Control: Manager.
• Fully implemented change • Focus on improving process and
control system for all documents product, resulting in lower costs
for a fully compliant Quality and improved quality.
Management System. • Minimize effort for customers.
• Device Master Records (DMR)
• Device History Records (DHR)

8. Design & Engineering
• Engineering staff with extensive • Software
background in all phases of • Solidworks 3D CAD system
design & development. • MiniTab
• Types of Engineers: • Adobe Professional Programs
• Design
• Manufacturing
• Biomedical
• Quality
• Specialize in medical
device disposables
• Design for Manufacturing (DFX)
• Rapid Prototyping

9. Project Management
• Dedicated Project Manager assigned for:
• New Design
• Design Changes
• Manufacturing Transfers
• Project Management
• Device review including regulatory requirements.
• Document review coordinated with CRI team.
• Manufacturing transfer coordinated with project plan and outline.
• Inventory transfer documentation and coordination.
• Inventory control for product life cycle.
• Project cost estimates.
• Budget & performance tracking monthly.
• Detailed invoicing with individual time logs.

10. Supply Chain Management
• Supply Chain Management
• Focus on economic order quantities
based on:
• Price
• Delivery
• 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 customer’s
due dates.

11. Quality and Regulatory
• FDA registered manufacturer, • Recent audits:
and specification developer • FDA
• Only one minor finding
recorded during last two FDA
• ISO 13485:2003 – CAMCAS inspections in eight years.
Certified
• Registrar is BSI America. • BSI Americas
• No major non-conformances.
• CE and CMDR compliance • Minor observations and
recommendations only.
• Notified Body is BSI (UK).
• Major medical device
• Quality System: customers
• Fully implemented, simple to use • No major non-conformances.
and compliant. • Minor observations and
• Three page Quality Manual recommendations only.
designed as a tool to navigate
the Quality System. • Internal audit program
• CAPA system utilized and fully • Twelve employees trained by BSI
compliant during audits. to perform internal audits.
• 100% on time per schedule.

12. Quality and Regulatory
• CRI Quality Policy:

13. Customer Focus
• Customer Service staff focused on being the internal advocates
for our customers to ensure a high level of satisfaction.
• Receives and confirms all customer orders.
• Manages special requests for shipping,
receiving, and invoicing.
• Documents customer inquiries and tracks
RMAs, complaints, and feedback.
• Provides quotations.
• Monitors on time delivery
and customer satisfaction.
• Coordinates surveys from customers
for vendor approval:
• Vendor Capabilities, Quality surveys/certifications,
ROHS, DEHP, BPA, Latex.
• Initial point of contact when customers
want to initiate change.
• Customer Focus is part of CRI’s
Quality Policy and is valued by all employees.

14. News, Events, and Community
• Recent News and • Community:
Upcoming Events: • Annual ACS ‘Strides Against Breast
• January, 2012 BioCrossroads Cancer’ walk in October.
Frameworx Event Featured COO • Annual Thanksgiving Campaign:
Christine Cook as Panelist. • Food Drives and/or Monetary Donations
• CRI to host IUPUI Biomedical benefiting Wheeler Missions, Local
Families, Gleaner’s Food Bank.
Engineering senior design class
visit in April 2012. This will be the • Annual Christmas Campaign:
4th annual event. • Gift Drives and/or Monetary Donations
benefiting Samaritan’s Purse, United
• Thomas Medical to exhibit at 2012 Christmas Service.
ACOG May 5th-9th, San Diego,
• Many other community events
booth # 730.
including:
• Thomas Medical to Exhibit at 2012 • School Supply drive for employees, Flu
ASRM Oct 20th -24th , San Diego, shots for employees, American Red
booth # 219. Cross Donations for national disasters.

15. Our Team
Bio’s available : http://www.catheterresearch.com/AboutCRI/OurPeople.asp