Catheter Research, Inc.

Company Overview

2012

Catheter Research, Inc.5610 W. 82nd Street

Indianapolis, IN 46278

Phone: (317) 872-0074

Fax: (317) 872-0169

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.

About CRI

• History: Established in 1987 as an engineering firm focused on catheter development.

• Current Status:

• ISO 13485:2003 Certified.

• 100% Medical Portfolio.

• 130 Employees.

• 100% ESOP – Employee

Owned.

• Customer Types: Medium to

large medical device

manufacturers.

77%

20% 3%

Contract Manufacturing

CRI proprietary products

sold directly to end user

Contract design and

design for manufacturing

• Business Model

• Thomas Medical• Proprietary product line

for OB/GYN market.

Overview

Manufacturing

• Proprietary products:• Hysterosalpingography

Catheters

• Uterine Manipulators

• Loop Electrodes

• Endometrial Samplers

• Sono-Inject Catheters

• Custom products:• GSL (anesthesia capnography)

• BPH device

• Electro-Physiology catheter

• Spinal steerable catheters

• Guidewires

• 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

Manufacturing

• Assembly Capabilities

• Heat Forming

• Welding/Bonding

• Ultrasonic Welding

• RF Welding

• Plasma Treatment

• Balloon Bonding

• UV / CA & Solvent Bonding

Techniques

• Pad Printing

• Insert Molding

• Tipping

• Swaging/ Crimping

• Hole Punching / Skiving

• Extrusion In-House

• Single lumen, high volume

• Extrusion Sub-Contractors

• Multi Lumen / Metal Reinforced

Tubing

• Bump / Taper Extrusion

• Cleanroom Operations

• ISO Class 8 Cleanroom Facility

• Packaging and Labeling

• Laser Etching/Marking

• Tooling for high volume throughput

• Test and Calibration• Tensile Testing

• Accelerated Aging

• Sterilization validations

• Bioburden / Biocompatibility

• Burst Testing

Manufacturing

• Manufacturing Principals:

• Lean Manufacturing:• Maximizes customer value while

minimizing waste .• Results in lower and controlled costs.

• Visual Manufacturing:• Organized work centers and

processes .• Indicators at all stages of process.

• Document Control:

• Fully implemented change

control system for all documents

for a fully compliant Quality

Management System. • Device Master Records (DMR)

• Device History Records (DHR)

• Made to Manage ERP System:

• Fully integrated sales,

engineering and production

modules with financial reporting.

• Team Approach for manufacturing transfers:

• Assign dedicated Project

Manager.

• Focus on improving process and

product, resulting in lower costs

and improved quality.

• Minimize effort for customers.

• Software

• Solidworks 3D CAD system

• MiniTab

• Adobe Professional Programs

Design & Engineering

• Engineering staff with extensive background in all phases of design & development.

• Types of Engineers:

• Design

• Manufacturing

• Biomedical

• Quality

• Specialize in medical device disposables

• Design for Manufacturing (DFX)

• Rapid Prototyping

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.

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.

Quality and Regulatory

• FDA registered manufacturer, and specification developer

• ISO 13485:2003 – CAMCAS Certified• Registrar is BSI America.

• CE and CMDR compliance• Notified Body is BSI (UK).

• Quality System:• Fully implemented, simple to use

and compliant.

• Three page Quality Manual designed as a tool to navigate the Quality System.

• CAPA system utilized and fully compliant during audits.

• Recent audits: • FDA

• Only one minor finding recorded during last two FDA inspections in eight years.

• BSI Americas• No major non-conformances.

• Minor observations and recommendations only.

• Major medical device customers

• No major non-conformances.

• Minor observations and recommendations only.

• Internal audit program• Twelve employees trained by BSI

to perform internal audits.

• 100% on time per schedule.

Quality and Regulatory

• CRI Quality Policy:

• 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 customerswant to initiate change.

• Customer Focus is part of CRI’sQuality Policy and is valued by all employees.

Customer Focus

News, Events, and Community

• Recent News and Upcoming Events:

• January, 2012 BioCrossroads

Frameworx Event Featured COO

Christine Cook as Panelist.

• CRI to host IUPUI Biomedical

Engineering senior design class

visit in April 2012. This will be the

4th annual event.

• Thomas Medical to exhibit at 2012

ACOG May 5th-9th, San Diego,

booth # 730.

• Thomas Medical to Exhibit at 2012

ASRM Oct 20th -24th , San Diego,

booth # 219.

• Community:

• Annual ACS ‘Strides Against Breast

Cancer’ walk in October.

• Annual Thanksgiving Campaign:

• Food Drives and/or Monetary Donations benefiting Wheeler Missions, Local Families, Gleaner’s Food Bank.

• Annual Christmas Campaign:

• Gift Drives and/or Monetary Donations benefiting Samaritan’s Purse, United Christmas Service.

• Many other community events

including:

• School Supply drive for employees, Flu shots for employees, American Red Cross Donations for national disasters.

Our Team

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