CRI Company Overview 2013 updated 4

Catheter Research, Inc.

Company Overview

2013

Catheter Research, Inc.

5610 W. 82nd Street

Indianapolis, IN 46278

Phone: (317) 872-0074

Fax: (317) 872-0169

About CRI

Catheter Research Inc. (CRI) is a market leader in medical device manufacturing, contract development, and product life cycle management.

CRI specializes in catheter design /assembly, medical tubing /extrusion, and OBGYN Disposables.

CRI provides excellence in project management, lean manufacturing techniques, supply chain controls, and regulatory compliance .

About CRI

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

• Current Status:

• ISO 13485:2003 Certified.

• 100% Medical Portfolio.

• 145 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

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Manufacturing

• Proprietary products:• Hysterosalpingography

Catheters

• Uterine Manipulators

• Loop Electrodes

• Endometrial Samplers

• Sono-Inject Catheters

• Custom products:• GSL (anesthesia capnography)

• Benign Prostate device

• Breast Biopsy devices

• Electro-Physiology catheter

• Spinal Steerable catheter

• Voice Prosthesis catheter

• Guidewires

• 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

• Pad Printing

• Insert Molding

• Tipping

• Swaging/ Crimping

• Hole Punching / Skiving

Syneo Skiving Equipment

Arburg Injection/ Insert Molding

Vante Catheter Tipping

ManufacturingCRI Extrusion

• Extrusion In-House

• Single lumen, high volume

• Extrusion Sub-Contractors

• Multi Lumen / Metal Reinforced

• Bump / Taper Extrusion

• Nikon Vision System (Off-Line Final Inspection)

• ID/OD

• Wall Thickness

• Concentricity

• Roundness

Manufacturing• Manufacturing Principals:

• Lean Manufacturing

• Visual Manufacturing

• Document Control:• Fully implemented change control

system for all documents for a

compliant QMS. • Device Master Records (DMR)

• Device History Records (DHR)

• Made to Manage ERP System:• Fully integrated sales, engineering,

production, and finance modules

• Cleanroom Operations

• ISO Class 8 Cleanroom Facility

• Packaging and Labeling

• Laser Etching/Marking

• Tooling and Fixturing

• Test and Calibration• Tensile Testing

• Accelerated Aging

• Sterilization Validations

• Bioburden / Biocompatibility

• Burst Testing

Design & EngineeringEngineering staff with extensive background in all phases of

design & development, from Concept to Manufacturing:

• Engineering Disciplines: Design, Manufacturing, Mechanical, Biomedical, Quality

• Software Used: Solidworks 3D CAD System, Mini Tab, Adobe Professional

Project Management

• Dedicated Project Manager assigned for:

• New Design

• Design Changes

• Manufacturing Transfers

• Project Management

• Device review

• Document review

• 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:

• Price

• Delivery

• Storage Costs

• Minimal obsolescence.

• Change management agreements

including multiple department

approvals at critical suppliers.

• Utilizing MRP system for ensuring

on time deliveries to meet customer’s

due dates.

• Seven consecutive years at 98%+ on

time deliveries to all customers.

Quality and Regulatory

• CRI Quality Policy:

• 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.

Quality and Regulatory

Certifications and Audit Performance

• FDA Registered • Audit Performance: Only one minor finding

recorded during last two FDA inspections.

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

• Audit Performance: No major non-conformances; minor observations and recommendations.

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

• Other Audits • Major Medical Device Customers

• No major non-conformances; minor observations and recommendations.

• Internal Audit Program• Twelve employees trained by BSI

• 100% on time per schedule.

• 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’s Quality Policy and is valued by all employees.

Customer Focus

News & Events

Press Releases:

• August 2012: CRI recognized as one of the 2012 Indiana Companies to Watch.

• September 2012: CRI to provide Innovative Contract Sterilization Service

through partnership with Noxilizer.

• January 2013: Thomas Medical Acquired Specific Assets of Marshall Medical

• March 2013: CRI and Thomas Medical Introduced the Miller Advance Catheter.

Please Visit Us:

• CRI 2013 Tradeshows: MD&M West, MD&M East, MD&M Chicago

• Thomas Medical 2013 Tradeshows: ACOG, ASRM, AAGL, Local ACOG meetings.

News and Community updated regularly:

• CRI Website: http://www.catheterresearch.com/NewsCommunity.aspx

• CRI QMED Qualified Supplier Directory: http://www.qmed.com/supplier/catheter-

research-inc

• CRI Linked IN and other media profiles.

Our Team

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