Catheter Research Inc. is a leading medical device manufacturer specializing in catheter design, medical tubing, and OBGYN disposables. It has 145 employees and is ISO 13485 certified. CRI provides contract manufacturing services for medium and large medical device companies as well as produces its own proprietary OBGYN product line under the Thomas Medical brand.

1. Catheter Research, Inc.
Company Overview
2013
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) 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 .

3. About CRI
• History: Established in 1987 as an • Business Model
engineering firm focused on catheter 20% 3%
Contract Manufacturing
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
• 145 Employees. for OB/GYN market.
• 100% ESOP – Employee Owned.
• Customer Types: Medium to large
medical device manufacturers.

4. Overview
This image cannot currently be display ed.

5. Manufacturing
• Proprietary products: • Custom products:
• Hysterosalpingography • GSL (anesthesia capnography)
Catheters • Benign Prostate device
• Uterine Manipulators • Breast Biopsy devices
• Loop Electrodes • Electro-Physiology catheter
• Endometrial Samplers • Spinal Steerable catheter
• Sono-Inject Catheters • 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

6. Manufacturing
• Assembly Capabilities
• Heat Forming
• Welding/Bonding
• Ultrasonic Welding
• RF Welding
• Plasma Treatment
• Balloon Bonding
• UV / CA & Solvent Bonding
Syneo Skiving Arburg Injection/
• Pad Printing Equipment Insert Molding
• Insert Molding
• Tipping
• Swaging/ Crimping
• Hole Punching / Skiving
Vante Catheter Tipping

7. Manufacturing
CRI 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

8. Manufacturing
• Cleanroom Operations • Manufacturing Principals:
• ISO Class 8 Cleanroom Facility • Lean Manufacturing
• Packaging and Labeling • Visual Manufacturing
• Laser Etching/Marking • Document Control:
• Fully implemented change control
• Tooling and Fixturing system for all documents for a
• Test and Calibration compliant QMS.
• Tensile Testing • Device Master Records (DMR)
• Accelerated Aging • Device History Records (DHR)
• Sterilization Validations • Made to Manage ERP System:
• Bioburden / Biocompatibility
• Burst Testing • Fully integrated sales, engineering,
production, and finance modules

9. Design & Engineering
Engineering 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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

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