Trinity Biomedical Capabilities

COMPANY OVERVIEW

Trinity Biomedical supports the Medical Device industry by specializing in cleanroom device assembly, CNC wireforming, advanced machining, automated ultrasonic washing and passivation, systems automation building, along with a technically advanced staff.

With Trinity's broad array of capabilities, foremost attention to quality, responsiveness and lean operation we can either supply a single component or the entire device with a speed to market timeline matched by few.

Trinity offers a state-of-the-art US Fed STD 209E Class ISO-6 / ISO-7 / ISO-8 cleanroom dependent on your needs and requirements. Trinity is supported by ISO 9001-2008 and ISO13485; we are also AS-9100 compliant.

Trinity supports volume requirements from one to thousands of articles. Sourcing your needs to Trinity Biomedical provides you the means to quickly accomplish the development and manufacturing of medical devices for today’s global markets without major investments of people and capital within your organization.

TRINITY BIOMEDICAL’S PATH TO SUCCESS

Our VisionTrinity Biomedical, Inc. will strive to be a global leader in the creation and production of medical components to meet the needs of the medical device industry.

Our MissionOur Team is committed to supporting the medical manufacturing industry resulting in an improved quality of human life.

Our Quality PolicyTrinity Biomedical is committed to surpass all of our customer’s quality expectations through effective quality objectives and an enthusiastic drive to continually improve all aspects of the organization.

OUR TEAMSQUALIFICATIONS

• Med device experience since 1965

• 22 years CNC medical machining

• 22 years cleanroom assembly

• 22 years medical wire forming

• 28 years medical wire EDM

• 49 years medical tooling

• FDA regulatory experience

ISO 9001:2008

ISO 13485:2003

ISO 146144.1 Class 6 Cleanroom

AS-9100 Compl iant

QUALITYCERTIFICATIONS…………………………………

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OUR STATE OF THE ART FACILITY

• 52,000 ft2 Manufacturing facility

• Class 1000 – 100,000 Cleanroom

• Lab Testing – Particulate,

Non-Volatile, Residue

• CMM/Laser Scanning Inspection

• Statistical Process Control

• Reverse Engineering

• Product Research & Development

• Rapid Prototype Development

OUR PROCESSES

• CNC Milling & Swiss Turning

• Multi-Sonic Washing & Citric Passivation

• Dynamic Waterjet

• Wire EDM

• Wire & Spring Forming

• Metal Stamping

• Cleanroom Assembly & Packaging

• Warehouse & Distribution

CNC MILLING & SWISS TURNINGTrinity Biomedical is heavily invested in modern CNC machining equipment. We have advanced the process of prototype and production stage quantities of medical components to new levels of speed and precision:

• Machine travels up to 85”X 50” X 36” (x, y, z).

Parts up to 116” long.

• Spindles up to 20,000 RPM for true, high speed machining.

• 1000 PSI thru-the-spindle coolant. Drilling speeds up to

7x faster than with HSS drills.

• Shrink-fit tool holders for the ultimate in machine tool

accuracy and rigidity.

• Software tool-path can reduce cutting times up to 50%.

• Tool position tolerances are generally to within 0.0005“.

WATER JET CAPABILITIES

Trinity Biomedical’s dynamic, abrasive water jet cutting system brings high tolerance, rapid cutting to a new level. This versatile 4-axis head provides 3-dimensional cutting head movement.

Its 60,000 PSI, dynamic cutting head can provide reduced cutting times and provide walls with zero taper. Edges are smooth, heat-zone free and accurate to within 0.003”.

We are experienced in cutting steel, aluminum, titanium, brass, composite material, glass, plastic, ceramic tile, rubber, granite, and marble.

Capable of material cut up to 9" thick with a table travel of 6' x 12’.

WIRE EDMAs a full service EDM source, we specialize in precision machining with quick turn-around using the following:

• State-of-the-art submersible machines w/ automatic wire threading

• 30” x 20” x 14” machine travel

• Wire Ø down to 0.004”

• EDM Drilling Ø 0.008 to 0.250”

• Solid Modeling

• In-house block prep & heat treat.

WIRE FORMING

Trinity Biomedical has 22 years of experience in Wire Forming:• Wind Wire, Coil Wire, Form

Wire as small as 0.002 inch.

• Tension and Pitch Controls,

along with variation w/in single

wound or coiled length.

• Cannula Reinforcement Wires

• Coil-Reinforced Tubing for

Catheters

• Introducer wires, Suture snare

wires

• Compression / Extension /

Torsion springs

• Exotic materials specialists:

Titanium, Inconel, Beryllium,

Elgiloy, Chrome Vanadium, AL

Vanadium, AL 286, etc.

• Electroplating, Tumbling, Shot

Peen & Passivation

Trinity Biomedical manufactures springs for a range of medical device applications including:

Various surface treatments are available including:

• Implants

• Hearing Aids

• Pacemakers

• Urology Manufacturing

• Pumps

• Dispensers

• Diagnostics Equipment

• Monitoring Device/Devices

• Guide Wires

• Tempering, hardening & annealment

• Ultrasonic cleaning, passivation, deburing & shot peening

• Zinc, Electro polish, phosphate, powder coating and color topcoat

SPRING MAKING

Since 1965 Trinity Biomedical has had experience in the production Medical Metal Stampings. From Progressive, Transfer or Draw dies we have the experienced toolmakers to get you the die you need.

• Complex, intricate and close tolerance components

• Short, medium and high production volumes

• Titanium, Inconel, beryllium and other exotic metals

• Rapid prototyping

METAL STAMPING

At Trinity Biomedical, we place significant emphasis on Rapid Prototyping response for our customers.

Whether it is a precise machined component, an intricate stamping, a medical instrument or a first-to-market assembly, we are here to quickly respond to your needs and requirements.

For the medical industry, we specialize in the following types of prototyping:

• Surgical tools / instruments

• Medical devices

• Medical components

• Hypo- Tubes Implants

• Medical Poly Drape sealing

• CNC machined, waterjet, EDM components

• Stampings, springs and wire forms

RAPID PROTOTYPING

Trinity Biomedical is an industry leader in ultrasonic washing. Our state-of-the-art washers are capable of U/S frequencies of 25, 40, 72 and 104 kHz.

Water purity is the key ingredient to the success of our process. Using a Reverse Osmosis de-ionized water treatment system capable of achieving 18 meg ohms of purity, we are a leader in the field of washing.

Trinity has capabilities to qualify all of our washing techniques using one or all of the following test methods:

• Particulate testing

• Non-volatile residue testing

• Testing for bio burden & endotoxin

MULTI-SONIC WASHING

Trinity Biomedical offers a citric acid passivation service within an ISO Class 6 Cleanroom suitablefor implantable components.

CLEANROOM PASSIVATION

Trinity Biomedical assembly options include:

• Medical Device & Instruments

• Multi-Component Assemblies

• Thermo Soldering

• Ultraviolet Gluing

• Tig / Mig Welding

• Laser Welding

• Medical Kits

• Surgical Kits

• Emergency Kits

CLEANROOM ASSEMBLY

Our ISO 14644.1 Class 1000 cleanroom provides high level manufacturing, cleaning and packaging capabilities. Trinity Biomedical offers years of experience in the assembly of ultra fine wires, guidewires, catheters, electronics, aerospace and machined medical devices.

Trinity Biomedical cleanroom packaging options include:

• Package Design Development

• Manual Bagging

• Kit Packaging

• Bulk Packaging

• Tray Sealing

• Skin Pack

• Coating

• Pouch Sealing

• Labeling

CLEANROOM PACKAGING

OUR PRODUCTS & SERVICES

Trinity Biomedical houses a convertible Class 1000 – 100,000 clean room for your Ultrasonic Washing / Passivation, assembly and packaging requirements. We are capable of handling all your production programs as well as managing the entire process from prototype through production. Programs are run in secure private assembly rooms when requested.

Services Offered Include:

• Medical Device Washing and Assembly

• Precision Contract Manufacturing

• Precision Component Assembly

• Clean Room Packaging Services

• Contract Ultrasonic Washing & Packaging

OUR PRODUCT DEVELOPMENT

& MANAGEMENT

Early Trinity Biomedical involvement with your product at the initial design stage can yield enhanced quality and functionality to new product developments. Improved manufacturability and optimization of material usage have the potential to generate competitive advantages to your Company.

Critical elements within the design and management stages include:

• Refinement of Customer Goals into Final Product

• In House Design – SolidWorks and AutoCad.

• Extensive Knowledge of Metrologic Functions

• Fixture and Process Qualification and Validation

• Tool Procurement with Design Oversight

• In-House Project Management

• In-House Designers

OUR MEDICAL COMPONENT IMAGES

OUR AFFILIATIONS

OUR ULTIMATE GOAL & OBJECTIVE

We leverage our 49 years experience, our accumulated lean manufacturing practices, innovation and technology, so that we deliver our to customers quality components within industry leading timelines.

We Absolutely

Stand Behind

Our Products &

Commitments

Tom McAdams, General Manager

[email protected]

Cell: 262-389-2458

Office: 262-252-4786

Fax: 262-252-4791