Trinity Biomedical 2013

Trinity Biomedical, Inc.W175 N5750 Technology DriveMenomonee Falls, WI. 53051

www.trinitybiomedical.comP: 262-252-4786 F:262-252-4791

Medical Device Contract Manufacturing

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 400M 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 capitalwithin your organization.

Company Overview


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.

Trinity Biomedical’s Path to Success


Our Certifications

▪ Med device experience since 1965▪ 20 years CNC medical machining▪ 21 years cleanroom assembly▪ 21 years medical wire forming▪ 23 years medical wire EDM▪ 48 years medical tool manufacture ▪ FDA regulatory experience

■ ISO 9001:2008

■ ISO 13485:2003

■ ISO 146144.1 Class 6 Cleanroom

■ AS-9100 Compliant


Our Capabilities

■ 52,000 ft2 Manufacturing facility■ Class 1000 - 100,000 Cleanroom ■ Lab Testing - particulate, non-volatile residue■ CMM Lab Inspection■ Statistical Process Control■ Reverse Engineering■ Product Research & Development■ Rapid Prototype Development

Our Processes■ CNC Milling & Swiss Turning■ Dynamic Waterjet■ Wire EDM■ Wire & Spring Forming■ Metal Stamping ■ Multi-Sonic Washing & Citric Passivation■ Cleanroom Assembly & Packaging■ Warehouse & Distribution


Our Processes - CNC Milling & Swiss Turning

Trinity 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-pathing can reduce cutting times up to 50%.

■ Tool position tolerances are generally to within 0.0005”.


Our Processes - 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 up to 70% 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’.


Our Processes - Wire EDM

As 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”

■ Drilling Ø 0.008 to 0.250”

■ Solid Modeling

■ In-house block prep & heat treat


Our Processes – Wire Forming

Trinity Biomedical has 25 years of experience in Wire Forming:

■ Wind Wire, Coil Wire, Form Wire as small as 0.0001 mm.

■ 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


Our Processes – Spring Making

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

■ Implants ■ Dispensers■ Hearing Aids ■ Diagnostic Equipment■ Pacemakers ■ Monitoring Devices■ Urology ■ Device Manufacturing■ Pumps ■ Guide Wires

Various surface treatments are available including:

■ tempering, hardening & annealment

■ ultrasonic cleaning, passivation, deburing & shot peening

■ zinc, phosphate, powder coating and color topcoat


Our Processes – Metal Stamping

Trinity Biomedical has 46 years experience in the production Medical Metal Stampings:

■ Complex, intricate and close tolerance components

■ Short, medium and high production volumes

■ Phenolic stampings

■ Titanium, inconel, beryllium and other exotic metals

■ Rapid prototyping


Our Processes – Rapid Prototyping

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


Our Processes - Multi-Sonic Washing

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 bioburden & endotoxin


Our Processes - Cleanroom Passivation

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


Our Processes – Cleanroom Assembly

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


Our Processes – Cleanroom Packaging

Trinity Biomedical cleanroom packaging options include:

■ Package Design & Development■ Manual Bagging■ Kit Packaging■ Bulk Packaging■ Tray Sealing■ Skin Pack■ Coating■ Over Packing■ Pouch Sealing■ Bar Coding■ Labeling

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.

Our Products & Services


Trinity Biomedical houses a 2500 ft2 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


Product Development and Management

Critical elements within the design and management stages include:

■ Refinement of Customer Goals into Final ProductRefinement of Customer Goals into Final Product■ In House Design In House Design –– SolidWorks and AutoCad.SolidWorks and AutoCad.■ Extensive Knowledge of Metrologic FunctionsExtensive Knowledge of Metrologic Functions■ Fixture and Process Qualification and ValidationFixture and Process Qualification and Validation■ Tool Procurement with Design OversightTool Procurement with Design Oversight■ Eight InEight In--House Project Managers House Project Managers ■ Six InSix In--House DesignersHouse Designers

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.


Medical Component Images


Medical Component Images

Our Associations



Contact Information

■ Tom McAdams General Manager

[email protected]

Cell: 262-389-2458Office: 262-252-4786Fax: 262-252-4791

Our Ultimate Goal & ObjectiveTo leverage our 46 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

Business

Trinity Biomedical 2013