Medical Device ContractManufacturingTrinity Biomedical supports the Medical Device industry by specializing in cleanroom deviceassembly, CNC wireforming, advanced machining, automated ultrasonic washing andpassivation, systems’ automation building, along with a technically advanced staff.With Trinitys broad array of capabilities, foremost attention to quality, responsiveness and leanoperation we can either supply a single component or the entire device with a speed to markettimeline matched by few.Trinity offers a state-of-the-art US Fed STD 209E Class ISO-6 / ISO-7 / ISO-8 cleanroomdependent on your needs and requirements. Trinity is supported by ISO 9001-2008 andISO13485; we are also AS-9100 compliant.Trinity supports volume requirements from one to 400M articles. Sourcing your needs to TrinityBiomedical provides you the means to quickly accomplish the development and manufacturingof medical devices for today’s global markets without major investments of people and capitalwithin your organization.Company Overview
Medical Device ContractManufacturingOur VisionTrinity Biomedical, Inc. will strive to be aglobal leader in the creation and productionof medical components to meet the needs ofthe medical device industry.Our MissionOur Team is committed to supporting themedical manufacturing industry resulting inan improved quality of human life.Our Quality PolicyTrinity Biomedical is committed to surpass allof our customer’s quality expectationsthrough effective quality objectives and anenthusiastic drive to continually improve allaspects of the organization.Trinity Biomedical’s Path to Success
Medical Device ContractManufacturingOur 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
Medical Device ContractManufacturingOur 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 DevelopmentOur Processes■ CNC Milling & Swiss Turning■ Dynamic Waterjet■ Wire EDM■ Wire & Spring Forming■ Metal Stamping■ Multi-Sonic Washing & Citric Passivation■ Cleanroom Assembly & Packaging■ Warehouse & Distribution
Medical Device ContractManufacturingOur Processes - CNC Milling & Swiss TurningTrinity Biomedical is heavily invested in modern CNCmachining equipment. We have advanced the processof prototype and production stage quantities of medicalcomponents 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 fasterthan with HSS drills.■ Shrink-fit tool holders for the ultimate inmachine tool accuracy and rigidity.■ Software tool-pathing can reduce cutting times up to50%.■ Tool position tolerances are generally to within0.0005”.
Medical Device ContractManufacturingOur Processes - Water Jet CapabilitiesTrinity Biomedical’s dynamic, abrasive water jetcutting system brings high tolerance, rapidcutting to a new level. This versatile 4-axis headprovides 3-dimensional cutting head movement.Its 60,000 PSI, dynamic cutting head can providereduced cutting times up to 70% and providewalls 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 atable travel of 6 x 12’.
Medical Device ContractManufacturingOur Processes - Wire EDMAs a full service EDM source, wespecialize in precision machining withquick turn-around using the following:■ state-of-the-art submersiblemachines w/ automaticwire 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
Medical Device ContractManufacturingOur Processes – Wire FormingTrinity Biomedical has 25 years of experiencein Wire Forming:■ Wind Wire, Coil Wire, Form Wire as smallas 0.0001 mm.■ Tension and Pitch Controls, along withvariation w/in single wound orcoiled 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, ALVanadium, AL 286, etc.■ Electroplating, Tumbling, Shot Peen & Passivation
Medical Device ContractManufacturingOur Processes – Spring MakingTrinity Biomedical manufactures springs for a rangeof medical device applications including:■ Implants ■ Dispensers■ Hearing Aids ■ Diagnostic Equipment■ Pacemakers ■ Monitoring Devices■ Urology ■ Device Manufacturing■ Pumps ■ Guide WiresVarious surface treatments are available including:■ tempering, hardening & annealment■ ultrasonic cleaning, passivation, deburing &shot peening■ zinc, phosphate, powder coating and colortopcoat
Medical Device ContractManufacturingOur Processes – Metal StampingTrinity Biomedical has 46 years experience in the productionMedical Metal Stampings:■ Complex, intricate and close tolerance components■ Short, medium and high production volumes■ Phenolic stampings■ Titanium, inconel, beryllium and otherexotic metals■ Rapid prototyping
Medical Device ContractManufacturingOur Processes – Rapid PrototypingAt Trinity Biomedical, we place significant emphasis on Rapid Prototyping response for ourcustomers.Whether it is a precise machined component, an intricate stamping, a medical instrument ora first-to-market assembly, we are here to quickly respond to your needs and requirements.For the medical industry, we specialize inthe 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 andwire forms
Medical Device ContractManufacturingOur Processes - Multi-Sonic WashingTrinity Biomedical is an industry leader inultrasonic washing. Our state-of-the-art washersare capable of U/S frequencies of 25, 40, 72 and104 kHz.Water purity is the key ingredient to the successof our process. Using a Reverse Osmosis de-ionized water treatment system capable ofachieving 18 meg ohms of purity, we are aleader in the field of washing.Trinity has capabilities to qualify all of ourwashing techniques using one or all of thefollowing test methods:■ particulate testing■ non-volatile residue testing■ testing for bioburden & endotoxin
Medical Device ContractManufacturingOur Processes - Cleanroom PassivationTrinity Biomedical offers a citric acid passivationservice within an ISO Class 6 Cleanroom suitable forimplantable components.
Medical Device ContractManufacturingOur Processes – Cleanroom PackagingTrinity Biomedical cleanroom packagingoptions include:■ Package Design & Development■ Manual Bagging■ Kit Packaging■ Bulk Packaging■ Tray Sealing■ Skin Pack■ Coating■ Over Packing■ Pouch Sealing■ Bar Coding■ LabelingOur ISO 14644.1 Class 1000 cleanroom provides highlevel manufacturing, cleaning and packaging capabilities.Trinity Biomedical offers years of experience in theassembly of ultra fine wires, guidewires, catheters,electronics, aerospace and machined medical devices.
Our Products & ServicesMedical Device ContractManufacturingTrinity Biomedical houses a 2500 ft2 convertible Class 1000 –100,000 clean room for your Ultrasonic Washing / Passivation,assembly and packaging requirements. We are capable ofhandling all your production programs as well as managingthe entire process from prototype through production.Programs are run in secure private assemblyrooms when requested.Services Offered Include:■ Medical Device Washing and Assembly■ Precision Contract Manufacturing■ Precision Component Assembly■ Clean Room Packaging Services■ Contract Ultrasonic Washing & Packaging
Medical Device ContractManufacturingProduct Development and ManagementCritical elements within the design and managementstages include:■ Refinement of Customer Goals into Final ProductRefinement of Customer Goals into Final Product■ In House DesignIn 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 ManagersHouse Project Managers■ Six InSix In--House DesignersHouse DesignersEarly Trinity Biomedical involvement with your productat the initial design stage can yield enhanced qualityand functionality to new product developments.Improved manufacturability and optimization of materialusage have the potential to generate competitiveadvantages to your Company.
Medical Device ContractManufacturingMedical Component Images
Medical Device ContractManufacturingMedical Component Images
Medical Device ContractManufacturingContact Information■ Tom McAdams General Managertmcadams@trinitybiomedical.comCell: 262-389-2458Office: 262-252-4786Fax: 262-252-4791Our Ultimate Goal & ObjectiveTo leverage our 46 years experience, our accumulated leanmanufacturing practices, innovation and technology, so that wedeliver our to customers quality components within industryleading timelines.We Absolutely Stand Behind Our Products & Commitments