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- Developing Your Medical Device
- From Concept to Production
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- Founded in 1980 as Mechanical Engineering & Design Company
- New Ownership / Name April 1996
- Transition to Medical
- Market Emphasis
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- Single source for any or all medical device development services from concept
to production, including design, analysis, prototyping, testing, FDA
submissions, pilot plant production, transfer to production
- Extensive experience with applications for disposables, durables and
equipment
- Custom catheter design, development and production background
- No waiting to begin your project; rapid prototype development
- Miniaturization and Nanomolding™
- We will be with you on every step of the development path to your
destination
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- 24 full time engineers and technicians
- Educational background
- Mechanical Engineering
- Biomedical Engineering
- Quality Engineering
- Chemical Engineering
- Manufacturing Engineering
- Materials Science
- MBA
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- 2-D CAD
- 3-D Solid Modeling
- SolidWorks
- Pro Engineer
- Cadkey
- Analysis
- COSMOS (FEA)
- C-Mold (plastic flow)
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- Pebax
- Tecoflex
- Nylon
- Hytrel
- PET
- Silicone rubber
- PEEK
- Polysulfone
- Polyethylene
- Polyimide
- Titanium
- Polypropylene
- Noryl
- FEP, PTFE, PFA Teflon
- Polycarbonate
- Elastomers
- Thermoset epoxy, polyester
- Nitinol
- Stainless steel
- Hypotubes
- Shrink tubing
- Biodegradeable polymers
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- Braider (16 & 48 end)
- Vertical shrinker
- Balloon blower
- Hot die necker
- Injection molding machines (3)
- NanoInjection machines
- LIM (Silicone Rubber) injection molding
- Tube forming
- Ovens/Furnace
- Fluidized bed furnace
- Milling machines & lathes
- Clean room
- Wire rolling mill
- Pressure tester
- Tube flaring
- Pad printer
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- Plastic processing
- Nano Injection molding
- Pressure forming (balloon blowing)
- Heat shrink bonding
- Extrusion
- Compression molding
- Insert molding
- Bonding, joining, blending
- Laminating
- Other processes
- Sonic welding
- Laser welding
- Miniature hole drilling
- Tip forming
- Machining
- Casting
- Sheet metal forming
- Pad printing
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- Industrial Design
- Electronic / Software
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- Software Development
- Electronic Hardware Design
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- Biotech
- Cardiology
- Dental
- Diabetes
- Dialysis
- Hearing
- Home Monitoring/Care
- Infusion
- Neurology
- Nanomolding
- Obesity
- Respiratory Therapy
- Spinal
- Sleep Apnea
- Syringe Safety
- Urology
- Vision
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- Cardiovascular balloons
- High pressure drug injection catheter
- Esophageal balloons
- Ultrasonic imaging catheter
- Steerable catheter
- Stent
- Stent delivery catheters
- Guidewire
- Pressure sensors embedded in catheter
- RX exchange guides
- Stone retriever
- Pressure sensing guidewire
- Thermal-ablation
- Low temperature ablation
- Atherectomy catheter
- Guiding catheter
- Sensor delivery catheter
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- Catheter and injection
- port assembly
- Braid example
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- Catheter handle assembly
- Sensor Integration
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- Ultrasonic Catheter assembly
- Ultrasonic sensor
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- Catheter assembly
- Catheter kit
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- Sesame NanoMolding
- Machine
- .01 to 80 mm3 parts
- Silicone rubber or thermoplastic
- Insert molding
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- Bioabsorbable implants
- Silicone Rubber – polycarbonate molding
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- Tube
- ID = 90 micron
- OD = 280 micron
- Length = 1.8 mm
- Volume = 0.1 mm3
- Weight = .0001 g
- Material - TPE
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- Implant
- ID = .11 mm
- OD ~ .60 mm
- Length = 1 mm
- Volume = 0.4 mm
- Material - Silicone
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- Light cure gun
- Tooth manifold
- Composite delivery
- Syringe heater
- Multiple dental fluid
- dispenser
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- Micro-array robotic handling system
- Surgery control module
- Hybridization station
- Dialysis fluidic system
- Infusion pump
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- Prototype Documentation
- Design for Manufacturability
- Validation Fixtures & Tools
- Product Reliability Testing
- Released Documentation
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- Operating under and pursuing ISO 13485 (anticipate certification June
2005)
- FDA Registered
- UL, CE Mark, FDA 510K & PMA
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- Low to medium volume production
- Braiding
- Bonding
- Welding
- Molding
- Assembly
- Testing
- Sensor wiring
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- Understand the Project Requirements
- Understand the Necessary Steps to Successful Completion
- Address Project Risks Early
- Clear Communication with Partners and Clients
- Execute Each Step Decisively
- Test for Successful Completion
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- Research
- Design
- Model
- Develop
- Test
- Miniaturize
- FDA Submissions
- Biocompatibility *
- Sterilization *
- Packaging design
- Early stage production
- Produce or transfer
- * Manage services by others
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- Catheters
- Stents
- Embolic Filters
- Stent Placement
- Artificial Discs
- Biopsy
- Ultrasonic Imaging Catheter
- Stone Retriever
- Catheters with embedded elec.
- Nanomolding
- Isotope Delivery
- Systems
- Balloon Blower
- Tube Flaring
- Tube Forming
- Ultrasonic Guide Catheter
- Sensing Guidewire
- Hemodialysis
- Light Curing
- Corseting
- Drug Delivery
- Multiple Fluid Dispensing
- DNA Hybridization
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- Single source from concept to production
- No hidden processes or technologies
- More choices without interruption to your regular business activities
- We have a unique combination of project experience, people, facilities,
equipment, and sense of urgency to competitively deliver “your desired
results”
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