Job Shop Case Studies: How to be sucessful in the Medical Device Sector

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description

An overview of Industrial Laser Applications in Medical Device Manufacturing

Transcript of Job Shop Case Studies: How to be sucessful in the Medical Device Sector

Page 1: Job Shop Case Studies: How to be sucessful in the Medical Device Sector
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Directed Light Inc., Directed Light Inc., founded in 1983, is founded in 1983, is comprised of three comprised of three divisions: Advanced divisions: Advanced Technology Job Shop, Technology Job Shop, Custom Systems Custom Systems Integration, and Integration, and Components and Service. Components and Service.

Our objective is to provide Our objective is to provide high quality products and high quality products and services to a wide variety services to a wide variety of manufacturing sectors.of manufacturing sectors.

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Directed Light has Directed Light has designed and engineered designed and engineered over 130 precision over 130 precision systems for advanced systems for advanced manufacturing. manufacturing. Applications span a wide Applications span a wide variety of industries, variety of industries, including biomedical, including biomedical, aerospace, telecom, aerospace, telecom, semiconductor, and semiconductor, and electronics.electronics.

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Directed Light provides service and support for a broad selection of lasers. This includes industrial, medical, and scientific environments. We stock an extensive inventory of mission-critical laser components, and provide immediate attention and prompt handling of urgent customer requirements.

We have been establishing and maintaining long-term, mutually beneficial relationships with our customers and our component manufacturers for nearly a quarter of a century.

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Directed Light’s Advanced Directed Light’s Advanced Technology Job Shop has the Technology Job Shop has the ability to process many ability to process many materials utilizing different materials utilizing different wavelengths. From R&D to wavelengths. From R&D to production, our engineering production, our engineering and technical staff can handle and technical staff can handle the most complex customer the most complex customer requirements.requirements.

Our diverse applications toolbox Our diverse applications toolbox allows us to perform many allows us to perform many applications including; welding, applications including; welding, cutting, drilling, ablation, surface cutting, drilling, ablation, surface treatment, and marking; DLI’s vast treatment, and marking; DLI’s vast applications experience and years applications experience and years of processing expertise have of processing expertise have earned us the reputation as a earned us the reputation as a complete outsourcing solution.complete outsourcing solution.

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Wide variety of Wide variety of materials and part materials and part configurations from 2D configurations from 2D & Multi Axis& Multi Axis

Laser cutting of sheetmetal, Laser cutting of sheetmetal, exotic materials, and other exotic materials, and other implantable alloys. Products implantable alloys. Products include; bone saws, include; bone saws, connective plates, operating connective plates, operating room gurneys, room gurneys, & wheelchairs accessories.& wheelchairs accessories.

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Tube cutting micro: Tube cutting micro: cardio and neuro stents cardio and neuro stents and surgical needles and surgical needles

Image Courtesy of Lasag

Tube cutting macro:Biopsy probes and cannulas

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Ceramic

Plastic Membrane Key Switch

Glass

Nylon Screen

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Instruments, Disposable Probes, and BatteriesInstruments, Disposable Probes, and Batteries

Titanium

Dissimilar Materials

Biopsy Probe

Batteries

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Hermetic Welding of PacemakersHermetic Welding of Pacemakers

DefibulatorsDefibulators

Neuro Stimulators

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High Power Deep Penetration Welding High Power Deep Penetration Welding (.025”< 1mm - .100”/4mm) (.025”< 1mm - .100”/4mm)

Pressure Sensors(Courtesy of GSI)

Surgical tools

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Ti housing

Silver Marker

Radioactive Implant(J124, Pd 103decay 50 days)

Images Courtesy of Lasag

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Catheters, Drug Delivery Devices, Catheters, Drug Delivery Devices, Pharmaceuticals, Lab Instruments, and Pharmaceuticals, Lab Instruments, and

Microvia.Microvia.

Catheter

Microfluidic Device Chemical Analysis

Microvia Drilling

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Surgical Instruments, Implantable Devices, Surgical Instruments, Implantable Devices,

Surgical Tubing, and PackagingSurgical Tubing, and Packaging

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Converting & PackagingConverting & Packaging

Shape Cutting, Scribing, and Drilling

Converting

Scoring, Micro-Perforating, and

Shape Cutting

Packaging

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Laser Trimming - Resistor & CapacitorLaser Trimming - Resistor & Capacitor

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Biocompatibility & Cell AdhesionBiocompatibility & Cell Adhesion

Laser cladding to improve cell adhesion in implantable devices

After 3 Hours After 18 Days

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Disposable Medical and Diagnostic Components

Portable Electronics and Disposable ComponentsPortable Electronics and Disposable Components

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Plastics and Polymers – Plastics and Polymers –

When to use COWhen to use CO2,2, Femto Second, Pico Second, or UV Femto Second, Pico Second, or UV

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WiresWiresNano Devices

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Making the TransitionMaking the TransitionPrototyping in the Lab

Prototype ModelsProduction

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Hiring the Right PersonnelHiring the Right Personnel

Professionals

Compatible Team

Robots for Production

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Flexible PlatformsFlexible Platforms

Multi Adaptable Tooling Concepts

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Hermetic Leak Detectors

Optical ComparatorHigh Resolution CMMMeasurement System

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Instron MachinesInstron Machines

Torque Gauges

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Class 10,000 CleanroomsClass 10,000 Cleanrooms

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510(k) OverviewSection 510(k) of the Food, Drug and Cosmetic Act requires those device

manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also

called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been

classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into

commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could

be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

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Six SigmaSix Sigma

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New opportunities through technological innovation and the

utilization of multiple wavelengths in the electromagnetic spectrum.

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Thank You

IZB 12.10.2006

Thank You Laser PioneersThank You Laser Pioneers

Gordon Gould

Arthur SchawlowCharles Townes

Theodore Maiman

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3WIN NVAcceleronACW Technology Ltd.AvecinnaAXOCoherentDr. Juan Pou - Univ. de VigoDr. Richard Sherlock – NCLAGSIIMG CannulasInstronLasagLaservallLASXMedtronic

Metal Craft Machine and Engineering

Motion Dynamics Corp.Naeem Jee Corp

Nashua LaserNiagra Tools

NorhternLights LaserPrecision Aero Products

PrecoQuallion LLC

Range Finder MagazineResonetics

SpectralyticsSynrad

UK Laser Micro Machining CenterUSAF