An overview of Industrial Laser Applications in Medical Device Manufacturing

2. Directed Light Inc., founded
in 1983, is comprised of
three divisions: Advanced
Technology Job Shop,
Custom Systems
Integration, and
Components and Service.
Our objective is to provide
high quality products and
services to a wide variety of
manufacturing sectors.

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

4. 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.

5. Directed Light’s Advanced
Technology Job Shop has the
ability to process many materials
utilizing different wavelengths.
From R&D to production, our
engineering and technical staff
can handle the most complex
customer requirements.
Our diverse applications toolbox allows
us to perform many applications
including; welding, cutting, drilling,
ablation, surface treatment, and
marking; DLI’s vast applications
experience and years of processing
expertise have earned us the reputation
as a complete outsourcing solution.

7. Wide variety of materials
and part configurations
from 2D & Multi Axis
Laser cutting of sheetmetal,
exotic materials, and other
implantable alloys. Products
include; bone saws, connective
plates, operating room gurneys,
& wheelchairs accessories.

8. Tube cutting micro:
cardio and neuro stents
and surgical needles
Image Courtesy of Lasag
Tube cutting macro:
Biopsy probes and cannulas

9. Ceramic
Plastic Membrane Key Switch
Glass
Nylon Screen

10. Instruments, Disposable Probes, and Batteries
Biopsy Probe
Titanium
Batteries
Dissimilar Materials

11. Hermetic Welding of Pacemakers
Neuro
Stimulators
Defibulators

12. High Power Deep Penetration Welding
(.025”< 1mm - .100”/4mm)
Surgical tools
Pressure Sensors
(Courtesy of GSI)

13. Ti housing
Silver Marker
Radioactive Implant
(J124, Pd 103
decay 50 days)
Images Courtesy of Lasag

14. Catheters, Drug Delivery Devices,
Pharmaceuticals, Lab Instruments, and Microvia.
Microfluidic Device
Microvia Drilling
Chemical Analysis
Catheter

15. Surgical Instruments, Implantable Devices,
Surgical Tubing, and Packaging

16. Converting & Packaging
Converting
Packaging
Shape Cutting, Scribing, and Drilling
Scoring, Micro-Perforating, and
Shape Cutting

17. Laser Trimming - Resistor & Capacitor

18. Biocompatibility & Cell Adhesion
Laser cladding to improve cell adhesion in implantable devices
After 3 Hours
After 18 Days

19. Disposable Medical and Diagnostic Components
Portable Electronics and Disposable Components

20. Plastics and Polymers –
When to use CO2, Femto Second, Pico Second, or UV

21. Wires
Nano Devices

22. Prototyping in the Lab
Making the Transition
Prototype Models
Production

23. Hiring the Right Personnel
Compatible Team
Robots for Production
Professionals

24. Flexible Platforms
Multi Adaptable
Tooling Concepts

26. High Resolution CMM
Measurement System
Optical Comparator
Hermetic Leak Detectors

27. Instron Machines
Torque Gauges

28. Class 10,000 Cleanrooms

29. 510(k) Overview
Section 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.

30. Six Sigma

31. New opportunities through technological
innovation and the utilization of multiple
wavelengths in the electromagnetic
spectrum.

32. Thank You Laser Pioneers
Thank You
Gordon Gould
Charles Townes
Theodore Maiman
Arthur SchawlowIZB
12.10.2006

33. 3WIN NV
Metal Craft Machine and Engineering
Acceleron
Motion Dynamics Corp.
ACW Technology Ltd.
Naeem Jee Corp
Avecinna
Nashua Laser
AXO
Niagra Tools
Coherent
NorhternLights Laser
Dr. Juan Pou - Univ. de
Precision Aero Products
Vigo
Preco
Dr. Richard Sherlock –
Quallion LLC
NCLA
Range Finder Magazine
GSI
Resonetics
IMG Cannulas
Spectralytics
Instron
Synrad
Lasag
UK Laser Micro Machining Center
Laservall
USAF