Medical product marking with lasers

FOBA’s new Holistic Enhanced Laser Process is designed to overcome the
marking and traceability challenges faced by medical device manufacturers.

The increasing life expectancy of Australia’s aging population combined
with their desire to remain active and independent has led to a growth in the
number of orthopaedic implants. From 65,000 implants in 2006 at a cost of over
$1 billion, this number is expected to more than double by 2016. However, this growth
is not without its challenges for manufacturers of surgical components and
tools, continuously faced with expectations for improvement in quality,
performance and product life and stringent requirements of traceability.

Medical device manufacturing is a complex process, requiring tight
controls along the whole production system. For instance, the manufacture of a metal
femoral stem includes key steps of forging, trimming, drilling, cone finishing,
bead blasting and finally, plasma etching to create the microporous surfaces
that are essential for the growth of the bone to the implant. At the completion
of this extensive manufacturing process, each individual item requires a
permanent identification mark placed in a precise location with exacting
precision to meet standards regulated by the Australian Therapeutic Goods
Administration (TGA).

Manufacturers and importers face challenges to meet regulatory
requirements of creating accurate individual permanent marks that are easily
traceable. Ensuring the mark is clear, accurate and easily readable at point of
distribution is difficult to achieve, considering some manufacturers continue
to use unsophisticated product marking practices, resulting in ‘glitches’ in
the text and misaligned marks. Correcting these marking defects presents real
challenges of time and cost effectiveness. Worse, marked defects are often not
found until they are about to be used, creating real issues. To date,
manufacturers use solutions such as inspection stations and specifically
designed fixtures to minimise errors and faults.

FOBA’s Holistic Enhanced Laser

Holistic Enhanced Laser Process or HELP is a laser marking process
developed by German laser company FOBA to increase accuracy of the laser mark, along
with a visual identification facility to check the location and mark using the
machine’s built-in camera system IMP (Intelligent Mark Positioning). Together,
FOBA’s laser marking machines, software and built-in vision system offer a
ready laser marking solution for manufacturers and distributors of medical

FOBA’s HELP system comprising of built-in automatic inspection,
alignment and validation tools has been developed to overcome many of the
current laser marking challenges faced by medical device manufacturers. The
validation techniques for authentication of a part by inspecting shape and
dimension will automatically notify the operator of any mismatch, and the laser
will not initiate a mark.

Additionally HELP software will flag an already marked part, stopping
the laser from double marking, a problem that can arise with very small parts
such as bone screws. Intelligent Mark Positioning (IMP) works to ensure parts
are accurately aligned prior to laser marking by tracking the positional
location on each individual part as it is placed in readiness.

Laser marking is the preferred identification process for medical
components as it provides permanent, high-quality and precise marks with text
smaller than the eye can see. While data matrix codes are generally preferred
over human-readable text, the attraction is in the data storage content of a 2D
code that can fit 30 traceable characters into a millimetre square.

Laser marking capabilities available today help meet the demands of
medical manufacturers and health administrators with precise, permanent and
traceable codes applied on small items. The increases in efficiency and
effectiveness developed by the engineers at FOBA provide friendly and efficient
solutions using enhanced laser process.

HELP coupled with the leading edge Intelligent Mark Positioning
technology is just one example of how laser technology is assisting the growth
and development of the orthopaedic implant sector.

FOBA products are distributed in Australia by Raymax Applications