Medical Design Briefs - November 2022 - 37

Medical Device Machining: Precise and Reliable Parts
for Critical Applications
A zero-defect approach
ensures the highest
reliability.
Halcyon Manufacturing
San Jose, CA
For the medical device industry, the cutting
edge of parts machining goes far beyond
having the latest CNC equipment and
accessories. It also means engaging at the
earliest stages of the process using the latest
in design for manufacturing (DFM), simulation,
and process verification processes
prior to cutting the first part. It is then critically
important to have the commitment to
inspect with the most precise tools throughout
the process. The goal of this approach
is to give customers the knowledge that
when machining begins, the parts are going
to be 100 percent right, with zero defects,
the first time and every time.
Typically, potential customers seeking
a machine shop to make a complex part
are looking for the latest equipment and
current certifications including ASQ,
ISO 9001 and AS9100. There is a tremendous
benefit, however, for a customer
to look beyond these prerequisites for
a machine shop that will work with them
from the design phases through manufacturing
to predict and resolve failures
before they happen. The ability to predict
when failures could occur requires
proactive communication and early engagement
with an expert machine shop.
n Design for Manufacturing
A DFM process enables the machine
shop to anticipate possible complications
and limitations in the machining
process upfront.
" With design for manufacturing, the
goal is to make the product manufacturable
in an efficient and cost-effective way
and that starts with reviewing the parts
and discussing the specifications openly, "
says Tony Doan, CEO of San Jose,
California-based Halcyon Manufacturing,
an advanced ITAR registered and
AS9100/ISO9001-certified
manufacturing
shop for complex parts.
This analysis and feedback are part of
an ongoing manufacturing collaboration
Medical Design Briefs, November 2022
A design for manufacturing process enables a machine shop to anticipate possible complications and limitations in
the machining process upfront. (Credit: Halcyon)
between a medical device client and their
contract machining partner well before
production starts from the inception of a
project through prototyping. Halcyon,
for example, applies the DFM protocol
across a wide spectrum of metal machining
from bar grade 6061 aluminum, brass,
copper, titanium, stainless steel, and plastics.
The company also works with quartz,
ceramic, graft, titanium, and a variety of
steels and serves customers in the medical,
aerospace, home defense, automotive,
and semi-conductor sectors.
" When you can use the latest simulation
and process verification technologies
prior to cutting the first chip of metal or
plastic, then when you start manufacturing,
you know that the parts are going to
be 100 percent right the first time, every
time, " says Doan.
n Inspecting Quality Upfront
To complement the machining capabilities
and nimbleness, a shop must also
have state-of-the
more than the finished goods, " he adds.
" A machine shop should be inspecting in
real time such things as the setups and
the speed throughout the process which
enables data to be captured for statistical
predictive process control. "
For medical device manufacturing, machine
shops should use automated coordinate
measuring machines (CMMs) that
perform process inspections and produce
first article reports. In addition, they
should use a digital multimeter (DMM)
with scanning capability that can take
thousands of data points during a scan of
a complex curved surface. This results in
very
precise and accurate
product evaluations.
n Ensuring Zero Defects
art metrology equipment
for advanced inspections guided by
a proactive zero-defect mindset.
" It's not about making parts and sorting
out the bad ones and shipping the
good ones, " says Doan. " You need a machine
shop committed to not making the
bad parts at all. To produce the most precise
parts, you must be able to inspect
www.medicaldesignbriefs.com
Medical device and other sectors that
rely on machine shops to produce precision
parts to extremely tight tolerances
with consistency should look beyond the
basic certifications and CNC capabilities
for those with the expertise to optimize
the manufacturing process before any
items are manufactured. By ensuring a
zero-defect approach, OEMs and medical
device contractors can be certain their
parts are of the highest reliability for their
most critical applications.
For more information, visit www.
halcyonmfg.com or call 408-520-4655.
37
repeatable

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Medical Design Briefs - November 2022

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