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May 2014 | ManufacturingEngineeringMedia.com 63
Finding the best fit of device to part is especially
significant for metrology companies with a
diverse portfolio. That is the case for Mitutoyo
(Aurora, IL), according to Allen Cius, their vision
optics manager. The company offers over 6000
products, from hand calipers to horizontal arm
CMMs that can measure objects the size of whole car bod-
ies. Mitutoyo metrology capital equipment systems fit within
three basic families of products: vision-based systems, form
measurement machines, and CMMs. “Vision systems can
very accurately measure 3D with camera and high-resolution
Z scales,” said Cius. Form devices use dedicated devices to
measure surface roughness, roundness, or profiles. CMMs
are CNC-driven three-axis devices that use probes or spe-
cialized sensors to measure parts according to programs.
Sensofar is introducing a new
system for measuring only stents.
To date, the majority of metrology
equipment in medical is more
general purpose, able to measure a
wide variety of biomedical devices.
Medical Metrology Finds the Best Fit
There are a number of ways of measuring and inspecting biomedical devices. Which way is best?
Bruce MoreyContributing Editor
Measurement & Inspection
However, Cius noted, these distinctions are blurring.
“These platforms are expanding in capability,” he said. CMMs
are now outfitted with contact probes, line laser scanners,
and even surface roughness probes. Vision systems use laser
scanners that collect thousands of points per second, in addi-
tion to touch and scanning probes.
“It is often the case that we start with the piece that needs
to be measured and after some experimentation, decide what
is best,” he said. Cius offers the following list of factors that
should be considered:
• Does the part require contact or noncontact sensing?
Size, flexibility, and fragility of the surface influence
this parameter.
• What accuracy is required? This may be process
dependent as well, for instance, less accuracy may
be required to maintain a production line, while more
is needed during design investigation or first-article
qualification.
• What density of measurements is needed? Are a few
critical characteristics enough, or are surface or con-
tour measurements required?
• Precise metal and plastic marking capabilities
• Generous 32″ x 20″ work area
• Advanced job control for increased throughput
• Power configurations up to 50 watts
• Joystick control for easy operation
• High-quality, USA-made equipment
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64 ManufacturingEngineeringMedia.com | May 2014
Measurement & Inspection
Multisensor vision systems such as this system from OGP
often use three separate measuring devices, especially
a telecentric vision system, a TTL laser, and touch probe,
according to the company.
• What is the anticipated volume of measurements? Will
R&D researchers be using the device, or is to be used
in controlling manufacturing processes on the shop
floor? A hand-held device may be good for one, while
an automated, “lights-out” system is the only solution
for the other.
Cius said that biomedical parts that are now measured
with Mitutoyo vision measuring systems include orthodontics,
angioplasty inserts, stents, hearing aids,
and GI bag-clamps. Most of the time with
medical applications, research leads to
the selection of a vision measuring sys-
tem, often Mitutoyo’s Quick Vision vision-
based systems. The wide range of op-
tions and variety of sensors now available
for the Mitutoyo Quick Vision means a
solution can be found for most any part,
from simple to complicated. Sensors
outfitted on the Quick Vision foundation
besides the 2D camera include touch
probes, structured light interpretation,
lasers, and a new chromatic sensor.
Vision Systems Popular
with Device Makers
Another supplier of multiple metrol-
ogy systems is Carl Zeiss Industrial
Metrology (Brighton, MI). “Zeiss is
one of the few one-stop shops for your
medical inspection needs,” said Kevin
Legacy, business manager for Metrology
Services for Zeiss. He points to three
measuring machines suitable for medi-
cal implants: the Metrotom, O-Inspect,
and Micura. Companies using more
than one device can benefit from the
fact that Zeiss’ Calypso software drives
each. “A module of Calypso called
Master Control Center provides tools to
manage two important FDA criteria,”
he said. The first is revision control of
CMM inspection programs. The second
is compliance to CFR Part 11, which
covers the trustworthiness of electronic
records and signatures.
For measuring inside parts nonde-
structively, or for parts that are flexible
or transparent, Legacy recommends the
Metrotom Computed Tomography CMM.
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Measurement & Inspection
The system exploits X-rays for metrology, with recent improve-
ments in measuring volume and combining data scans that
he believes benefits medical molding. For ultra-precise, small
medical parts where tolerances are ≤ 5 µm (0.0002"), he
recommends the Micura CMM outfitted
with a VAST XTR scanning analogue
probe that provides a 4th axis. It boasts
a maximum permissible error of MPEE
= 0.8 +L/400 (µm). Finally, for shop-
floor use, he recommends the Zeiss O-
Inspect. “It offers the ability to combine
inspection tasks,” he explained. “A
white-light sensor is used for measuring
clear materials. Blue and red lighting
combined with backlighting is used for
high contrast needs and tactile scan-
ning for optimum accuracy.”
Jamie Murray, senior applications
engineer at Optical Gaging Products
(OGP; Rochester, NY) also notes that a
vision-based system tends to be the most
popular with their biomedical device
customers. OGP’s SmartScope family
includes three lines of multisensor vision
systems—Flash, ZIP, and Quest. Each
product line features an optical system
and optional sensors to serve a range of
part and feature sizes, with appropriate
accuracy and precision. SmartScope
Quest is a popular solution for medi-
cal devices, according to Murray. “The
TeleStar optical system is fully telecentric
throughout its range which is critical for
high accuracy on many types of medical
parts.” What attracts biomedical device
manufacturers is the range of sensors
available on the Quest, including conven-
tional touch trigger probe, scanning ana-
logue probe and the patented TeleStar-
Plus interferometric TTL laser. Quest also
offers a range of micro-probe options
for measuring very, very small features.
Measuring envelopes for the Quest family
start at 300 × 300 × 250 mm with ac-
curacies of (1.5 +5L/1000) µm.
Murray also reports that the combination of fully telecentric
optics and a high-performance interferometric laser are ideal
for measuring biomedical devices. “Medical implants tend to be
rounded and shiny—characteristics that make them difficult to
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image accurately with conventional optics. Stem tibia, knee, and
hip implants, stents, or highly polished bone plates with rounded
edges,” he said. Profile and other Geometric Tolerances define
the complex and compound curves of orthopedic implants.
These require a dense data set, which in turn requires analysis
software to match it to the original CAD data, Murray said. OGP
offers SmartProfile software to aid in the analysis. Other types of
medical parts, such as molded plastic items, microelectronics,
and even eyewear present different sorts of measurement chal-
lenges. Syringes and surgical stapler components, for example,
require special illumination sources and fixturing to reliably
image or provide access to critical features.
Murray also reports that medical customers choosing mul-
tisensor vision-based systems usually ask for three sensors.
These include their telecentric vision system, a TeleStar TTL
laser, and touch probe.
General Systems, Shop-Floor Applications
For companies with fewer, more advanced metrology
devices in their portfolio, finding the right niche within the
industry sometimes requires educating their potential users.
“The medical device community is getting more interested in
3D scanning,” said Pierre Aubrey, President of ShapeGrab-
ber (Ottawa, ON, Canada). The company specializes in 3D
laser line scanners. “We are still in the early days in terms of
adoption in the medical industry. These early adopters are
using ShapeGrabber scanners because their requirements
are so pressing they have to turn to a fast laser system.” The
strength of systems like their Ai310 is speed and data den-
sity—the ability to collect a million points within a few seconds
to about a minute. “These are good for complex, curved
shapes such as you find in orthopedic implants, ergonomic
tools, and medical enclosures and housings,” said Aubrey.
Aubrey noted that their 3D laser scanners have resolutions
down to 2 µm and accuracies down to 16 µm (ISO 10360
method), making them ideal for items with unusual shapes
with reasonably tight but not extreme accuracy require-
ments. A number of biomedical devices, from pace makers to
implantable drug-delivery pumps have intricate, small parts
which may have very tight accuracy requirements. These
small parts are typically enclosed in a housing or attached to a
frame. “The ShapeGrabber Ai310 automated scanner is ideal
to measure such housings. Parts inside the enclosure—flat
gears, valves, and other prismatic parts—are probably best
measured using other sensor modalities that can attain tighter
tolerances,” he said.
Another category of often-used metrology equipment is
the venerable Optical Comparator, recently upgraded into an
all-digital version by VISIONx (Pointe-Claire, Quebec, Canada
distributed in North America by Methods Machine Tools Inc.;
Sudbury, MA). The company’s VisionGauge system uses the
part’s CAD data to produce a high-contrast image for com-
parison, eliminating the need for Mylar overlays. The company
also claims that it is more accurate, enables faster measure-
ment, and has a smaller footprint compared to traditional opti-
cal comparators. “Our system shines where tight tolerances
need to be measured on complex geometries and where there
are many small-lot productions because there is virtually no
setup time,” explained Patrick Beauchemin, president and
CEO for the company. “That describes many medical manu-
facturing applications.” Measured accuracies are as fine as
0.0001" to 6 σ, Beauchemin said. An optional laser is offered
for depth and height measurements.
“Where we are seeing the most enthusiastic adoption of
our system in the medical industry are bone screws and larger
implants, such as knee and hip replacements,” Beauchemin
said. “Knees and hips have both plastic and metal, and on
traditional optical comparators the plastic surfaces have glare
that our system completely eliminates.” A large depth of field
on their system, up to 4" (100 mm), allows them to measure
68 ManufacturingEngineeringMedia.com | May 2014
Measurement & Inspection
The heart of Orthoflex from Marposs is a visual system
that collects data as it scans the surface of super-finished
spherical shoulder and hip joints.
bone screws along the helix angle, the preferred method.
“You might measure it 12° towards and away from the camera
and we can focus on the whole bone screw at once,” he said.
Craniomaxillofacial components—complex curved implants
for face and head applications—are another important com-
ponent of his business.
Medical devices implanted in the body tend to be small.
CNC machines make many of them and a growing trend is
to measure parts directly on a CNC
machine to provide control for in-process
machining. This would then require
on-machine probes that are small as
well. The new M&H subcompact infrared
40.50 probe from Hexagon Metrology
(North Kingstown, RI) seems ideal.
“Medical manufacturing can be very
complex, and the more complex the
geometry of the part, the more valid this
probe is,” said Adrian Johnson product
manager for Hexagon Metrology. The
entire probe is the size of a thumb drive.
Suitable for three-, four-, or five-axis ma-
chining, it boasts a repeatability of ±1 µm
to 1 σ. “This probe is good for any part
that has a free form, compound surface
with an organic shape. Orthopedics, for
example, such as knees, hips.” He also
notes that this type of process is best in
repetitive, high volume applications.
Targeted Applications
There is a new trend to build spe-
cialized, purpose-built machines that
excel at one application. One example
is the Marposs Orthoflex system. “We
recognized that there was a problem
in the super-finishing operations of
certain orthopedic implants, such as
hip, shoulder, and knee joints,” said
Luca Trevisani, technical manager for
Marposs (Auburn Hills, MI.) These
biomedical implants cannot tolerate
any surface scratch or defect since a
perfect finish is vital to longevity. “These
implants are expected to last many
years in someone’s body but those tiny
defects affect their lifetime,” he said.
Today, humans inspect them manu-
ally at end-of-line, rejecting those with
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70 ManufacturingEngineeringMedia.com | May 2014
Measurement & Inspection
defects. “Sometimes, bad parts are not caught during the
production process, and they will be inspected and rejected
at the hospital prior to an implant,” he said. Rejection by a
doctor is, according to Trevisani, a significant issue for both a
hospital and supplier.
To move away from a subjective process with potential bias
influenced by an operator, Marposs developed the Orthoflex
automatic inspection system. The heart of the system is a
visual system that collects data as it scans the surface of
super-finished spherical shoulder and hip joints. Scratches,
nicks, and other surface defects are identified and visualized
on a screen and a report is produced that is uniquely identi-
fied with each implant’s serial number. The system currently
works for the spherical portions of shoulder and hip implants,
while knee inspection would require further development,
according to Trevisani. Introduced four years ago worldwide,
the company reports that acceptance by companies used to
end-of-line inspectors is slow but steady. “The difference with
Orthoflex is that once it is set with proper reject thresholds it
does not miss bad parts,” Trevisani said.
Another dedicated device—for measuring stents—is just
now coming on the market from Sensofar (Carefree, AZ).
The motivation behind a dedicated device is clear to Ferran
Laguarta, president and CEO of Sensofar Medical. “There are
over 15 million stents produced worldwide, 5 million in the
USA alone and each one needs to be inspected,” he said.
Today, that also means a human-intensive process or automa-
tion combined with existing metrology equipment that makes
for an expensive solution. “We have been very conscious of
price while developing our system,” he said.
Their solution is the Q six that combines a high-resolution
color camera, three different lighting sources, and an inter-
ferometric sensor for 3D measurements. The 2D imaging
produces inspections of inner and outer surfaces and the
sidewalls of the stents for CD measurements and defect
detection and classification. The 3D modes provide surface
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72 ManufacturingEngineeringMedia.com | May 2014
Measurement & Inspection
roughness, surface topography, and coating thickness mea-
surements. The company claims the Q six is fully compliant
with USA 21 CFR part 11 reporting requirements. Stent sizes
can range from 1.5 to 15 mm in diameter, up to 100 mm in
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Their target markets are on-line inspection, process
development, and industrial R&D. Laguarta said that the first
deliveries of the system are expected to be in June 2014.
Flexibility, Throughput, Uniqueness
Given the wide range of potential biomedical devices and
metrology solutions, perhaps there is no simple answer to
what is best. This seems to be especially true for metrology
systems designed for in-process control. “We offer measuring
components such as transducers, measuring arm setups, and
air gages. We also act as a gage builder, creating gage fixtures
for biomedical devices,” said Gary Sicheneder manager of
new business development for Marposs. “What we use truly
depends on the application.”
Marposs has delivered metrology systems that measure
both biomedical implants and surgical tools used to install
them. Other items were check bearings on dentist drills
and orthodontic devices. Flexibility is often needed because
of the variability required of systems in the biomedical
industry. “For example, we conceptualized a system to
identify and inspect femoral implants,” he said. They were
of various sizes and thicknesses. The contour of each was
unique, different from each other. “They needed a flexible
system and we quoted a laser-based system that we had
adapted from an airfoil inspection system for the aero-
space industry we had developed earlier,” he said. Perhaps
measuring and inspection in biomedical devices is not so
different after all. ME
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May 2014 | ManufacturingEngineeringMedia.com 73
Hexagon Metrology Inc. Ph: 800-274-9433
Web site: www.HexagonMetrology.us
MarpossPh: 248-370-0404
Web site: www.marposs.com/ worldwide_address.php/ eng/usa
Methods Machine Tools Inc.Ph: 978-443-5388
Web site: www.methodsmachine.com/
Mitutoyo America CorporationPh: 888-648 8869
Web site: www.mitutoyo.com.
Optical Gaging Products (OGP)Ph: 800-OGP-GAGE
Web site: www.ogpnet.com/
Sensofar USA LLCPh: 800-530-3097
Web site: www.sensofarusa.com
ShapeGrabberPh: 613-247-1707
Web site: www.shapegrabber.com/
Carl Zeiss Industrial Metrology LLCPh: 800-327-9735
Web site: metrology.zeiss.com/ industrial-metrology/en_us/home.html
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