medical metrology finds the best fit - sme - home 2014 | manufacturingengineeringmedia.com 63 f...

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

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• High-quality, USA-made equipment

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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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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



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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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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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

length. Lateral resolution is 0.1 µm and vertical resolution is

0.01 µm.

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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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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