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Metrology equipment and services are playing an increasingly important role in medical device manufacturing. Some of the key ways that advances in metrology are benefitting medical device companies:

 

Improved Accuracy and Precision

Many medical products such as implants, surgical tools, and diagnostic equipment require extremely tight tolerances and precision manufacturing. Metrology tools like coordinate measuring machines (CMMs), optical scanners, and vision inspection systems can measure parts to micron-level accuracies. This ensures medical products meet strict specifications for dimensions, form, and finish.

Metrology equipment that provides micron-level accuracy is critical for medical device manufacturing, where products must adhere to tight engineering tolerances. For items like surgical instruments and implants, even the slightest deviation can impact performance and safety. Metrology gives manufacturers the precision needed for reliable medical products.

 

Enhanced Quality Control

Metrology is critical for quality control and process control. Measurement data helps identify defects and production issues early. In-line metrology systems allow real-time inspection during manufacturing. This saves costs by catching problems before more value is added. Medical device companies rely on metrology data to prove products are made correctly.

Real-time metrology inspection during production enhances quality control for medical device manufacturers. By catching errors early, problems can be corrected before additional time and resources are wasted. The quality data metrology provides is crucial for showing medical products meet specifications.

 

Reverse Engineering Abilities

Advanced metrology scanning can quickly and accurately create detailed 3D models of parts. Medical device firms use this to inspect legacy parts when documentation is missing. It also aids product redesign when improving existing devices. Metrology assists medical device research by creating digital models for on-screen study and manipulation.

Reverse engineering through precise 3D scanning helps medical device manufacturers work with legacy parts lacking documentation. Metrology data assists with redesigning products and manipulatable digital models enable detailed research and analysis.

 

Detailed Wear Analysis

Metrology examinations can measure tiny amounts of wear, corrosion, and usage effects. This helps medical device companies determine product durability and useful lifespan. Highly accurate surface measurement is critical for medical implants that interact with the human body. Wear analysis ensures coatings remain intact.

 

Improved Production and Design

In addition to quality control, metrology boosts production efficiency. Automated inspection reduces bottlenecks. Data helps optimize machining parameters to save time and materials. Metrology also assists product development by providing detailed data to improve designs digitally before physical prototyping.

In summary, metrology delivers accuracy, precision, quality, and efficiency benefits that help medical device manufacturers succeed in the highly regulated medical industry. Investment in metrology systems and expertise pays dividends for companies striving to elevate product reliability, capabilities, and performance.

 

Is Investing in Metrology Equipment Worthwhile for Medical Device Manufacturers?

Given the stringent requirements and regulations facing the medical device industry, investing in metrology equipment and expertise is certainly worthwhile. The level of accuracy and precision metrology tools provide is becoming a necessity, not just an option, for medical device firms.

Metrology technologies allow manufacturers to verify that their products meet the tight tolerances needed for proper functioning in the human body. This helps companies avoid costly recalls and other problems when products deviate from specifications.

While quality management using metrology requires upfront costs, the expense pales in comparison to the financial and reputational damage caused when defective medical devices reach patients. Metrology provides the data medical device companies need to operate successfully and profitably in a hypercompetitive industry.

 

FAQs About Medical Device Metrology

What are some common metrology instruments used?

Coordinate measuring machines (CMMs), optical comparators, vision systems, laser scanners, ultrasonic and X-ray systems, surface profilometers, and microscopes are widely used metrology instruments in medical device manufacturing.

How does metrology improve medical device quality?

Metrology gives objective measurement data to precisely verify medical devices meet design specifications. This helps avoid deviations that would make a device unsafe or ineffective. Metrology supports quality control throughout production.

What metrology techniques help ensure biocompatibility?

Scanning electron microscopy, 3D surface profilometry, and spectral reflectance measurements analyze surface morphology, coatings, textures and roughness to ensure proper integration of devices with biological systems.

Can metrology reduce medical device manufacturing costs?

Yes. Metrology enables just-in-time inspection to reduce waste. Data helps optimize processes to improve efficiency. Metrology also prevents costly recalls by catching issues before shipment.

At what stages is metrology used in manufacturing?

Metrology is useful through the entire product lifecycle, from R&D to prototyping to production to post-market surveillance for wear and failure analysis. In-line metrology for process control is common.

Medical

CRYSTA-Apex V500/700/900

The highly versatile CRYSTA-Apex V series CNC Coordinate Measuring Machines offer multi-sensor flexibility with vision, laser, surface finish and scanning probe technologies for fast and accurate measurements.

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CRYSTA-Apex EX 1200R

The CRYSTA-Apex EX 1200R series is an advanced CNC CMM equipped with the REVO 5-axis scanning probe head. The 5-axis operation allows for faster probe movements and measurements.

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FALCIO-Apex 2000G/3000G/4000G/4500G

The FALCIO-Apex series is a large gantry CNC CMM designed to measure large, heavy pieces with high-accuracy and high-drive speed.

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Legex 500/700/900/1200

The Mitutoyo LEGEX Series ultra-high accuracy fixed-bridge CNC CMM is the ultimate in the world’s high-accuracy measurement technology. LEGEX series CMMs are suitable for complex small-to medium-sized workpieces that require dimensional accuracies with small tolerances like gears, bearings, lenses and precision dies.

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MACH-Ko-Ga-Me

The Mitutoyo MACH Ko-Ga-Me is a compact, in-line/near-line automated 3D CNC CMM configurable for almost any process. Use this measuring system for stand-alone applications or integrate into cells.

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MACH-V

The MACH-V is the world’s fastest vertical axis near-line/in-line CNC CMM making it an optimal, flexible measuring system that replaces dedicated gauge measurement in a production line without sacrificing accuracy.

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MACH-3A

The MACH 3A CNC CMM is designed for 24-hour operation. This CMM achieves high throughput by increasing drive speed, acceleration and measuring speed, making it one of the fastest horizontal CNC CMMs on the market.

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MiSTAR 555

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Turnkey MiSTAR with PH6M $68,218

Turnkey MiSTAR with PH10M $78,379

Orders must be received by March 31st 2024

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SJ-210 – Portable Surface Roughness Tester

The Surftest SJ-210 surface roughness measuring instrument offers surface roughness measurement in both X and Y-axes.

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SJ-310 – Portable Surface Roughness Tester

The Surftest SJ-310 surface roughness measuring instrument is a compact, portable and easy-to-use surface roughness measurement instrument equipped with extensive measurement and analysis features.

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SJ-410 – Portable Surface Roughness Tester

The Surftest SJ-410 surface roughness measuring instrument offers numerous innovative features to provide smoother operation and more accurate measurements in an easy-to-use, portable unit with a high straightness specification of 0.3 – 0.5μm over a traverse length of 25 – 50mm.

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FTA-S3000

Rapid measuring unit speeds help make the FTA-S3000 one of the fastest surface roughness testers, available in many different model sizes and three different surface roughness detector holders.

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Contracer CV-2100 – Contour

The Contracer CV-2100 contour measuring instrument provides remarkable operability and functionality revolutionizing contour measuring machines for faster, easier and more accurate measurements. This measuring instrument’s Z-axis detector measuring range of 50mm accommodates larger workpieces.

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FTA-C3000

New features and software make the FTA-C3000 one of the fastest contour measurement machines in its class with the ability to easily upgrade the machine and make surface roughness measurements as well.

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RA-2200 CNC – Extreme Type

The Roundtest Extreme RA-2200 CNC Roundness, Cylindricity and Surface Roughness Measuring System offers automated measurement with independent and simultaneous multi-axis CNC control.

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SV 2100 – Dedicated Processor – Column Type

The Surftest SV-2100 surface roughness tester offers easy-to-use benchtop operation with highly precise measurement results.

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RA-120 /120P – Roundness

The Mitutoyo Roundtest RA-120/120P for compact roundness measurement is compact, affordable, and simple-to-use for measuring part geometry on the shop floor.

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RA-H5200 – Roundness / Cylindricity Capable

The Roundtest RA-H5200 roundness/cylindricity measuring system combines world-class accuracy with superior maneuverability and analytical capabilities for large-size and heavy workpieces.

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Roundtracer Flash

The Mitutoyo Roundtracer Flash optical measuring unit is capable of measuring parts up to 300mm in length without any vertical movement of the sensors or the part itself.

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FTA-C4000

A dual-sided stylus and many new features and software makes the FTA-C4000 one of the fastest, most efficient and easy-to-use Contracers on the market.

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Roundtracer Extreme

The RTX Roundtracer Extreme all-in-one measuring system that integrates roundness, contour and surface roughness measurement functions on a single platform to save time and improve productivity. This advanced CNC machine utilizes speed, accuracy and operability at the highest level to measure a wide variety of workpieces with various geometries, such as camshafts and bearings.

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Formtracer Extreme CS-5000CNC / CS-H5000CNC

The Formtracer Extreme CS-5000CNC/ CS-H5000CNC measuring instrument simultaneously measures surface roughness and contour in a single measurement trace at high speeds and high-accuracy.

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FTA-D4000 – Dual Detector – Dual-sided Contour Stylus Type

Hybrid dual detector, dual-sided contour stylus type and surface roughness measuring system with better measurement speed and efficiency, automation for easier operability, a wide variety of features, and expandability with optional detectors.

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FTA-D3000 – Dual Detector – One Sided Contour Stylus Type

A versatile hybrid dual detector system with a single-sided stylus that makes contour and surface roughness measurements quickly and efficiently. The detector heads are easily swapped to change measurement types.

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PH-A14 with M2 2D

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CS-3300 – Singular Detector Type

The Formtracer CS-3300 Series are highly functional and user-friendly surface roughness and contour measuring systems with innovative design features.

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PH-3515 Profile Projector

The PH-3515F profile projector provides upright images suitable for thread pitch measurements and will not produce blurred or distorted images with the workpiece is angled.

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Quick Scope – Digital Microscopes

The Quick Scope series digital microscope with new optical technology provides industry leading vision measurement accuracy with easy-to-use, intuitive software for any operator. The Quick Scope is a manual system with high-speed, high-accuracy optical auto-focus for 3D measurements.

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Manual Quick Image

The manual Mitutoyo Quick Image is a simple-to-operate, easy-to-use 2D Vision Measuring System that provides unique features and measures over a large range with stitching (up to 400mm) for improved measurement efficiency and productivity.

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Motorized Quick Image

The motorized Mitutoyo Quick Image is a simple-to-operate, easy-to-use 2D Vision Measuring System that provides unique features and measures over a large range with motorized image stitching (up to 300mm) for improved measurement efficiency and productivity.

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Quick Vision Hyper Hybrid Type 1

The Mitutoyo Quick Vision Hyper Hybrid measuring system produces highly accurate, non-contact 3D measurements with its camera and laser scanning sensor.

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Quick Vision Apex Pro

The Mitutoyo Quick Vision Apex Pro is a high-accuracy CNC vision measuring system equipped with the new StrobeSnab function for high-speed, accurate measurements for a variety of applications.

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Quick Vision ACCEL

The Mitutoyo Quick Vision ACCEL CNC Vision Measuring System was designed with a primary focus on measurement speed and efficiency. The machine drives the X- and Y- axes at 400 mm/s.

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Quick Vision Ultra

The Mitutoyo Quick Vision Ultra CNC Vision Measuring System is designed and constructed to provide some of the most accurate measurements from a vision measuring system.

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Quick Vision Hyper Pro

The Mitutoyo Quick Vision Hyper Pro CNC vision measuring system is equipped with a high-resolution/high-accuracy scale for precise 3D measurements with an increased measurement throughput by about 40% compared with conventional models.

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Quick Vision Active

The Mitutoyo Quick Vision Active measuring system produces highly accurate, fast non-contact 3D measurements in a compact machine at an affordable price point.

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Quick Vision Apex Pro Hybrid Type 4

The Mitutoyo Quick Vision Apex Pro Hybrid Type 4 is a dual system high-accuracy CNC vision measuring system equipped with a non-contact displacement sensor, updated camera and the new StrobeSnab function for high-speed, accurate measurements for a variety of applications.

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MiScan Apex

The Mitutoyo MiScan Apex is a highly accurate, multiple sensor microscopic-form measurement system and combines the advantages of both a vision machine and a scanning CMM into a single platform.

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CMM-Manager

CMM-Manager by QxSoft is a task-oriented, highly intuitive, 3D CAD based, software package for any CMM. Software is available for both new and existing CMM hardware. We offer software for vision, manual, portable, and CNC coordinate measuring machines. Avoid costly hardware retrofits, our software connects directly to your existing CMM or Metrology equipment by plug-n-play retrofit.

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Native CAD Import

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PolyWorks Reviewer

The free 3D dimensional investigation solution that brings 3D measurement results in the hands of your engineering and manufacturing teams

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Offline Seat

  • Create Programs without interrupting CMM.
  • 50% Discount from comparable Online Seat.
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  • Import Help Desk File to replicate Online Environment.
  • Teach DCC or Manual Features by CAD Pick or Key-In Values.
  • Automatic / Collision Free, Clearance Plane or Local Path Planning.
  • Create and Share Programs to DCC, Manual or Portable Equipment.
  • Add USB Dongle or Network License for multi-workstation access.

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Quick Vision Hyper Pro Hybrid Type 4

The Quick Vision Hyper Hybrid Pro Type 4 vision measuring machine uses a dual scanning system with a non-contact displacement sensor and scanning function that enables measurement of minute height differences and 3D shapes at high speeds.

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PolyWorks Inspector

The 3D dimensional analysis and quality control solution to gain control of your product engineering and manufacturing process

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PolyWorks Talisman

The smart remote control for PolyWorks|Inspector™ that boosts measurement efficiency on the shop floor

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PolyWorks AR

The mixed reality solution that enhances your perception of 3D metrology

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Quick Vision Hyper WLI

The Mitutoyo dual-head Quick Vision Hyper WLI uses White Light Interferometry to create a 3-dimensional shape of the feature being measured. This can be used for a wide range of measurements including surface analysis, depth measurements, and height measurements.

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SNAP 300

The SNAP™ 300 is a compact unit equipped with a Large FOV Telecentric lens and a motorized stage with a 250 x 150 mm measuring area. Dual-Mag optics increase capability by providing a much larger magnification range, even within a program. Measure-X™ metrology software supports simple “walk up and measure” use, comparison to an electronic overlay, creation and running of automatic programs, including complex measurements and GD&T. AutoID limits operator requirements.

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SNAP 350

The SNAP™ 350 is a floor-based unit equipped with a Large FOV Telecentric lens and a motorized stage with a large 450 x 450 mm measuring area. Dual-Mag optics increase capability by providing a much larger magnification range, even within a program.
Measure-X™ metrology software supports simple “walk up and measure” use, comparison to an electronic overlay, creation and running of automatic programs, including complex measurements and GD&T. AutoID limits operator requirements.

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PolyWorks ReportLoop

The digital interoperability solution that integrates inspection data in Excel for reporting and advanced analysis

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SNAP 200

The SNAP™ 200 is a compact unit equipped with a Large FOV Telecentric lens and a motorized stage with a 250 x 100 mm measuring area. Dual-Mag optics increase capability by providing a much larger magnification range, even within a program. Measure-X™ metrology software supports simple “walk up and measure” use, comparison to an electronic overlay, creation and running of automatic programs, including complex measurements and GD&T. AutoID limits operator requirements.

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SNAP 100

The SNAP™ 100 is a compact unit equipped with a Large FOV Telecentric lens and a fixed stage with a 62 mm x 46 mm measuring area. Measure-X™ metrology software supports simple “walk up and measure” use, comparison to an electronic overlay, creation and running of automatic programs, including complex measurements and GD&T. AutoID limits operator requirements.

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SprintMVP 624

With a massive granite base for stability, SprintMVP™ 624 is a fully automatic, 3-axis dimensional video measuring machine designed to handle large, heavy parts and fixtures. SprintMVP 624’s moving bridge design allows all measurement sensors to be moved out of the way for part loading/unloading.

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SprintMVP 1550-1552

SprintMVP™ 1500-1552 floor model measurement systems offer fully automatic, non-contact video measurement for very large parts or groups of parts. An impressive list of standard features, including solid granite bases, make these systems a great value and are ideal for accurate, repeatable measurements.

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SprintMVP 400 & SprintMVP 600

SprintMVP 400 and SprintMVP 600 systems are large capacity, fully automatic, 3-axis dimensional video measuring systems featuring high precision and capacity in a compact footprint. SprintMVP 400 and 600 feature heavy-duty construction and stable materials for use in harsh shop-floor conditions.

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Fusion 600

Fusion® 600 systems from OGP® are 3D capable, high accuracy large field-of-view (LFOV) multisensor floor model systems with an expansive measuring range of 600 x 560 x 300 mm.

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Fusion 400

Fusion® 400 systems from OGP® are 3D capable, high accuracy large field-of-view (LFOV) multisensor floor model systems with a measuring range of 400 x 300 x 250 mm.

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ShapeGrabber Ai820

Shapegrabber Ai820 is a floor model 3D scanner designed to serve a wide variety of parts in minutes with a high density of data points.

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ShapeGrabber Ai620

ShapeGrabber Ai620 3D scanner is a precision, metrology-class 3D scanner. Ai620 measures the complete surface of complex shaped plastic, metal, and 3D printed parts in minutes with a high density of data points.

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STRATO Apex 500/700/900/1600

The Mitutoyo state-of-the-art STRATO Apex Series of CNC Coordinate Measuring Machines delivers high-accuracy measurements with smooth, high-speed operation for top scanning performance.

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SmartScope SP 332

SmartScope® SP systems are designed for optimum scanning probe performance. Starting with a rigid base structure, the system mechanics are designed to optimize dynamic data acquisition critical to scanning probe performance. Most performance specifications for SP models are according to ISO 10360 standards.

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Surftest SJ-500 / 500P

The SJ-500 surface roughness tester offers benchtop or portable operation with highly precise measurement results.

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ShapeGrabber Ai320

ShapeGrabber Ai320 is an automatic, compact 3D scanner designed to serve a wide variety of parts in minutes with a high density of data points.

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MiScan Hyper

The Mitutoyo MiScan Hyper Vision Measurement System combines the advantages of both a vision machine and a scanning CMM into a single platform. The MiSCAN Hyper can be fitted with different scanning probes for small features.

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Offline Programming for Vision

Take offline programming to the next level with CMM-Manager Optical for both Manual and DCC Vision Measurement Systems. Leverage the power of 3D CAD and eliminate interruptions on your production Vision Systems.

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SmartScope SP 463

SmartScope® SP systems are designed for optimum scanning probe performance. Starting with a rigid base structure, the system mechanics are designed to optimize dynamic data acquisition critical to scanning probe performance. Most performance specifications for SP models are according to ISO 10360 standards.

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SmartScope SP 663

SmartScope® SP systems are designed for optimum scanning probe performance. Starting with a rigid base structure, the system mechanics are designed to optimize dynamic data acquisition critical to scanning probe performance. Most performance specifications for SP models are according to ISO 10360 standards.

SmartScope SP 663 is a moving bridge system designed for larger, heavier parts. During measurement the part remains stationary while the optics and sensors are moved around it.

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Flash 200 | Compact Benchtop System

SmartScope® Flash™ 200 – the smallest member of the Flash family of systems – is a 3D multisensor dimensional measuring system that fits on a benchtop.

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SmartScope Quest 250

SmartScope® Quest™ 250 is an advanced-technology 3D multisensor measurement system. This benchtop system is specifically designed to measure smaller parts, or for situations where space is at a premium. Its rigid structural design provides full access to the measurement volume for fixturing flexibility.

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SmartScope Quest 300

SmartScope® Quest™ 300 offers 3D multisensor measurement versatility and accuracy needed for the most critical, demanding parts. A compact machine with an unique “elevating bridge” design that yields large XYZ measurement volume to accommodate large parts, it combines state-of-the-art video and autofocus to deliver high productivity.

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SmartScope Quest 450

SmartScope® Quest™ 450 is an extremely accurate floor stand coordinate 3D multisensor measurement system. Both the 450 and 450 with extended Y-travel are designed to measure larger parts, or to accommodate fixtures of multiple parts or rotary indexers. A solid granite bridge design platform rests on a sturdy steel support structure. This yields high-speed stage translation without vibration, maximizing measurement throughput. The bridge design limits measured part motion to the Y axis.

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SmartScope Quest 650

SmartScope® Quest™ 650 is the largest high-accuracy system. Its massive granite base and thermally stable Meehanite® bridge support high-performance linear motor drives.

SmartScope Quest 650 provides high throughput and high accuracy simultaneously. This system comes standard with TeleStar® telecentric 10:1 zoom optics for the highest level of optical performance. SmartScope Quest 650 provides high accuracy movement of large parts.

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SmartScope Quest 800

SmartScope® Quest™ 800 is an extremely accurate floor model coordinate measurement system incorporating scanning probe, touch probe, micro-probes, and the patented TeleStar® Plus TTL laser for versatility and accuracy.

The Quest 800, with its extensive 790 x 815 x 300 mm XYZ measurement volume (and available 400 mm Z-travel), is designed to measure very large parts. A solid granite bridge platform rests on a sturdy steel support structure and the bridge design limits measured part motion to the Y axis, offering measurement stability.

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CRYSTA-Apex V1200/1600/2000

The CRYSTA-Apex V1200/1600/2000 series are large sized (starting at 1.2M/47.24″), high-performance, high-accuracy CNC CMMs priced competitively while meeting and exceeding global standards. Vibration is minimized during high-speed, high-acceleration movement.

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SmartScope ZIP HR 250

SmartScope ZIP® HR 250 combines a wide field objective lens, digital zoom, and 5-megapixel monochrome digital camera, providing a distortion-free image at low zoom, with high resolution at high zoom.

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Smart Scope Flash 670

SmartScope® Flash™ 670 is an extra-large capacity 3D multisensor measurement system with a large XYZ measuring range. It is a Floor model system with solid granite base and moving bridge, providing a highly rigid structure for accurate positioning and repeatability.

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Benchtop Multisensor Measurement System

SmartScope® Flash™ 302 is a unique high capacity benchtop multisensor measurement system and one of the most versatile benchtop systems OGP offers.

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SmartScope Flash 500

The SmartScope® Flash™ 500 is the perfect large capacity 3D multisensor measurement system. It offers all the great Flash features and performance in a large travel bridge-design system. Parts move on a precision DC motor-driven Y-axis stage while the optics assembly travels in the X-axis across a stable bridge cross member.

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SmartScope ZIP 450

SmartScope ZIP® 450 is a floor model metrology system offering video and multisensor measurement for large parts. It has a reputation for extreme reliability and proven metrological performance. Traditionally strong in video measurement, it is also available with contact and non-contact probes, as well as the TTL laser.

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SmartScope ZIP 635

SmartScope ZIP® 635 is a floor model metrology system offering high speed multisensor measurement of large parts. Its high acceleration and velocity in all three measurement axes contribute to measurement productivity, while its granite base and extruded, lightweight aluminum bridge provide a rigid platform for built-in measurement stability.

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SmartScope ZIP 800

SmartScope ZIP® 800 is a floor model metrology system offering multisensor measurement of large parts, due to its large XYZ measurement volume. Measurement stability is built-in with ZIP 800, since its granite base and bridge provide a rigid, orthogonal base for accurate measurements. SmartScope ZIP 800 is also available with an optional 300 mm of Z-axis travel.

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SmartScope Flash 1500 | 1550 | 1552

SmartScope® Flash™ 1500 |1550 | 1552 are floor model 3D multisensor measurement machines with an extended XY measuring range where the instrument head moves in the X axis across a steel bridge while the entire bridge moves on parallel tracks in the Y axis. The large measurement range of these systems accommodates large parts, such as LCDs, plasma displays, circuit boards, and multi-component fixtures.

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SmartScope ZIP 300

SmartScope ZIP® 300 is a fast, accurate floor model metrology system offering a combination of hardware performance, optical capability, and ease-of-use. A rigid cast iron base ensures stability and metrological accuracy

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SmartScope Flash 635

SmartScope® Flash 635 is a high-speed 3D multisensor dimensional measuring system for large parts that provides measurement speed and stability. A granite base and extruded, lightweight aluminum bridge provide a rigid orthogonal structure for measurement stability. While the instrument head moves in the X, Y, and Z axes, the part being measured remains stationary.

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