Medical Device

Solutions Guide
Ensure safety and compliance with machine vision, AI,
barcode reading, and barcode verification solutions
Machine vision-enhanced inspection and traceability
ensure patient safety and regulatory compliance
As a medical device brand or contract manufacturer, it’s critical
to maintain safety and quality and adhere to regulations for
everything from basic tools to complex implants and machinery. Table of Contents
Unique Device Identifier (UDI) rules demand traceability systems
that use barcodes to avoid counterfeit items and provide an Digitalization and Self-Regulation.............................3
easier way to facilitate a recall, thus boosting trust among
patients and physicians. Medical Device Part Inspection..................................4

Cognex offers an extensive array of vision sensors and systems, UDI Marking and Quality Inspection..........................6
along with barcode readers that enhance digital quality control
and ensure full traceability. These easy-to-use and flexible Medical Device Traceability........................................7
AI-integrated solutions simplify the deployment of crucial vision
technology for manufacturers of all sizes, enabling fast-moving Package Integrity and Sterility...................................8
automation, shorter changeover times, and applicability across
different applications and sites.
Pack Assembly and Kit Inspection............................9

These vision tools are built on sophisticated machine vision Pack Aggregation and Palletization...........................11
algorithms. They are designed for simple integration, providing
flexibility to accommodate custom, sustainable packaging
Cognex AI.....................................................................12
designs, various products, unusual package forms, and the
Cognex Global Services..............................................13
interpretation of intricate barcodes and labels.

Did you know?

Improving efficiency and
product quality while complying with
regulatory compliance remain principal
investment motives among medical device
manufacturing professionals.1

1
2023 Capital Spending Study – Quality | Clear Seas Research. (n.d.). https://clearseasresearch.com/product/capital-spending-study-quality/

Medical Device Solutions Guide 2

Digitalization and Self-Regulation

Industry 4.0 is driving change in the packaging industry as Sample Use Case
manufacturers seek to capitalize on emerging innovations in
advanced automation. Machine vision, Big Data, cloud computing,
Many medical device products must be properly sealed to protect
and machine learning are revolutionizing manufacturing
sterility. There are a wide variety of defects, such as underseals,
processes. Moving along the journey to Industry 4.0 presents an
overseals, voids, and foreign material that if missed, can cause
opportunity to digitalize processes that bolster productivity, reduce
contamination and product recalls. These defects can be caused
waste, improve product quality, enhance manufacturing flexibility,
by various issues with sealing machines, such as improper or
and decrease operating costs. Implementing a digitalization
uneven heating or misalignment of the sealing material to the
strategy also presents an opportunity to address ongoing labor
backing. Given the variety of production issues that can occur,
shortage challenges.
it is challenging to maintain consistent product quality without
As Industry 4.0 compatible edge systems and devices, Cognex detailed inspection results data.
machine vision and AI-based solutions create valuable digital
To overcome this challenge, a machine vision or AI-based
data that serves two purposes. First, these systems capture
system can provide inspection data in a closed loop process with
real-time information such as inspection and measurement data
the sealing machine so it can automatically respond to specific
that facilitates automatic in-line quality decisions. In addition,
defects by adjusting machine parameters in real time.
companies see great value in either feeding this data back
into the process in real time or aggregating this data over time,
performing off-line analytics, and using the resulting insights to
drive process improvement and predictive maintenance. Cognex
vision systems facilitate the digitalization of quality control
processes through easy integration into industrial networks via
standard communication and file transfer protocols such as
TCP/IP, PROFINET, EtherNet/IP, SLMP, OPC/UA, and FTP.

Medical Device Solutions Guide 3

Medical Device Part Inspection
Medical devices come in many complex shapes, sizes, and materials, from a shiny metal knee replacement to the small webbing of a
stent. Because medical devices are used on or implanted inside the human body, quality inspection of the part is critical. Machine vision
and AI-based solutions help identify microscopic surface defects, scratches, dents, or contamination that could be harmful to a patient.

Surgical Equipment Gauging Hip Replacement Defect Detection

Gauging, measuring, and ensuring high quality standards is an AI-powered image analysis software detects defects on metal
integral part of the medical device manufacturing processes. In order surfaces of knee or hip replacements as reliably as human
to comply with rigorous quality standards, Cognex vision systems inspectors, but with the speed of a computerized system.
provide high accuracy and repeatability.

Stent Webbing Inspection Contamination Detection

Dust

Stent quality is notoriously challenging to solve with traditional Contamination can occur at any stage of the manufacturing process
machine vision because of complex geometries and materials. and is hard to catch on medical device parts. AI-enabled solutions
AI-based technology understands complex shapes and patterns and can detect contaminated surfaces such as dust on a pacemaker.
can correctly identify abnormalities.

Medical Device Solutions Guide 4

Face Mask Quality Control Inspection Transdermal Patch Inspection

Cognex AI-powered technology inspects face masks for random Transdermal patches are checked for accurate dosages of active
defects, such as rips, stains, and stitching errors to rigorous quality medical ingredients using AI-based technology before packaging.
standards.

Ward Automation and Cognex team

up to drive defects out of medical
and pharma products and ensure
traceability through the supply chain

“Working with Cognex shows our customers

that they are working with a company that
places as high an emphasis on product quality
inspection as they do themselves.”
—Kenny Ward, Business Development Manager,
Ward Automation

Watch the video

Medical Device Solutions Guide 5

UDI Marking and Quality Inspection
UDI marks include device and production identifiers with important information like lot number, serial number, manufacture and
expiration dates. The mark must be readable and decipherable throughout the device lifecycle to maintain compliance. Machine
vision and AI-based solutions verify that codes and text are present and accurately formatted. Barcode verifiers ensure codes meet
quality standards.

DPM Code Quality Inspection and OCR Label-based Verification on Packaging

Maintaining UDI compliance is critical. Machine vision systems Inline barcode verifiers grade the quality of label-based barcodes on
equipped with OCR technology verify that UDI codes are present medical device packaging to ensure they meet quality standards.
and marked correctly.

Challenging OCR Code Reading DPM Code Verification on Metal Parts

For challenging OCR codes including laser-engraved or chemically- Readability of direct part mark codes on medical device parts
etched DPM text, AI-enabled OCR tools read and verify that the requires verification of symbol quality with ISO-compliant barcode
chain of numbers and letters is correct. verifiers.

Medical Device Solutions Guide 6

Medical Device Traceability Track:
Where is it now?

After the marking or label printing process, codes can be low

contrast or damaged, recessed, marked on shiny or white
surfaces, or printed under shrink-wrap that makes them hard
to track and trace. Image-based barcode readers and machine Trace: Control:
vision OCR technology can ensure medical devices of all shapes Where has Where is
and sizes are properly scanned and can be easily identified and it been? it going?
located in the event of a product recall.

High-Speed Barcode Reading

Laser-Etched Barcode Reading Under Shrink Wrap

Handheld barcode readers decode small laser-etched codes on shiny Fixed-mount barcode readers decipher label-based codes
and cylindrical surfaces like those found on medical instruments and quickly and reliably on high-speed lines, even under shrink-wrap.
artificial implants such as a replacement hip or knee.

Multiple Barcode Reading Optical Character Recognition (OCR)

With large depth-of-field and wide field-of-view coverage, Cognex Machine vision systems with OCR technology reliably read
barcode readers combined with High-Speed Steerable Mirror alphanumeric date/lot codes throughout the supply chain.
technology read multiple codes simultaneously.

Medical Device Solutions Guide 7

Package Integrity and Sterility
Package, label, and seal integrity are critical to ensure packaging is correct, sterile, and contaminant-free when heading into a doctor’s
office or operating room. Machine vision and AI-based solutions check for bubbles or punctures and reliably identify foreign objects,
void seals, and a host of other issues that can impact medical device package integrity and sterility.

Seal Inspection with AI Seal Inspection with 3D Vision

OK NG

Seal inspection has previously been a complex and expensive Cognex 3D solutions ensure even and consistent final packaging
process using ultrasonics and operators to find defects. AI-based either during or at the end of a medical device packaging process.
technology resolves complex issues such as underseals, overseals,
voids, and foreign material to avoid contamination and product recalls.

Defect and Contamination Detection Package and Label Integrity Inspection

NG OK NG
OK
AI-powered technology allows medical device manufacturers to AI-enabled image analysis software detects packaging defects,
capture cosmetic defects in real time before shipment. This includes bubbles in labels, torn labels, and other package integrity and
white on white anomalies and other hard to capture defects cosmetic defects that could otherwise result in device mix-ups or
previously impossible to inspect using traditional vision technology. scrappage.

Medical Device Solutions Guide 8

Pack Assembly and Kit Inspection
Kitting or system and procedure pack applications must verify that the correct item is in the correct location of a kit and confirm the
presence or absence of items. Regulations also require patient implant cards, directions, and/or caution documents to be included in
the assembly. Machine vision and AI-based solutions verify that all medical devices and other items are present and accurate, even
under shrink-wrapped packaging.

Medical Kit Assembly Verification Vaccine Kit Assembly Verification

Cold pack Aspirin

Gauze Missing

AI-enabled systems count, ensure proper orientation, and maintain AI-powered solutions inspect vaccine kits for overlapping or
correct quantities for a number of kit assembly applications, from missing parts and ensure the correct parts are present and in the
syringe sets to medical device components. right orientation.

Patient Implant Card Confirmation Final Assembly Verification

Cognex AI-based technology reliably locates and identifies the insert Completed and packed medical and drug kits made up of several
in boxes regardless of orientation and lighting conditions to prevent parts are checked for completeness and damage through x-ray
recalls and ensure patient safety. inspection combined with AI-based technology immediately
before shipping.

Medical Device Solutions Guide 9

Drug Delivery Device Final Assembly Verification
Cognex AI-enabled solutions
ensure device completeness
and functionality after
packaging.

Advanced Image
Formation Technology
High Dynamic Range Plus (HDR+) is a
patent-pending technology that delivers
a high-contrast, uniform image in a single
acquisition for multi-point inspections of parts with
varying depths of field and lighting conditions.
Conventional Sensor HDR+

Conventional Sensor HDR+

Medical Device Solutions Guide 10

Pack aggregation and palletization
In preparation for shipping, kits are aggregated into cases according to specific orders and then put on pallets. The accuracy of the case
contents must be verified, and any missing items identified. Image-based barcode readers and vision-guided robotics are able to read
multiple codes at one time in a large field of view and perform advanced inspections for reliable pack confirmation.

Robotic Case Packing Robotic Palletization

Packing objects with complex geometries can be very challenging. Vision-guided robotics palletizes cases for distribution, eliminating
Cognex 3D toolsets communicate to robots for easy case packing. the need to physically handle the products and risk contamination.

Multiple Barcode Reading on Pallets Large Depth of Field Barcode Reading

Cognex has optimized and engineered specific multi-barcode Image-based barcode readers with high-powered integrated torch
reading and vision systems to manage wide fields of view with high light adapt to changes in pallet heights and ensure codes are read
read rates for inbound and outbound pallets. quickly and accurately.

Medical Device Solutions Guide 11

COGNEX AI
Cognex AI learns to spot patterns and anomalies from
example images. It solves tasks that are too complicated and
time-consuming to program with rule-based algorithms, while
providing a consistency and speed that aren’t possible with
manual inspection.

Edge learning:
Designed for ease of use
Edge learning is a subset of AI in which processing takes
place on-device, or “at the edge,” using a pre-trained set of Missing OK
algorithms. The technology is simple to setup, requiring smaller
image sets and shorter training and validation periods than
traditional deep learning-based solutions.
Mismatch Missing

Deep learning:
Designed for complex applications
Capable of processing large, detailed image sets, deep
learning is designed to automate complex or highly
customized applications. The technology enables users
to analyze vast image sets quickly and efficiently, while
differentiating between acceptable and unacceptable
anomalies, to deliver accurate results.

Cognex AI resources

Watch Machine, Deep, or Edge Read Edge Learning: Read Getting Started with a Deep
Learning: What’s the Difference? The Power of AI for Everyone Learning Factory Automation Project

Medical Device Solutions Guide 12

COGNEX GLOBAL SERVICES
Technical Support ▪ Product Training ▪ Self-Service Portal ▪ Lifecycle Management

Cognex serves an international customer base from

offices located throughout the Americas, Europe, and
Asia and through a global network of highly-trained
partners, system integrators, and distributors.
From development to deployment, Cognex is there
to get your vision systems up and running as fast as
possible. Whether you’re considering machine vision
for the first time or are already an expert user, Cognex
global services provide the expertise to help your
organization succeed.

20+
www.cognex.com/support/cognex-services
Offices in countries

500+ Global partners in 30 countries

Medical Device Solutions Guide 13

 The Global Leader
in Machine Vision and Barcode Reading
For over 40 years, Cognex has helped the world’s most innovative companies
make their manufacturing and distribution faster, smarter, and more efficient.
Cognex machine vision solutions combine hardware and software to capture and
analyze visual information. The company’s wide range of solutions automates
manufacturing and distribution tasks for customers worldwide, improving
efficiency and quality in applications like inspecting, identifying, locating, and
measuring components, products, and packaging. Cognex products incorporate
advanced technologies including artificial intelligence to simplify implementation,
increase accuracy, and deliver a faster ROI.

>40 years in business 500+ global customer support

resources
$830M+ 2023 revenue
17% of revenue into R&D
>60% revenue from EU & Asia
>1,100 technology patents
25K+ global customers
>8 years developing AI for
400+ channel partners industrial machine vision

Medical Device Solutions Guide 14

Visit www.cognex.com/products
 BUILD YOUR VISION
Vision Systems
Automate inspection tasks, from defect
detection to assembly verification and text
reading, with easy to deploy vision systems.
www.cognex.com/machine-vision

Barcode Readers
Track and trace, from the floor to dock door,
with powerful readers and verifiers designed to
handle any code type.
www.cognex.com/barcodereaders

Industry Solutions
Solve applications across a wide range of
industries with flexible and reliable machine
vision and barcode reading solutions.
www.cognex.com/solutions

Companies around the world rely on Cognex vision and barcode reading
solutions to optimize quality, drive down costs and control traceability.

Corporate Headquarters One Vision Drive Natick, MA 01760 USA

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