ZEISS Medical Industry Solutions​
ZEISS MEDICAL INDUSTRY SOLUTIONS

Quality Assurance for Orthopedic Implants​

Quality solutions for all types of implants​

Different implants, same manufacturing processes​

While many different implants and fixation philosophies exist, and the solutions are diverse, the manufacturing processes of the individual components remain similar. Due to their material properties, orthopedic implants can be classified according to the manufacturing processes. This enables us to offer tailored quality solutions in the individual segments, which leads to an increase in productivity in your process. Explore the quality gates for the metal manufacturing process and the plastic manufacturing process.​

Dental implants​

Due to the shape of dental implants, the thread measurement of the entire component surface is most challenging. Manufacturers have to reliably measure small structures & tolerances in fast cycle times.​

Shoulder implants​

A shoulder implant consists of a glenosphere, a glenoid implant, peripheral screws, and a humeral stem. The measurement of narrow stem's freeform profile is the biggest metrological challenge for this type of implant.​

Spinal implants​

The full inspection of rods without datum references is the greatest difficulty in measuring spinal implants. For these implants, intervertebral discs are fixed by spinal rods and monoaxial pedicle screws.​

Hip implants​

It is the low tolerance of multiple parts made of several materials that makes measurement of hip implants challenging. These implants are comprised of an acetabular cup, a polyethylene liner, a femoral head and a femoral stem.​

Knee implants​

When measuring knee implants accurately, it is important to ensure that no white marks are left behind. A knee implant consists of metallic and plastic components.​

Bone implants & screws​

Bone screws and bone plates are used for implants in the field of trauma & extremities. The biggest metrology challenge of bone plates are multi-axis measurements of shallow bores on a freeform surface.​

Metal working process​

Metal working process

From raw material to finished parts​

Orthopedic implants must function flawlessly even under the demanding physiological conditions in the human body. This makes it a central requirement for manufacturers to gain a deep understanding of orthopedic materials - metallic compounds, ceramic, and polymers - and the resulting organic reaction. One of the most important steps in the metal working process is assessing the raw materials properties to ensure the performance of the product. Other important challenges are the geometric dimensioning, technical cleanliness during the manufacturing process and efficiency gains through minimizing waste.​

Quality gates and solutions​

  • Metallography - analysis of raw material
    Quality Gate 1

    Metallography​

    Analysis of raw material​

    Challenge​s

    • Assure constant quality of raw material from a micro to nano scale with respect to e.g., porosity, voids, cracks, fissures and grain size

    Your benefits with ZEISS​

    • Determine the root cause of failure to improve overall reliability​
  • Quality of raw parts - inspection of primary shape
    Quality Gate 2

    Quality of Raw parts​​

    Inspection of Primary Shape​

    Challenge​s

    • Ensuring that the components are produced in good shape and without fissures, voids, cracks or critical inclusions

    Your benefits with ZEISS​

    • Fast inspection of produced components to prevent cost-intensive failures later in the manufacturing process
  • Incoming inspection - efficient verification of supplied parts
    Quality Gate 3

    Incoming inspection​

    Efficient verification of supplied parts​

    Challenge​s

    • Ensuring supplied parts are within the margins for machining and processing​
    • Fast inspection cycle times to reduce probability of bottlenecking​

    Your benefits with ZEISS​

    • Programmable inspection plans, which are executable in CNC​
    • Optimize your machining time and sort out waste parts before they turn into products​
  • in process controll - observation of process quality
    Quality Gate 4

    In process control​

    Observation of processing quality​

    Challenge​s

    • Detect and classify particulate contamination to fulfill the quality standards in the medical industry​
    • Inspections in process steps are necessary to control the processing and avoiding unnecessary scrap​

    Your benefits with ZEISS​

    • Combine particle detection and classification in a Technical Cleanliness workflow that not only finds particles, but also helps classify them by contamination or wear origin​
    • Avoid further processing of scrap parts​
  • Geometric dimension - final dimensioning
    Quality Gate 5

    Geometric dimensioning​

    Final dimensioning

    Challenge​s

    • Critical factors for quality assurance are cycle time and reliability of results​
    • Tight profile tolerance on polished surfaces and complex freeforms are a challenge for traditional inspection methods​

    Your benefits with ZEISS​

    • Increase usable acceptance range by decreasing measurement uncertainty​
    • Reduce operator influence and need for manual inspection by using CNC inspection​
    • Fast contactless evaluation of freeform surface analysis​
  • Surface analysis - final visual inspection
    Quality Gate 6

    Surface Analysis​

    Final visual inspection​

    Challenge​s

    • Finished products have to be checked to guarantee the correct layer thickness and a flawless surface quality​
    • Polishing results in a mirror-like finish that poses challenges for optical inspection​

    Your benefits with ZEISS​

    • Fast contactless evaluation of roughness​
    • Reproduceable and fast results in final inspection​

Plastic manufacturing process

Plastic Manufacturing Process​

From raw material to machined parts​

Due to the manufacturing process, plastic implants can be produced very efficiently as large batches, but also individually. Sometimes these are customized parts that have been specifically manufactured for the patient. This is because the great advantage of plastics in medicine is that they can be shaped in a variety of ways and can therefore be adapted well to the respective needs of the patient. Especially ultra high molecular weight polyethylene (UHMWPE) has seen great successes in medical implant applications due to its high abrasion resistance, high toughness, and great biochemical inertness. The precise manufacture of the sometimes very small parts with complex geometries is now technologically possible thanks to ultra-modern machines and systems.​

Quality gates and solutions

  • Incoming inspection - efiicient verification of stock
    Quality Gate 2

    Incoming inspection​

    Efficient verification of stock​

    Challenge​s

    • Ensuring supplied parts are within the margins for machining and processing​
    • Fast inspection cycle times to reduce probability of bottlenecking​

    Your benefits with ZEISS​

    • Programmable inspection plans, which are executable in CNC​
    • Optimize your machining time and sort out waste parts before they turn into products​
  • Quality Gate 3

    Geometric dimensioning​

    Final dimensioning​

    Challenge​s

    • Critical factors for quality assurance are cycle time and reliability of results​
    • Tight profile tolerance on polished surfaces are a challenge for traditional inspection methods

    Your benefits with ZEISS​

    • Increase usable acceptance range by decreasing measurement uncertainty​
    • Reduce operator influence and need for manual inspection by using CNC inspection​
    • Evaluate GD&T supported by smart software tools and workflows

Quality assurance for additively manufactured implants

Additive manufacturing is a modern manufacturing method. It offers a lot of potential for a wide variety of customizable medical devices: From hip and knee to spine implants, trauma components through to Patient Specific Products (PSP). To produce precise, reproducible, and FDA-compliant additively manufactured medical parts, strict quality assurance requirements must be met. ​

See how other customers have experienced ZEISS Medical Industry Solutions

Automated ATOS 5 3D scanning knee implant components on a fixture inside ScanBox.
14.08.2024

Increased throughput and inspection information of medical products

Medical device manufacturer Orchid Orthopedic Solutions requires accurate and repeatable inspection to ensure components meet customer specifications. By using optical scanning, the company was able to increase throughput and inspection information.

ZEISS Axio Imager.Z2m for Industry use
15.12.2023

AI automates testing of implant coatings

The medical technology group Smith+Nephew uses AI-supported light microscope ZEISS Axio Imager to inspect coated implants. The innovative solution has been handling image segmentation and is shortening the entire measurement process to just a few minutes.

Precision at every turn
16.06.2020

Precision at every turn

The Icelandic company Össur measures components with complex geometries with ZEISS solutions and thus guarantees the quality of its high-tech prosthetics.

Application in action

  • Let's talk medical
  • Medical application
  • CONTURA / Measurement of femoral implant
  • ZEISS O-DETECT: Application in Action - Medical Components
  • Millionen Schritte weit
  • Let's talk: Medical!
  • Medical Application!
  • CONTURA / Measurement of femoral implant
  • ZEISS O-DETECT: Applications in Action - Medical Components
  • Millions of steps far
  • ZEISS & Smith+Nephew: AI automates testing of implant coatings

Download

  • ZEISS Medical Industry Solutions Brochure Orthopedics EN

    Pages: 17
    File size: 3 MB

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