ZEISS Medical Industry Solutions

Quality Assurance for the Highest Medical Standards

ZEISS Insights: Technical Papers

Metrology Solutions for Medical Components

With its high regulatory requirements and many products that have a direct impact on the quality of peoples’ lives, the medical technology industry depends on reliable quality assurance systems.

ZEISS understands the regulations, their requirements and the challenges faced by manufacturers and their quality departments. Our connected quality intelligence portfolio offers tailored hardware and software solutions that support industry standards and work as a coherent system to give the manufacturers the certainty they need to gain the productivity they desire.

Clearing all Hurdles With the ZEISS Connected Portfolio

Proof of Quality

Guideline Compliance FDA, MDR, etc

Data Handling Regulation FDA 21 CFR Part 11

Quality Management Regulation ISO 13485:2016, FDA 21 CFR Part 820

quality assurance software showing capability and compliance for record keeping in medical industry

ZEISS offers a comprehensive and connected portfolio of hardware solutions that includes tactile and optical coordinate measuring machines (CMMs), 3D scanners, microscopes as well as CT and X-ray solutions. Our customers benefit from class-leading resolution, accuracy, measurement speed and powerful automation functions.

ZEISS Software Solutions include:

Compliance with the requirements of DIN EN ISO 13485 and FDA 21 CFR Part 11
Secure user management
Integration of audit trail and release management
Automated creation of certificates and manufacturer test certificates
Continuous validation
Versioning of documents and protection from modification
Detailed authorization concepts including electronic signatures
Disaster recovery
Company-wide online performance indicators and key performance indicators

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.

Dental Implants

Due to the shape of dental implants, the thread measurement of the entire component surface is most challenging.

Dental implants are manufactured within a metal working process.

Image of a dental implant in jaw. Challenge; Metal working of small components with tight tolerances.

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.

While the glenoid implant is made of plastic, the other components are produced by means of metal.

Shoulder implant. Challenge; Metal, Plastic Large variance in component size capabilities required

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.

All components of spinal implants are made of metal.

Spinal Implant Challenge; Metal Both rods and screws require the highest accuracy when measuring their axis.

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.

The polyethylene liner is made of plastic, while the acetabular cup and the femoral stem are components of metal processing. The femoral head consists of ceramic and metal.

Hip implant in hip and femur. Challenge; Metal, Plastic, and Ceramic. Different material processes all with small tolerances

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.

The femoral implant as well as the tibial tray are manufactured within a metal working process. The tibial insert is produced within a plastic manufacturing process.

Knee implant Challenge; Metal and plastic processing. Need for an interference fit between tibial plate and insert with an aligned fit with femoral implant

Bone Implants

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.

Bone implants are made of metal.

Bone plate implant in leg. Challenge; Metal working a plate with contouring surface and locking splines in different axis

Metal Working Process

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.

From Raw Material to Finished Parts

Quality Gates and Solutions

Stock cylindrical metal. Colored to show grain size and direction of metal domains with an image from a microscope to the top left of the cylinder.

Metallography

Analysis of Raw Material

The challenge

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 benefit with ZEISS

Determine the root cause of failure to improve overall reliability

Software Solutions

Light Microscopy Systems

Electron Microscopy Systems

Initial Forging of the hipstem from stock material. Voids in blue to show possible defects in forging process. Magnified voids above the stem.

Quality of Raw parts

Inspection of Primary Shape

The challenge

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

Your benefit with ZEISS

Fast inspection of produced components to prevent cost-intensive failures later in the manufacturing process

Software Solutions

Scanning Solutions

CT- and X-Ray Systems

Forged stem shown to show flashing form the forging process. Would be as received part from the supplier.

Incoming Inspection

Efficient Verification of Supplied Parts

The challenge

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

Your benefit with ZEISS

Programable inspection plans, which are executable in CNC
Optimize your machining time and sort out waste parts before they turn into products

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Stem further processed. Image above shows microscope image of debris on filter. From cleaning processed part.

In Process Control

Observation of Processing Quality

The challenge

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 benefit 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

Software Solutions

Light Microscopy Systems

Electron Microscopy Systems

Scanning Solutions

Mostly processed stem. Lines describing nominal lengths. Image above to show stylus making contact with the part to measure said dimensions.

Geometric Dimensioning

Final Dimensioning

The challenge

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

Your benefit with ZEISS

Increase usable acceptance range by decreasing measurement uncertainty
Reduce operator influence and need for manual inspection by using CNC inspection

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Completed hip stem. Showing highlighted witness marks. A topography image above the stem shows morphological characteristic of the finished surface.

Surface Analysis

Final Visual Inspection

The challenge

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 benefit with ZEISS

Fast contactless evaluation of roughness
Reproducable and fast results in final inspection

Software Solutions

Light Microscopy Systems

Surface Inspection & Characterization

ZEISS Insights: Technical Papers

Learn more about geometric dimensioning of orthopedic implants using the example of the components of a knee implant:

Femoral implant
Tibial insert
Tibial tray

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Plastic Manufacturing Process

Due to the manufacturing process, plastic implants can be produced very efficiently as large batches, but also individually. Sometimes these are individual 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.

From Raw Material to Machined Parts

Quality Gates and Solutions

Initial geometric dimensions of stock material and shape.

Incoming Inspection

Efficient Verification of Stock

The challenge

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

Your benefit with ZEISS

Programable inspection plans, which are executable in CNC
Optimize your machining time and sort out waste parts before they turn into products

Software Solutions

Scanning Solutions

Coordinate Measuring Machines

Processed plastic part with highlighted dimensions. Image above shows voids on the interior of the part.

Geometric Dimensioning

Final Dimensioning

The challenge

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

Your benefit with ZEISS

Increase usable acceptance range by decreasing measurement uncertainty
Reduce operator influence and need for manual inspection by using CNC inspection

Software Solutions

Scanning Solutions

CT- and X-Ray Systems

Coordinate Measuring Machines

Get more Insights into Quality Assurance for Medical Components

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Your Global Partner

Shape the Future of the Medical Industry together with ZEISS

Medical parts are rarely produced in a single location. Yet measurement and inspection issues can pop up in any country and at any supplier. Our global network of application engineers and service are here to help solve your quality assurance challenges so you can keep traceability and quality at a consistently high level.