ZEISS MEDICAL INDUSTRY SOLUTIONS

Quality Assurance for Additively Manufactured Implants

From powder to finished additively manufactured parts

3D printed hip cup non-destructively inspected with x-ray to detect the presence of voids, cracks, and any other issues

Additive manufacturing 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.

ZEISS Medical Industry Solutions focus on establishing safe and stable processes with holistic data integrity. Our portfolio of hardware and software solutions inspires a virtuous circle whereby the drive to meet medical industry standards propels your quality assurance effectively and efficiently to new heights.

Next-Level Manufacturing Process

Layer-by-layer additive manufacturing enables customized orthopedic implants, but appropriate quality assurance processes are necessary to handle the new steps involved. Manufacturers must test all steps to avoid defects, and ZEISS solutions target early defect detection to save time and money. We work with customers from feasibility testing through to non-destructive inspection, keeping pace with evolving technology and giving them confidence to commit to additive manufacturing in an economical way.

Quality gates and solutions

Quality gate 1:
Powder and material characterization

Analysis of raw material

Challenges

Particle size distribution and material chemical composition must be precisely monitored since they influence spreadability and the formation of defects

Your benefit with ZEISS

Capture large sample size with powder particle analysis using light microscopy to ensure consistent quality of material feedstock, e.g. via early detection of fluctuations in powder particle size or shape
Automated EDX measurements reveal material chemical composition via electron microscopy analysis
3D software evaluation of powder particles following inspection with X-ray microscopy
Improved monitoring of material recycling and re-use strategies

Microscopy Solutions
Quality Gate 2:
Post-print heat treatment and part removal

Analysis after print

Challenges

Post-processing treatments ensure dimensional accuracy and optimal material properties. Heat-treating after printing relieves stress, with some parts then heat-treated again to address microstructure changes.
Warping of functional parts due to different cooling rates within the build
Need to compensate for build and/or heat treatment with reverse engineering tools

Your benefits with ZEISS

CMM or optical 3D scanners verify post-print compliance with part tolerances and help with understanding how heat-treating address microstructure changes and how these processes influence final accuracy
Dedicated software uses model compensation to ensure tolerances are met.

Coordinate Measuring Machines

Optical Scanners
Quality Gate 3:
Internal defect and structural inspection

Structural integrity of the part

Challenges

The printed part must be inspected to detect the presence of voids, cracks, and any other issues affecting the internal structure.

Your benefits with ZEISS 

Light microscopy solutions are used to evaluate weld pool characteristics with direct impact on mechanical properties
Volumetric part scans can be performed with industrial CT systems and X-ray microscopes

CT- and X-Ray Solutions
Quality Gate 4:
Post-print material quality inspection

Analysis before final processing

Challenges

Processing parameters have a major influence on the grain structure for medical alloys and therefore the part properties
3D displacement and surface strains must be analyzed while implant is under working load

Your benefits with ZEISS

Analyze etched surface with light microscopy to reveal microstructure
Electron backscatter diffraction (EBSD) in an electron microscope and laboratory diffraction contrast (LabDCT) with X-ray microscopy handle grain types and orientations in 2D and 3D respectively.
Energy-dispersive X-ray spectroscopy (EDX) detects intermetallic phases and segregations.
ARAMIS 3D camera systems promote understanding of 3D displacements, 3D deformations, and surface strains

Microscopy Solutions

ARAMIS 3D Camera Systems
Quality Gate 5:
Dimensional inspection and surface quality inspection

Final analysis for qualification

Challenges

Dimensional control of highly complex 3D external geometries and internal structures/features
Non-contact topography checks must be performed on complex hidden inner surfaces

Your benefits with ZEISS

CMM performs fast and accurate part measurement, while industrial CT simultaneously measures interior and exterior features.
Complex requirements relating to the external surfaces can be handled with light and electron microscopy solutions. Industrial CT systems cater to hidden internal surfaces.

Coordinate Measuring Machines

CT- and X-Ray Solutions
Quality Gate 6:
Process data statistics and analysis

Process stability

Challenges

Data is gathered from the entire process chain for fast analysis and visualization

Your benefits with ZEISS

ZEISS software supports central data collection and calculation of metrics
ZEISS ZEN Data Storage enables centralized management of data, reports, and more for light and electron microscopy. The GxP module guarantees traceable analyses for compliance with regulation and certification requirements
ZEISS arivis Cloud infrastructure promotes easy collaboration and access to AI image analysis tools.

Software Solutions