Increased Throughput and Inspection Information for Medical Devices

In 2019, Orchid's automation engineer led an effort to seek technologies that would automate their dimensional measurement and quality processes to decrease inspection time and increase information. Orchid also considered 3D measurement solutions with the ATOS system. After reviewing the results of a gage R&R (repeatability and reproducibility) study performed with the technology, Orchid purchased a non-contact blue light 3D scanner including ZEISS INSPECT and VMR (Virtual Measuring Room) App to fully automate final inspection, in-process and production inspection.

Because many of Orchid's customer requirements dictate what metrology equipment is acceptable for inspection, implementing ATOS technology took gaining buy-in from those customers.

"They want a gage R&R, and they want to make sure that no matter how many different ways you set the part up on a fixture, that inspection will find the part the same way every time and correlate with a computerized CMM inspection method, which has historically been the industry standard. So, if we could correlate the CMM and show a good gage R&R, which is about 10% of the feature tolerance, it's much easier for customers to buy off on the process. There's a lot of other inspection systems out there, but they're not able to get down to 10% of the feature tolerance, which is where we want to be," said Frank Sears, Lead Quality Engineer at Orchid's Oregon location. In addition, ATOS measures full-field surface geometry using advanced blue light fringe projection technology, thus creating a digital twin of the entire product.

After ATOS technology passed numerous correlation and gage R&R studies, Orchid earned buy-in from two customers for a total of five different products within the first 12 months following the purchase.

Sears and his team use the Smart Teach offline and online programming functions in the VMR App to automatically position and optimize the robotic arm inside the ScanBox to achieve optimal angles for the ATOS sensor to collect adequate data. To advance their process further, they worked with the ZEISS team of automation experts to create a customized template using scripting methods to perform automated 3D scanning and inspection specific to Orchid's customers’ requirements. The script is processed through the Kiosk Mode, which seamlessly communicates to the VMR App to execute batch scanning for multi-part inspections. The operator places multiple knee implant components, averaging 24 at a time, onto a fixture within the ScanBox. Pressing a button activates the ScanBox to begin digitizing the batch of parts. The software intelligently separates the 3D mesh data sets of the multiple components and stores each in a specified folder. The software then loops and takes each individual data set, applies the proper measurement inspection template, and automatically generates a report.

By implementing this process, Orchid's initial goal of decreasing inspection time and increasing part information was immediately met. "One knee implant product previously took us about four minutes a piece to inspect, and we only had four features being measured on it using a traditional measuring method. The customer wanted us to check a lot more features, so we added many more features to be inspected than we normally would and using our ScanBox, we still save time – 40 pieces would take three hours to inspect just four features on each piece with a single point trigger CMM. Now it takes us about 45 minutes to an hour for the same number of parts, and we're inspecting way more features," said Kirk Dorr, a Quality Control Supervisor at Orchid Orthopedic Solutions.

Orchid's team also benefits from interacting with ZEISS INSPECT visual data to display the information more clearly, while having the flexibility to make it as detailed or undetailed as necessary. The ability to process the data flexibly to display inspection features, visualizations and models helps make inspection reports that support clear customer communication and collaboration.

"ZEISS INSPECT provides a 3D surface map (color map, heat map) where you can rotate and analyze it in real-time in 3D coordinate space. Color maps show you where the high points are, exactly where you need to rework, and other areas that may need improvement. It's been really helpful," said Sears.

Orchid's future plans include gaining more customer acceptance of ScanBox technology to expand the product families they can inspect with this advanced technology. Time savings is one reason for this push, but the biggest driver is cost savings.

"Over the past year and some, we've processed more than 100,000 castings using our ScanBox that used to be CMM inspected. We wanted to calculate our actual savings and found that we received the return on investment within the first 12 months and the cost savings are only going to continue to get better as we transition more parts from CMM to ScanBox,“ said Sears. "Our plan is to continue saving money and speeding up inspection by adding more products to the ScanBox. Our current ScanBox sits at an 80% utilization rate over two eight-hour shifts. A second ScanBox will enable us to process more product per day, eventually doubling our throughput and savings by moving more product families to the ZEISS."