Robot-Driven Orthopedics Manufacturing

In the intricate world of orthopedic device manufacturing, precision quality isn’t just a requirement, it’s the cornerstone of life-changing patient outcomes. SpiTrex Orthopedics, a global leader in medical device contract manufacturing, specializes in implants for the spine, trauma, and extremity markets (Spi.Tr.Ex.), including spinal rods, cross connectors, hooks, and a variety of stateof-the-art screws, nails, and plates. The company has a multi-site smart factory manufacturing footprint across North America and Europe.

Faced with surging demand and labor shortage challenges, SpiTrex needed to expand capacity and throughput while maintaining the highest standards of quality. To achieve its objectives, SpiTrex kicked off a fast-track initiative for robotic digitalization in production operations relying on Flexxbotics advanced robotic machine-tending solution for robot-driven manufacturing.

Challenge

As SpiTrex embarked on its initiative, specific capacity bottlenecks that impacted throughput due to prolonged setup times and ongoing manual intervention were identified in the production process for robotic automation. The company aimed to overcome these challenges by leveraging advanced robotic machine tending with in-line inspection to optimize manufacturing for continuous operation.

SpiTrex initially targeted 10 FOBA laser marking machine work cells where an hour or more of an engineer’s time was necessary to change over and set up each new job, and the machines required an operator to run. This stage of the process was determined to have the highest return on investment (ROI) and business-critical impact for robotic automation because all parts produced funneled through the unique device identifier (UDI) laser marking step for serialized traceability and FDA compliance.

Solution

Early on, SpiTrex identified the need for robot+machine communication and coordination due to the multistep nature of the laser marking operation and their previous experience with production robotic automation projects. Flexxbotics’ solution was chosen based on the open connectivity that enables interoperability and powerful functionality for robot and machine orchestration to run unattended.

“Flexxbotics is the only robot machine tending software solution we found capable of delivering the precision, cycle-time and closed-loop compliance required,” notes Brett Gopal, SpiTrex orthopedics senior vice president of operations.

The breakthrough FlexxCORE technology enables robots to securely connect and communicate with the FOBA laser marking and engraving equipment, including the integrated camera systems for robotic control of part processing with in-line inspection enabling autonomous process control. The solution coordinates each robot’s actions with three-stage marking process which includes part inspection prior to marking, automatic mark alignment, and subsequent validation of the marking along with vision-assisted workflows for accurate touch-up if necessary.

“It was clear the benefit of Flexxbotics’ solution horizontally integrating from one FOBA machine to another. What made their solution extremely unique was their ability to vertically integrate to our premachining process, post process and IT systems,” says Gopal.

After the laser marking processing, SpiTrex vertically integrated Flexxbotics to its premachining and post-processing workflows, streamlining operations and delivering closed-loop quality control. It directs the robots to use a COGNEX vision system to determine the pass/fail status of each part and autonomously sort parts based on the results. In addition, it then sends alerts with the camera images to quality engineers and the quality system repository when nonconformance issues are detected from steps that occurred in previous operations to close the loop in real time resulting in less scrap and rework for higher yields.

“We are impressed with Flexxbotics’ autonomous process control using robots, and the ability to close-the-loop by alerting upstream and downstream work cells of quality problems based on automated inspection results which is quite unique,” Gopal says. Flexxbotics’ expert consultants led the initiative to design, deploy, and optimize the collaborative robots in the work cells. Working together with SpiTrex personnel, the Flexxbotics team identified the business outcomes, technical requirements, and the part presentation, facility, and safety considerations necessary for success.

Project rollout plans were time-phased to incrementally automate work cells in order to minimize disruption and maximize ongoing output. As each work cell was robot enabled, an optimization period was undertaken to ensure that yield targets and utilization levels were achieved.

The solution directly connects the robots to the FOBA laser marking systems as well as other machinery and systems in the factories, enabling coordinated communication and orchestration for the processing of each part, and the ability to change jobs in real time, reducing changeover setup time to less than 10 minutes from over an hour previously.

“The autonomous changeover process coupled with the closed feedback loop functionality enables us to produce extremely high tolerance parts through continuous flow which reduces the overall lead time by 20+ percent,” says Gopal. “Flexxbotics directly improves our throughput and ROC (return on capital), which in turn increases profitability.”

Measurable Results and Benefits

• 83 percent reduction in changeover time for set-up of new jobs.
• 20 percent reduction in production lead time due to capacity increases.
• 10:1 man-to-machine ratio, enabling continuous operation and long unattended runs.
• Extensibility to start with initial work cells, get success quickly, and scale factory-wide.

Conclusion

By embracing advanced robotic machine-tending automation, SpiTrex unlocked new levels of precision, capacity, utilization, and profitability. The successful deployment of robot-driven manufacturing with autonomous process control using Flexxbotics marks a transformative milestone for SpiTrex Orthopedics’ smart factory operations.

“Rolling out Flexxbotics across all FOBA laser marking workcells results in a 10:1 machine-to-man ratio, which enables continuous operation allowing us to ship more high-quality parts even with labor shortage challenges, making it a game changer for our business,” notes Gopal.

As the company continues to harness and expand the use of production robotics at scale for “lights out” manufacturing, it remains poised to lead the industry with agility and excellence.

This article was written by Marc Lind, chief strategy officer/ chief marketing officer, Flexxbotics, Boston, MA. For more information, contact Lind at This email address is being protected from spambots. You need JavaScript enabled to view it. or visit here .

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