MEDdesign

Laser Automation and Robotics Support Medical Device Design Innovations

By David Locke
August 18, 2021


• Categories: 01-Digital Health, 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, MEDdesign

Robotics is just one of the technology pillars that has shaped Industry 4.0. Manufacturers have been successfully deploying robots to tackle complex assignments for some years, but today they are evolving for even greater utility. Robots have become more flexible and user-friendly as well as offering quality and precision that cannot be duplicated by manual methods. An area where these technologies are making a significant contribution is in medical device manufacturing which, coupled with sophisticated lasers and customizable vision systems, can offer the reliability, quality and precision necessary to satisfy complex regulatory requirements.

It is critical to mark all medical devices with a Unique Device Identifier (UDI), which is the globally accepted system for validation of uniform marketing of medical devices. For regulatory compliance, the requirements for UDI markings are rigid. For example, the markings must be long-lasting, clearly legible and feature strong visual contrast. The marked surfaces must be clean and hygienics and must be resistant to sterilization and cleaning operations through their entire lifecycle. Additionally, they must be traceable worldwide to protect against counterfeiting or possible recalls.

This article will view how automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification. Robotic grippers, automation solutions in conjunction with robot handling systems or robotic pick-and-place solutions are just part of a vast portfolio of possible solutions that can be deployed depending on the requirements of the part—large or small.

Laser Techniques for UDI Marking

Lasers are an excellent option for durable medical device product marketing, particularly for short production runs and for high-volume production runs. A contactless laser marking process can guarantee high-quality markings on almost all materials very precisely, regardless of size. When using a laser, layers of the surface are vaporized. This does not affect the properties of the surrounding material, nor does it affect the deeper layers. This makes it possible to achieve low melt, burr-free marking at a high level of precision—even on the tiniest contours of very hard material surfaces. This makes even the minutest of 2-D code layout easily legible and surrounded by clear outlines. Furthermore, a laser marking process eliminates thermal influences of the kind that can cause metals to decompose, degrading the material properties.

Lasers must be able to conform to a wide variety of materials to ensure that UDI markings are meeting all production and regulatory requirements. These materials include both metals and plastics. These laser systems, along with customized software, should be developed to conform to GMP (Good Manufacturing Practice), a system for ensuring that products are consistently produced and controlled according to quality standards. This system is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Consequently, the best approach for determining the best and most innovative techniques is to recognize that there are multiple laser system technologies and software that can be customized to optimize production of wide-ranging and diverse medical products in various sizes, shapes, materials and production volumes. This may include fiber lasers, nanosecond, picosecond and even femtosecond lasers offering different wavelengths that meet specific material requirements.

Automation = Software, Hardware and Robotic Assist

Today’s robotic automation solutions incorporate greater computing and communications capabilities than ever before, enabling them to be more tightly integrated with control systems and supervisory software. This is particularly good news, as the proliferation of innovative and more complex medical devices will require the use of increasingly sophisticated automation solutions not only to gain precision and reliability efficiencies, but also for cost savings and to meet regulatory requirements. These modular automated systems also lead to optimized workflows, precision/reliability as well as provide flexibility for production processes.

For automated processes, software is frequently customized to align with a customer’s production flow and process certification. While many machine builders leave that challenge to customers, others will work to define customer specifications. Such custom software might even consist of defining and limiting access to different levels of personnel (operators, administrators, developers), counting parts (both good and rejected), sending messages when faults are encountered or targets are met, or even scanning barcodes to call up the appropriate laser program.

Another key component of automation is a tightly controlled vision system. These systems, which work in tandem with cameras and robots during the marking process are important for a number of tasks in medical device manufacturing, such as production monitoring as well as inspection and quality checks of parts as they are processed, including verification of UDIs. Inspection capabilities assure the detection of defects before any issues compromise the entire production line. They utilize both OPR (optical part recognition) and OCR (optical character recognition). OPR uses cameras to locate a feature on a part and is able to adjust the marking program to accommodate the position or sends a message that there is an anomaly to be adjusted. OCR basically “reads” the characters that were laser marked to confirm they are correct or, in the case of a barcode, that it is readable and accurate.

Robotics round out the collaborative environment. A pillar of Industry 4.0, robotics have made tremendous advances since their introduction to the manufacturing floor. For example, a multi-axis robotic arm with sensitive grippers can gently, but dynamically, pick and place devices into proper position for marking with a precision not able to be easily accomplished manually. Thus, these robotic “partners” are particularly suited for the logistics involved in laser applications for medical devices, which often involve components that are not only being reduced in size but require more sensitive touch to manufacture.

Laser Automation + Robotics Support Medical Device Design Innovations

Automation opportunities for medical devices will continue to expand exponentially as demand for more sophisticated, yet smaller and easier to handle devices are required by the healthcare industry. Investments in patient self-case devices are trending today along with more user friendly and flexible devices to be used in operating theaters. Each of these devices will need UDI markings and will have the same strict regulatory requirements—or maybe more so in the years to come. Today’s laser technologies, combined with special modules and automation components, are keeping pace with current trends. Expectations are that these technologies, like the devices, will continue to evolve with customer design innovation and market demand.