Manufacturing technology
These machines leverage a range of enabling manufacturing technologies. Take, for instance, fast and precise gantry stages that support the latest machining and 3D printing methods. These platforms support exceptional repeatability of operations with nanometre-level precision. Robotic laser systems achieve exact dimensions and tight tolerances while making cuts and welds. This allows the design and production of microparts with superior structural integrity while minimising material waste. Machining medical microparts can be tricky because, in addition to the size constraints, they often require a very precise surface finish. For example, “surgical needles cannot have any kinds of small chips on the edges of their surfaces”, says Jay Lee, director of the Industrial AI Center at the University of Maryland. With advances in 5-axis computer numerical control (CNC) machines, it’s now possible to achieve extremely precise control during machining to meet the most stringent surface finish requirements. Capable of simultaneously operating along three linear and two rotational axes, they can create features like internal cavities and intricate geometries unrealisable by human operators. 3D printing is enabling new medical part designs, too. “With additive manufacturing improvements, you’re seeing the ability to translate very complex geometries that have been either impossible or challenging to reliably or cost-effectively machine,” says Dustin Vaughan, VP, R&D, robotics, at Asensus Surgical. As these designs make their way into the market and the clinic, Vaughan says, “there is a huge shift in the way people are designing medical devices”. Modern CNC and additive manufacturing systems can also be heavily automated. Parallel advanced robotic systems can manipulate tiny parts with unparalleled accuracy. Putting together these developments allows medical device companies to execute a significant portion of the manufacturing process within fully automated cleanrooms. This prevents contamination from lodging in tiny surfaces and grooves, typical in many medical devices, where they are harder to disinfect. The entire assembly can be performed without any human operators entering the cleanrooms, keeping the devices completely sterile.
Manufacturers can assemble syringes and non- critical surgical tools in Class 8 standard cleanrooms, and catheters and stents, among other medical devices, in ISO Class 7 standard cleanrooms. The sterile conditions are maintained after assembly as well. Robotic packaging systems, capable of operating within cleanrooms, can encase devices in protective packages without damaging them. Combined with automated sterilisation, this ensures medical parts
www.medicaldevice-developments.com
The role of 5-axis CNC machining
5-axis CNC machining is pivotal in the fabrication of complex medical devices, enabling the production of intricate geometries with high precision. This advanced manufacturing technique moves the cutting tool along five axes – three linear (X, Y, Z) and two rotational (A, B) – allowing for simultaneous multi-directional movements. Such capability is essential for creating components like orthopaedic implants, surgical instruments and microfluidic devices, which often require tight tolerances and complex shapes. For instance, a study from the University of Connecticut demonstrated the conversion of a 3-axis milling machine into a 5-axis system, effectively producing an implantable flow sensor. This adaptation showcased the feasibility of utilising 5-axis machining for medical applications, highlighting its potential in enhancing manufacturing capabilities for the medical industry.
The integration of 5-axis CNC machining in medical device manufacturing not only improves the precision and complexity of components but also contributes to the advancement of personalised medicine and minimally invasive procedures. Source: University of Connecticut
meet the strictest hygiene standards as they leave the manufacturing facility.
Testing at speed Testing is necessary to ensure that a device that’s produced quickly is also produced correctly. Manufacturers test a product at multiple steps during the manufacturing process, including when it’s finished. “Most manufacturers test far more than required from a regulatory perspective because it’s much more effective economically to catch these mistakes well before they make it to end-of-line testing,” says Vaughan. However, each test slows down the assembly process. When the assembly is fast, testing becomes the rate- limiting step. “If you make it fast but test it slow, it doesn’t help you too much,” says Lee. To bridge this gap by coupling high-speed assembly with automated quality control, medical device companies are integrating AI-based inspections in their manufacturing operations. For example, robotic vision systems continuously scan products along the assembly line and can spot even micron-scale chips on needle surfaces. Improvements in computer vision are essential drivers of faster integrated inline quality inspections. Combining ultrafast cameras with the latest AI algorithms, vision systems can precisely and accurately measure the shapes, dimensions and features of microparts. “We can place a pile of parts on the imaging bed, and the system will automatically identify the count and do dimensional checks,” says Vaughan. “Those tools are enormously faster than even your best operator could ever be and are very effective,” adds Vaughan.
A crucial way high-speed, high-precision machines speed up medical device testing is by reducing the number of assembly steps. “Manufacturers inspect a lot between steps, and that is going away with some of the improvements that we’re seeing,” says Vaughan. For example, previous machining or additive manufacturing technologies relied on designs that incorporated features to hold the part during the
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