The promotion of true mass customisation through the use of 3D printing has long been seen as a game changer in the field of manufacturing, and the ability to produce individual products with unique characteristics in a timely and economic way in some situations is vital. In the area of medical device manufacturing, for example, the implementation of new regulations that streamline the tracking and tracing of specific medical devices highlights an area that 3D printing can be used as a key facilitating technology. The specific regulations in question are those surrounding the application of Unique Device Identification (UDI) codes.
The highly regulated medical device sector has required the application of UDIs in various geographies for a number of years. In Europe, the existing regulatory framework on medical devices dates back to the 1990s, but two relatively new regulations — Regulation (EU) 745/2017 on medical devices, and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices — which were adopted in April 2017 are just beginning to be applied. The medical device UDI regulation was applied last week on 25th May 2020, and the regulation for In Vitro medical devices will be applied on 25th May 2022.
A UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. The UDI system facilitates easier traceability of medical devices, significantly enhance the effectiveness of the post-market safety-related activities for devices, and allows for better monitoring by competent authorities. It also helps to reduce medical errors and to fight against falsified devices.
The permanence of a UDI on a device depends on the type of device being manufactured. In some instances, for example with single-use disposable medical devices, the application of a UDI will be acceptable on packaging alone. Medical devices that are intended to be used more than once, however, or which are intended to be re-processed prior to each use must have a directly-marked UDI (this is called a direct part mark, or DPM). Usually this is applied in the form of a barcode etched or abraded onto the surface of a device to ensure the device’s identifying information is not lost over time. It is here that the role of 3D printing which promotes mass customisation finds its niche.
In general terms, it is easy to see why 3D printing is such a crucial technology when looking at the area of mass customisation. Personalized products are a market opportunity manufacturers cannot ignore.
In most instances, quick production turnarounds are not feasible with traditional manufacturing methods given the lead-times and change-over costs associated with tooling and fixtures. In a traditional manufacturing setting, mass customization means smaller batch sizes and smaller production runs. Between each run, tools must be changed, and the next batch must be set up, which increases the time spent between production runs. When using this method, mass production is more efficient than mass customization because there are fewer changeovers and downtime. Lost time in productivity results in higher costs and can make the overall process uncompetitive.
By its nature, 3D printing does not require tool changes, and this means the elimination of the time and cost associated with production changeovers. By using 3D printing, the design cycle is compressed and, in many cases, can be as short as a couple of days. That is a significant gain over traditional manufacturing methods. Realizing a faster time-to-market is a key advantage that can help offset the near-term costs to deliver mass customization.
Inventory and distribution cost reduction is another area where 3D printing aids in justifying the higher costs of mass customization infrastructure and processes. Mass customization requires a diverse set of parts, but the ability to print parts on demand can help manufacturers save considerably on inventory and storage costs. Plus, when items are produced on demand, the risk of excess and obsolescence decreases. Furthermore, because production can happen where the demand is, shipping time and costs are nearly eliminated.
All the general advantages of the use of 3D printing as a spur for mass customisation apply to its use in the applications of UDIs to individual or small batches of medical devices. It is also an area that is ideally suited to the use of one of industry’s most precise and repeatable 3D printing technology from Israel-based additive manufacturing innovator Nanofabrica.
Nanofabrica’s AM process encapsulated in the Tera 250 AM platform uses an ultra-high resolution Digital Light Processor (DLP) engine, achieving repeatable micron levels of resolution by combining the DLP engine with adaptive optics. In conjunction with an array of sensors, this allows for a closed feedback loop, which is at the heart of why the technology achieves very high accuracy while remaining cost-effective as a manufacturing solution.
Nanofabrica is consistently experimenting in the area of AM mould tool fabrication as it recognises the huge potential benefits for manufacturers, and is consistently achieving ground-breaking improvements in mechanical capabilities, mould designs, materials, and the accuracy and integrity of parts injected using the AM mould tool.
In general Nanofabrica’s work in the area of DRST unlocks new business possibilities for mould makers and manufacturers who up until this point have been restricted to the use of long lead time and expensive traditionally manufactured mould tools for the achievement of any volume of moulding, from prototype runs all the way through to mass manufacture. Nanofabrica’s focus on mould production should stimulate the business case for a process chain that includes DRST, with a dramatically shorter lead time of about 2 hours from file to injected part and at costs reduced from thousands of dollars to tens. Its value as a cost-effective and timely stimulus to mass customisation and application to the area of UDI fulfilment is obvious.