New 3D printing applications: 3D printed medical device packaging – 3DPrint.com

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We all know that 3D printed orthopedic implants are a 3D printing success story. For example, we know that 3D-printed hip acetabular implants provide patients with better bone adhesion than those made with conventional means. Other 3D-printed devices may match the modulus of the bone more closely or change the property of the implant in new ways.

We could also see a dramatic further expansion of personalized devices. However, even without an increase in patient-specific products, there are already numerous FDA 510(k) clearances for 3D-printed medical devices, orthopedic implants, and more.

At the same time, we are seeing an expansion of 3D printed hip and knee devices into a growing market for spinal fusion cages and other extremity products. Some of the benefits of additive manufacturing of these items include: the need for fewer steps, more precise designs, improved porosity and pore sizes, better buy-to-fly ratios, and unique shapes. I think we can all agree that this is truly a golden age for 3D printed metal implants.

The packaging market

However, there is an overlooked opportunity that is growing in combination with 3D printed implants. Medical packaging for medical devices, implants and instrumentation is a booming market. This packaging must be sterile, while keeping the contents sterile during transport and use. From the point of manufacture to sterilization, transport and actual use in the operating room, this chain of security cannot be broken.

Imagine an instrument that is difficult to remove from its packaging and can therefore become contaminated near the implantation. Or imagine a courier dropping a package and the barrier film breaking. If custom implants expand, another layer of complexity will be added with each package having slightly different dimensions.

Under pressure

At the same time, surgeons, hospitals and manufacturers are under pressure to bring better products to market faster with shorter turnaround times. This pressure comes from the fact that there are a lot of innovations going on, with devices that are really improving patient outcomes. Then there are the waiting lists that accumulate in many health systems. This was further exacerbated by the short-term impact of COVID, which delayed many surgeries for months. Compared to years ago, the devices are also much more complex and their variation is much greater. Cumulatively, we are seeing a recipe for disaster in implants, with significant time and revenue pressure colliding with greater product complexity. Riding a tricycle is hard enough, but doing it on a new tricycle under stress will increase accidents.

Packaging tools for medical devices, CCIT image.

The increased specificity of surgical devices

The integrity and sterility of the device itself and its packaging are not the only concerns. Now, many products may feature specially designed coatings that may require their own maintenance. There are also a myriad of tools that come with the implants, in addition to specific fixtures, screws, and bits that must be sterile. In addition, these attachments can be specific to a given place and stage of the body. In many cases, a particular order of use of these components has become increasingly important.

Traditionally, large sterilization caddies or trays are used to collocate all these tools and devices. We see a limit to these, but also a tendency to package each item individually, which then leads to increased costs for implants. Amid this profusion of SKUs, variance, and packaging, there is a constant need for traceability. To complicate matters, there is a profusion in the number of sterilization processes: gamma sterilization, electron beam sterilization, X-ray sterilization, vaporized peracetic acid sterilization, NO2 sterilization and — this really sounds like a bad idea — ethylene oxide sterilization. They have their relative merits and can all react differently to different packaging, coatings and devices. The approval and manufacture of different materials, coatings, implants and sterilization processes can also be quite complex.

Packaging sterility test, Image QES.

There are usually a number of issues with trays that also come to the fore. These include trays undergoing steam sterilization without being manufactured for this; creep in the barrier surface; sterilization thresholds not reached; sterilization issues with tool handles, and more.

Regulators seem to be uncomfortable with custom chainrings. I can’t say if this is a temporary caveat or if it would largely impede the use of 3D printing to produce trays and other methods of protecting and packaging medical implants.

The benefits of 3D printed medical packaging and trays

What we can see from the sum total of these developments is that the market for instrument trays and implant packaging, as well as individual items like screws, is ripe for disruption. Now, especially in implantology, “measure 10 times cut once” is a good adage. This is not a “go fast and smash things” game. So any progress will be purposeful and cautious (thank goodness, by the way!). But this set of challenges for medical device and implant packaging would lend itself well to a 3D printable solution.

Packaging validation by Advanced Packaging Technology Laboratories.

Time to market

To reduce time to market, 3D printed mold tooling could save time for market players. Vacuum forming and thermoforming tooling could be made much faster with 3D printing. Reactive injection molding and other short run molding techniques can also make tools and parts available more quickly.

Additionally, mold cycle times can be reduced with optimized 3D printed mold tooling. 3D printing metal molds can also make tooling available faster in some cases. Rejuvenating mold tools with 3D printing can make molds available faster.

Greater specificity for trays

Thermoformed and vacuum formed mold trays could be made more specific by 3D printing with different mold tools and inserts for them. Provided we were to test each instance, it would be possible to produce trays for each operation scenario, with parts ordered for the appropriate procedure. Tighter and better fitting inserts would prevent tools and implants from bumping into each other.

A fitted outer case could then be made from an impact-resistant material to provide more protection for the trays and instruments inside. Molds for soft protective materials (e.g. EVA, foams) could further protect trays and instruments.

Packaging and labeling

The additive could be used to produce tooling for cardboard tools specially adapted to protect instruments and devices in transit. Tools for die casting and stamping QR codes, identification marks and tracking codes on all kinds of labeling and packaging can also be 3D printed.

Construction of bridges

In the event that a manufacturer changes materials or processes, 3D printing could be used as a transition technology to produce the necessary packaging. The same applies when new sterilization techniques are being developed or a product is recalled.

Other Tooling Applications

With more SKUs, more variations, more materials, and more complexity, testing will also become more complex. 3D printing could be leveraged to produce jigs, fixtures and tools for testing packaging.

Quality assurance and inspection will also become more complex. 3D printing could further be used to produce better tools and platforms to properly inspect the more variable packages and tools that will become available.

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