3D Printing for Healthcare: Advantages & Cautionary Notes
You don’t need to be a news junkie to know the background.
On March 11, 2020 the World Health Organization declared a global pandemic. Within days, country after country came face to face with the stark reality that it was completely unprepared for the task ahead. The global shortage of medical supplies and personal protection equipment (PPE) continues to make headlines as governments scramble to obtain desperately needed equipment. Reactions from various countries have ranged from extreme rationing to assignment of emergency powers.
Among the too-few positive news items of this new era is the staggering philanthropic response of the global 3D printing community. Within days, if not hours, designers had uploaded digital files of 3D-printable PPE; much of this is free and available to anyone with a 3D printer and a desire to help. Some of the more popular designs (the Prusa face shield, for example, or the Copper 3D Nanohack mask) have seen thousands of downloads, and hundreds of thousands of prints and donations to regional health authorities.
Some of the most powerful benefits of additive manufacturing are now on full display. One current example illustrates this especially well: The American government contracted a 3D printing company to deliver 1,000 specially designed clips for disinfectant spray carriers. Originally these components had been injection-molded, but they had been rendered obsolete by the original manufacturer and medical authorities urgently needed an alternative. Within 48 hours, new clips were designed, approved, produced and post-processed at a final cost approaching only $1.00/component.
These are, after all, the benefits additive manufacturing promises:
- Rapid prototyping
- Iterative improvements
- Quick turnaround time
- Little to no capital requirement
- No minimum batch size
But wait. All these benefits and no drawbacks?
The technology is indeed revolutionary in its capacity to meet urgent demands such as those medical facilities now face. But yes, there are drawbacks to the application of additive manufacturing to health care needs in the current crisis. It is precisely because the technology is so new and not widely understood that it can sometimes be used to create products that are actually poorly suited to their intended use.
At i3D, we applaud all those pitching in to help. We do however believe a few cautionary notes are in order, and they pertain to guidelines and standards.
In the first weeks of the pandemic, most of the designs produced and made available over the internet were created with little to no oversight from (or even consultation with) the medical community. Obviously medical authorities need to be certain that donated items will perform to medical standards for design. In a healthcare setting, not just any face mask design will do.
Suitable design is not the only consideration, however. Material must also be relevant to the end use setting and needs. For example, the vast majority of 3D-printed PPE was produced by enthusiastic members of the 3D printing community in the most commonly available FDM polymers: polylactic acid (PLA) and polyethylene terephthalate (PET). However, these polymers cannot be subjected to many widely used sterilization protocols in clinical settings. (This is only very recently changing, as we discuss HERE.) Consequently, healthcare institutions have been understandably reticent to accept some PPE donations. Those that were accepted by medical institutions were mostly designated single-use plastics. (Recyclable of course. But.)
So knowing healthcare requirements for these prints is essential. This will allow us, as a community, to provide materials that are truly effective in the fight against COVID-19 — and truly beneficial to frontline workers.
3D Printing and the Supply Chain Concern
The most current news of the hour is the potential jeopardy of value and supply chains and how that may threaten the way we live and do business for months to come.
In this context, the value of integrating additive and digital manufacturing technologies is now in sharp focus. Digital manufacturing refers to automated manufacturing and can include any CNC device including lathes, cutters, breaks, etc. (Additive manufacturing, 3D printing, is a sub-category of digital manufacturing. For a short primer of the additive process, click here.)
Can additive manufacturing help resolve supply chain concerns?
Without a doubt.
Let’s look at how the unique benefits of 3D printing can be part of the solution.
Efficient Supply Chains
Additive manufacturing gives us ‘Just-in-Time’ production in the most literal sense. Production of key components can be localized, and delivery can be just hours or days away. Moreover, digital manufacturing can reduce costs connected to overstocking and associated risk as suppliers gain better insight into supply chain issues (e.g. inventory levels, delivery status and demand cycles).
Digital storage and transmission of design files for parts, components and products allows for production WHEN needed, WHERE needed. (The Prusa face shield, for example, was developed in Czechoslovakia, but they are being printed all over the world.)
Similarly, parts suppliers in remote locations (such as Fort McMurray, AB, or Juneau, AK, or smaller islands, for example), can literally download an approved file and have the part(s) ready to deliver within hours.
No storage, no shipping. Reduced overhead and reduced wait. That can spell relief in times of crisis.
Design collaboration and improvement is simplified and faster.
An example: the Nanohack mask.
Within days of the pandemic being officially declared, Copper 3D released the Nanohack 1.0 mask. The Nanohack design adopted an innovative means of blending the benefits of Copper 3D’s core strength – its unique antibacterial filament – with the properties of the base polymer, in this case PLA. The design could be printed flat on a build plate, and then thermoformed with relative ease to fit the wearer’s face. A great start! But over the following days, some limitations became apparent (mostly the difficulty achieving proper sealing and of insufficient airflow with the lone vent). Feedback from the medical community and other 3D designers quickly birthed the Nanohack 2.0, a considerable improvement over the first iteration.
In addition to human feedback and input into the design process, digital manufacturing also allows for predictive analytics, machine learning, connectivity and 3D modeling. All invaluable tools in a continuous cycle of development and innovation.
Automated, cloud-based solutions streamline processes and improve product quality. Analytics are more accessible, reducing costly rework and downtime. Detailed product representations are possible, performance monitoring is simplified and delivery to the market is expedited.
Efficient Use of Resources
The additive manufacturing process is inherently ‘lean’ and ‘green’. Incrementally building a part ‘up and out’ – layer by layer – ensures that only the right amount of material is used. This stands in stark contrast to subtractive manufacturing processes which generally result in a fair amount of waste. A CNC lathe making a spindle or a gun barrel creates a mound of waste metal chips (“swarf”; our word for the day!) These chips are not easily recyclable as they are contaminated with cutting fluid and often cross-contaminated with other metals.
A Call to Action…
Additive manufacturing is beginning to flex its muscles. The days of watching multi-hour FDM prints and questioning reliability and production capacity are fading fast, and are being instead replaced with ‘what’ and ‘how many?’
In order to unleash the full potential of additive manufacturing however, industry and use-specific standards must be developed. When additive manufacturing is used simply for prototyping or non-functional components, designers are free to use whatever settings and materials they deem most suitable. However, where additive manufacturing is producing functional end-use components, industry standards are needed to ensure safety and performance. Organizations such as ASTM, ASME and the FDA have done significant work already in standards development for additive manufacturing. However the sheer breadth of applications for additive technologies, the seemingly constant addition of new methods and new materials all present moving targets.
Is your business looking to create end-use products for health care institutions or otherwise? It will be worthwhile to invest a little time researching needs. Identify any industry standards that may already be in place and go on to ensure that materials and design meet the needs of the end-user and the governing body’s requirements.
Can you see the potential for additive manufacturing to step up to the plate to address the risk to your own supply chain? We’d love to talk with you about how your business or organization can boost efficiency by integrating additive manufacturing into your operations.