Perhaps no other industry in the U.S. felt the impact of the COVID-19 pandemic on its supply chain quite like the medical industry—particularly in the early stages of the pandemic, when hospitals, medical clinics, senior housing facilities and more struggled to obtain much-needed supplies and personal protective equipment (PPE).
Yet this chaotic time also yielded valuable takeaways. Specifically, the importance of having local, distributed manufacturing to offset the burden of large-scale supply chain disruptions.
That’s where industrial 3D printing, or additive manufacturing (AM), comes in.
Consider this: Of the more than 47.9 million units of emergency medical supplies and PPE delivered to healthcare providers between March and August 2020, one third of those were created using 3D printing. This makes up the largest percentage of production used to create emergency medical supplies, according to a survey by Open Source Medical Supplies and Nation of Makers (opensourcemedicalsupplies.org/impact).
The mass use of AM with emergency authorizations is almost as unprecedented as the pandemic itself. Worldwide supply chain disruptions required everyone to identify local solutions to manufacture emergency medical supplies and equipment. As a result, AM came out on top as an on-demand, production-capable, locally sourced solution.
However, AM is more than a short-term fix. Medical industry professionals need to look at AM as a vital tool in their production toolbox and identify how it can—and should—fit into their manufacturing strategy. This includes understanding AM’s abilities to alleviate future supply chain disruptions.
In traditional supply chains, suppliers provide materials to manufacturers who assemble and then send the produced parts to wholesalers. The wholesalers then sell goods to retailers, and eventually it reaches the end customer.
While this long, linear supply chain isn’t perfect, its shortcomings are more easily overlooked as long as each element of the supply chain moves goods to the next phase in a relatively efficient manner. However, when strains, shortages, or blips occur, they can hold up the entire process. The more significant the issue, the longer the delay.
Distributed ecosystems, on the other hand, rely on a central server, or “control tower,” where numerous elements of the supply chain revolve. We often refer to these as “Centers of Excellence,” where AM designing can take place. Not only does this integration ensure transparency throughout, the information is also shared to streamline planning, ordering, and confirmation conversations between all points in the supply chain.
A good example of this is Amazon. Over the last decade, the company has slowly simplified its ordering and fulfillment. In the beginning, Amazon used standard shipping processes. An order would go to a faraway fulfillment center and get picked up by warehouse staff, packaged and shipped via the postal service. As Amazon built up its network of fulfillment centers, it transitioned to a distributed manufacturing model that no longer relies on big factories or distribution networks. Local fulfillment centers paved the way for Amazon Prime shipping and getting products to customers quickly.
For the medical industry, the same principle can be applied. Except instead of regional fulfillment centers, medical professionals can create a digital inventory of products created with on-site 3D printers or by partnering with local companies with production-level 3D printing capabilities.
There are also greater opportunities to share resources. For example, to help slow the spread of COVID-19, a small medical device engineering firm in Spain created a 3D printed nasal swab design, managed testing, and got emergency use authorization in its country. The team then shared the digital file and specifications with other organizations around the world. Another company in Canada picked up the design and is getting it vetted by Canadian regulators.
By sharing digital files, the Canadian company didn’t have to spend time designing and testing. Since the Spanish team completed all those steps, they could fast-track it to their respective health authorities and get the swabs out to the community as soon as possible.
This collaboration is one of many that occurred as a result of COVID-19 shortages. Beyond urgent needs, however, AM’s democratization means designs can be produced anywhere in the world and tweaked for specific requirements.
With AM-powered distributed supply chains, you don’t need a completely different line of manufacturing. You can use the same equipment and the same qualifications yet produce parts more locally appropriate to that population.
Through traditional supply chain models, the equipment or part you need may be in a warehouse hundreds or thousands of miles away. With a digital inventory, however, design files for those parts are a few keystrokes away in a digital warehouse located on your servers or the cloud. This way, you can access the files and 3D print each part as needed.
This process involves identifying areas where you might need a particular type of equipment and then creating a digital pathway for your production. Not only does this significantly reduce the time it takes to get the parts you need, it also creates flexibility in terms of access to parts or equipment in case of an emergency and in deciding what should be housed physically in a warehouse versus digitally.
For instance, it might still make sense to manufacture large, minimum-quantity orders through traditional means, but items like braces and orthotics that are much more customized can be created on-demand using AM and tweaked as needed.
As we come out of the pandemic, we’ll likely see a pendulum swing where we find a middle ground between emergency authorizations and the traditional process of devices going through regulatory bodies. Since regulatory bodies base decisions and regulation on risk/benefit to the patient, how and when do we create devices that can move through a digital inventory concept to meet a specific need while maintaining safety and efficacy? Are there instances where hospitals can make lower-risk parts onsite more easily? Where does this leave medical device OEMs, and how does it play into the regulatory framework?
We may have more questions than answers at the moment, but COVID-19 has kick-started conversations that will reshape how the medical industry uses additive manufacturing.
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