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Rapid Response Manufacturing in the Medical Industry

By Ashley Eckhoff Principal Engineer, Siemens
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A PPE filter mask, 3D printed on-demand and custom fit to the user. (Provided by Siemens)

Newspaper headlines during the flu pandemic of 1918 may look suspiciously familiar to those of 2020. Articles from that era discuss global supply chains being brought low by a worldwide pandemic. In 1918, headlines referenced mines in Peru stopping production of copper and coal, with miners falling prey to the flu pandemic, and copper and coal deliveries to Geneva, Switzerland being halted.

Similarly, the situation in 2020 also laid bare the weaknesses in global supply chains as products were unable to be transported from their point of manufacture to their point of use. This resulted in shortages of not just everyday essential items but also PPE and other health-related products as store shelves were quickly emptied.

One bright spot amongst the pandemic news has been the rise of rapid response manufacturing.

Meeting the Need Fast—and Locally

Rapid response manufacturing describes gathering manufacturing resources to meet an immediate and acute need in a short period of time. This has allowed companies to respond to changing global needs with local manufacturing. For example, companies that once produced auto parts could shift operations to manufacturing medical supplies.

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Custom fit hearing aids can be designed in one country and rapidly printed for the patient in another. (Provided by Siemens)

This type of rapid manufacturing shift has not always been possible. For example, many parts for medical equipment, such as ventilator machines, were traditionally injection molded from polymer materials. To manufacture these parts, a high-quality mold must first be produced. These molds typically have a lead time of months, which is unacceptable in an emergency. To compound the problem, molds often cost tens of thousands of dollars, a cost that most companies are not willing to incur to meet a short-term need. The mold then becomes an up-front necessity that holds back the ability to injection mold necessary parts in such times of acute but short-term need.

This is where new technologies like additive manufacturing (AM) come into play. AM, also known as 3D printing, produces parts without upfront requirements for molds or tooling. Lacking those upfront requirements, AM can produce parts for medical equipment quickly and relatively inexpensively at distributed points across the globe, negating the risk of supply and shipping disruptions.

Enabled by the Digital Twin

Modern medical products like ventilators are manufactured using a number of methods, including injection molding, machining and sheet metal forming. Regardless of how they are made, individual parts begin life in software where the engineer defines the shape and function of the “digital” part before the “physical” part is manufactured. This in-software version of a part is called sometimes called the “digital twin.”

The beauty of the digital twin is that digital data can be sent across the globe very quickly. So, the plans for producing a ventilator, along with the shape of every part that constitutes the ventilator, can be sent to the point of need for local production at a moment’s notice. If an epidemic breaks out on the other side of the world, resulting in a shortage of ventilators, the digital twin of the ventilator can be sent to local manufacturers in that area and they can begin producing the needed parts. This type of rapid, local manufacturing can help to avoid problems like the global disruption of shipping and supply chains.

This becomes even easier when the digital twin is paired with additive manufacturing because AM can produce parts in both polymers and in metal. Effectively, AM can produce the majority of the parts of a modern product without the upfront need for tooling or molds, and without relying on global supplies of pre-manufactured parts, as is the norm. This is especially true in emergency situations where characteristics like final product finish may not be as important as meeting the medical needs of a population.

Additive Manufacturing in Healthcare Delivery

One of the major lessons of 2020 has been the realization that rapid response manufacturing is uniquely positioned to meet needs in times of emergency. One can envision multiple scenarios where supply chain disruptions may impact the ability to care for local populations. Natural disasters, economic disruptions, political disruptions, and, of course, pandemics are all situations where supply chains are often interrupted and where populations often require medical care.

In 2010, a magnitude 7.0 earthquake struck Haiti, leveling the capital city, Port-au-Prince, and the surrounding area. The medical system of hospitals and treatment centers in the area was devastated by the destruction. Some estimates put the percentage of medical equipment in the area post-quake that was working and being used for purpose at less than 30 percent. This disaster resulted in a massive effort to bring healthcare supplies and experts to Haiti to aid in recovery. However, during the quake the radio and lighting systems at Toussaint Louverture International Airport were damaged, hampering the capability to ship supplies to the island. Local rapid response manufacturing is one possible way to address the need for medical supplies locally immediately after disasters such as this.

In general, as healthcare companies the world over respond to the evolving needs of a world population, reducing reliance on physical supply chains and outside actors becomes more important. During economic and political disruptions, the world has repeatedly seen how medical aid from external sources has often been confiscated by disingenuous actors, only to be sold on the black market for profit. Medical product manufacturing at the point of need has the potential to reduce the diversion of needed supplies. By producing the necessary equipment closer to the point of need, reliance on vulnerable shipping channels can be reduced. This surely will not eliminate product diversion and supply chain issues, but every positive impact is a step in the right direction.

Fluctuating Demand and Rising Innovation

Even in times of calm, rapid manufacturing can still aid in delivering medical products to market. The normal lifecycle of a product is for the initial demand to be small as the product is introduced. Demand grows as the product is adopted and then slows as the market is saturated or the product becomes outdated. These changes in demand, which occur gradually throughout the product lifecycle, can be better handled by additive manufacturing than by legacy methods.

As development cycles for new products shrink, many companies are using rapid manufacturing technologies to aid in product development and delivery. Human interface points like handles and grips can be inexpensively printed during the design phase to test for ergonomics and effectiveness. Then, as the product moves to production, rapid manufacturing can be used to create the molds and tooling necessary for full-scale production. Finally, as a product matures and begins to be phased out, rapid manufacturing can be used to support maintenance of legacy models with on-demand production of replacement parts without the need for expensive long-term storage.

Rapid Response in an Ever-Changing World

In 2020, we saw first-hand that ensuring care continuity in the face of disruption is where tools like additive manufacturing are proving their value. But these tools are being used across the production lifecycle in times of crisis and times of calm. Swiftly changing world events and quickly shrinking product development cycles mean that rapid response manufacturing technologies like additive manufacturing are becoming necessary for the delivery of medical products to populations of need the world over.

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