The global supply chain was falling flat on its face in areas critical to fighting the pandemic, even prior to its global outbreak. For example, medical facilities needed millions of N95 masks in the United States during the peak of the outbreak. This need became even more dire after the FDA banned 65 manufacturers from producing N95 masks for medical use. Millions of these faulty masks were produced in China, the world’s largest exporter of goods since 2009.
However, for the 3D printing community, the sudden shortage of medical goods appeared as an ideal problem, tailor-made for an additive manufacturing solution. There was an emergency shortage of critical medical supplies, many of which are made from injection molded plastic, and the clock was ticking. People’s lives were hanging in the balance.
As the #millionmaskchallenge trended on Twitter, the 3D printing community rose to the challenge as a collective, led by larger companies such as HP, Stratasys and Materialise.
CEO Fried Vancraen described the internal machinations of his team of engineers and designers at Materialise. To present workable solutions to medical supply shortages, they were in an ideal position to create alternative products to fill the need. They had a track record of 3D printing medical products under strict guidelines and regulations. They developed and maintained relevant relationships to collaborate in the medical sector. Materialise had 30 years of experience to draw from, and Vancraen noted that to address challenges presented by the breakdown in supply chains caused by COVID-19, they would have to draw from their deep roots and quickly design prototypes for alternative medical products using a mixture of old methods and new techniques. He noted that indeed, 3D printing used to be referred to as rapid prototyping.
During the early phase of the outbreak, Vancraen stopped their entire engineering team one afternoon at Materialise and posed an old-fashioned rapid prototyping challenge: he asked them to concoct their best 3D printed door handle designs in 24 hours. The next morning, they would choose which designs were the most promising ones.
Crucially, he highlighted, this meant following proper protocol by investing heavily in the initial development phase. The team performed a risk analysis and attempted to anticipate any potential problems. This approach led to a series of analyzed design parameters within which the team designed their initial door handle designs. After selecting the best designs the following day, the team began to optimize the five chosen ones. Within another 24 hours, they had fully optimized each design.
A similar process was repeated at Materialise in designing their other alternative devices. Their mask fitters, like their door handles, were designed and optimized with heavy emphasis on the initial phase. The best designs were selected, optimized and prototypes manufactured. But this time an additional step was added to the iterative process: a trip to a local hospital.
By field-testing mask fitter prototypes with local medical staff, their professional feedback was looped into the iterative process and repeated. Cycling through this value-added rapid prototyping process saw the team finish the final mask fitter within just a few days.
Another important part of this instance of rapid product development was parallelization. By investing heavily in the initial design phase of multiple design, simultaneously testing multiple designs and field-testing prototypes, the iterative process could proceed rapidly through multiple product design cycles. Integrating universally applicable design feedback from one product to another created a valuable reinforcement loop of design decision-making for the end user, adding value both in function and reducing time-to-market for the final product.
Vancraen described how his company addressed local increased demand for medical products caused by a temporary meltdown in the global supply chain. Materialise could not realistically hope to design and produce the same products as the injection molded plastic products medical professionals were accustomed to under normal conditions. But they could quickly develop alternatives that were slightly re-engineered versions of the originals. Luckily, the supply chain of materials used by the 3D printing sector was not affected by the temporary disfunction of global supply chain streams.
A serious issue caused by the temporary fracture of the global supply chain of medical goods was the poor quality of mass-produced goods. Quality counts. It’s sometimes difficult to quantify quality, but not in the case of N95 masks. Though the word “quantity” is more associated with “counting,” the quality of mass-produced medical goods became critical. Nowhere does the maxim of “quality over quantity” stand taller than in the story of the mass-produced N95 mask. Millions of low-quality N95 masks were manufactured by China and disapproved of by the FDA in the United States. And further compounding the issue, not only were the millions of N95 masks delivered prior to satiate unprecedented demand during the peak of the outbreak rendered useless, but the millions of N95 masks shipped before COVID-19 first spread from China were also rendered useless for use in medical facilities. The FDA was forced to disqualify 65 global manufacturers of N95 masks as unsafe for medical use, right in the middle of the pandemic.
But Materialise proved that localized 3D printing can be judged by localized quality feedback to produce workable alternative medical goods in a time of crisis. Starting with risk analysis and instructions, as well as investing heavily in the initial phase of rapid prototyping were two facets built into the DNA of Materialise and, because of this, quality assurance was not an unanticipated issue for Vancraen and the engineering team.
To help fill the need for the shortage of masks, the team at Materialise began developing a mask fitter accessory to substitute for the N95 masks. They were able to test out the design at a local medical facility and were privy to the head of safety engineers. The designs were tested on local healthcare workers, giving the company immediate ergonomic feedback.
Materialise was able to work with members of the Belgian government and UZ Gasthuisberg prevention advisor Herman Devriese to develop the reusable Materialise Mask Fitter which fits over the N95 mask. It is connected by elastic straps. This design resolved the issue noted by medical professionals that the masks were too loose and leaked air into the user’s airways.
Bottom Line
By returning to the rapid prototyping roots of 3D printing, Vancraen and his team of engineers were able to create a number of alternative medical products to fill the local gap in supply caused by the absence of critical medical products and mass-produced medical supplies that were not suitable for medical professionals treating patients with COVID-19. By leveraging relationships with a local hospital facility during the initial development phase, they were able to incorporate valuable end-user feedback into their design. By iterating multiple prototypes in parallel, they were able to speed up the product design lifecycle considerably.
These are valuable lessons for product design of any type, but critical lessons for alternative product design in the face of a global supply chain gone haywire.