“I have a 3D Printer and I am ready to join the fight against COVID-19” is the buzz among the technology developers. There is euphoria to use 3D printers to manufacture a variety of medical products and equipment such as face masks and shield, Personal Protective Equipment (PPE) clothing, respirators, ventilators, nasal swabs etc., for use by doctors and hospitals given that these are consumed at a rapid rate and are currently low in stocks. Although production for these has been augmented at industrial units, yet not sufficient enough given that Covid-19 infected people across the world have crossed the two million mark. Elsewhere, non-health industries, entrepreneurs, start-ups and innovators have come forward in a wartime-like effort to produceshort supply medical equipment. The overall mood is to marshal Fourth Industrial Revolution (4IR) technologies such as 3D Printing and support global efforts to fight the pandemic.

Additive Manufacturing

Additive Manufacturingalso referred as 3D printing uses metals, plastics, polymers, ceramics and other derivatives to make three dimensional solid objects by using a digital file of the object. It is possible to produce intricate and complicated objects of complex geometry, shape, contour and mold with cavities which are normally produced using traditional manufacturing methods of ‘cast and forge’. Among the many uses of 3D printing, the most common is manufacturing machinery parts and equipment. 3D printing not only shortens production time, it cut down costs, enhances efficiency, reduces material waste and shrinks delivery time.

The ongoing pandemic has witnessed 3D printers supplement the production demand of medical equipment and there are a number of success stories of manufacturing select medical equipment and products. Among the many stories concerning the use of 3D printers to fight Covid-19, the production of valves for ventilators by Italian entrepreneurs made headlines in March 2020. Brescian in Italy with 250 coronavirus patients in intensive care was one of the most Corona-infected parts of the country. Faced with a grim situation, the hospital had run out of valves for ventilators and the Chinese supplier could not meet the sudden high demand. The hospital sought help from a local engineering firm Isinnova, who in partnership with Lonati, another 3D printing company, were successful in producing 100 respirator valves in 24 hours.¹

Producing Medical Equipment

Perhaps the biggest demand during the Covid-19 pandemic has been of facemasks. As early as January 2020, the World Health Organisation (WHO) had put out an advisory that besides hand hygiene, “wearing a medical mask is one of the prevention measures to limit spread of certain respiratory diseases,”² The global demand for facemask sky rocketed and China, a major supplier of the equipment, began manufacturing 200 million masks daily including 600,000 standard masks of N95 category. China's mask-making ‘army’ included car makers, electronics and aircraft businesses and oil companies who set up in-house production lines to produce facemasks.³ Yet it was unable to meet the global requirements. The market analysts have pegged face mask industry at US$ 4581.9 million in 2020 and it is anticipated to record a CAGR of 24.2% through 2026.⁴

Similarly, the PPE has been in short supply since the Covid-19 pandemic came to the forefront. The WHO in its 27 February 2020 guidance stated that the “current global stockpile of PPE is insufficient, particularly for medical masks and respirators; the supply of gowns and goggles is soon expected to be insufficient.” ⁵ The guidance also noted that “misinformation, panic buying and stockpiling” were adding to shortages of PPE globally and the existing production infrastructure cannot meet the current demand of PPE and ventilators.

The urgency to build capacity to mass produce ventilators during the epidemic has been acknowledged. A UK report has stated that “30% of Covid-19 hospitalised patients are likely to require mechanical ventilation” and the UK government had drawn plans to acquire over 1200 ventilators and this demand would touch 30,000 at the peak of the outbreak.⁶

Quality Assurances, Certification and IP Issues

As noted earlier, start-ups and industrial giants across the globe are producing urgently needed medical and hospital equipment and products using 3D printing technology. Interestingly, in China, 3D-printed ‘micro-homes’ or ‘pods’ for quarantined coronavirus patients have been built.⁷ However, shortages in ventilators are a harsh reality and there are fears that it will worsen in the coming days as the number of Corona virus infections continue to grow across the globe. It is estimated that nearly 880,000 more ventilators would need to be produced to meet demands in the US (75,000) and France, Germany, Italy, Spain and the UK collectively requiring 74,000 devices to fill the gap.⁸

No doubt, the 3D printing community i.e. inventors, AM providers and designers are working at breakneck speed and rapidly manufacturing ventilator prototypes. Their innovative spirit and resourcefulness is exemplary. If that be the case, then why is there a shortage of ventilators in the world? The answer is that these machines need to be subjected to quality assurance protocols before being certified as ‘fit for use for human’.

AM production is also not free of legal entanglements. There are issues concerning Intellectual Property Rights (IPR) and in one such case it emerged that the owner of the equipment threatened to sue the AM user. Fracassi, the Italian company which produced valves for the ventilators at the hospital in Brescian has been threatened with potential legal action from the Chinese company that owns the patent for the oxygen valves.⁹

However, there are now calls from the international community to freely make available tools and services to fight the pandemic. In this context, Costa Rica has called upon the international community to “establish a freely accessible pool of rights for tools to fight the pandemic. Rights holders would voluntarily contribute IP rights on any data, treatments, diagnostics, vaccines, or Covid-19 technologies to the pool, which would then be made available to a number of manufacturers to quickly scale up production and access to such tools.”¹⁰

Indian Scenario

The demand for ventilators in India is likely to be in several thousands, and according to CDDEP (Center for Disease Dynamics, Economics & Policy), a public health research group, it could be as high as one million ventilators when infections hits peak whereas the current estimated capacity of production is just 30,000 to 50,000 units.¹¹ While India is thinking of importing ventilators,¹² local engineering units, startups, universities and researchers are ready to support national efforts to fight the pandemic. For instance, IIT Kanpur has developed hospital grade surgical mask of the N95 variety that filters at least 95 per cent of airborne particles¹³and the Bangalore based Biodesign Innovation has claimed that it can mass produce portable, low-cost ventilators called RespirAIDs for use during emergencies. ¹⁴

The Indian military establishment has put on display a number of medical equipment such as ‘air evacuation pod’¹⁵ to airlift any Covid-19 patient from ship or shore, portable ventilators will be produced by the Defence Research and Development Organisation (DRDO) and the Indian Telephone Industries (ITI),¹⁶ ‘Portable Multi-feed Oxygen Manifold (MOM)’ by Naval Dockyard at Vishakhapatnam,¹⁷ etc. Then there are creative ideas for ordinary masks including fashionable ones.

Concluding Thoughts

The 3D-printing industry is at the forefront of the global efforts to manufacture COVID-19 related medical equipment. Its current mantra ‘innovate to help save lives’ is noteworthy. While that may be so, there are constraints in terms of availability of materials for manufacturing 3D printed medical equipment. Also, there are issues concerning stringent protocols for quality control and certifications, which need to be addressed given that many of the lifesaving medical equipment cannot be put to use purely based on DIY concept; yet these can surely be a useful backup.

It is also fair to assume and argue that 3D printing will become more popular among the medical establishments. It would not be surprising to see some hospitals setting up their own manufacturing units at their own premises to overcome supply chain issues as also produce these on-demand. This could also expand to production of medicines to overcome issues of storage and expiry.

Notes

1. “How is the 3D printing community responding to COVID-19?” https://3dprintingindustry.com/news/3d-printing-community-responds-to-covid-19-and-coronavirus-resources-169143/ (accessed 15 April 2020).
2. ‘Advice on the use of masks the community, during home care and in health care settings in the context of the novel coronavirus (2019-nCoV) outbreak” https://www.who.int/docs/default-source/documents/advice-on-the-use-of-masks-2019-ncov.pdf (accessed 15 April 2020).
3. “COVID-19 Has Caused a Shortage of Face Masks. But they're Surprisingly Hard to Make”, https://www.npr.org/sections/goatsandsoda/2020/03/16/814929294/covid-19-has-caused-a-shortage-of-face-masks-but-theyre-surprisingly-hard-to-mak(accessed 15 April 2020).
4. “Face mask market to surpass $21.2 billion by 2026”, https://www.globenewswire.com/news-release/2020/03/31/2008963/0/en/Face-mask-market-to-surpass-21-2-billion-by-2026.html(accessed 15 April 2020).
5. “Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19)”, https://apps.who.int/iris/bitstream/handle/10665/331498/WHO-2019-nCoV-IPCPPE_use-2020.2-eng.pdf (accessed 15 April 2020).
6. “Covid-19: The race to build coronavirus ventilators”,https://www.bbc.com/future/article/20200401-covid-19-the-race-to-build-coronavirus-ventilators (accessed 15 April 2020).
7. “People are Isolating from Coronavirus in Tiny Homes Built in Two Hours”, https://www.euronews.com/living/2020/03/13/people-are-isolating-from-coronavirus-in-tiny-homes-built-in-two-hours(accessed 15 April 2020).
8. “880,000 more ventilators needed to cope with coronavirus outbreak, says analyst”, https://webcache.googleusercontent.com/search?q=cache:pFCCuDOZFg4J:https://www.nsmedicaldevices.com/analysis/coronavirus-ventilators-global-demand/+&cd=1&hl=en&ct=clnk&gl=in(accessed 15 April 2020).
9. “How is the 3D printing community responding to COVID-19?” https://3dprintingindustry.com/news/3d-printing-community-responds-to-covid-19-and-coronavirus-resources-169143/ (accessed 15 April 2020).
10. “The Netherlands Joins COVID-19 IP Pool Initiative; Kentucky Governor Requests 3M Release N95 Patent”,https://www.healthpolicy-watch.org/the-netherlands-joins-covid-19-ip-pool-initiative-kentucky-governor-requests-3m-release-n95-patent/ (accessed 15 April 2020).
11. “Coronavirus: Why are ventilators essential in the fight against Covid-19?”https://www.indiatoday.in/science/story/coronavirus-covid-19-what-is-a-ventilator-1661739-2020-03-31 (accessed 15 April 2020).
12. “India to procure ventilators, PPE kits from China, not testing kits”, https://www.indiatoday.in/india/story/india-to-procure-ventilators-ppe-kits-from-china-not-testing-kits-1661495-2020-03-30 (accessed 15 April 2020).
13. “Covid-19: IIT Kanpur to manufacture cost efficient antiviral coating masks”,https://economictimes.indiatimes.com/news/politics-and-nation/india-slams-uscirf-for-spreading-misguided-reports-on-religious-freedom/videoshow/75172818.cms(accessed 16 April 2020).
14. “Coronavirus: Why are ventilators essential in the fight against Covid-19?”https://www.indiatoday.in/science/story/coronavirus-covid-19-what-is-a-ventilator-1661739-2020-03-31 (accessed 15 April 2020).
15. “Indian Navy develops air evacuation pod to safely airlift COVID-19 patient”, https://www.dnaindia.com/india/video-indian-navy-develops-air-evacuation-pod-to-safely-airlift-covid-19-patient-2821026 (accessed 16 April 2020).
16. “Covid-19 pandemic: DRDO, ITI to ink MoU to manufacture portable ventilators”, https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/covid-19-pandemic-drdo-iti-to-ink-mou-to-manufacture-portable-ventilators/articleshow/75059265.cms?from=mdr (accessed 16 April 2020).
17. “To help fight COVID-19, Indian Navy's innovation will allow Oxygen cylinder to support multiple patient”https://www.newindianexpress.com/nation/2020/mar/31/to-help-fight-covid-19-indian-navy-innovates-oxygen-cylinder-to-support-multiple-patients-2123616.html(accessed 16 April2020).

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