3D printing has made tremendous contributions throughout healthcare. It has been able to improve clinical outcomes, reduce operation duration and also reduce overall treatment cost. 3D printing has been serving major applications across the globe such as replacing human organ transplants, producing cheaper versions of required surgical tools, speeding up surgical procedures, and improving the lives of patients on prosthetic limbs. Newer tools, advanced technologies are helping in delivering better treatments and devices that are customised to better serve the patient.
As per a recent report by Markets and Research, the global automated 3D printing market was valued at $507.8 million in 2020 and is expected to grow at a compound annual growth rate (CAGR) of around 37.14 per cent over the forecast period (2021 - 2026). Although the additive printing market has witnessed growth in India as well, there is still a lot of untapped potential.
Despite the potential of 3D printing technology, there is no global policy on the same. Globally industries are looking at 3D printing technology as the technology of the future, governments need to take this into account and try and regulate the sector as and when the need arises. It would be helpful as different countries currently are in different phases of 3D printing technology adoption across industries. For instance, in 2018, China issued guidelines for regulation and registration of 3D printed medical devices which included custom-built additive produced medical devices. China further issued several guidelines for different 3D printed medical devices including a 2020 technical guidance for 3D printed artificial vertebrae and acetabular cups.
In the US in 2017, Food and Drug Administration (FDA) issued guidelines for additive manufactured medical devices, including recommendations for testing of devices that include at least one additively manufactured component or additively fabricated step. The European Union has specific legislation for 3D printing in the manufacturing of medical devices. During the onset of the COVID-19 pandemic, special guidelines were issued for 3D printing for COVID-19 relief.
On the other hand, India’s National Policy on Electronics, 2019 promotes R&D and startups in emerging areas of technology including additive manufacturing. However, domestic manufacturing is yet to realise the full potential of 3D printing. India has some sector-specific laws, such as in medicine, which can be interpreted to include 3D printing. Even India’s Drugs and Cosmetics Act, 1940 does not specifically address 3D printed objects but the Ministry of Health and Family Welfare expanded its definition of ‘drugs’ under the Act in February 2020, which include appliances used for diagnosis, prevention, or treatment of a disease. There is still a lack of clarity on the applicability of this legislation to 3D printed devices.
3D printing pioneers
The global market is dominated by 3D Systems, Inc, GE Healthcare, Electro-Optical Systems, Stratasys, Renishaw plc. Major manufacturers are focusing on the development of intermediates by offering a wide range of 3D bioprinting.
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