The push for personalized products, open source innovations and cost-effective products are big trends that are impacting our everyday life. The healthcare industry is also dramatically changed along with them. Addictive manufacturing also better known as 3D printing is changing the medical landscape. 3D manufacturing can help the healthcare industry to navigate these trends by reducing time-to-market, improving inventory management, lowering logistics costs and increasing flexibility in meeting patients needs.
However, several legal challenges arise in the use of 3D printing technology in medicine.
Some of the key issues are intellectual property, privacy concerns, regulation requirements, health risks, limitations of the products and standardization of democratically manufactured products. Whether medical devices are printed ion central location or at hospitals, or even at patients’ home, several issues that arise will need to be assessed in the future.
Some of the key ethical issues are:
3D printers use filaments that are acrylonitrile-butadiene-styrene (ABS) and polylactic acid (PLA) filaments. These release ultrafine particles (UFPs) and volatile organic compounds (VOCs) during the printing. The number of particles is not uniform and they are depending upon the complexity of the printers. These can cause respiratory symptoms and some of them are carcinogenic. Although, the long-term effects are still to be studied. The study conducted by Stephens and his research group in 2013 measured particle concentrations and emission rates resulting from standard, commercially available 3D printers inside a typical office. They found printers using acrylonitrile butadiene styrene (ABS) filaments were more dangerous to the health of workers than polylactic acid (PLA) filaments.
3D printing in healthcare attracts privacy concerns. Computer Aided Designs and replicas might contain personal data, especially in cases where 3D printers are often used to test surgeries. In such cases, doctors often get manufactured a copy of the patient’s organ to see whether during the surgery the patient will encounter any issue. But do hospitals require patients for a privacy consent to the 3D printing of their organs? And what happens to that 3D printed organ after the tested surgery? Could they use for Transplantation without patients consent?
3D printing will generate legal questions particular to the medical devices sector. 3D printing might impact industries reliant on mass production. The route to market for 3D printed medical devices is expensive and requires significant investment. Quality assurance and the maintenance and calibration of 3D printers will be challenged, and solving these in a manner that meets regulatory standards will in itself give rise to considerable innovation.
The FDA has gone through a number of iterations of drafting guidelines for the assessment and approval of medical inventions that use additive manufacturing and clearly expects a considerable amount of innovation to take place in this field in the near future.
These four points might just be scratching the surface of new, deeper ethical and social issues that will emerge as the 3D printing technology progresses. The future of 3D applications holds the promise of better treatment while challenging healthcare communities to address emerging ethical questions.
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How do you protect the IP of 3D printed drugs and medical devices? https://www.lexology.com/library/detail.aspx?g=b7d7b4f1-51f1-4317-a564-9d3533879d3b