3D Printing is expected to rise to a value of $2.32 billion by 2020, with a CAGR of 26.2% during the forecast period. Growing demand for personalized healthcare solutions is driving the industry, with the technology allowing for entirely customized treatment. Further, it provides precise and more efficient solutions as well as compensates for the growing dearth of organs for transplants.
For 3D printing to sustain its growth and meet its potential, it must overcome several challenges. To meet custom orders in a timely manner, all around the world, it must surpass geographic and production limitations and be able to respond to data from multiple sources accurately and in real-time. This will impose an additional concern of security, as requests and producers will need to be verified and sensitive data will need to be protected.
Additionally, as 3D printing begins to increase distribution, and provide products to hospitals and patients, it will need to clear higher regulatory hurdles. For example, 3D printers have been called upon during COVID-19 to print nasal swabs for testing kits, and many cannot do so simply because they do not have the FDA clearance to do so. To achieve FDA clearance involves presenting huge amounts of data, and can be a compliance nightmare.
For the FDA to regulate the industry is a challenge in itself. Last December, the agency issued a guidance on 3D Printing, referred to as additive manufacturing, covering device design, testing of products for function and durability, quality systems requirements and what to include in premarket submissions. This is only a preliminary set of thoughts, as the industry is expected to dramatically evolve, for example including nontraditional manufacturers like hospitals in the future.
Given that there is currently little standardization in the industry, the FDA must constantly keep up with a changing landscape on multiple fronts. If they do not succeed in properly regulating the industry, the effects could be dire. For example if companies print nasal swabs that are not up to standard, then COVID-19 patients could receive false negative results, leading them to think they don't need to quarantine and further spreading disease.