Incredibly, that seemingly distant Star Trek future is upon us now; but, there is no regulation of the technique – until now.
In early December this year, the US Food and Drug Administration (FDA) published the first technical framework on 3D printed medical products and devices to guide manufacturers in relevant product registrations with the agency. Titled "Technical Considerations for Additive Manufactured Medical Devices", the guideline also aims to provide much-needed clarification on FDA's current stance on the critical aspects of 3D printing including "device design, testing of products for function and durability, and quality system requirements."
“Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology,” explained FDA Commissioner Scott Gottlieb, MD.
Long-awaited guidance still needs workThe publication is a more extensive version of the draft guidance published last May and is expected to further vitalise the existing 3D medical device market – as manufacturers now have a better idea of what FDA expects of their product. The technical framework also lays the foundation upon which future regulatory approaches could rely on as a benchmark.
The agency was careful to categorise the new guidance as a "leap-frog" guidance. Such categorisation implies significant market dynamics within the 3D printing industry where the guidance only represents FDA's current thinking on the issue and their recommendations to manufacturers are "likely to evolve as the technology develops in unexpected ways."
But legal experts still have concerns as, “both the courts and the FDA lag behind technology,” writes Richard H. Rubenstein and Jianlin Song, attorneys at Wilson Elser, a reputable law firm across the US.
“Our current regulatory system is designed to regulate mass-produced medical devices. As such, is it sufficiently equipped to protect consumers against the newly created risks presented by these 3D printed, individualised products?” they ask.
“If the 3D-printed medical device market continues to grow at the same exponential rate as it has, our legal and regulatory institutions may soon find themselves in need of new rules.”
What does it mean for other countries?Also known as additive manufacturing (AM) in the FDA guidance, 3D printing is a technology that caught global attention. The prospect of on-site, patient-specific manufacturing capability to produce affordable medical devices is attractive to many developing countries – the so-called emerging markets such as India, China and also Southeast Asian countries like Malaysia.
Efforts to capitalise 3D printing for medical benefits range from simple customised implants, splints or prosthetics to sophisticated, cell-based, and functional living constructs that build or restore the functions of various tissues or organs. Prior to the guidance publication, the industry faces notable regulatory challenges as the existing framework does not cater to this niche area specifically.
Conventionally, developing countries tend to look towards both the FDA and the European counterparts, the European Medicine Agency (EMA), for guidance. It is expected that this time will not be an exception. It remains to be seen, nevertheless, how local regulatory agencies propose to harmonise regional regulatory framework with what was recommended by the FDA. Such strategy is important to ensure the framework can match the unique attributes of any 3D medical device produced locally, as these may vary significantly from region to region.
Limitless opportunities for 3D printingWhile a 3D printer is still technologically "inferior" to the Replicator, they can spew out an impressive array of medical devices – from simple finger splints to complicated prosthetics, researchers and entrepreneurs have been actively bringing innovative and creative ideas to the field.
There are also instances where researchers leverage 3D printing technology to explore tissue engineering. For example, scientists from Harvard University had invented a method to create “tissue containing human bone marrow stem cells surrounded by connective tissue.” The cells would then be stimulated to differentiate into bone cells over a period of one month, as reported by Harvard Gazette.
In 2015, FDA also approved the first antiepileptic drug, Spritam, that utilises 3D printing technology for human use.
If guided appropriately, and given the right amount of stimulus to grow, 3D printing technology could become one of the most impactful technology to disrupt the healthcare sector. It is hoped that the FDA guidance would usher in a golden age for the technology and for the benefit of all mankind. MIMS
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