3D Printers Used to Manufacture Medical Parts Should Be Regulated

As a company that has been inventing and manufacturing 3D printers and materials for 15 years, our company has had a front-row seat to amazing changes in the way things are made. We are also confident that much more progress is on the horizon, especially when it comes to medical applications.

While the benefits to consumers, businesses and the economy as a result of 3D printing can be profound, so, too, is the painful disruption.

Unfortunately, a great deal of that disruption is happening to manufacturers themselves. Increasingly, they find themselves cut out of the equation as 3D printers enable the process of making things to move closer and closer to the end user and, in many cases, take manufacturing of certain objects out of actual manufacturing facilities altogether. In many cases, 3D printing is also reducing demand for traditional processes, putting a squeeze on, say, cutting tool makers.

Take the dental industry, where sales of our 3D printers were up 75% in 2016 over the prior year.

Dentists and orthodontists are buying 3D printers to manufacture objects that were once made nearly exclusively by dental laboratories and manufacturers. Today, these doctors can 3D print a custom device — say, a bite splint, partial restoration or model for a thermoformed aligner — without any involvement of a lab or manufacturer.

While some of those labs and manufacturers, such as Albensi Laboratories in Pittsburgh and LSK 121 in Chicago, are figuring out ways to adopt to these changes, with their own new approaches to 3D printing services, it’s still a painful period for many companies. They must contend with lower demand for their services or reinvent their business models.

At the same time, this shift to more local manufacturing also raises serious safety and regulatory issues. For example, should an orthodontist office with a 3D printer now face the same kind of regulatory review as a laboratory or manufacturer to protect part quality and patients? Do all 3D printers really offer the same level of quality as a laboratory or manufacturer? Or, should the regulation fall on the printer and materials themselves?

These are serious questions whose answers will directly impact patient safety. In fact, we believe the existing lack of rules in key areas is already creating potential problems in the marketplace. At EnvisionTEC, for example, we routinely see 3D printers being advertised to clinicians that cannot deliver the accuracy they promise or that is required for some applications. Or, sometimes they actively promote 3D printing devices such as night guards in materials that are not approved for long-term use in the mouth.

In May 2016, the FDA issued “Technical Considerations for Additive Manufactured Devices” to solicit guidance on these types of issues. In August, AdvaMed, the association for medical device manufacturers, encouraged the FDA, in the interest of patient safety, to consider adding a statement “that a point-of-care establishment that installs 3D printers and uses those 3D printers to routinely manufacture devices … are subject to relevant FDA requirements, including premarket review if applicable, and post-market controls such as establishing and maintaining quality systems and adverse event reporting.”

Johnson & Johnson raised similar objections, saying “the installation of 3D printers and the routine manufacturing of devices using additive manufacturing techniques in hospitals, physician offices, finishing laboratories and similar establishments exceed the limits” of an exemption that had been set for “licensed practitioners, including physicians, dentists and optometrists, who manufacture or otherwise alter devices solely for use in their practice.”

While we recognize medical device manufacturers want to protect patients, and also themselves, from the threat of manufacturing directly at the point of clinical service, EnvisionTEC does not want to see progress staunched by unnecessary regulation. We believe the recommendation by AdvaMed places too high a burden on clinicians and compromises the time and cost progress that 3D printers offer clinicians and patients.

That said, we do recognize that the market for 3D printers for clinicians has become a bit like the Wild West. We know, for example, that 3D printers are being marketed and sold to orthodontists that cannot meet the requirements set by the American Board of Orthodontics for accuracy, which call for “scan accuracy must be at 0.20mm or better” and “scan resolution must be at 0.10mm or better.”

As a result, we at EnvisionTEC welcome direct regulation of 3D printers and materials to protect both consumers and clinicians, who may be convinced to buy products that simply cannot meet clinical needs that laboratories and manufacturers have strived so diligently to meet for years.

As manufacturers of the 3D-Bioplotter and desktop and production printers that make in-ear, in-mouth and other medical devices for use in and outside of the body, we are registered with the FDA and take quality seriously.

So, yes, this recommendation is an extra burden for 3D printer companies such as EnvisionTEC, but it’s one we increasingly believe is necessary and responsible.

Al Siblani is the CEO of EnvisionTEC