Regulatory issues and challenges for 3D-printed medical devices

Lander Veulemans
March 30, 2019

3D printing, also known as additive manufacturing, is on the rise in the medical world. The process of creating a three-dimensional item by constructing successive layers of raw material has already proven its purpose in orthopaedic surgery and related fields in the last 10 years. However, a new technique often entails difficulties seeking regulatory approval.

At Spentys, we join the innovative wave of creating 3D printed external orthoses. However, this is not the only trend seen in the additive manufacturing world. The American Food and Drug Administration (FDA) has authorized a lot of other medical devices, for instance, instrumentation devices or implants, that were manufactured with the same sort of technology we use at Spentys. Though 3D printing is no longer new, only a few papers concerning orthopaedic applications have been published in recent years. Another notable observation is the challenging process for a company to get a product on the market in a legal way. To address why these phenomena emerge in this field, Spentys focuses on the regulatory framework for 3D printed orthopaedic medical devices.

3D printing of soft tissue

It is not always convenient to initiate clinical investigations of a new medical device. Many obstacles can accompany the generation of clinical data. The objective of a clinical investigation or evaluation to assess safety and efficacy on a 3D printed device depends on the purpose and the population for whom it is intended. In certain areas where clinical outcomes are bound to compliance of the patient, 3D printing can improve clinical results. At Spentys, we are convinced that this is partly due to the shift from mass production to mass personalization.

3D printing might be seen as a conventional step forward in the medical world, but using this additive manufacturing technique in the medical industry is a very progressive climbing of the ladder. It may cause issues for regulatory authorities since anyone owning a 3D printer and a blueprint could start manufacturing its own devices. Luckily, the FDA has issued recent guidance for 3D printing of medical devices, removing some regulatory uncertainties, particularly regarding design-,  manufacturing-,  and device testing considerations.

To evaluate rules set by authorities, we must distinguish two classes of medical devices:

Class I medical devices can be created using any production process, including 3D printing. Manufacturers only need to prove their final product is largely the same as the product that is already on the market. They are considered to be ‘safe'. The main problem here is that these are the only devices that are on the market at the moment. Multiple issues arise with the regulation of patient-specific devices, e.g., custom-made prostheses. Hence, there can be a problem for each personalized device. Future regulations should focus on the individual differences between people and personalized healthcare, rather than similarities. Currently, regulatory bodies try to fix this by setting a maximum and minimum for custom-made devices.

On the other hand, class II medical devices are considered to be a ‘higher risk' and must undergo a pre-market authorization procedure as there is nothing similar on the market yet. Still, there are too many contradictory regulations from all the bodies, both national and international. This hitch lags the progression of the innovating process, which is 3D printing. In addition, all the regulatory authorities try to achieve one main goal: irrespective of your location, the production of a medical device can use one set of standards and be able to meet all country's regulations. The principal issue is that the ISO (International Organization for Standardization), ASTM (formerly known as American Society for Testing and Materials), and others make their own unique standards for 3D printing rather than duplicating from traditional manufacturing.

Though there are many contradictory regulations, the FDA continues to study all new technologies to better comprehend them when reviewing the medical products or offering guidance to manufacturers. The role of the FDA is important. It tries to regulate the medical product, conduct research for advancing regulatory science and serve as a response to encourage innovation concomitantly preserving the innovation process.

Today, there are still some obstructions in terms of regulations. It is not a smooth process for a company to launch a new product. The ambivalence between the effort of some authorities to ameliorate a manufacturing process and the unconsidered rules set by others overrules the need for innovation.


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