May 10, 2016 | By Alec

The US Food and Drug Administration (FDA) has a strange relationship with 3D printing. Though they are now seeing the advantages of 3D printed prosthetics and drugs, the FDA has been slow to approve them in large numbers due to concerns over qualification processes and the impact of different materials and 3D printing technologies. In an effort to make FDA testing processes easier for all parties involved and enable developers to prepare as best as possible, they have now finally released a long-awaited draft guidance for 3D printed medical devices.

Broadly speaking, the FDA is being confronted with two types of 3D printed products: drugs and medical devices. Back in 2015, they approved the first type of 3D printed pills: SPIRITAM, an epilepsy drug by New Jersey-based pharmaceutical developer Aprecia. The huge advantage of SPIRITAM is that the 3D printed pills disintegrate far more rapidly than regular pills, making them easier to swallow. Incidentally, these 3D printed pills have been available since March 2016. Various other types of 3D printed drugs with similar benefits are under development, though the FDA has been slow to approve them.

In contrast, 85 3D printed medical devices such as prosthetics and implants have received FDA approval already. Back in March, a 3D printed tritanium PL posterior lumbar cage was approved. But so far few of them include high-risk devices that require premarket approval. The FDA feels that this group is more likely to benefit patients in the short term, so their new draft guidance is fully focused on these medical devices. Its goal? To provide developers with more insights into FDA thinking about the technical considerations and validation processes that 3D printed devices require.

Specifically, the FDA’s new draft guidance is focused on two of the most important development areas: design and manufacturing, and device testing. The guidance thus provides insights into the most important obstacles for approval, such as characterization, validation and verification. They also caution developers that ‘point-of-care devices’ (tested with or near patients) may bring additional technical considerations with them that have not been covered in the draft.

The most important point of the draft is that the FDA will require that 3D printed devices adhere to all quality system requirements to insure all perform as intended. But because of the many 3D printing processes, materials and post-processing techniques involved, developers seeking approval need to “clearly identify each step in the printing process… from the initial device design to the post-processing of the final device.” Developers also need a full understanding of all upstream effects of different manufacturing steps. “For example, the ratio of recycled to virgin powder can affect melting properties, which affects the energy needed to create consistent bonding between layers, which in turn affects [a device's] final mechanical properties,” they write.

When 3D printed devices are tested, the FDA requires data that is based on a device's “intended use, risk profile and classification.” This means that different considerations will be taken into account for implants and custom-made prosthetics, for instance. In the latter case, data on the full range of dimensions for all possible sizes will greatly help the FDA during the approval process.

Generally speaking, however, tests for 3D printed devices are very similar to tests for non-3D printed devices. The same performance characteristics are studied. The difference is that the medical device’s orientation relative to the 3D printer can also impact performance. “Since mechanical properties of the device may be impacted by orientation and location, it is important to ensure that production processes are properly developed, conducted, controlled, and monitored to ensure devices or components are not adversely affected by fabrication orientation,” the FDA writes.

As part of the release, the FDA has also reiterated their belief that 3D printing holds numerous advantages for the development of medical devices. “[3D printing] has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient's own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches,” they write.

However, they add, it also brings unique challenges to the FDA’s work, especially where characterization and validation are concerned. These problems were again highlighted during a 2014 public workshop on 3D printing, where the FDA received extensive feedback. The need for more guidelines on material control, the impact of 3D printer hardware and post-printing processes also became apparent during the workshop. This new draft will hopefully go a long way towards helping developers realize more 3D printed medical devices. The full FDA draft can be found here.

 

 

Posted in 3D Printing Application

 

 

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