The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices. According to FDA Commissioner Scott Gottlieb, the guidance is meant to "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." He further points out that this is only intended to provide the FDA's initial thoughts on the subject of 3-D printing. For our purposes, this guidance also extends the discussion regarding innovation and patenting in the field of 3-D printing and its intersection with regulatory issues.
The FDA guidance demonstrates the agency's concern for various additive manufacturing methods, the materials that can be used, the interaction between machine and material as well as post-processing validation.
Below are three areas where the regulatory and patent issues are particularly prominent:
1. A patient-matched device design must inherently be concerned with clinically relevant design parameters. Patient-matched devices "may be produced within a defined design or performance envelope. This performance envelope is determined before patient-matching can be initiated and describes the minimum and maximum dimensions, mechanical performance limits, and other clinically relevant factors." Modifying these parameters within acceptable regulatory ranges on a per patient or per cohort basis is an FDA concern. Such modifications may also be a patentability and patent enforcement concern. We suggest clients consider essential parameters for patient-matched devices and range endpoints for those parameters when considering patent protection for such innovations.
2. As expected, the new guidance indicates FDAs concern with the effects of material choice and consistency during additive manufacturing. This has been a rich research area and we have seen it is also a rich area for innovation. Under the guidance, the regulatory requirements for materials will likely be concerned with the detailed specifications of any starting material, the additive manufacturing process used and its effects on the materials, and the intended use of the final device. When innovating in the field of materials for use in additive manufacturing of medical devices, these regulatory criteria should be considered. Structural changes in a material due to the manufacturing process can be intended and beneficial or damaging. For patenting purposes, it is often important to note data from both successful and unsuccessful experiments.
3. The use of imaging in additive manufacturing will likely be common for patient-matched devices but it will also be commonly used for other 3-D printed devices. Resolution, completeness, accuracy, compression, algorithmic normalizing and file conversion all play a role in regulatory compliance and may all require validation according to the new guidelines. These are also patentability considerations. It might be possible to patent software in this area due to its relationship with a device.
Even though the guidance leaves many unanswered questions and fails to clarify known ambiguities, early development of medical devices will be more thorough when guided by these pronouncements. These considerations may also help create more comprehensive invention disclosures, making the patenting process more efficient. And, interestingly, we have already seen the guidance spur innovation.