We Can Grow a New Ear, But How Do We Regulate It?

The promise of 3D printing, along with broader additive manufacturing techniques, has expanded into the medical field. Scientists can now print realistic organs to practice surgeries, bio-matrices to support damaged tissues, or even new ears to replace those that are injured or affected by congenital birth defects. As the utility of 3D printing continues to grow, so does the need for appropriate regulation of these products by the Food and Drug administration (FDA).

Experts from academia, government, industry and foundations discussed the emerging science and regulatory considerations of 3D printing at a forum in the fall of 2017. A sub-group of participants led by Joan Adamo, Ph.D., director of Regulatory Support Services at the University of Rochester Clinical and Translational Science Institute (UR CTSI), and Scott Steele, Ph.D., director of UR CTSI Regulatory Science Programs, recently published their findings and recommendations in the Journal of Clinical and Translational Science.

The biggest challenge to assess the safety and efficacy of 3D printing medical technology is that the field is rapidly evolving. Uses for this technology are continuing to evolve, and new uses will likely be developed as fast or faster than appropriate regulation can be analyzed and established. Therefore, it is important to consider exactly which steps in the process are being regulated and who is responsible for each step.

For a single 3D printing process, there may be several articles to regulate, each offering a separate regulatory path to licensing, clearance or FDA-approval. The “ink” used in 3D bio-printing, which is often composed of cell-based or cell-derived material; the hardware and software to design the printed product; and the printed product itself are all logical points of regulation. The authors recommend regulating these emerging technologies where it will have the broadest impact on future technologies.

To help regulatory science keep pace with rapidly advancing 3D printing technologies, the authors recommend developing educational opportunities. By training individuals in the process, development and regulatory science of 3D printing, the group believes regulation will develop at a similar speed as the technology.

The field of 3D printing represents an exciting avenue for medical advance. Ensuring that the technology makes it to patients in a safe and consistent manner will take work. Fortunately, stakeholders from government, industry, academia, and non-profit sectors are already working together to ensure the future workforce is well educated, and these new technologies can reach patients as quickly as possible.

Read the review.

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This article is part of a broader effort initiated by the UR CTSI and the Regulatory Science to Advance Precision Medicine Working Group of the Clinical and Translational Science Awards (CTSA) Program. The working group was established by Adamo and Steele as part of the CTSA Program’s Methods and Processes Domain Task Force.  In 2017, the working group held a forum in collaboration with PhRMA Foundation where members of the National Institutes of Health, FDA, CTSA Program, foundations and industry discussed to key opportunities for regulatory science to advance precision medicine.''

Written by Heather Natola.

Michael Hazard | 1/31/2019

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