Thanks to 3D printing in the healthcare industry, doctors can create tools that precisely follow the patient's unique anatomy. In the healthcare sector, 3D bioprinting is used to create living human cells or tissues for use in regenerative medicine and tissue engineering. Organovo and EnvisionTec are the pioneers of this technology. Aprecia Pharmaceuticals Spritam for epilepsy is the first and only 3D printed drug approved by the FDA.
While many problems need to be solved in order to be able to 3D bioprint complex organs (such as the heart or liver) and then transplant them to a patient, simple organs such as the bladder have been transplanted to patients since the early 2000s. These include collaborations between other 3D printing companies, the biopharmaceutical industry, research institutes and universities. And according to Pew Trust, the healthcare market for 3D printing increased dramatically during the COVID-19 pandemic, when many hospitals depended on this technology for the deployment of personal protective equipment (PPE) and medical devices. While 3D printing presents significant opportunities for clinical innovation, many institutions face reimbursement and security issues related to the integration of rapidly evolving technology in a highly regulated field.
In the biopharmaceutical field, recent collaborations include Aprecia Pharmaceuticals and Purdue University on 3D printed pharmaceutical products, and Poietis and Assistance Publique — Hôpitaux de Marseille (APHM) in a phase I clinical trial of a 4D bioprinted product for skin healing. While 3D printing has been used in the healthcare industry for more than a decade to manufacture titanium and stainless steel implants, something called PEEK plastic will allow the technology to be used in more laboratories and clinics around the world. In the case of medical 3D printing that is performed outside the scope of FDA regulation, there is little formal oversight. This briefing explains how medical 3D printing is used in health care, how the FDA regulates the products being manufactured, and the regulatory issues facing the agency.
In some clinical scenarios where 3D printing could be used, such as the printing of an anatomical model that is used to plan surgery or perhaps one day the printing of human tissue for transplantation, it is not always easy to distinguish between product and practice. And while questions still remain about how common 3D printing will be in healthcare, the reimbursement policies applicable to these products, and much more, these are some of the main ways in which hospitals and health systems are benefiting from existing technology and how 3D printing could transform clinical care in the future. The fields of education and surgical planning are two of the main investors in 3D printing for the healthcare industry. Medical devices that are printed at the point of care include anatomical models, prostheses and surgical guides compatible with the patient, which are tools that help guide surgeons on where to make an incision during an operation.
In recognition of this complexity, the FDA Center for Devices and Radiological Health is developing a risk-based framework that includes five possible scenarios in which 3D printing can be used to manufacture medical devices at points of care. The FDA does not regulate 3D printers themselves; instead, it regulates medical products manufactured using 3D printing.
