The healthcare sector has seen a revolution in recent years with the introduction of 3D printing technology. This innovative technology has enabled the production of lighter, stronger and safer products, with reduced delivery times and lower costs. In healthcare, 3D bioprinting is used to create living human cells or tissues for use in regenerative medicine and tissue engineering. Aprecia Pharmaceuticals Spritam for Epilepsy is the first and only FDA approved 3D printed drug. Medical 3D printing is increasingly being implemented in clinical and research-based healthcare activities.
It involves the creation of physical replicas of anatomical structures using 3D printing processes (also known as additive manufacturing). A digital computer model is developed to describe the structures to be printed, where patient-specific models for 3D printing are derived from 3D imaging processes such as MRI and X-ray CT. Small batches (even from a single unit) can be manufactured due to the flexibility, speed and relatively low cost of the 3D printing process. The models themselves make it easier for hospitals and other point-of-care (POC) organizations to plan surgeries and serve as an aid in teaching or explaining complex medical concepts, for example, to a patient who must undergo surgery. Rady Children's Hospital created its own 3D Innovation Lab to print 3D models, including models that mimic human tissue, such as airways, heart, and bones.
For medical device manufacturers and research-based healthcare activities, medical 3D printing can provide an economical tool for advancing iterative design or process improvements due to its rapid prototyping capability. Custom 3D printed implants represent a flexible solution for difficult orthopedic cases and may generate more treatment opportunities in the future. The ability to 3D print medicines using downloadable pharmaceutical prescriptions directly to a suitable 3D printer will have enormous implications for the pharmaceutical industry. 3D metal printing enables medical device designers to produce implants that work better, match better and last longer, for the knees, spine, skull, or hips. Importantly, 3DP makes it possible to manufacture objects in a single run that are impossible to obtain with any other manufacturing method. The FDA does not regulate 3D printers per se; instead, it regulates medical products made through 3D printing.
This summary of issues explains how medical 3D printing is used in healthcare, how the FDA regulates the products being manufactured, and what regulatory questions the agency faces. For example, implants or prostheses are 3D printed for a specific user's body, optimizing the technology to work for an individual, not an average user, as with most mass-produced products. In addition to providing a simple and accurate workflow for exporting models to 3D printers, Simpleware software is also used to prepare models for future CAD design work, for example, for medical device manufacturers performing implant analysis and iterative designs. 3D printing speeds up the process, as custom molds for clear aligners can be manufactured directly from digital patient scans. These include collaborations among other 3D printing companies, the biopharmaceutical industry, research institutes and universities.
