3D Printing (3DP) or Additive Manufacturing (AM) is a revolutionary method of manufacturing a three-dimensional object by building successive layers of raw material.
In 3DP, each new layer built is attached to the previous one until the object is complete. The object can be built in almost any possible shape as defined in a computer-aided design. 3DP allows manufacturers to make changes effortlessly without setting up additional equipment or tools.
3D-printed products are being used in a wide range of advanced industries such as in the Aerospace, Defense and Automotive industries, but the most fascinating advances can be found in the world of healthcare. 3DP in the medical device industry has started in the early 2000s, when dental implants and custom prosthetics were manufactured. According to Gartner’s Hype Cycle, which is used to assess the market hype, maturity, business benefit and future direction of a specific technology, 3DP in the medical device industry is at the peak of the hype curve.
3DP in the medical device industry has many advantages, including customization and personalization of medical equipment, increased cost efficiency and enhanced productivity. By early 2016, around 88 3D-printed medical devices were cleared by the FDA and these include instrumentation (assists with proper surgical placement of a device), implants (e.g. cranial plates or hip joints) and external prostheses (e.g. hands). The FDA cleared these devices through the following pathways:
- The traditional 510(k) pathway
- The emergency use pathway, in which a physician can treat a patient with an unapproved medical device under certain emergency circumstances
- The compassionate use pathway, in which a physician can use an investigational device in cases where alternative therapies are unsatisfactory
- The custom device exemption pathway, in which a custom device can be manufactured to comply with a physician’s order
Despite many potential advantages that 3D printing offers, the limitations include a requirement for huge investment, safety, security, patent, copyright and regulatory concerns.
3DP is estimated to become a $9bn (approximately) industry by 2024, with around $2bn (approximately) to be spent on medical applications. Research on the use of 3DP to manufacture living organs such as heart or liver, is in the early stages of development.