3D Printing: Setting New Standards for Medical Device Manufacturing

3d-printing-setting-new-standards-for-medical-device-manufacturing

Three-dimensional (3D) printing, also referred to by the more technical term of “additive manufacturing,” has been technically feasible since the 1980s. The technology has since undergone rapid technological advances, and prices of 3D printers have dropped substantially. The result is that the 3D printing industry offers significant potential to realize innovative applications and products, from dental and medical to automotive and aerospace, while democratizing the manufacturing process to become more decentralized and customized.

The technical aspects of how a particular 3D printer works depend on multiple factors, including the type of additive manufacturing process, material, and printer being used; but the basic concept of additive manufacturing remains consistent across the different methods in that the components are built up layer by layer. A 2016 report from the National Science and Technology Council’s Subcommittee for Advanced Manufacturing, Advanced Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government, characterized the additive manufacturing field as:

A process of joining materials to make objects from three-dimensional model data, usually layer upon layer, as opposed to subtractive manufacturing methodologies. Additive manufacturing can encompass metals, polymers, and electronics. Additive manufacturing can apply to a range of structural and functional materials and to a range of components for defense and energy applications. An advantage of additive manufacturing is that parts can be fabricated as soon as the three-dimensional digital description of the part is created, thus establishing a new market for on-demand, mass customization manufacturing. Most importantly, these processes minimize material waste and tooling requirements, and drastically compress the supply chain. In addition, novel components and structures can be produced from additive manufacturing processes that cannot be cost effectively produced from conventional manufacturing processes such as casting, molding, and forging.

Strong Collaborations Working on Additive Manufacturing

In the United States, additive manufacturing has received strong endorsement at a federal government level. The manufacturing innovation institutes that make up Manufacturing USA, the national network for manufacturing innovation, seek to foster cross-sector collaboration to promote and coordinate research and development (R&D). America Makes is the national additive manufacturing innovation institute serving as the national accelerator for the development of standards, tools, education, and research. In collaboration with the American National Standards Institute (ANSI), the America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC) seeks to coordinate the development of industry-wide additive manufacturing standards.

3D Printing as it Applies to Health-Related Applications

Health-related applications of 3D printing are commercially viable. For example, the manufacture of custom implants and medical devices, such as hearing aids, dental implants, and prosthetics, is technically feasible. The 3D printing process in medical applications can involve one of several different approaches. The choice of a manufacturing approach often depends on the intended final use of the product. For example, some devices can be printed from a standard design to make multiple identical copies. Other devices, referred to as “patient-matched” or “patient-specific devices,” are created from a specific patient’s imaging data.

The U.S. Food and Drug Administration (FDA) has two laboratories to assess how 3D printing may affect the manufacturing of medical devices, such as what parts of the printing processes and workflows are key to ensure the quality of the finished medical device. 3D printing has also become a focus of the regulatory science practice, which represents the foundation to its decision-making approach. The FDA’s Additive Manufacturing Working Group issued draft guidance on Technical Considerations for Additive Manufactured Devices and the type of technical information that may be required to meet regulatory requirements.

Challenges for the Future of Transformative Medical Applications

Despite technical advances in 3D printing, key challenges remain to realizing transformative medical applications, which include:

  • Unrealistic Expectations and Hype: Promotes unrealistic projections as to when some of the more exciting possibilities, such as bioprinting, will become a reality.
  • Safety and Security: 3D printing has given rise to safety and security concerns, such as the potential to be used to manufacture substandard counterfeit medical devices or medications.
  • Patent and Copyright: To sell or distribute without permission a 3D-printed version of a patented item that has previously been manufactured though more traditional means that would violate patent law.
  • High Cost Barriers to Market Entry: Future regulatory frameworks could potentially pose a barrier to widespread medical applications of 3D printing if substantive testing and trials are required for approval.
  • Non-Traditional Device Manufacturers: It remains unclear as to how the FDA intends to regulate non-traditional manufacturing and supply chain practices in a more decentralized manufacturing model.
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