If additive manufacturing (AM) has not made its way onto your “topics to watch” list, it soon should.
Unlike traditional subtractive forms of manufacturing (e.g., casting, machining) that have gone through decades of regulatory fine-tuning, additive manufacturing is still in its infancy when it comes to standard development and regulatory requirements. AM describes various production technologies, such as 3D printing, that are transforming the way objects are made. These technologies use digital files to print components and products layer-by-layer. What began as a tool to make prototypes is now being applied across industries from medical devices to aerospace components. AM is expected to increase in popularity because it allows users to create complex 3D objects that cannot be achieved with conventional manufacturing. Moreover, some manufacturers might eventually need to turn to AM technologies in order to stay competitive. This proliferation of a new technology used by everyone from hobbyists to fortune 500 companies will only heighten the demand for practical standards and requirements.
The American Society for Testing and Materials (ASTM) International Committee F42 is leading the way in standard development, but the amount of materials characterization and lifecycle testing required makes progress slow moving. In the meantime, the legal industry should prepare for an increase in AM-related cases that are likely to arise in the following areas:
- Product Liability – Because AM product designs rely on digital files that are easy to share or modify, issues with counterfeiting, supply chain responsibility, and quality control must all be taken into consideration.
- Toxic Tort – Powdered materials used for AM could pose potential safety hazards to untrained workers or hobbyists. Companies and individuals should be aware of breathing, ingesting, or explosion hazards associated with powdered materials and follow all appropriate safety measures.
- Patent Infringement, Copyrights, and other Intellectual Property (IP) issues – The lines of ownership can be unclear when multiple people modify original work or adopt someone else’s design and use it for personal profit. Because AM has a different set of supply chain characteristics, IP issues are blurred for now and may require a new set of rules specifically for the additive manufacturing industry.
This list represents just a few of the legal challenges surrounding AM. Stay tuned for updates and expert analyses on each of these issues and more.