Aug 10, 2023 The recent tragedy of Titan submersible implosion reminds us how wonderful ideas require rigorous experimentation and the importance of regulation and policy changes surrounding innovations. New designs, new manufacturing methods, and new materials for new applications generate often unpredictable outcomes. Sometimes these outcomes can cause catastrophic harm to passengers or patients alike. In the case of healthcare 3D printing, where new ideas surface daily, it is even more important to invest in establishing and adhering to legal and regulatory guidelines to ensure successful outcomes and commercial actualization. We have published quite a few blogs focusing on policy and the legal landscape. This article intends to tie everything together with updates, focusing on the following areas of legal and policy trends we think will be critical to the healthcare 3D printing and bioprinting industry:1) Intellectual Property Rights, 2) Product Safety and Liability, 3)Export Controls and National Security, 4) Privacy and Data Protection, 5) Environmental Regulations and Sustainability, 6) Taxation
I. Intellectual Property Rights
A classical scenario was probably described by an earlier 3DHEALS blog by Erik Berkeneder regarding a 2011 case “Ritani, LLC v. Aghjayan”, regarding the verdict of “stolen” 3D printable CAD jewelry designs. The verdict was disappointing for owners of original designs. However, as 3D printing technology becomes more accessible and widespread, increasing concerns about copyright infringement and IP protection will surely arise.
First of all, there are a number of key concepts that are important to understand.
- Copyright: Copyright law protects original works of authorship, including 3D designs. This means that the creator of a 3D design has the exclusive right to reproduce, distribute, perform, display, and create derivative works of the design.
- Patents: Patent law protects inventions, which are new and useful processes, machines, manufacturers, compositions of matter, or improvements thereof. This means that the inventor of a new 3D printing process or technology may be able to obtain a patent that gives them the exclusive right to make, use, sell, or offer to sell the invention.
- Trade secrets: Trade secret law protects confidential information that has commercial value because it is not generally known or readily ascertainable by others. This means that the owner of a trade secret, such as the 3D printing process used to create a particular product, may be able to keep that information confidential and prevent others from using it without permission.
- Trademark: Trademark law can protect the brand names and logos of 3D-printed products. This means that someone else cannot legally use a trademark without the permission of the trademark owner.
II. Product Safety and Liability
A. General Regulations/Policies on 3D Printed Products
3D printing is a rapidly growing technology with a wide range of potential applications. However, as with any new technology, there are also potential safety risks associated with 3D printing. These risks can vary depending on the specific application, but they can include:
- Health hazards: Some 3D printing materials can release harmful fumes or particles into the air. This can pose a health risk to users and bystanders. We have a past Expert Corner blog focusing on dental resin.
- Fire hazards: 3D printers can overheat and start fires. One word, don’t put a printer in your house.
- Mechanical hazards: 3D printers can contain sharp blades or moving parts. This can pose a risk of injury if users are not careful.
Therefore, it is important to establish safety standards and liability regulations for 3D-printed products, including the regulation of materials, printers, and user protocols.
Major regulatory bodies include:
American Society for Testing and Materials (ASTM): ASTM is an international standards organization that develops voluntary consensus standards for a wide range of products and materials. ASTM has published a number of standards for 3D printing, including standards for 3D printing materials, 3D printing processes, and 3D printed products.
International Organization for Standardization (ISO): ISO is another international standards organization that develops voluntary consensus standards for a wide range of products and materials. ISO has published a number of standards for 3D printing, including standards for 3D printing terminology, 3D printing data exchange, and 3D printing safety.
American National Standards Institute (ANSI): ANSI is a US-based standards organization that develops voluntary consensus standards for a wide range of products and materials. ANSI has published a number of standards for 3D printing, including standards for 3D printing terminology, 3D printing data exchange, and 3D printing safety.
National Institute for Occupational Safety and Health (NIOSH): NIOSH is a US government agency that conducts research and develops recommendations for occupational safety and health. NIOSH has published a number of guidelines for the safe use of 3D printers, including guidelines for the safe use of 3D printing materials and the safe design of 3D printers.
B. Regulations/Policies on 3D Printed Medical Devices
While there are many regulatory bodies focusing on 3D-printed or bioprinted devices, FDA is leading the way to establish more clarified regulations around these devices. For those who are interested in regional regulations, we have past Expert Corner focusing on Australian (TGA), EU, and more international perspectives.
Separate departments within FDA regulate biological (i.e. bioprinted, biofabricated devices) and non-biological devices (i.e. anatomical models, implants, etc).
More specifically, they are:
Center for Biologics Evaluation and Research (CBER): CBER regulates biological products, including those that are used in tissue engineering. This includes products such as cell-based therapies, tissue-engineered products, and bioinks.
Center for Devices and Radiological Health (CDRH): CDRH regulates nonbiological 3D printed medical devices. It has developed a framework for regulating 3D-printed medical devices. This framework takes into account the unique characteristics of 3D printing, such as the ability to create customized devices and the ability to produce devices in a decentralized manner.
The FDA’s regulatory approach for 3D-printed medical devices is based on the following principles:
- Risk-based regulation: The FDA’s level of oversight will be proportionate to the risk posed by the device.
- Flexibility: The FDA will allow manufacturers to use innovative manufacturing processes, such as 3D printing, to develop safe and effective medical devices.
- Transparency: The FDA will work with manufacturers to ensure that the public has access to information about 3D-printed medical devices.
The FDA has published a number of guidance documents on the regulation of 3D-printed medical devices. Here are some of the specific regulatory requirements for 3D-printed medical devices:
- Premarket review: The FDA may require manufacturers to submit a premarket submission, such as a premarket notification (510(k)) or a premarket approval (PMA) application, for 3D printed medical devices.
- Manufacturing controls: Manufacturers must implement appropriate manufacturing controls to ensure the quality and consistency of their 3D-printed medical devices.
- Labeling: Manufacturers must provide clear and accurate labeling for their 3D-printed medical devices.
- Postmarket surveillance: Manufacturers must conduct postmarket surveillance to monitor the safety and effectiveness of their 3D-printed medical devices.
Here are some relevant guidance documents that the FDA has published in recent years:
Non Biologic 3D Printed Medical Devices:
- Technical Considerations for Additive Manufactured Medical Devices (2017): This guidance document provides information on the classification of 3D printed devices, the PMA process, and the labeling requirements for 3D printed devices.
- 3D Printing Medical Devices at the Point of Care: Discussion Paper (2018): This discussion paper discusses the regulatory challenges associated with 3D printing medical devices at the point of care.
Bioprinted Therapies:
- Framework for the Regulation of Regenerative Medicine Products (2017)
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (2019)
- Evaluation of Devices Used with Regenerative Medicine Advanced Therapies (2020)
For those who want to learn more about these areas, you can check out the following links from our past events and publications:
Interview with Sean Burke: Product Liability
The Legal Landscape in Healthcare 3D Printing (IP and Product Liability, On Demand, Video)
Product Liability: Biocompatible Materials in 3D Printed Products
Patent Protection for Medical 3D Printing & Bioprinting Technologies
Importance of Patent Search for Regenerative Medicine Inventions
3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies
Legal and regulatory landscape (On Demand, 3DHEALS2020, Session 19)
III. Export Controls and National Security
With the increasing use of 3D printing for the manufacture of parts and products, governments may impose export controls to protect local industry or national security. Such controls could limit the types of materials that can be exported through 3D printing technology, as well as where and how those materials are used. Policymakers may also consider introducing or revising measures to ensure that digital files used in 3D printing do not contain sensitive information or violate export regulations.
If a 3D-printed medical device is subject to export controls, it will need to be authorized for export before it can be shipped to another country.
Here are some additional details about the export control of 3D-printed medical devices:
- Dual-use items: Dual-use items are items that have both civilian and military applications. 3D-printed medical devices that are considered to be dual-use items may be subject to export restrictions because they could be used to develop or manufacture weapons.
- Authorization: Authorization is the process of obtaining permission to export a controlled item. The specific authorization requirements will vary depending on the specific item and the specific country.
- Export control specialist: An export control specialist is a person who is trained in the export control regulations. They can help to determine whether or not a specific item is subject to export controls and to obtain the necessary authorizations.
Some examples of export control entities in various countries include:
United States: The United States controls the export of 3D printed products that are considered to be defense articles or dual-use items. The International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR) regulate the export of 3D printed products in the United States.
China: China controls the export of 3D printed products that are considered to be sensitive or strategic. The State Administration for Foreign Trade and Economic Cooperation (SAFE) regulates the export of 3D printed products in China.
European Union: The European Union controls the export of 3D printed products that are considered to be dual-use items. The Dual-Use Regulation regulates the export of 3D printed products in the European Union.
India: India controls the export of 3D printed products that are considered to be strategic or sensitive. The Department of Commerce (DoC) regulates the export of 3D printed products in India.
IV. Privacy and Data Protection
As more businesses rely on digital files for 3D printing operations, there is an increased risk of data breaches or other security issues. For the healthcare industry, handling patient data with HIPAA compliance is even more important. Here is a past Expert Corner blog focusing on such a subject. Since the publication of this blog, however, the digital health industry has significantly advanced policies and infrastructures behind patient data management.
More specifically, the 3D printing industry should consider the following when handling patient data:
- Data security: The data used to create a 3D-printed medical device must be kept secure. This includes the patient’s medical records, as well as any other data that is used to create the device.
- Data privacy: The patient’s data must be kept private. This means that the data should not be shared with anyone who does not need to have access to it.
- Data consent: The patient must give consent before their data can be used to create a 3D-printed medical device. This consent should be specific and informed.
- Data disposal: The data used to create a 3D-printed medical device must be disposed of properly. This means that the data should be deleted or destroyed in a way that ensures that it cannot be recovered.
V. Environmental Regulations and Sustainability
The environmental impact of 3D printing is a complex issue. There are a number of factors that can contribute to the environmental impact of 3D printing:
Materials
Some materials, such as plastics, can be made from petroleum, which is a non-renewable resource. Other materials, such as metal powders, can be made from recycled materials.
Energy consumption
The energy used to power the 3D printer, as well as the energy used to heat the print bed, can contribute to the overall environmental impact of the process.
Waste
Some 3D printing processes produce waste in the form of support structures, which are used to support the print during the printing process. These support structures can be made from the same materials as the print itself, or they can be made from different materials. The waste produced during 3D printing will depend on the specific process used.
The environmental impact of 3D printing can be reduced by:
- Using sustainable materials, including sustainable materials such as recycled plastics and biopolymers.
- Reducing energy consumption: The energy consumption of 3D printing can be reduced by using energy-efficient printers and by optimizing the printing settings.
- Minimizing waste: The waste produced during 3D printing can be minimized by using printers that produce less waste and by recycling support structures and other waste materials.
VI. Taxation
An area that is often ignored but impactful to the business bottom line is taxation around 3D-printed medical devices. With the disruption of the traditional manufacturing value chain, so would taxable events change. While new technologies may reduce manufacturing and supply chain-related costs, there will likely be new taxable events that local governments may establish in the future. Double taxation or new taxation for using digital blueprints are both potential outcomes.
However, more immediately, 3D-printed medical devices may be eligible for research and development tax credits. A number of jurisdictions offer research and development tax credits for the development of new products and technologies.
- United States: The United States R&D tax credit is a federal tax credit that can be used to offset up to 20% of the cost of research and development.
- Canada: The Canadian R&D tax credit is a federal tax credit that can be used to offset up to 35% of the cost of research and development.
- United Kingdom: The UK R&D tax credit is a tax credit that can be used to offset up to 33.33% of the cost of research and development.
- Germany: The German R&D tax credit is a tax credit that can be used to offset up to 25% of the cost of research and development.
- France: The French R&D tax credit is a tax credit that can be used to offset up to 30% of the cost of research and development.
Finally, while we will not discuss bioethics in this article, this is a very important topic that we have addressed previously (see below) and will continue to monitor policy trends in the space. And yes, we need to deliver Part III of this series soon. =)
Bioprinting Ethics and Regulation – Part I, The Good
3D Bioprinting Ethics and Regulation – Part II, The Bad
Reference:
What Is Medical 3D Printing—and How Is it Regulated?
Understanding the Medical Device Excise Tax (updated for 2020)
In a world of 3D printing, how will you be taxed?
Related Links:
The Ultimate Resource Center for Healthcare 3D Printing
Bioprinting Ethics and Regulation – Part I, The Good
3D Bioprinting Ethics and Regulation – Part II, The Bad
Interview with Sean Burke: Product Liability
The Legal Landscape in Healthcare 3D Printing (IP and Product Liability, On Demand, Video)
Product Liability: Biocompatible Materials in 3D Printed Products
Patent Protection for Medical 3D Printing & Bioprinting Technologies
Importance of Patent Search for Regenerative Medicine Inventions
3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies
Legal and regulatory landscape (On Demand, 3DHEALS2020, Session 19)
Comments