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

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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.

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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.

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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

Protecting the Intellectual Property (IP) in your 3D Printable Digital Files: A Case Study in the Theft of CAD Files

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)

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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.

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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

Protecting the Intellectual Property (IP) in your 3D Printable Digital Files: A Case Study in the Theft of CAD Files

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)

The post Exploring Six Policy Areas Impacting Healthcare 3D Printing, Bioprinting- Guide appeared first on 3DHeals.

On Jan 21st, 2021, we invited four legal and technological experts from world-class institutions (Identify3D, NYU, MedCrypt, Duane Morris ) to present their perspectives on the future landscape of cybersecurity for 3D printed medical devices. Given the nascent nature of our field, many in the healthcare 3D printing ecosystem have not considered cybersecurity as the number one priority in their product design or adoption, and that is why 3DHEALS organized this event to lay the foundation of this likely important conversation. The cyberattack has made multiple headlines this year, and not in a good way. Major headlines related to medical device malfunction or cybersecurity breach in the healthcare system and 3D printing space will happen with certain, and it’s just a matter of when and how. I have compiled the important takeaways from the webinar, relevant resources, and data into this guide. Hopefully, this will at least inspire you to learn more and start critical conversations. Full event speaker biographies can be found here.

Readers can download the presentation slides at the end of this article, and can also download the white papers from MedCrypt and Identify3D via the links.

3DHEALS Live webinars are free to the public and recordings are available to registered attendees for 48 hours. On-demand webinar videos are free to 3DHEALS premium and enterprise members. Personalized 3DHEALS Certification of Completion is available through our Courses webinar module, which is also free to our premium and enterprise members.

Why Cybersecurity for (All) Medical Devices?

Vidya Murthy, VP of Operations for MedCrypt provided a general overview of why medical device manufacturers need to pay attention to their cybersecurity strategies. Perhaps lesser known to this audience, Vidya started with a story on how Mayo Clinic requested device makers to address cybersecurity vulnerability when Dalai Lama was getting treatment there. Mayo’s concern was if the nation-state will use the vulnerability to harm the well-known patient. This concern is not irrational, as a pacemaker has been hacked into on stage during Def Con as early as 2008.

The key takeaways from Vidya’s presentation are there are commercial and regulatory momentums for device makers to start to implement cybersecurity strategies more proactively before shipping their products. Hospitals, FDA, and increasingly individual end-users will request cybersecurity features before using the device, especially since cybercrime is getting increasingly intentional and complex.

Vidya also mentioned that the pandemic could be an accelerating factor for increased vulnerability to cyber attacks because cybersecurity regulation is often omitted due to the emergency nature of our healthcare responses, including recent exponential growth of telehealth.

How Can We Secure Medical Devices?

Stephan Thomas is currently the Co-founder and Chief Strategy Officer of Identify3d, and he outlined the major cybersecurity challenges to the digital supply chain faced by 3D printing manufacturers. Stephan pointed out that currently, the 3D printed medical device industry is very small (around 1.6-1.8 billion), but the future growth of this sector is poised to be exponential, up to 425 billion in 2025. He emphasizes that manufacturing is the third most targeted sector by cybercrimes, right behind attacks targeting governments and the financial industries. The many recent articles highlighting these attacks are listed below.

Out of these many potential risks, Stephan highlighted five major cybersecurity risks, which he has detailed in our past 3DHEALS Expert Corner blogs.

It is eyeopening to learn that block chain technology is NOT solution to all in cybersecurity during the panel discussion.

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Relevant recent headlines from Stephan’s presentation:

Triton is the world’s most murderous malware, and it’s spreading

Manufacturers of Medical Devices Warned About Hacking

A virus specialized for AutoCAD, a perfect cyber espionage tool

Manufacturing: A Rising Target for Cybercriminals

A Cyberattack Has Caused Confirmed Physical Damage for the Second Time Ever

How Can You Protect Off-line AM Devices?

Nikhil Gupta , a professor in the Department of Mechanical and Aerospace Engineering at the NYU-Tandon School of Engineering gave us a more technical review both on cyber vulnerability and strategy of additive manufactured devices. Dr. Gupta mentioned that cyberattack in AM often happens as an insider job throughout the AM process chain, which is a cyber-physical system. Of the many issues that could arise, professor Gupta focused on the issues related to Reverse Engineering and Counterfeit AM devices.

He also provided four examples of potential solutions, which include new audio based lossless encryption method, a 3D QR like code embedded in the authentic products, and CAD code that require authentication to be properly printed. Many steps used by hackers to reverse engineering a physical product can also provide potential solutions to future cyberattack.

How To Manage Liability Risk of Cybersecurity in Medical Devices?

Sean Burke, partner, and vice-chair of the products liability trial division at Duane Morris, focused more on the latest legal challenges related to the liability risks related to cyberattacks in medical devices. Sean has written a great Expert Corner blog focusing on general product liability for us recently.

Sean mentioned that there is an exponential increase in medical device related lawsuit in recent years, driven by a combination of media, FDA recalls, and economic incentives from the plaintiff lawyers.

The legal challenges against future cyberattacks in medical devices come from a lack of existing ruling, regulation, and also knowledge of the kind of potential attacks in the future. Uncertainty and unpredictability in this space will be major challenges for device manufacturers.

Sean suggests the following “now” solutions which were echoed by the other panelists as well:

1. Following census standards
2. Maintaining an open dialogue with FDA
3. Having insurance coverage
4. Consulting cybersecurity experts
5. Having well-written Indemnification agreements

Obviously, this is an extremely complex subject that will only grow in importance to the medical AM industry in the near future, but I hope this blog and webinar can serve as a starting point for you to consider your next cybersecurity step.

Relevant Links:

Cybersecurity for 3D Printed Medical Devices Webinar Recording On Demand (3DHEALS certification available)

Mitigating Litigation Risks with 3D Printing in Life Sciences (Expert Corner: Sean Burke)

Five Reasons Cybersecurity Will Play a Critical Role in 3D Printing in Healthcare – Part 3

Patent Protection for Medical 3D Printing & Bioprinting Technologies

3D Printing Poses Unique Security Risks for Medical Devices

Government Shutdown and 3DHEALS: There is a Connection, Believe or Not

Protecting the Intellectual Property (IP) in your 3D Printable Digital Files: A Case Study in the Theft of CAD Files

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With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality.  Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. 

The role of 3D printing in response to the COVID-19 pandemic provides a publicized example of both the unparalleled benefits and potential litigation risks with 3D printing. At the start of the pandemic, the United States scrambled to address the personal protective equipment (“PPE”) shortage.  While traditional manufacturers struggled to meet demand, 3D printing shoe manufacturers and even college students with a 3D printer in their garage were able to quickly obtain PPE CAD files and raw materials and immediately manufacture gowns and face shields.  It was a public glimpse into the unparalleled benefits of this innovation.  

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Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.  With a technology where barriers to market entry are somewhat minimal, the variables in manufacturing are multiple. Additionally, the parties involved in the chain are sometimes unknown to each other. Therefore, there is an increased potential for a catastrophic event to occur, with multiple parties possibly exposed to tort liability. 

While product liability laws are well established for the traditional design and distribution chains, the uniqueness of 3D printing will lead to many challenges and unknowns that do not fit into the current legal landscape.  This article will discuss some of those unknowns and identify challenges and potential areas of increased litigation risks with 3D printing for the various companies and individuals involved in the life sciences additive manufacturing chain: 

(1) the CAD file and/or product designer;

(2) material suppliers;

(3) software providers/manufacturers;

(4)  printer manufacturers;

(5) the individuals or entities printing the products.

A Brief Products Liability Overview

Although there are a number of nuances and exceptions under various states’ laws, a basic understanding of product liability will help guide entities as they develop labeling, quality control, and other procedures. 

In general, product liability exposure attaches when a product is deemed to be defective and that defect caused the alleged injuries.  A product may typically be found defective in one of three ways—design, manufacture, or labeling. 

Generally, a design defect is found when the manufacturer could have reduced a foreseeable risk of harm by adopting a reasonable and economically feasible alternative design.  Many states also consider design defect(s) by evaluating whether a product is “unreasonably dangerous” after weighing the utility of the product against its risks. 

A manufacturing defect claim requires proof that the product at issue somehow deviated from its intended design.  For example, a deviation could be that one specific product was not manufactured within the tolerances specified in the design drawings.

Finally, a defect in labeling, commonly referred to as a failure to warn, typically requires proof that a manufacturer failed to provide an adequate warning when it was known or reasonably ought to have been known that a product was unsafe for use by its expected and intended users.

Again, every state has different laws and wrinkles that may impact what steps an entity considers in trying to protect itself from liability.  Nevertheless, this general overview will help frame the discussion and analysis set forth below concerning litigation risks with 3D printing in the life sciences industry.

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Unknowns with Regulatory Compliance and Industry Standards

Before discussing issues specific to each entity in the 3D printing chain, one general issue is exposure created by a lack of established FDA regulations and industry standards.  Generally, compliance with FDA, ASTM, and/or ISO regulations and standards are important shields for companies to employ in defense of a lawsuit.  Even if your company or entity is not required to comply with FDA regulations, well-established guidance helps companies understand issues and expectations. With 3D printing, however, it does not have the same extensive history or regulatory framework safety net.  

On December 5, 2017, the FDA adopted the final form of its guidance document on 3D printing entitled “Technical Considerations for Additive Manufacturing.” The guidance does not cover the point of care printing nor bioprinting issues.  The guidance does not establish specific requirements but rather describes issues to be considered and addressed by manufacturers during product testing and manufacturing development stages. While the guidance does suggest having procedures and validation processes to address certain issues unique to 3D printing—such as the use of reused materials, software integration, and build path variables—it does not identify any specific “how to’s” for those procedures or tests.  Without such guidance or applicable standards, manufacturers are in the unenviable position of having the FDA identify a concern, but not offering any consensus standard for addressing it.  

ASTM International has developed some consensus standards for additive manufacturing. Committee F42 has developed standards for testing and evaluating methods for the materials used as well for the manufacturing processes. However, there are no specific standards addressing many of the issues and validation processes identified in the FDA’s guidance.

Unknowns Facing Each Entity Involved in the 3D Printing Chain

Traditionally, products liability exposure falls on the device manufacturer and may extend to other parties in the chain of distribution depending upon the applicable state’s laws. 3D printing, especially in the point of care context, challenges this general tenet, as questions arise regarding what is the product (i.e., the CAD file or the finished printed device) and who is the manufacturer (i.e. the company designing the CAD file, the printer company, or the hospital)? Responses to those questions could be a textbook chapter by themselves. At this stage of 3D printing, however, parties cannot assume how these questions will be answered or how the laws will develop.  Instead, all parties involved in the 3D printing process, from suppliers and vendors through to the party doing the final printing, should carefully consider these unknowns and ways to best protect themselves against uncertainty. 

Litigation Risks for CAD File/ product specifications designer

The primary challenge for the “designer” of point of care printed products is that the “product” being sold is not the finished device or drug, but rather a CAD file.  The pre-market testing and post-market quality control typically required by the FDA cannot be performed by these design companies with the same predictability as with traditionally manufactured products.  For example, a tenet of testing in the device industry is testing the “worst-case scenario”—meaning testing the product size with the highest torque or the most stresses.  But with the point of care printing, allowing for customization of devices and guides to fit a patient’s specific anatomy, the “worst-case scenario” is limitless.  

To address this issue, as well as other potential concerns, design companies should consider issuing warnings and instructions with the CAD file addressing unknowns and limits.  In the above example, the designing company may want to indicate what “worst-case scenario” they have tested, and which specifications would exceed any completed testing. Further, the company may also want to indicate other important factors or variables in the products they have tested. 

For example, if all testing and design work was done using a precise build path or print environment, such specifications should be communicated.  The same holds true for the materials used in tests, how much recycled print materials, if any, are advisable, and the significance, if any, of temperatures and areas to avoid for the physical placement of the printer (i.e. away from windows, air vents, etc.). 

By way of further example, design companies may also want to detail their recommended post-processing steps such as the removal of print residues or heat treatments designed to remove residual stresses.  In sum, the challenge for companies selling design files is to understand what conditions were critical to obtaining a finished product within specifications and to carefully communicate those conditions through labeling.  This is a unique challenge to the drug and device industries where manufacturers are not accustomed to selling anything other than a finished product.

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In addition to warnings and instructions, sellers of CAD files may also want to carefully consider the breadth of distribution.  While widespread sales may be attractive to a company, when the distribution of the CAD file becomes so broad that it is difficult to monitor or control who is using it, there is an increased chance that an issue may occur.  This not only increases concerns with the protection of intellectual property, but it also raises product liability concerns.  For example, it becomes more difficult to ensure updated warnings or changes in labeling are properly communicated to the consumer base when that base is largely unknown. 

Litigation Risks for 3D Printing Materials suppliers

Raw material suppliers also face challenges of their products—powders, fibers, or other print materials—being used for applications or in ways outside of what may have been tested or intended.  For example, one issue identified by the 2017 FDA guidance concerns re-used print materials, such as powders. The FDA guidance document recommends that printing companies have controls in place for the percentage of recycled powders permitted in any print. Although the FDA guidance is directed to the design and manufacture companies, the provider of these materials may want to consider issuing warnings or disclaimers accompanying their product if it has knowledge or is aware of uncertainties with using the product over multiple prints (i.e. concerns with properties of the material changing if heated, exposed to air, etc.).  Other warnings and instructions, including recommendations for the temperature to maintain the materials, may also be considered.  

Further, when negotiating supply contracts with manufacturers or the user doing the printing, material providers will want to consider indemnity and defense provisions, offering protection from the buyer if the supplier is named in any lawsuits resulting from the use of the materials.

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Litigation Risks for Printer manufacturer and software programmer/manufacturer

Software providers and the makers of traditional manufacturing equipment are not often the target of product liability lawsuits. However, given that the printer and the software are two variables in the manufacturing process of 3D printed devices, it may still be advisable to carefully consider warnings, instructions, and contractual protections when entering the 3D print market.  

The FDA, in its 2017 FDA guidance document, spends several pages detailing considerations to ensure proper software and printer integration. This attention from the FDA suggests recognition on its part that glitches in these systems can lead to potential manufacturing deviations. Software providers and printer manufacturers may consider warnings to include regarding the integration process, advising against any alterations to printers, and suggestions about maintenance and updates.  

Similar to material providers, software providers and printer manufacturers may also want to negotiate indemnity and defense provisions when contracting with any medical device manufacturer or point of care printer. 

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Litigation Risks for Party printing the device

While all entities face new challenges and unknowns with compliance and liability protections regarding 3D printing, the end manufacturers may often be the group tackling these challenges for the first time.  In the point of care printing scenario, the hospital may be the entity printing the finished device. Typically, a hospital is not concerned nor experienced with product liability issues.  However, with 3D printing, they may become the most obvious target if legal action is pursued.  Currently, there are many unknowns with how hospitals or other entities printing the actual product may be treated by regulators or under the law.  The 2017 FDA guidance document expressly excludes its application to point of care printing.  Further, case law in this area is not developed, thus questions of whether the entity printing the device would be considered a manufacturer or even what is considered the “product” is unclear. 

With all of these uncertainties, entities considering printing medical devices must carefully evaluate the potential exposure and risks before proceeding.  If the entity proceeds with the point of care printing, there are a number of procedures and safeguards that must be considered.  For example, point of care manufacturers should consider adopting procedures and quality controls to ensure compliance with CAD files, printer, software, and material warnings and instructions. They will also need to consider a “post-manufacture” inspection process and controls designed to verify a product was printed as intended and in compliance with instructions.  

Conclusion

3D printing is an exciting innovation with endless potential. It is tempting to want to get ahead of the competition and jump into the market without carefully considering the risks.  There are many unknowns in how potential liability exposure could play out in the future with 3D printing.  However, by considering basic product liability concepts and employing time-tested protections, companies may be able to reduce future exposure against litigation risks with 3D printing. 

About the Author:

Sean Burke is the partner and vice-chair of the products liability trial division at Duane Morris. He is in the firm’s Washington, DC office.  Mr. Burke’s practice focuses on the representation of manufacturers of medical devices in product liability cases across the country, including in consolidated multi-plaintiff matters in both federal court and state courts. His experience includes the defense of large total joint replacements (hips, knees, ankles, and shoulders) and resurfacings, tissue matrices and patches, fusion plates, and surgical instruments. 

He has a particular interest and focuses on additive manufacturing, consulting, and advising clients on best practices in the early stages of development to reduce the risk of product liability exposure.  He has tried medical device cases before juries in both state and federal courts while also handling numerous mediations.  He works closely with scientific experts to advance causation and liability defenses in the areas of biomechanical engineering, toxicology, histology, epidemiology, orthopedic surgery and FDA regulations. Click here to read more about Duane Morris’ medical device litigation practice.

Sean K. Burke
Partner and Vice Chair of Products Liability and Toxic Tort Trial Division
Duane Morris LLP
sburke@duanemorris.com
202-776-5236

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The post Mitigating Litigation Risks with 3D Printing in Life Sciences appeared first on 3DHeals.

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On the evening of January 22nd, 2018, 3DHEALS hosted the first pilot executive working conference at the Washington DC office of ReedSmith, a law firm with special interests in liability issues related to 3D printed medical device. The goal of this conference aims to bring executives from different healthcare organizations, additive manufacturing industry, bioprinting and pharma companies, academia, and the government policy experts together to tackle some of the tougher problems facing the healthcare 3D printing and bioprinting industry. In theory, the small group format will allow decision makers in each organization to have a multi-disciplinary conversation, outside of the silo they often found themselves in.
There was no sales pitch in this conference. The goal was one and only: Finding out what are the top challenges facing the industry, and have a conversation to initiate solutions. We named this 3-hour event, “3DHEALS: Taming the Wild West of 3D Printing”, and focused on policy related issues for the attendees. While due to inopportune government shut-down no government entity was present (i.e. FDA, DOD, NIH, etc), the conversations were filled with enthusiasms and inspiration. Below is our meeting minute and we think sharing the notes will be beneficial to everyone in the ecosystem. 
Attendees: Mike Tilkin (American College of Radiology), Ankit Saharan (EOS), Robert Weseley (St. Louis Children’s Hospital), Jay Morris (Mayo Clinic), Lee Dockstader (HP), Celeste Letourneau (Reed Smith), John Jameson (Winningconnections), Ben Holmes (Nanochon), Kara Noack (BASF), Rik Jakobs (3DSystems, NextDent), John Hartner (VC/Digital Industrialist LLC), Matt Jacobson (Reed Smith), Jenny Chen (3DHeals), Daniel Ortiz (3DHeals)

Clinical Trials Group: 9:00 – 9:15 pm

(Participants: Jenny Chen, Celeste Letourneau, Rik Jacobs, Ben Holmes)

Topic 1: Challenges for clinical trials on evidence or efficacy of 3D printing in healthcare.

Group Summary:
Costs:

• • There are several ways to get additional funding for clinical trials. Government funding and funding from non-profit organizations are available. If the clinical trial involves routine care, then the trial is often qualified to participate in cost-sharing coverage (by insurance companies).

• • Starting legal advice early (at phase 1 of trial) can de-risk cost of a trial down the line.

• Designing a business model to decrease the risk of trial is important.

Design: Design trial also serves to contain cost. To increase the chance of cost containment, strategies include pairing with larger entities (such as NIH), being beyond phase 1 trial, optimizing the timing of the clinical trial. For example, the trial for a rare disease will take longer (i.e. more costly). A well-known, outspoken research sponsor with a rich network will potentially decrease the timing of the trial.
Communication is the key. Picking a good spokesperson (who doesn’t have to be a PR firm) is important. This person should be a good listener and also able to communicate in multiple different industrial languages that are easy to digest. This is especially important when the audience is the government/legislator.
Benefits of conducting clinical trials: Clinical trial can serve side-goal of establishing a pathway to the reimbursement and educate the communities you will get paid from.
Roundtable Discussion:
– A lot of the scientific work takes 5-10 years before attempts at reimbursement discussion.
– Sometimes trials are attempting to provide solutions to problems that don’t exist or doesn’t actually answer the problem.
– A local insurance company in Minnesota will pay for some 3D prints even though CMS will not (becaused of assumed value added).
– Nontraditional funding exists and can be a good source of funding. 

Manufacturing Potential of Hospitals: 9:15 pm – 9:32 pm

(Participants: John Hartner, Matt Jacobson, Jay Morris, Lee Dockstader)

Topic 2: What is the potential for the hospital to become a 3D printing manufacturer?

Group summary:
It is important to define what is a medical device. In common sense, they can include surgical models, surgical guides, implants, and surgical tools. Depending on who you ask, the definition of “medical device” is different in FDA’s lingo versus that of the law (liability law). Even if a diagnostic model causes harm, it’s still held liable.
Roundtable Discussion:
What should be within the scope of the hospital? What should be okay for hospitals to produce?
Several suggestions:
– Non-diagnostic surgical models are okay for hospitals to produce.
– Common opinion: Class II/III medical devices should not be at manufactured the hospital level.
– Are surgical instruments okay? Depending on the resources of the institution, the manufacturer should be accredited.
– Living tissue like live cartilage in wide geographic distribution is not yet a reality. Some larger institutions will have a GMP. In hospital tissue engineering still seems a future possibility.
Eventually, a system or device production in the hospital would have to be accredited by a regulatory body like the ACR. Although the cost of the device goes down with in-house production, the liability and related insurance will go up.

3D printing process vs end device regulation: 9:32 – 9:43 pm

(Participants: Mike Tilkin, John Jameson, Robert Wesley, Kara Noack, Ankit Saharan)

Topic 3: Should regulation be at the 3D printing process or end device level?

Group Summary:
Although 3D printing process regulation/qualification is eventually needed, we are not there yet. It is still more practical to just regulate end device. The process to be regulated will include regulation on materials, sterilization process, manufacturing environment, documentation, and personnel certification.
FDA reviewer knowledge and efficiency vary from one to another. They can be a novice to that specific device/industry. The industry needs to spend more time and efforts to educate the public, including the FDA.
FDA document  (recent technical guidance) is a step forward but still at the leadership level. It will take awhile for it to trickle down to the reviewer level.
Roundtable discussion:
FDA typical approval/clearance pathways: PMA, de novo process, etc. Default goes to PMA, which is the most stringent pathway. Companies should consider going to de novo process. “Me too” process has funding implications and is widely variable.
General discussion
In the Netherlands, after being encouraged by 3D printing entrepreneur, the local dental school now has 3D printing in the dental school curriculum.
It is very important to ensure education and have diverse collaboratives.
ReedSmith White Paper on 3D Printed Medical Device and Liability Law:
o   3D Printing of Manufactured Goods: An Updated Analysis
o   3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

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The post Government Shutdown and 3DHEALS: There is a Connection, Believe or Not appeared first on 3DHeals.

Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

The US Food and Drug Administration (FDA) published its guidance document on the use of additively manufactured medical devices on December 5th, 2017. This is the finalized version of the draft document issued in May of 2016.

The recommendations and considerations outlined in the document are largely the same from the draft document. An interesting comparison of the two documents can be found here. (The draft document is on the left, the finalized document is on the right.)

Major changes/additions include:

• A statement that all the guidelines and recommendations within the document may not be appropriate for all the various additive manufacturing methods. It is the responsibility of the medical device manufacturer to determine and justify which considerations are appropriate for them.

• More information on patient-matched design considerations. This includes considerations when imaging soft tissue to be used in patient-matched designs.

• Addition of “Complex design files” section. This highlights the need to validate any file conversions of the patient data from the patient images to the digital representation used to create patient-matched designs.

• Addition of “Cybersecurity and Personally Identifiable Information” section. The need to protect patient data gathered to create patient-matched devices was highlighted and other guidance documents are referenced.

• Addition of “Validating and Automating Software Process” section. The document points readers to the general FDA guidance on this subject.
• More guidance on validating the quality process for medical device manufacturing and that test coupons may not be necessary if the process is well defined.

Information on non-traditional manufacturing centers (e.g. hospitals) is not addressed in this document. However, the importance of this finalized version is that medical device developers have a much clearer picture of what the FDA expects in an application for a new medical device.

The post Finalized, FDA guidance document “Technical Considerations for Additively Manufactured Medical Devices” appeared first on 3DHeals.

“The ‘law of 3D printing,’ if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.”

Martin Galese is General Counsel for Formlabs, a desktop 3D printing company. Formlabs produces high-resolution desktop 3D printers for engineers and designers. Before joining Formlabs, Mr. Galese worked as an IP litigator at the law firm of Kirkland & Ellis LLP in New York City and pursued his passion for 3D printing after hours. Mr. Galese’s earlier Patent-Able project, turning expired patents into 3D printable models, has been covered by both the NY Times and Popular Science. Mr. Galese has previously spoken about legal and policy issues involving 3D printing at the Annual Corporate IP Counsel Forum, 3D Printshow New York, 3D/DC and before the Intellectual Property Owners Association, the Boston Bar Association, the Harvard Journal of Law and Technology, and the Cardozo Arts & Entertainment Law Journal.

Q: What is your vision on the intersection of 3D Printing and healthcare?

A: Of all the industries benefiting from the 3D printing revolution, healthcare has the potential to be among the most radically transformed. As the pharmaceutical industry moves steadily towards personalized drug interventions, so too will medical devices become increasingly customized for patients and treatment needs. 3D printing is the enabling technology for that transformation.

Formlabs Class I Biocompatible : Dental SG Resin

Q: What do you specialize in? What is your passion?

A: I see my role as General Counsel for Formlabs as providing the integrated approach and broad view of generalist to a field of increasingly focused and silo-ed field-specific legal experts. The “law of 3D printing,” if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.

Q: What inspired you to do what you do?

A: As a sci-fi fan, I have dreamed about what a post-scarcity world might look like. And as an IP litigator, I have had the opportunity to see the ways in which legal rules shape R&D today and might shape our technological future. I see 3D printing bringing these threads together, providing innovators, scientists, and doctors with tools today to help bring future technologies to everyone more quickly. The chance to work in this industry, help it grow, and provide such powerful tools to our customers is very fulfilling and inspiring for me.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: One of the more significant challenges lies in training healthcare workers, who may be largely unfamiliar with any manufacturing technology, in the appropriate use of 3D printing technology. Without excellent resources and support, medical users of 3D printers may lack the tools and skills to provide the full benefits to their patients.

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“People aiming to work in the 3D printing industry should strive to think outside the box given all of the legal and regulatory unknowns with 3D printing. This mindset is critical to exploring ways to shape the law and regulations to promote innovation in healthcare in an ethical manner.”

As a senior associate in Reed Smith’s Complex Litigation Group, Farah Tabibkhoei’spractice focuses on product liability, managed care, creditors’ rights, and 3D printing. As a 3D printing enthusiast and member of Reed Smith’s cross-disciplinary 3D Printing Team, she closely monitors the complex legal and regulatory issues arising from additive manufacturing, affecting clients across a wide range of industries from healthcare to manufacturing to automotive, to identify risk, develop risk management strategies, and effectively problem solve. Ms. Tabibkhoei has been an invaluable contributor to the 3DHEALS legal blog. You can see some of her writings here. She will also be a speaker at 3DHEALS2017

.Q: What is your vision on the intersection of 3D Printing and healthcare?

A: 3D printing will vastly improve patient care by allowing surgeons to use 3D-printed surgical models for pre-surgical planning, thus reducing time in the operating room. 3D printing will also enhance patient education because it will help physicians explain medical conditions and treatment options to their patients by using 3D models, which will facilitate informed treatment decisions.

Q: What do you specialize in? What is your passion?

A: I am a senior associate in Reed Smith’s Complex Litigation Group and a member of the firm’s 3D Printing Task Force with a focus on medical device product liability, 3D printing, and managed care. My passion is high-stakes litigation and exploring the ways new technologies such as 3D printing shapes the law.

Q: What inspired you to do what you do?

A: I became inspired to expand my practice to 3D printing after watching Dr. Anthony Atala’s TED talk on printing a human kidney. It became clear to me that 3D printing would not only transform medicine by creating customized, on-demand medical supplies and medications, but would also force traditional legal principles to change to keep up with the technology.

Q: What is the biggest potential impact you see 3D printing having on the healthcare industry?

A: The biggest potential impact 3D printing will have on the healthcare industry is improved access to healthcare in rural and poverty-stricken areas of the world where medical resources are scarce. 3D printing will allow greater and quicker access to more affordable and customized medical supplies and procedures for those in need.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: Challenges in the 3D printing healthcare sector will include widespread adoption of 3D printing among physicians, costs associated with training personnel on how to use 3D printing, and getting health plans to provide reimbursement for 3D printing procedures and/or devices because the risks are relatively new and unknown.

Q: What is the best business lesson you have learned?

A: Do what you love and the money will follow.

Q: What is the biggest business risk you have taken?

A: The biggest business risk I have taken is going to law school.

Q: What crucial skill should people aiming to work in this industry acquire?

A: People aiming to work in the 3D printing industry should strive to think outside the box given all of the legal and regulatory unknowns with 3D printing. This mindset is critical to exploring ways to shape the law and regulations to promote innovation in healthcare in an ethical manner.

Q: How will accessibility of the technology affect the cost of procedures?

A: The costs of procedures will depend, in large part, on whether health plans will reimburse doctors and hospitals for these procedures. There needs to be more funding for 3D printing research and development in the medical field to prove its safety and efficacy compared with traditional medical procedures. Additionally, widespread adoption of the technology among clinicians will help lead to greater reimbursement of these procedures and lower costs.

Q: Where do you get the training required to make informed decisions?

A: I read and learn about the latest developments in 3D printing through industry and legal experts including a talented and cross-disciplinary team of attorneys (insurance, environmental, IP, to name a few) within my firm who are similarly vested in the future of 3D printing.

Q: How will 3D printing impact product liability?

A: 3D printing raises new and unanswered legal questions with respect to product liability including what is a product, who is a manufacturer, and where does liability fall when a 3D printed product is found to be defective? Does the strict liability doctrine apply to 3D printing or are we left with negligence?

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As companies continue to innovate, they are turning to 3D printing technology to build customized, patient-matched 3D printed dental and medical devices that incorporate biocompatible materials. Advances in 3D printing technology have made it possible to print human tissue using a combination of stem cells and biocompatible materials. Researchers are working on using 3D printing technology to print organs suitable for transplantation, with the goal of alleviating the shortage of donor organs and saving lives. Earlier this year, Vertex Dental, based in the Netherlands, developed the first CE Class IIa-certified materials, which are biocompatible, and approved for 3D printing dental applications such as dental splints, crowns, and bridges.
Biocompatible materials are not without risks. On June 16, 2016, the FDA issued a FDA Guidance entitled “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’” to assist manufacturers of devices that come into contact with the human body in evaluating the potential for an adverse biological response resulting from contact of component materials of the device with the body.
For suppliers of these component materials that are shipped to manufacturers to be integrated into end products used by patients, this raises the question of whether a component part supplier may be liable for injuries caused by defects in the end products. In other words, if a 3D printed device that comes into contact with a patient’s body causes an adverse reaction, can the supplier of the biocompatible material be held liable for defects in the finished product that incorporates the material?
In a decision published in May 2016, Webb v. Electric Co., 63 Cal. 4th 167 (2016), the California Supreme Court explained that suppliers of component parts are not liable for injuries caused by a finished product unless (1) the component itself was defective and caused injury or (2) the supplier participated in integrating the component into a product and the integration caused the product to become defect and cause injury. The reasoning is that while component suppliers must adequately warn buyers (e.g., manufacturers integrating the components into end products) of risks associated with the component, it is not reasonable to expect them to monitor all of the potential products that may incorporate their component part and all the potential risks associated with these finished products.

Furthermore, under the bulk supplier doctrine, where a raw material that is a component of a finished product, is supplied in bulk and intended for further processing (e.g., heating, cooling, etc.), the raw materials supplier is not liable for harm caused by the defective design of a finished product. The rationale is that it would be overly burdensome to require raw materials suppliers to become experts on all of the end products in which the raw materials may be used and investigate the use of these materials by manufacturers over whom these suppliers do not exert control.
To mitigates risks of liability, materials suppliers should provide adequate warnings of the inherent risks associated with these component materials to the immediate purchaser of these products and take reasonable measures to ensure that appropriate warnings will be conveyed to those encountering these materials. Suppliers should also disclaim warranties about the suitability of the materials for use in end products. Additionally, suppliers should notify manufacturers that they are responsible for determining the suitability of the component materials for the devices they are manufacturing.

About the Author :

Farah Tabibkhoei is a member of the Complex Litigation Group at Reed Smith LLP.  Her practice focuses on medical device product liability, managed care disputes, and 3D printing.  Farah can be reached at FTabibkhoei@ReedSmith.com.

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Although cyber threats are nothing new to the healthcare industry, the rise of 3D printing in the medical industry presents unique cybersecurity challenges for medical device manufacturers and hospitals.  In July 2016, researchers at the New York University (NYU) Tandon School of Engineering found that 3D printing poses cybersecurity risks in the manufacturing process that could affect the reliability of the end product.  The study found that a hacker could potentially alter the printer head orientation without detection, affecting the strength of the device by as much as 25 percent.  Alternatively, a hacker could manipulate a 3D printer while it is connected to the internet to introduce internal defects as the device is being printed.

Although 3D printing offers many manufacturing benefits by making it possible to print customized devices on demand offering better fit and greater comfort for patients, the digital transmission of design files makes it more challenging to ensure sensitive confidential patient information is protected.  Confidential patient information contained within patient imaging  (e.g., computed tomography (CT) or magnetic resonance (MR) imaging) is vulnerable to being compromised or stolen in the digital transmission process.  Mishandling HIPAA-protected information carries heavy penalties and has resulted in more than $9 million in fines in 2016, according to the U.S. Department of Health & Human Services.

The FDA has acknowledged the need for effective cybersecurity measures to ensure the safety and efficacy of medical devices and protect patient health.   In October 2014, the FDA issued a guidance entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidance, although not specific to 3D printed devices, sets forth recommendations for manufacturers to develop cybersecurity controls during the design and development stages of a medical device as well as in preparing FDA premarket submissions for software and devices using software.  The FDA urges manufacturers to establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis required by 21 C.F.R. part 820.30(g) governing design validation.  The FDA also recommends that device manufacturers adopt security measures to protect medical devices including, but not limited to, limiting access to devices to trusted users only and ensuring trusted content.

While the FDA recommends the use of design controls to assure medical devices will maintain their integrity from the point of origin to the point at which the device leaves the control of the manufacturer, 3D printing raises the question, “When is a device considered to have a left a manufacturer’s control?”  Unlike traditionally-manufactured medical devices that get physically shipped, 3D printed medical devices are sent electronically in the form of a CAD file from the manufacturer often to a service bureau to print off-site.  Has the device left the manufacturer’s control after the CAD file was sent?  After the medical device is 3D printed?   The law is unsettled on these issues.

The FDA has also addressed the postmarket management of cybersecurity issues in medical devices.  In January 2016, the FDA released a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices, which sets forth the FDA’s post-market recommendations.  The FDA encourages manufacturers to monitor, identify, and address cybersecurity vulnerabilities as part of their postmarket management of medical devices and sets forth elements of an effective postmarket cybersecurity program.  The program includes defining the risk acceptance criteria of a device; identifying cybersecurity signals and creating a process for intake and handling of vulnerability information; conducting cybersecurity risk analyses; and implementing device-based features to mitigate the risks on a device’s functionality.

In May 2016, the FDA issued a draft guidance regarding 3D printed devices for the first time.  The guidance entitled Technical Considerations for Additive Manufactured Devices addressed technical considerations associated with the design, manufacturing, and device testing of 3D printed devices.  Although not addressing cybersecurity, the FDA acknowledged patient safety risks associated with the file format conversion process.  Because additive manufacturing requires files to be compatible across the various software applications that are used, the file formats must be converted to ensure compatibility and this process creates a risk of errors that can negatively affect the shape and dimensions of the finished device.  The FDA explained that “patient-matched devices that follow the patient anatomy precisely are especially vulnerable” to errors in the file conversion process because “anatomic curves are typically geometrically or mathematically complex and can create difficulties when calculating conversions.”  The FDA recommends that manufacturers “test all file conversion steps with simulated worse-case scenarios to ensure expected performance, especially for patient-matched devices” and maintain and archive final device files in standardized formats that are able to house additive manufacturing information.

It remains to be seen whether the FDA will issue a guidance regarding cybersecurity considerations specific to 3D printed devices.  However, device manufacturers and hospitals should regularly conduct cybersecurity risk assessments in conjunction with their Information Technology, risk management, and legal departments under the protection of applicable legal privileges to minimize exposure to regulatory or legal action.

Farah Tabibkhoei is a member of the Complex Litigation Group at Reed Smith LLP.  Her practice focuses on medical device product liability, managed care disputes, and 3D printing.  Farah can be reached at FTabibkhoei@ReedSmith.com.

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The post 3D Printing Poses Unique Security Risks for Medical Devices appeared first on 3DHeals.

As the organizers of 3DHEALS events, it may surprise people that we could never accurately predict the outcome of 3DHEALS conferences. That includes what the speakers will discuss, what kind of audience we will attract, and what kind of new connections will be made.
Since its inception, 3DHEALS events have pleasantly surprised us in many ways every time.  The community we have attracted is small, intimate, but also powerful and capable. That is probably the most constant thing we can predict.
For our August 3DHEALS legal conference, we had the pleasure of listening to the most original presentations on legal issues related to healthcare 3D printing, from IP/Patent concerns (Erik Birkeneder from NixonPeabody), to medical device liability (Colleen Davies from ReedSmith), to new digital security software development for healthcare 3D printing (Stephan Thomas from Identify3D).   The Q&A session moderated by past FDA fellow Dr. Mirza was as stimulating as the presentations, as the audience was composed of the usual mixed of intellects with backgrounds ranging from healthcare consultants, legal, journalist, engineering, environment risk scientist, healthcare providers, and beyond.
Our readers can watch the recordings of the conference on YouTube soon.
 
 

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August – Edgeinterns , Francis Kong and Megan McLeod

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

The post 3DHEALS EVENT RECAP: Legal Landscape of Healthcare 3D Printing – Knowing the Unknown appeared first on 3DHeals.