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3D Printing and Medical Devices: Opportunities and Challenges | By Jess Harris, CSP, ARM, Vice President, Risk Control Life Science & Technology, Sompo International, North America and Lauren Bauschard, Vice President, Head of Claims Account Management, Sompo International, North America

Summation

  • The rapid progress of 3D printing technology outpaces industry standards and regulations, and while the FDA has issued guidance and standards, they do not specifically address the application of 3D printing at healthcare facilities.
  • As technology continues to advance at a remarkable pace, the life science industry must closely consider the resulting risks, and regulatory frameworks must adapt to ensure that the benefits outweigh the liabilities.
  • Thirty-five years after the development of the world's first 3D printer, the 3D printing industry has made significant technological strides, particularly in the field of life sciences.

Thirty-five years after the development of the world’s first 3D printer, the 3D printing industry has made significant technological strides, particularly in the field of life sciences. The benefits that 3D printing presents today are numerous, but with these opportunities come associated challenges. As technology continues to advance at a remarkable pace, the life science industry must closely consider the resulting risks, and regulatory frameworks must adapt to ensure that the benefits outweigh the liabilities.

First, a little history: what is 3D printing and how has its use evolved?

3D printing, or additive manufacturing, can transform digital designs into tangible objects with the touch of a button by layering materials to construct three-dimensional objects. In contrast to traditional manufacturing methods that involve cutting away materials, 3D printing allows for the creation of complex shapes and structures that were once unimaginable.

The origins of 3D printing trace back to 1945 when science-fiction author Murray Leinster envisioned a machine that could bring drawings to life by melting plastic and forming them into 3D objects. Just four decades later, in 1988, Charles Hull pioneered the development of the world’s first commercially viable 3D printer. Since then, each successive decade has brought significant changes in 3D printing, spurring innovation in industries ranging from transportation to food and fashion. Today, a wide range of businesses leverage the technology to customize products, create prototypes, utilize fewer resources, manage supply chain, and save time and costs.

The life sciences industry is no exception. In the 1990s, the medical world witnessed the introduction of 3D-printed anatomical models for reconstructive surgeries. Soon after, orthopedic implants, hearing aids, and dental prosthetics emerged. In the ensuing years, surgeons successfully printed bone parts, and the US Food and Drug Administration approved the first 3D-printed pharmaceutical drug for the treatment of epilepsy. In 2018, 3D printing even made it possible to create a life-saving kidney for a three-year-old boy. Today, from hearing aids and dental crowns to bone plates, hip cups, spinal cages, and facial implants, 3D printing is reshaping the landscape of medical innovation.

With all of these advances, there are also some inevitable issues to watch.

3D printing technology is rapid, flexible, accurate, and cost effective – and its relative ease of access makes the technology attractive. But alongside the transformative capabilities of 3D printing come challenges in regulation and oversight, and both must evolve as 3D printing advances.

There are also some potential product liability concerns. The rapid progress of 3D printing technology outpaces industry standards and regulations, and while the FDA has issued guidance and standards, they do not specifically address the application of 3D printing at healthcare facilities. The absence of FDA oversight and regulation in this area could lead to unintended consequences.

All three primary theories of product liability law—Design Defect, Manufacturing Defect, and Failure to Warn—raise concerns with regard to 3D printing. Design defect issues revolve around the appropriate testing of customized and unique 3D printed components. If hardware causes harm due to a software defect, the manufacturer of the hardware becomes liable. Similarly, if a 3D printer malfunctions due to embedded software, the manufacturer of the printer could be held strictly liable, even if the printer’s functionality primarily relies on software.

Manufacturing defect concerns center around the entity considered the “manufacturer.” In the case of 3D printing, hospitals utilize another company’s software to create components. They also employ printers that may be owned and maintained by a third party, raising the question of who assumes the role of the manufacturer for 3D printed products.

The last set of liability concerns stem from failure to warn. Before a device is introduced to the market, the FDA thoroughly evaluates the instructions for use (IFU). However, ensuring strict adherence to these instructions and effectively distributing them can pose challenges. Liability may arise if the IFUs are not followed according to instruction or the IFU is not properly distributed in point-of-care manufacturing settings.

3D printing litigation should be closely watched.

Although major litigation related to 3D printing has not yet surfaced, it is inevitable that precedence-setting lawsuits will emerge. Here are a few key cases to watch.

Fire/explosion Litigation (Indiana Farm Bureau Ins. v. Shenzhen Anet Tech. Co.) – Wal-Mart was found not liable when a printer sold through Walmart.com caught fire and caused significant property damage. The insurer subrogated against Wal-Mart and its marketplace seller. At issue was whether Wal-Mart was the seller or manufacturer when the printer was sold through marketplace. 

3D Printer Fatality (Hoi Kwong Yu Et Al v. Alibaba Group U.S.) – Alibaba, an e-commerce digital marketplace, is being sued in the US by parent of a man who bought a printer sold through Alibaba.com. The printer caught fire and caused property damage and bodily injury resulting in the death of the son. The final verdict has not been determined.

Workers’ Compensation Claim (Ferguson v. Concept Laser) – The claimant in this case alleged that an employee was cleaning a 3D printer when it exploded causing bodily injury. This suit involves litigation against six defendants, including manufacturers and distributors.

Toxic Tort Litigation (Coene v. 3M Co.) – The plaintiff in this case worked for Eastman Kodak Company creating prototype camera parts through 3D printing. After contracting lung disease, which the plaintiff contends was caused by the materials used in the 3D printing process, the plaintiff sued the manufacturer of the respirators he used during the process.

Looking ahead: identifying critical risk factors can help eliminate the potential for loss.

3D printing’s potential is undeniable, but at the same time, it poses inevitable challenges for regulation and oversight. Regulators must evolve as 3D printing advances, and life science organizations that use the technology must keep a close eye on changing regulations and legal precedents to determine how their businesses may be impacted. By staying informed, companies can proactively navigate the evolving legal landscape and mitigate the risks effectively – all while making the most of this innovative technology and its limitless potential.

About the Authors:  Jess Harris has been Vice President, Senior Casualty Specialist with Sompo International’s Risk Control team since 2020.  She has over 30 years of experience in the industry and is responsible for evaluating and providing consultative service to customers in the Life Sciences Industry Practice, including medical device manufacturers.

Lauren Bauschard, Vice President, Head of Claims Account Management, is responsible for leading Sompo’s team of Claims Account Managers to deliver an outstanding, tailored customer experience for its clients, brokers, and agents. With over 20 years of industry experience that includes all aspects of Client Service, TPA Management, and Risk Management, Lauren joined Sompo International in 2013, providing TPA oversite for the company’s Workers’ Compensation program before joining the Claims Account Management team.

 

 

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