Leaders in Pharmaceutical Business Intelligence (LPBI) Group

A number of uncharted legal issues arise out of one of the hottest product trends: the use of 3D printing to manufacture medical devices. The Reed Smith LLP Life Sciences Health Industry Group recently published a white paper on this very issue – 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles. The white paper covers key legal issues including the regulatory landscape, intellectual property, tort liability, environmental effects, health risks in the workplace, and insurance risks and recovery. It also provides an overview of how 3D technology is currently being used for patient treatment, from cutting-edge prosthetics, to dental and facial implants, to organ models and tracheal splints.

3D printing may well be the next greatest chapter in the industrial revolution, with the technology often moving more rapidly than the law. As such, Reed Smith’s white paper is significant because it is the first attempt to comprehensively analyze 3D printing across a wide range of practice areas relevant to medical devices.

Watch: The Impact of 3D Printing on Healthcare

One of the legal challenges explored in the white paper is the FDA regulatory framework for 3D printed medical devices. The FDA currently views 3D printing as another form of advanced manufacturing, and thereby fits this technology in its already existing framework. In fact, the FDA has already cleared (through its “510(k)” process) approximately 85 medical devices manufactured through 3D printing technology. However, manufacturing truly innovative medical devices through 3D printing will require a Premarket Approval (PMA) application and, according to Steven K. Pollack, director of OSEL, the FDA is “still waiting for devices that we haven’t been able to make before, and that’s when we’re going to see the PMAs.”

As the white paper points out, not only is the FDA currently trying to assess how to handle the advent of 3D printed medical devices, but 3D printing companies are as well. For companies investing in 3D printed medical devices, protecting their device designs and other intellectual property is a key issue. While companies have a number of options available to them under existing intellectual property laws, such as copyright, patent, and trade secrets, other legal options worth considering include licensing provisions and anti-counterfeiting protocols.

Other legal issues abound as well. Whether medical devices are printed in a central location or on-site at hospitals, university medical centers, or doctors’ offices, environmental issues and employee health risks may merit attention given that plastic filaments, combustible powders, and high temperatures all may be part of the 3D printing process.

Moreover, any company making products ultimately must get paid for those products to succeed. The paper addresses reimbursement issues that 3D medical device manufacturers face so that they can properly plan for reimbursement. Whether public- or private-sector, all third-party payors will want to understand the benefits that a given 3D printed product provides over its traditionally-manufactured counterparts, and whether the 3D printed product provides a substantial clinical benefit.

In addition, the paper explores tort liability risks. Product liability law itself developed when manufacturing transitioned from local artisans and workshops to assembly line processes, and product liability law may need to adapt now that 3D printers have the potential to change the concept of what is the product, and who is a manufacturer or producer. Traditional legal theories will be disrupted particularly if production of medical devices shifts from a central facility manufacturing site to hospitals, university medical centers, and doctor’s offices. These new liability risks are important to consider not only for the companies or facilities that use 3D printing to make medical devices, but for the manufacturers of the printers as well. Considering these risks early on can help in attempting to avoid potential liability and will also help in evaluating insurance needs.

The white paper not only points out the unknown legal issues that may result from 3D printing, but also offers strategic insights and guidance to in-house counsel on risk mitigation and avoidance, contractual duties, and regulatory compliance.