An article by Mike Carrol, SVP, Deputy Head of Life Sciences and and Todd Lauer, SVP, Sompo GRS Life Sciences Industry Vertical Leader
Once the purview of futuristic fiction, medical 3D printing has become a mainstream practice in recent years, and the entire life sciences industry is feeling the benefits. In all, the FDA has reviewed more than 100 products developed via 3D printing, and most have been medical devices. As more 3D printed products are approved for use in the life sciences field, it is incumbent upon the industry to understand the technology and how it is likely to impact medical businesses. As an insurer of life sciences companies, we recognize that this is an important topic for our clients, who must both determine the best ways to embrace the opportunities of medical 3D printing and manage the associated risks.
The process of 3D printing, also known as additive manufacturing, involves building items through successive layers of raw materials, using a digital file rendered from an MRI or CAD drawing as a guide., However, while the traditional methods are subtractive (in which a solid block of material is machined down to specifications), 3D printing is additive, using the layering of materials to arrive at the desired shape.
As the overall process and end products have rapidly improved and increased, so has the demand for the capabilities. According to the Pew Charitable Trust, in 2010, there were only three U.S. hospitals with centralized 3D printing capabilities; by 2019, that number had grown to more than 100.
3D printing is particularly exciting because of the potential it presents for medical conditions where a personalized approach is necessary. Because a 3D object’s design can be modified easily and products can be printed on demand, the technology lends itself to the making of items to specifically match a person’s anatomy. There are countless use cases for personalized objects. For example, radiologists could create exact replicas of a person’s spine to prepare for surgery, enabling them to visualize and even practice the procedure ahead of time. 3D printing can also be used to create customized prosthetic limbs, cranial implants, orthopedic implants, or other personalized elements that must be an exact fit for the patient.
It’s amazing to contemplate the potential that 3D printed organs could have on saving lives. According to the American Transplant Foundation, in the U.S. today, there are more than 113,000 men, women, and children on the transplant waiting list, with a new person added to that list every 10 minutes. An average of 20 people die each day while waiting for a transplant. These losses could largely be prevented with the advent of 3D printed organs. And not only does the technology have the potential to save lives, it could lead to reduced costs, as 3D printing is less costly than donor organ transplants.
Protheses and organ printing may be some of the first use cases that come to mind for 3D printing, but these aren’t the only opportunities this technology presents. Models and devices can be printed to aid in medical education and training and surgical planning, as well as in medical research, where scientists have had great success with creating synthetic tumors or 3D cell cultures to investigate disease growth. In addition, drug delivery can be facilitated with 3D printed devices, which can be used to fabricate topical drug delivery systems and produce drug tablets in shapes that allow better control over drug release profiles than traditional tablets.
Challenges and Emerging Risks
The 3D Printing Medical Devices Market Analysis & Forecast, 2020-2027 from Verified Market Research reports that the global 3D printing Medical Device market is growing at a compound annual growth rate of 17.1% and is projected to reach $3.9 billion by 2027. As with all new technologies, there is great potential in this rapidly growing field, but there are also challenges to overcome. One of the greatest challenges unique to the life sciences field is that of FDA oversight. Implants are high hazard medical devices, and as such, there are implications for patient safety related to their use. The combination of decentralized manufacturing and personalized products, coupled with the fact that production may be managed by individuals who may not have prior experience with FDA regulations will present challenges for the regulatory body, who must find increasingly scalable ways to provide oversight as this practice grows in popularity.
With personalized medicine and innovation in 3D printing advancing faster than existing industry standards and regulations, there are product liability concerns around this largely untested and somewhat unregulated trend.
The FDA has released guidance and standards, but at this time, these do not address point-of-care manufacturing at hospitals. Consider the three primary theories of Product Liability Law: Design Defect, Manufacturing Defect, and Failure to Warn. In the case of 3D medical device printing, Design Defect concerns include determining whether there is appropriate testing of customized and necessarily unique 3D printed components. Manufacturing Defect considerations include determining who the manufacturer is in situations where hospitals that print components are using another company’s software and/or a printer owned and maintained by a third entity. As for Failure to Warn concerns, the FDA currently reviews instructions for use prior to the device being marketed, however it may be difficult to ensure the instructions for use are being properly followed and distributed at the point-of-care.
Though there are still concerns with the ultimate patient safety and efficacy, 3D printed medical devices are an exciting and revolutionary product within the life science field. Regulatory bodies are currently challenged to established guidelines and an expedient application process to allow customized products to designed to meet the personalized medical needs of patients while ensuring the overall safety and efficacy of the process and product. It’s a daunting task, but the potential of 3D printed devices and personalized medicine to save lives makes the effort well worthwhile. As regulatory standards evolve, it will be incumbent upon the life sciences industry to keep up with the impact of these changes, and to prioritize risk management efforts accordingly.
There is no doubt that 3D printing of medical devices and pharmaceuticals has great potential, particularly when it comes to the ability to produce highly customized products at the point of care. At the same time, this capability will pose challenges for regulation and oversight. Regulation will need to evolve as 3D printing advances so that the potential benefits outweigh the risks.