3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.
Perhaps this seems pretty straightforward, but delving into the 3D printing of medical devices highlights the multiple aspects of this process, and underscores the potential challenges associated with the FDA’s current and future regulatory paradigm.
When it comes to printing medical devices, the first step involves developing a computer-aided design (“CAD”) file, or animation modeling software, which tells the printer what to make and how to make it. After the finished design file is sent to the 3D printer, the user chooses a specific material.
3D-printed medical devices allow for a high degree of customization. Think of 3D-produced dental implants which fit perfectly the first time because they are manufactured for your mouth. Or a map of a highly delicate cardiovascular procedure sized precisely to your needs or, more importantly, those of your newborn.
The applications are limited only by the medical profession’s imagination and requirements. Developing medical devices that allow for customization dovetails with FDA’s increased focus on promoting “personalized medicine.” As stated by FDA, personalized medicine (also known as precision medicine) “may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care.”
Given FDA’s interest in product development geared toward personalized medicine, perhaps it is not surprising that 3D-printed medical devices have caught its attention. For example, in October 2014, FDA hosted a public workshop to discuss the technical challenges surrounding the 3D printing of medical devices, as well as the FDA’s position regarding the regulatory standards applied to 3D-printed devices.
Beyond the considerations that FDA and industry face related to the 3D printing of products that we may think of as traditional medical devices (e.g., dental implants, heart stents), industry and FDA must also answer the question of whether, if at all, a 3D printer itself becomes a medical device.
Consider the following definitions of a medical device:
- It is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body. ..” FDCA Section 201(m).
Like drugs, foods and cosmetics, whether a product will be regulated as a medical device depends on its intended use. The definition of a medical device is extremely broad, and a wide range of products falls into FDA’s medical device jurisdiction, such as toothbrushes, tongue depressors, contacts, and contact solution. FDA also regulates software as a medical device to the extent it satisfies the above definition.
While the 3D printer itself may, in many instances, be considered analogous to a piece of traditional manufacturing equipment used to make medical devices, it is possible that FDA may take the position that certain 3D printers or the software they use are, in themselves, medical devices.
Consider the following criteria to determine if a 3D printer is software or a medical device:
- What if it monitors biostatistics? Let’s say a 3D printer designed to print food asks you for your daily exercise routine, weight, height, blood pressure, and even cholesterol levels or health conditions. Based on the input, the printer will analyze your statistics and subsequently print out a meal with specific nutrients or caloric levels designed to optimize your health.
Conclusion: The FDA may consider the software that analyzes the biostatics, and potentially the 3D printer itself, constitute a medical device.
- Am I printing a medical device? Even if it is pretty cut and dried as to whether the printer produces nothing more than a physical printed product without any analysis of personal information or biostatistics, it can still be challenging at times to determine whether the product that is printed constitutes a medical device. For example, electronic “facial spa” stimulation products, which might seem like merely a cosmetic product or everyday consumer electronic, are regulated as medical devices because they affect the structure or functions of the body.
Conclusion: Deciding whether a 3D printer is a medical device subject to FDA regulation can include a wide range of products and considerations.
- Is it an accessory to a medical device? A device that is intended to support, supplement, and/or augment the performance of one or more medical devices is called an “accessory” to a medical device and is also regulated as a medical device. For example, a guidewire augments the performance of a bone-cutting instrument by increasing precision of the parent device and reducing the risk to the patient.
Conclusion: To the extent the FDA deems the printer or the printer’s software necessary to effectively produce the 3D-printed medical device, the printer or the software may be regulated as a device.
From an IP perspective, medical device patent enforcement is difficult if 3D printers are not controlled and regulated. The risk of counterfeit, unsafe devices is high, and the resulting medical outcomes are far from satisfactory.
Claudia Lewis, Justin Pierce, and Heili Kim will be presenting at the Inside 3D-Printing conference, April 15th-17th in New York. Click here for more information.