Raymond Williams and Lauren Wilchek of law firm DLA Piper write…
Decades ago, we used to say technology was the wave of the future. Today, with technologies such as additive manufacturing, we are living in the future.
Additive manufacturing, or 3D printing, is being used increasingly across numerous industries, from automotive to entertainment to pharmaceutical and medical device.
According to a recent report, North America is expected to account for the largest share of the global 3D printing medical device market in 2017, a global market which is projected to reach USD 1.88 billion by 2022 from USD 0.84 billion in 2017.
While 3D printing is here, the future holds many questions. As the use of 3D printing continues to expand in the pharmaceutical and medical device space, how the FDA regulatory regime and traditional products liability principles will evolve are among these questions.
While its use is increasing, 3D printing has been in existence for over 30 years. Developed by engineer and physicist Charles “Chuck” Hull in the 1980s, the first 3D printing patent was issued in 1986. The 3D printing process and technology varies, but it generally begins with an electronic blueprint, typically a computer-aided design (CAD) file created by modeling software or a 3D scan of an existing object. The 3D printer is prepared by setting raw materials, such as powders, pastes, plastics, metals, or ceramics. The printer then builds the object according to the design specification, layer by layer, until the object is completed. In their early inception, 3D printers were large and expensive, which limited the technology to a small segment of the population. However, as new companies have entered the marketplace and the use of the technology has increased, 3D printers are becoming cheaper and more accessible to both small businesses and individuals, who can print objects from digital models created themselves or downloaded from the internet. Now available through retailers including Staples, Best Buy, and Amazon, the 3D printer may soon be a common fixture around the home.
The Food and Drug Administration (FDA) has approved one prescription medication and over 85 medical devices manufactured by 3D printing to date. The prescription medication is a disintegrating oral tablet for the treatment of seizures. Medications eventually manufactured on the same platform are sure to benefit both pediatric and elderly patients who struggle to swallow tablets. The medical devices include surgical instruments, external prosthetics, cranial implants, and titanium hips. In June of this year, the FDA approved one company’s denture material for the 3D printing of lifelike denture bases. Dentists and labs can use the material, along with the company’s already approved materials for the 3D printing of restorations simulating teeth, to print a full denture patients can wear for long-term use. This is one example of how 3D printing in the medical device space can be used to create patient-specific or patient-matched devices that were not possible under conventional manufacturing methods. 3D printing also can be used as an alternative manufacturing method for existing medical devices and device components.
Up until now, the FDA has treated 3D-printed medical devices no differently than devices manufactured by more conventional means. The majority of approved medical devices manufactured by 3D printing are Class II medical devices, however—devices of medium risk, subject to appropriate regulatory controls to assure safety and effectiveness. These devices are typically approved by the FDA under the 510(k) approval process, by which FDA approval is granted after the manufacturer demonstrates the device in question is “substantially equivalent” to a legally marketed device. No clinical trials are required, and the focus of the approval is on safety and efficacy, not the manufacturing methods. As 3D printing continues to evolve in the medical device space, 3D-printed Class III devices—devices of the highest risk— likely will be developed. Such devices will be subject to significantly higher regulatory review, which may include enhanced scrutiny of the manufacturing process.
The FDA has formed an Additive Manufacturing Working Group in response to the increase in utilisation of additive manufacturing and uncertainties relating to how additive manufacturing can affect the safety and effectiveness of the products. The Working Group held its most recent meeting in August 2017 in conjunction with the Radiological Society of North America to discuss technical considerations for additive manufactured devices, specifically 3D-printed patient-specific anatomic models. The FDA is also actively investigating how additive manufacturing may affect the manufacturing of medical devices in the future in two laboratories of the Office of Science and Engineering Laboratories. In May 2016, the FDA issued a draft guidance on technical considerations for additive manufactured devices. The guidance contains specific considerations for FDA submissions for 3D-printed devices, including quality systems and device testing considerations unique to additively manufactured products. The purpose of the guidance is not to set forth specific requirements, but to describe the issues to be considered and addressed during product development and premarket submission. The guidance may impact the FDA approval process for both Class II and Class III 3D-printed devices going forward. Exactly how the approval process will play out remains a question.
Another question is how products liability law will adapt in the wake of increased development and use of 3D-printed drugs and medical devices. Products liability law was developed to address injuries to individuals resulting from defects in products manufactured by a commercial seller. The law defines a product as “tangible personal property distributed commercially for use or consumption.” (See Restatement (Third) of Torts: Prod. Liab. Section 19(a)). It also indicates, in order to be subject to liability, a person or entity must be “engaged in the business of selling or otherwise distributing products”; liability does not apply to a “noncommercial seller or distributor” nor to an “occasional or causal” sale. (See Restatement (Third) of Torts: Prod. Liab. 1, comment c). As the products liability law framework focuses on mass-produced products, as opposed to custom-made items, many questions arise. Is the CAD, the blueprint for the 3D-manufactured drug or medical device, a product in addition to the product itself? If the pharmaceutical or medical device company creates only the CAD, and the CAD is not a product, is the company immune from liability? Would liability shift to those who printed the drug or medical device? Some envision a world where eventually people will simply print their own prescription medications from home. In such a world, would individuals have no remedy for a defective medication at all?
There is no question additively manufactured pharmaceuticals and medical devices already have had significant impact on patient care and treatment, and the opportunities for growth and advancement seem limitless. We can only speculate about the precise impact 3D printing will have on regulatory oversight of drugs and medical devices and products liability principles. The future holds the answer to these questions.
