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.