3D printing technology is the ideal solution for the healthcare industry’s need for the efficient production of complex and personalized products. A large number of market majors have shown deep interest in adopting 3D printing for its ability to customize drugs, active pharmaceutical ingredients (APIs) and medical devices, driving an era of personalized medicine. The field that is most likely to be disrupted by 3D printing is pharmacy distribution of drugs because of the ease of obtaining customized dosage quantities of medication.
“Using 3D-printed tissues for drug testing, clinical trials and toxicity testing will have a huge impact in the pharmaceutical sector, as they will help eliminate costly animal testing and use of synthetic tissues,” noted Frost & Sullivan TechVision Research Analyst Madhumitha Rangesa. “However, traditional, large-scale manufacturing is still more economical for mass production of drugs; 3D printing will be viable for small-volume production in orphan diseases.”
African organization ReFab Dar are hoping to use 3D printing to create vital medical supplies in Africa and other developing countries. In order to do so they are working on a number of initiatives including a design competition for 3D printed medical tools.
The program’s main aim is exploring, “how plastic waste can power entrepreneurship using 3D printers in Tanzania.” ReFab Dar are currently recycling waste and turning it into 3D printable plastic filament. From this, they intend to create medical supplies, farming equipment and even research tools like microscopes. In this ‘Hack 4 Health’ challenge they are focused initially on the creation of HIV prevention and birthing equipment.
Additive manufacturing, or 3D printing, already has begun to revolutionize how medical devices and other medical products are made, distributed, sold, and used. By printing layers of material on top of one another using a variety of materials, 3D printing allows for the manufacture of products whose forms are more fluid or organic, and whose structural integrity is the same as or greater, than traditional manufactured products.
According to a 2014 PwC survey, one-third of all manufacturers are adopting 3D printing. The medical device industry is no exception. Already, 3D-printed medical products such as customized implants, prosthetics, casts, teeth, and hearing aids are under development or commercially available. The FDA has approved or cleared more than 85 devices made using 3D printers. Where and how is 3D printing changing the medical device industry, and what does the future hold?
Basic steps you can take to protect your patrons and staff
As makerspaces and fab labs increase in popularity, more and more libraries are adding 3D-printing capabilities. According to a 2015 American Library Association (ALA) report, 428 public library branches have made this technology available. Some potential issues of 3D printing, such as the threat of printing weapons and copyrighted works, are often considered. However, discussion of the health hazards associated with 3D printing is rare.
Ultrafine particles and volatile organic compounds
Several studies have shown that 3D printers produce high amounts of ultrafine particles (UFPs) and volatile organic compounds (VOCs) while in use, and that these particles and vapors are detectable for many hours after the printers have been shut off. UFPs have been linked to adverse health conditions, such as asthma and cardiovascular issues, because they can pass through the lungs and travel to other organs. They can also transfer toxic material into the body, including blood and tissue cells. The US Environmental Protection Administration has classified many VOCs as toxic air pollutants. Exposure to certain VOCs, such as benzene and methylene chloride, has been linked to cancer.
Groundbreaking 3D printing and scanning techniques are improving access to fully customisable artificial limbs
Before the vehicle that she was travelling in flipped over and trapped her right leg, Leakhena Laing was a happy teenager who enjoyed climbing trees and playing football with friends. After her limb was amputated, she could only sit and watch.
“It was difficult to even get a glass of water. I felt hopeless, very sad and embarrassed to be around other people,” says Laing, who was forced to abandon school after the accident nearly four years ago.
She used crutches for two years, before receiving a below-knee (transtibial) prosthetic plaster limb, which improved the quality of her life, although it meant regular visits to a clinic in Phnom Penh, Cambodia’s capital, nearly 30 miles away from her home in Borset district, for refittings.
Three-dimensional (3D) printing—a type of additive manufacturing (AM)—has the potential to be the “next great step” in pharmaceutical manufacturing, enabling fabrication of specialty drugs and medical devices, said Emil Ciurczak, Doramaxx Consulting and CPhI expert panel member, in the 2016 CPhI Annual Industry Report. 3D printing could be used for personalized or unique dosage forms, more complex drug-release profiles, and printing living tissue, noted Ciurczak in the report.
Because 3D printing builds an object layer by layer, it could be used to print drug tablets with a personalized dosage, possibly combining multiple drugs into a single dose. Printing a barrier between APIs in a multilayer tablet could facilitate targeted and controlled drug release. Ciurczak proposed some applications where 3D printing could be of benefit. Orphan drugs, for example, may be limited because their market is too small to justify production costs, but a 3D printing process could minimize the cost. Another possible use is for making tablets to calibrate dissolution testers for United States Pharmacopeia testing. Ciurczak suggested that 3D printing could allow these tablets to be made in smaller lots, as needed, rather than once every few years, which could improve reproducibility. Products that would benefit from the lack of high compressive forces in 3D printing of tablets, such as abuse-proof tablets, may be another opportunity.
Over the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming, seeming to indicate that as disruptive as 3D printing promises to be, there must be a corresponding disruption to how we work on regulatory compliance to protect our assets.
But if we step back and look at the actual Food and Drug Administration (FDA) communications, the pace of adoption of 3D printing and real intersections of 3D printing and business processes, it appears that little has changed. The only disruption is when 3D printing revolutionizes a commercial process.