Medtech 3D printing: From a San Francisco happening to a legal limbo

3D printed organsIf you’re interested in the intersection of 3D printing and medical technology and happen to be near San Francisco, CA, next week, you might want to carve out some time to attend the 3DHEALS 2017 Global Conference: 3D Print Life. 3D HEALS is dedicated to the proposition that great things can happen if you bring together technologists from the start-up culture of Silicon Valley and the Bay Area and healthcare stakeholders under one roof.

The organization has been around for a couple of years and has produced five successful events during that time. By reaching out to various stakeholders in the healthcare system, technology, regulatory affairs and more, “it made us realize that it takes a village to make revolution happen, and many challenges can only be overcome by a well-organized ecosystem,” write event organizers on the website. “We are hoping that by organizing this global event, 3DHEALS will contribute to fostering this burgeoning yet still fragile ecosystem.”

The liability of hospitals and doctors printing 3D medical devices

 As 3D printing becomes more accessible, it will present significant liability questions for those injured by these devices. If a traditional manufacturer creates a 3D-printed device, that manufacturer is subject to products liability claims. But, when a hospital or doctor prints the device at their own facility, who is responsible if that device causes a patient harm? This article will provide a very brief overview of the existing legal landscape for those injured by medical devices printed by doctors and hospitals, but will not address the liability issues that arise when the 3D printer itself is defective.

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Research marks 3D printing as vital to pharma and medical device markets

The healthcare industry could benefit from the use of 3D printing technology to customise medical devices and drugs, market analyst Frost & Sullivan have said.

3D PrintingRecent research by the group’s TechVision  – 3D Printing for Healthcare Applications – has shown how a large number of markets have shown interest in adopting 3D printing in a drive towards more personalised medicine

More so, the research states how 3D printing can be merged with pharma practices such as continuous manufacturing (CM) to develop various dosage forms for a specific demographic. 3D printing can also be used to bring about a change in the structure of medication, making it easier for medication to be swallowed or dissolved.

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Healthcare must embrace the digital revolution

Integrating developments in advanced robotics, big data and 3D printing can help the health sector improve patient care and reduce costs.

Healthcare must embrace the digital revolutionThe rise of new digital technologies always inspires a wave of excitement and numerous predictions from healthcare experts about revolutionary changes that should be expected. For example, the first real use of 3D printing happened in 1999 and, since then, it has been heralded as a cost-cutting saviour for producing specialist medical equipment. It has even been predicted to be the solution to the challenge of organ transplant shortages. Clearly, the healthcare industry has much to gain from embracing new technology.

Those in the healthcare supply chain acknowledge the importance of new technologies, like advanced robotics, big data and 3D printing, in improving outcomes. In fact, in a recent survey1, 83% of respondents from healthcare and pharma said that big data was the most disruptive technology in the industry today, while 44% named advanced robotics as important to supply chain functions and 35% pointed to 3D printing as a significant disruptor.

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3D printing applications for Healthcare will transform medical devices and pharma industries

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.”

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3D printing to redefine the medical supply chain in Africa

Plastic due to be recycled. Photo via ReFab Dar. 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.

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Implications of 3D printing across the medtech value chain

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?

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The health effects of 3D printing

Basic steps you can take to protect your patrons and staff

3D printing closeupAs 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.

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How 3D printing can revolutionise the medical profession

Groundbreaking 3D printing and scanning techniques are improving access to fully customisable artificial limbs

Cambodian woman Leakhena Laing being fitted for a new device at CSPO private clinic, where 3D PrintAbility training has been taking place, in Phnom Penh.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.

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A vision for 3D printing in Pharma manufacturing

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.

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