In 2015, market research firm Gartner projected that medical 3D printing would become the pioneering field that would drive additive manufacturing (AM) into the mainstream in two to five years. Four years have passed, so we’ve decided to examine the industry to determine if Gartner’s predictions have come true.
In this article, we’ll explore a handful of medical 3D printing stories from the past year to gain perspective on the level of adoption at which the technology stands.
Recognizing the need for evidence-based recommendations in the sector, these guidelines have been developed over a period of two years, in review of over 500 recent papers published on the topic.
As the abstracts states, “The recommendations provide guidance for approaches and tools in medical 3D printing, from image acquisition, segmentation of the desired anatomy intended for 3D printing, creation of a 3D printable model, and post-processing of 3D printed anatomic models for patient care.”
3D printing technology applications come alive in applications ranging from developing packaging machinery to producing personalized medical devices to printing custom medications in a patient’s home.
The FDA acknowledges that “advances in material science, digital health, 3D printing, as well as other technologies continue to drive an unparalleled period of invention in medical devices.”
The perspective comes from a Nov. 26, 2018 statement by FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, outlining transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices.
Osseus Fusion Systems’ 3D printed titanium spinal implants won FDA clearance earlier this year, joining more than 100 devices and one drug currently on the market manufactured on 3D printers.
FDA Commissioner Scott Gottlieb has called 3D printing a transformative technology that could disrupt medical practice, and the agency is scrambling to keep abreast of new regulatory challenges.
Known as additive manufacturing, the process involves production of three-dimensional objects using a digital file. The printer layers successive images or files on top of one another until a solid 3D object is formed. The process allows designers to create 3D models of a patient’s anatomy for use in diagnosis or surgical planning. The technology is also being used to customize orthopaedic implants and accessories, prosthetics, hearing aids, dental implants and wearables, such as flexible sensors. In the future, doctors may be able to bioprint skin cells to help heal burn wounds and print out replacement organs.
Patients waiting for an organ transplant may soon have a new treatment option — print out the organ or tissue they need using a revolutionary form of 3D printing that may one may day eliminate the need to wait on transplant donations.
Organovo, a biotech company in San Diego is leading the revolution in bioprinting and Boston area researchers are weighing the benefits of 3D-printed tissue.
“It’s about personalized and customized treatment,” said Xuanhe Zhao, a professor of mechanical engineering at Massachusetts Institute of Technology. He said 3D printing could eventually eliminate the need for transplant donations.
Advances in medical technology are giving amputees more practical and adaptable options
After seven years of war, an estimated 86,000 Syrians are coping with losing a limb to amputation, according to the World Health Organisation and disability charity Handicap International. IRIN recently spent a day in neighbouring Jordan, exploring how 3D printing technology can produce a new generation of replacement limbs that are more comfortable and adaptable than traditional prosthetics.
3D-printed devices such as surgical instruments and implants offer treatment advantages for ASCs and hospitals but also entail liability risks if the device isn’t ‘manufactured’ properly, according to CNA Vice President of Underwriting Ryann Elliott.
The FDA defines a manufacturer as “any person who designs, manufactures, fabricates, assembles or processes a finished device.” Therefore, the FDA may be authorized to regulate and inspect healthcare facilities creating medical devices through 3D printing.
Facilities should implement these five strategies to mitigate risks:
1. Tracking. Implement procedures to track all 3D-printed products brought into the facility. Identify which physicians have the appropriate credentials and privileges to use the products.
Last month, legal practitioners, industry, and academics gathered at The Legal, Regulatory and Business Conference on 3D Printing to discuss the legal, regulatory, and business issues that arise when products are manufactured using 3D printing or additive manufacturing techniques, rather than traditional manufacturing methods.
During the conference, 3D printing was described as the digital revolution, the fourth industrial revolution, a game-changer, and a disruptive innovation. Although the conference focused on all different types of 3D-printed products and uses, it is safe to say that the printing of medical devices falls under each of these descriptors, and may comprise some of 3D printing’s most innovative uses.
Medical technology continues to advance all the time, with life-saving procedures and medicines that were previously unheard of. Now, Global Data believe that 3D printing could be as disruptive to healthcare as the internet has been to retail.
The company initiated a study for its Disruptor Tech database, and the results revealed that 3D printing could revolutionise the supply chain by limiting the gaps between sourcing, production, and distribution. 3D printing has the ability to create ‘clinical trial ready’ devices without the need for expensive tools, computer-aided manufacturing, and computer numerically controlled manufacturing. As a result of this, price is lowered and waiting times are also reduced.