Looking back over the last decade, it is clear from the vantage point of 2017 that additive manufacturing (AM) has caused significant disruption in the medical sector. Indeed, in no other sector has AM had such a profound and dramatic effect on the human condition in terms of improving lives — whether directly at the point of need within clinical environments or communities or indirectly as a manufacturing method for greatly improved medical devices. Currently, despite the direct approach dominating many ‘3D Printing’ headlines as surgeons and clinicians increasingly embrace the AM systems at the point of need for patient-specific applications, it is the latter, indirect approach, that has seen significant results for higher volume, serial production with AM by medical device manufacturers.
The medical sector!
Three little words that are used easily and frequently to describe a behemoth industry where commerce and politics often obscure the raison d’etre — the health of humanity. One of the fastest growing sub-sectors of the medical device industry (itself a subset of the medical industry) is medical implants, specifically orthopedic implants, a field that is leading the way for when, why and how to maximize the potential of 3D printing technology.
The medical discipline of ‘orthopedics’ is, broadly speaking, concerned with the human skeleton — or, essentially, our bones. A human, adult skeleton consists of 206 bones, a significant proportion of which provide a load bearing function such as the spine, hips, ankles, shoulders, knees and toes. The skull and face come under a further specialized medical categorization: ‘cranio-maxillofacial’ (CMF).
According to an in-depth report by SmarTech1, “The global orthopedics market, inclusive of a wide array of products, treatments, and medical practice areas, is massive. Most estimates for market sizing in orthopedics take into account devices, implants, procedures, and equipment used in surgical environments. These all-encompassing market sizing estimates show a global market projected to be worth close to $100 billion over the next eight to ten years.”
Moreover, implantable orthopedic medical devices are subject to stringent regulation due to the critical nature of them being placed within the human body to fulfil the function of body parts that no longer work and cannot be repaired, whether as the result of catastrophic injury or worn out through longevity. When such a prognosis is delivered it is invariably amid the suffering of ongoing physical pain that has a tremendous negative impact on an individual life and a long-term — safe — resolution is the desired outcome.
As a recipient — or future recipient — these regulations are desirable in terms of quality and safety. It means that the device manufacturers are put through some hoops to demonstrably prove the efficacy of the implants they develop. Today, that is kind of where we are with many 3D printed implants — still going through the hoops. We’re not even half way really. Going back to the 206 bones of the body, in 2016 the US Food & Drug Administration (FDA) quoted that it had granted approval for 85 implant devices produced using 3D printing — a significant proportion of which were for emergencies, not pre-planned surgeries.
Considerable research is ongoing into the development of superior, cost-effective orthopedic implants and the 3D printing ecosystem is contributing notably to these developments. An increasing number of medical device manufacturers — large and small — are utilizing an AM approach for the production of standard orthopedic implants to achieve improved design and functionality. The dominant (but not exclusive) process in this specialized medical field is metal powder bed fusion (laser and electron beam powered). These metal additive processes allow for the manufacture of the complex mesh structures of innovative implants that reduce production costs and lead-times compared with conventional manufacturing techniques of such products. The complexity involved in the production of an orthopedic implant is inherently linked to the ability to simulate bone structure, porosity and a surface texture that produces high-friction and allows for bone ingrowth around the implant. This is where industrial 3D printing excels, in a way that no other single process ever has previously. Which is why increasing numbers of medical device manufacturers are embracing the technology. As you might expect, the medical device sector is a competitive market, with a dual focus on R&D and profit, much like its equally massive sister market of pharmaceuticals. For both, the emphasis is somewhat removed from the point of care, but the medical devices are facilitating improved — and longer lasting — treatments by clinicians that use them for their patients.
Image Credit: Rachel Park/3D Printing Media Network