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The medical device market is booming and is expected to reach a value of $543.9 billion by 2020, and an increasing number of those devices are the result of 3D printing.

3D printing’s big advantage is its ability to produce implantable medical devices customized specifically for a patient  –  more quickly and cost-effectively than in traditional manufacturing methods.

Breakthrough research in AM for organ and tissue implants (aka “bioprinting”) and dental implants will continue to blow minds (and then even print minds). And, yes, 3D printing is used to produce anatomical models for surgical planning and patient-specific instruments, but let’s celebrate the variety of implantable medical technologies that are having real-world impacts in patients’ lives right now.

Here are the top 4 3D-printed Implantable Medical Devices

1. Orthopedic Implants

Of the more than 70 additive-manufactured medical devices approved by the U.S. Food and Drug Administration (FDA), the majority of 510(k) clearances are for orthopedic applications. Considering that hip replacement is the tenth most common surgical procedure in the U.S. and knee replacement is at number four in the list, it makes sense that medical device manufacturers consider additive manufacturing to create customized orthopedic implants.

Additive manufacturing allows for the volume production of complex implant geometries, like trabecular structures, that have both solid and porous sections  –  the spongy part of the inner bone. Currently, a variety of metal alloys are available to medical device manufacturers, including titanium-aluminum, cobalt-chromium, and stainless steel. The growing range of materials available for 3D printing increases options for surgical implants. For example, titanium alloys are lightweight and bacteria-resistant, making them the perfect choice for a sternum replacement surgery where the patient’s original sternum deteriorated due to an infection.

And what if surgeons need wiggle room in terms of the final shape of an implanted device? For example, if only a portion of the skull needs to be replaced, how likely is it that a hospital would stock a bin marked ‘Cranial Implants, All Sizes’? Not likely. Instead, surgeons can plan the final shape of replacement skull prior to life-saving cranial surgery and have the exact dimension printed sooner than in traditional machining methods.

Orthopedic implants and prostheses are medical devices that replace missing joints or bones, or that reinforce a damaged bone. Doctors have discovered that the human body builds natural connective tissue to implanted devices better when the implants have a porous surface. 3D printing gives manufacturers the advantage of creating shaped implants and prosthetic devices that include micro-pore structures, which promote the integration of the metal implant and bone  –  a process known as osseointegration.

For example, surgeons have already been implanting 3D-printed acetabular cups (the socket in the hip joint) and anterior lumbar interbody fusion cages to support degenerated spines –  both of which integrate porous surfaces to promote osseointegration instead of conventional bone grafting. Even ‘roughened’ 3D-printed titanium screws have shown a higher degree of osseointegration when compared to their polished counterparts.

2. Prosthetic Devices

Prostheses replace missing body parts lost through trauma, disease, or congenital conditions. In the U.S. alone, an estimated 1.7 million people rely on prosthetics, with that number projected to double by 2050 as a result of longevity and the prevalence of diabetes.

The 3D printing process allows the production of prosthetic limbs more quickly and affordably than through traditional subtractive manufacturing methods. Breakthrough technologies like 3D printing are not just putting dollar signs in investors’ eyes: they’re making a difference in the lives of individuals in need.  Consider the heartwarming stories about Ugandan children who received 3D-printed prosthetic legs and Project Daniel by Not Impossible Labs which established the world’s first 3D-printing prosthetic lab and training facility in war-torn Sudan.

And it’s not just the limbs that can be printed. Prosthetic users can have 3D-printed custom sockets embedded for a better fit with the prosthetic limbs. Without a custom-fitted socket, fitting a prosthetic device can be “a massive pain in the butt”, according to one prosthetic wearer. Who knows, perhaps one day, prosthetic wearers will have “quick-change” limb attachments to fit in their custom sockets.

3. Spinal Rods

A person’s spine has a natural curve, and supports the body’s structure and nerves. When the human spine is out of alignment even slightly, sharp pain and mobility issues follow. To restore spinal integrity requires a ‘perfect fit’ in terms of both the spine height as well as the angles of curvature along the spine. Once again, additive manufacturing comes to the rescue  –  this time for people suffering from degenerative disc disease and other severe spinal alignment disorders. 3D-printed spinal rods allow the production of patient-specific designs to match original spine dimensions.

4. Bone Plates

In bone breaks or other bone separations, the two separated surfaces can be held together by 3D-printed bone plates, which are attached to the bone with screws. The additive manufacturing process is ideal for situations where complex geometries are needed, as is the case in hallux valgus deformities  (more commonly known as bunions). Traditional manufacturing methods result in bone plates that are too thick and can cause patient discomfort when implanted.

Innovative additive manufacturing (AM) technologies produce small, precise components that are custom-made for each patient, with improved device-tissue integration. If you are considering what role AM needs to play in the manufacture of your implantable medical device, contact the 3D printing specialists at 3DEO to learn more.

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