Interview: FDA-approved 3D printed implants just the start as Osseus prepares to go international

On the back of a pretty significant seal of approval from the Food and Drug Administration (FDA), Osseus Fusion Systems gained a foothold in a market dominated by a host of multinational powerhouses. 

Emanating out of Dallas, Texas, the company consists of no more than a dozen people, of which just three are engineers. It was founded by Eric Hansen and Robert Pace in 2012, and harbouring a philosophy based on surgeon engagement, is delivering to market medical devices optimised to the preferences of doctors for a variety of spinal procedures. Having previously done so with CNC machining and other subtractive processes, after the FDA’s validation of its new Aries family of spinal implants, the company is set to prioritise 3D printing technology as the foremost manufacturing method for future products.

“As a small company, we have to compete with the Medtronics, and the Depuy Synthes, and the Zimmer Biomets, and the best way we can do that is by taking that extra level of care in terms of making sure our products are designed for every specific surgeon in mind, not just for a mass market approach,” Asher Breverman, an Osseus Additive Manufacturing Engineer, begins.

Though just six years old, the company has moved with the times while staying true to Hansen and Pace’s ideology. It is working closely with surgeons to provide implants of different sizes and shapes with regards the human anatomy, but perhaps surprisingly the 3D printed devices aren’t being manufactured specific to each patient.  

“There’s sub-categories of spine implants that are patient-specific where the implant is designed with that specific patient’s anatomy in mind. We just offer a much wider range of sizes than most companies in the industry and we do that to make sure that we can accommodate any surgeon’s procedure for any patient anatomy,” explained Breverman. “What we try to do with 3D printing is include the entire range of sizes that any surgeon would request in any capacity so that we can provide that specific patient implant size to the surgeon for that specific patient need in that specific patient’s case.”

Their purpose by and large is to combat the wear and tear of one’s spinal vertebrae. Degenerative Disc Disease, for example, affects more than 30 million people a year, and tends to occur as bone density decreases in a person’s later years, drying out and shrinking their discs, which in turn tightens the space around the nerves and spinal cord. In an attempt to prevent pains occurring, surgeons will look to remove the worn disc and replace it with a titanium interbody.

“We didn’t really have much trouble getting FDA-approval, which is a pat on the back for us.”

This interbody will be inserted in between two different vertebrae, packed with biomaterials and bone grafts – either the patient’s bone or a synthetic bio material – which will enable fusion within the spine and future pain should be prevented. The implant will also feature sharp teeth on its top and bottom to help keep it in place, and if all goes well, will remain inside the patient for the rest of their life.

Osseus is manufacturing the Aries devices, and future ones too, in volume batches with its in-house metal additive manufacturing systems from vendors like Renishaw, EOS, and 3D Systems. The company loves the technology: “[It] helps us maximise our output and maintain profitability in a very competitive industry,” Breverman said. “We take a lot of care designing our products to make sure we could fit as many as possible onto a single build plate. If you looked at one of our smallest implant sizes, you could probably manufacture a couple of hundred on a single build plate. If you looked at our biggest size of our biggest implant, you could probably only manufacture a couple dozen.”

The benefits of 3D printing don’t just lie in the manufacture of the implants, but in the design too. Upon announcing the FDA clearance last week, Osseus remarked that the Aries products boast 80% porosity. That level of porosity exists in the X, Y, and Z axes, and enables fusion throughout the entire implant, regardless of where the biomaterial and bone is packed into it. This increases the likelihood of a successful procedure first time round, and Osseus believes points to some serious advantages for 3D printing in titanium over conventional methods or even 3D printing in PEEK.

Another detail, a rather vague one at that, was the low stiffness that Osseus boasted about in last week’s announcement. This is another feature enabled by Aries’ 80% porosity, and one that enables the better representation of bone’s dense outer surface.

“One of the major disadvantages of using titanium as a spine implant is that it is a lot stronger than your bone, and so that can often lead to complications where the titanium breaks through your bone because of how strong it is,” explained Breverman. “What we did is use 3D printing to design micro-porosity inside our implants and that micro-porosity, that diamond structure through our implants, reduces the stiffness of the implant and makes it behave closer to cortical bone.

“We’re not going to say our implant is as close to bone as possible, that’s a very strong claim that we’re just not going to get into, but what we did was push it to the limit that we felt comfortable with given the regulations of the FDA and our concerns for patient safety.”

Much of the intricate details about the manufacture and post-processing of these implants remian undisclosed as the company awaits patent approval for its proprietary Pl3xus blend of production and finishing. But its Aries products breezed through the FDA’s scrutiny, as Breverman quipped, “we didn’t really have much trouble getting FDA-approval, which is a pat on the back for us,” and has earned this Texan company of 12 some status in a hotly contested market.

Osseus needed to prove Aries was as strong or stronger than current products on the market; it needed to show it could come through mechanical testing, cleaning testing, sterilisation testing; the implants needed their biocompatibility verified too. They are, the company did, and the devices don’t cause any toxicity once implanted into the human body either. All questions asked were answered, and now Osseus will begin shipping the Aries devices after the North American Spine Society Meeting in Los Angeles at the end of September.

Since Aries, the company has turned its attention to the development of standalone interbodies, expandable interbodies, and different screw systems. These will not only be manufactured with 3D printing, but designed with the help of generative design software tools from nTopology’s Element platform. The capabilities of generative design, Osseus says, is helping to produce devices with optimised surface structures which enable the company to achieve the clinical outcomes it, or rather the surgeon it is working with, wants. Breverman says Osseus is probably the smallest player in the market to be exploring the use of generative design, but expects it to help him and his colleagues to achieve big things.

“The design of your product is now 100% dependent on your ability to describe how your product needs to function,” he said. “Rather than telling your software what to do, you tell the software what it needs to do, and the software then tells you how to do it. That introduces a whole new element of design where we can take surgeon feedback to a whole new level, where we can take optimising designs, whether it is optimising for manufacturing, whether it is optimising for patient outcomes, and we can implement that throughout the design process, and remove that human error element from designing implants. It’s a really fascinating technology.”

A fascinating technology being used by a fascinating company prepared to write a fascinating story. The company sees itself somewhat as an underdog, made apparent by Breverman referencing Osseus’ small size 12 times in 30 minutes to emphasise the challenge it has faced in the spine implant space. But whereas many companies offer one or two devices to cater for lumbar interbody procedures, Osseus has brought to market a family of five, each of which can vary in size, and each of which serve a different spinal procedure.

It is a small company today, with a single office and ties with several distributors across the United States, but has little intention of remaining that way. Within the next year or so, it plans to go international. And through engaging with surgeons, its ability to serve them comprehensively, and harnessing generative design and metal printing technologies, plus its recently assumed know-how in getting 3D printed products ratified by the FDA, the company is aiming to climb to the top and compete with the big boys.

“It’s a really exciting time for us, we are trying to ride the wave of 3D printing, and use it not just as a way to design better products, but improve our overall company in terms of the services that we provide and how we can run our operations and maintain the quality of our products as we scale and grow the company,” Breverman said. “Because we use 3D printing in-house we’re able to launch products at a much quicker rate than can be accomplished at much bigger companies. We’re excited to continue making a good impression on this industry.”

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