Yes, you can, but should you? That is a good question to ask oneself at many personal and professional junctures. At Advanced Design & Manufacturing (ADM) Expo in Cleveland earlier this month, it came up a couple of times during a panel discussion devoted to medical 3D printing. The quasi-infinite possibilities of additive manufacturing have a profound resonance in the medtech space, and it’s easy (and fun) to extrapolate. Ultimately, though, the technology is worth pursuing only when it produces clear clinical and patient value, said Pete O’Neill, Executive Director at Cleveland Clinic Innovations and acting CEO of Custom Orthopaedic Solutions (Cleveland, OH), who participated in the panel. One project his company is involved with falls squarely on the “yes, you should” side of the ledger, according to O’Neill.
|Pete O’Neill, Executive Director at Cleveland Clinic Innovations and acting CEO of Custom Orthopaedic Solutions (Cleveland, OH), speaking at ADM Cleveland.|
He prefaced his discussion of the project with an overview of conventional airway stents. The generic devices do not conform to the curved shape of a patient’s airway, and pulmonologists typically customize the stent on site. “The result looks kind of Frankensteinish,” O’Neill told attendees as he showed one such modified stent on the screen. It definitely had a DIY look about it, and I would not have been surprised to see duct tape involved. Aesthetics aside, the stents do their job, O’Neill stressed. But a number of issues may affect the devices, including the formation of biofilm, the onset of severe halitosis and longevity—the stents last about two months, noted O’Neill.
Custom Orthopaedics has developed a stent—O’Neill did not overtly reveal the specific therapeutic purpose—that improves patient quality of life because it better suits individual patient anatomies and can be implanted for a longer period of time. By leveraging FDA’s compassionate use program, the stent has been implanted in three patients, and results show that it lasts for more than one year.
Reading is not only informed by what’s going on with us at that moment, but also governed by how our eyes and brains work to process information. What you see and what you’re experiencing as you read these words is quite different.
The company hopes to have 510(k) clearance from FDA by May 2018. It can go the substantial equivalence route, instead of the lengthier and more onerous premarket approval path, because it “is not a custom device, a term that has specific meaning within FDA,” stressed O’Neill.