Originally Posted by
baschuk
It will be interesting to see how this project progresses. As a Certified Prosthetist Orthotist, I have been watching this technology and its application very closely. I do think that there is a relevant clinical application. However, I want to point out two standard misconceptions that are consistently claimed as the reason for the application of 3D printing manufacturing in prosthetics and orthotics: cost and time.
1st Cost:
The standard claim in almost every article I have ever read about 3D printing of prosthetics and orthotics is that to 3D print a device costs around some number of dollars on the order of tens of dollars while a device provided by a prosthetist or orthotist costs on the order of thousands to tens of thousands of dollars. The error here is that for the 3D printed device the only costs accounted for are material costs, which admittedly are minimal. On the other hand, the cost quoted for the device provided by a prosthetist or orthotist, a trained medical professional, is inclusive of clinical care both prior to and after delivery, manufacturing labor, administrative costs such as seeking authorization and reimbursement from insurance, and finally materials. The materials cost of the device provide by a certified prosthetist or orthotist are really not any greater than the material costs of a 3D printed device. Material cost to material cost the devices are equivalent. The reason for the higher cost is the medical expertise, clinical care, and services that are being provided along with prosthesis or orthosis. Prostheses and orthoses are custom medical devices as defined by the FDA. As such, there are laws that require these medical devices to be provided my certified healthcare professionals.
Most healthcare professionals are reimbursed for their time and clinical care based on the procedures that they perform. Prosthetists and orthotists, however, are not allowed to bill for their time and instead are required to bill for the prosthetic and orthotic devices that they deliver to patients. This means that if a patient were to be seen 10 times related to the evaluation, provision, and follow-up care for 1 AFO over the course of 3-5 years, which is the expected life-time of a prosthesis or orthosis, then the orthotist, in this case, would only get to bill the patient once for that AFO on the day that the AFO was originally delivered to the patient.
In this particular article, they state that an AFO provided by an orthotist can cost as much as $2,000. In my experience, the only time and AFO can cost that much is if it is made of carbon fiber and has dynamic nature in which the orthosis stores and returns energy during the natural gait cycle to help the patient improve their gait efficiency. For clarification, an AFO, similar to what was printed by the group at Gonzaga University is called a Solid Ankle AFO because it is made of rigid thermoplastic with no motion allowed at the ankle. A solid ankle AFO like this is reimbursed by Medicare for around $660. Blue Cross pays less than $380 for the same orthosis.
Over the course of the 3-5 years that an orthosis is expected to last, the total amount of time spent by the practitioner, fabrication technicians, and front office administrative staff is easily in the neighborhood of 30 man hours. A little quick math reveals that a $660 orthosis reimburses at around $22 per hour of work. That doesn't go very far when you consider that this must pay the salary of the 3 people and cover the overhead costs of the building where the orthosis was fabricated and delivered.
This leads into the second misconception, time.
2nd Time:
Admittedly, the turn around time for providing a prosthesis or orthosis can be 1 month as claimed in this article. However, this is almost completely due to the insurance prior-authorization process and collecting the medical records from physicians and other healthcare professionals that justify the provision of the device. Without all of the paperwork in order and the prior-authorization in place, there is no guarantee that the device will even be paid for. Prior-authorization is still not even a guarantee of payment for the device. The actual amount of time that it takes to fabricate a solid ankle AFO from taking the cast of the patient's leg to completion of the finished product is around 4 hours total. If the insurance process were taken out of the picture, a patient could theoretically be seen in the morning for initial evaluation and casting and then be seen in the afternoon for delivery of the custom made AFO. I have done this in the past for patients who were paying cash out of pocket. I know that 3D printers are getting faster, but I have yet to see a printer that can produce an object the size of an AFO with 100% infill in less than 4 hours.
3D printing does have it's benefits though. For one, a 3D printer can work 24/7 with minimal supervision to produce products. This has a great potential to reduce labor costs. Also, the 3D printer has the potential of producing multiple devices at the same time. The amounted wasted material is also less using a 3D printer. An exciting feature is the ability to change the characteristics of the material finitely to match the needs of the patient. This makes it possible for tailor made devices with quantifiable characteristics that can be used to establish better outcomes. So I definitely think that there is potential for the appropriate use of the technology.
3D printers are beginning to be integrated into clinical practice. It is a fascinating manufacturing method that lends itself well the the prosthetic and orthotic industry. However, focusing on reduction of cost and time are not the real reasons that the technology will be beneficial. Medical devices are medical devices and as such are regulated by the FDA. It doesn't matter who makes them or how they are made. If they are provided to a patient, then they must be provided by a healthcare professional. Unless the way that orthotics and prosthetics are paid for changes, they are always going to seem "expensive" and that they take "forever" to be provided.
Please feel free to reach out to me with any other questions or comments. I would be happy to reply.
