The Perfect Wave? Central Fabrication Rides the Tide as O&P Evolves

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By Judith Philipps Otto

Changing technology creates ripples that become waves and drive movement toward still greater change. It's a tide—perhaps even a tsunami—that is currently carrying the O&P field into territory that some vowed never to enter. As fiercely as many O&P practices once resisted the opportunity to use central fabrication services, a changing world is making that resistance financially less feasible and in-house fabrication more inconvenient and less technologically state-of-the-art. Some experts believe that today's growing dependence on central fabrication reflects a necessary change in business strategy for O&P practices focused on survival.

As early as January 2009 ("Tomorrow's O&P: A Survival Guide Part 1: Trends to Track," The O&P EDGE ), James Wynne, CPO, FAAOP, Boston Orthotics & Prosthetics, Avon, Massachusetts, predicted that future practitioners would likely spend more time with patients, evaluating, fitting, and recording objective outcomes, and as a result, off-site fabrication could be a successful option "if you can find a suitable central fab that has staff who understand the clinical aspects and know exactly what you are trying to accomplish for the patient…."

Wynne indicates that the same influences and indicators he identified a decade ago are still operative: "The clinician's time is better spent seeing patients. Comprehensive evaluations, conducting outcome measures, developing and implementing the treatment plan, then documenting it all is how today's clinician spends their day. Spending more time in direct patient care requires the clinician to rely on the expertise of the central fabrication facility to help their patients achieve their goals. It's the evolution of our profession."

"There are three things that we must do as practitioners—patient care, documentation, and fabrication—and we really only have time to do two of them," agrees Frank Snell, CPO, FAAOP, Snell Prosthetics & Orthotics, Little Rock, Arkansas. "We have to do the patient care and the documentation, so we try to farm out the fabrication. Right now, we couldn't do without central fabrication."

Snell outsources work selectively but admits that the amount being sent out is increasing. He estimates that while only 10 percent of their prosthetic devices are fabricated elsewhere, around 80 percent of their orthotics are now handled by an outside lab.

"Orthotics is a changing field. Years ago, we made everything in-house—all of our spinal bracing, all of our body jackets, all of our metal ankle-foot orthoses. Now, you're seeing devices that are really good designs that are being manufactured in small, medium, and large, right and left. So, we have found in the past three to five years that we're much more successful getting a central fab laboratory to produce our orthotic items."

About 90 percent of his orders for cases that involve children with cerebral palsy go to a CFab facility that specializes in pediatric orthotic lower-limb devices. A different, local, fabrication lab now makes the custom-made Arizona braces that have replaced the metal AFOs Snell P&O previously made in its own lab.

"The advantage for us is that we save at least a week in shipping time, plus the cost of shipping—and that is no small amount of money when you do it as often as we do. It amounts to $1,000 a month just in UPS and FedEx charges."

Conversely, however, he finds that the normal prosthetic applications his practice addresses "require the expertise of the hands-on practitioner coordinating and dealing professionally with the patient. There's a lot of customization as you go along, addressed in dialogue with the patient to get the outcome that they're looking for."

For prosthetic cases they see less frequently (e.g., shoulder disarticulation or myoelectric devices), however, he relies on the device's manufacturer for fabrication, since the manufacturer has the best understanding of its own componentry.

Snell P&O's strides into increased outsourcing support findings reported by the O&P Almanac  in April 2015 that nearly 90 percent of O&P practices use central fabrication services to some degree.

Jeffrey Brandt, CPO, CEO of Ability Prosthetics & Orthotics, Exton, Pennsylvania, believes that over 50 percent of O&P companies are using CFabs, which is more than ever before—and that's a good sign. An early and active advocate for increased reliance on central fabrication, Ability makes use of an even broader array of central fabrication options by considering virtually all CFab labs.

"We profile our manufacturers, so we have a solution for every kind of case. This provides us with many more product offerings for our patients—and more scope for creativity in determining features and benefits of limb or brace design—because we're not limited by a desire to keep the device in-house or use one of just a few labs."

After doing his own comparison studies as a resident in two O&P practices where attitudes toward central fabrication were vastly different, he founded Ability 14 years ago as a 100 percent CFab-dependent practice. In response to the unusual business plan, people reportedly stopped him at conferences to ask, "What the heck are you doing?"

He founded Ability armed with the most advanced smartphone available in 2004, a Sony camera, internet, and laptop—and discovered how easy it was to communicate with manufacturers, who had orthotists and prosthetists on staff. "I was able to rent smaller square footage because I didn't need a lab on-site—and the air quality in my practice was wonderful because I wasn't fabricating on-site."

In addition to having more to offer patients, Brandt believes using CFabs also made it possible for him to increase his clinical productivity and shift his professional value proposition by seeing more patients each day, instead of spending a third of his time in the lab.

"I challenge the fabrication portion being included in our scope of practice," he argues. "To survive the path where healthcare is going, I know you have to get out of the back and in front of your patients—and away from your own lab's limited repertoire of what you can make with your own hands. We don't possess the hand skills or talents to solve all of our patients' needs.

"If we're not seeing more patients with the found time, we should be spending that time recording a better outcome, writing a treatment plan, making calls on physical therapists or physicians, or at a conference or in-service—elevating ourselves as a profession," he says.

After owning his own clinical practice for 20 years, Shandon Hime, CPO, FAAOP, Anatomical Designs, Bridgeport, West Virginia, says he is such a strong believer in the value of central fabrication that he recently started his own CFab on a small regional scale. At present, he is his own best customer but anticipates taking on additional work from other O&P facilities soon.

Hime noted that central fabrication is gaining in popularity, kicked off by the costly economics of maintaining and operating one's own fabrication facility. His use of CFabs mirrored the trend, increasing from 5 percent to about 20 percent during his 20 years in business.

Several sources credited the O&P master's programs with turning out new clinicians who have a focus on patient care and management, and minimal knowledge of fabrication, and Hime agrees.

Recognizing and anticipating a growing market for fabrication services as these clinicians enter the profession, he says, "I believe it's the evolution of our profession. A while back, dentists used to make their own appliances—now they send them out to a lab and let somebody else fabricate them. Looking back to our roots as orthotists and prosthetists, the orthopedic surgeon used to make the prosthesis, and we evolved out of that."

The education that newer clinicians are receiving, the need for increased documentation, and the recent law that makes clinician notes again part of the clinical record have caused priorities to change, he says, agreeing that patient care responsibilities leave little time for fabrication tasks.

His goal for his CFab is to ensure that it is on the cutting edge of automated processes. "We have our own CAD/CAM system. We have CNC [computerized numerical control] equipment from outside O&P that we have adapted to do O&P work. I think in three to five years a lot more of what we do will be 3D printed as the printers come down in price and the durability of the devices they create is improved. So, as technology becomes more mainstream in O&P, I see the role of a central fab to be heightened in the sense that a central fab that has invested a lot in technology will probably be able to turn out a really high-quality product at a lesser price point."

Alexander Lyons, CPO, Lyons Prosthetics & Orthotics, Conway, South Carolina, demonstrated his commitment to central fabrication by taking a step in the opposite direction. After starting as a technician 25 years ago—while going to school to finish prerequisites for O&P school—Lyons chose, like Brandt, to establish a practice of his own and designed it specifically to work around central fabrication.

"I started this practice doing 100 percent CFab 14 years ago, and I'm still at 100 percent," he says.

Designing such a practice allowed him to choose a smaller space with a smaller lab, which is used for modifications and adjustments. It decreased his overhead by eliminating the cost of large-scale fabrication equipment and the need to have a technician on staff.

"It also gave me a sense of quality control, since I could go to the best technicians out there and have them make an AFO or an artificial limb or a laminated brace and get the best result. I'll come up with a design, but I need the best technicians out there to execute it."

Like Snell, he chooses a few labs that excel in their field. "I don't stick to one lab. Probably on a regular basis I use five labs, depending on what their specialty is, and how well they do it. I have one lab specifically for orthotics, one for prosthetics, another for custom-molded inserts, and another for laminations and things like that, and I'm loyal to them.

"If they're really busy, I start searching out other options, and over the years I've had to find other sources because the lab became too busy."

There are always other labs happy to serve, Lyons notes, and to build a good working relationship with a customer who pays his bills on time and is reasonable to work with.

That relationship and good communication are key to exceptional results, he says. "I have them all on my cell phone. I communicate; I send pictures; I've been on video conference calls with the technicians. So, it's easier now, with the technology we have."

Brandt agrees with the sentiment, and encourages collaboration in the form of dialogue, accurate communication and feedback, but cautions against approaching CFabs with unfair or unrealistic expectations. "If you just use outsource manufacturing occasionally, for your hardest jobs, you never really get to close the learning curve. So you're always starting over. You can't half-participate in outsourced manufacturing and expect that you're going to get the best results," he warns.

The evolution of CFabs as partners also appears to be leading clinicians into increasing and professionally appropriate responsibilities in patient management, some believe.

"I'm finding, more and more, that we, as O&P clinicians, are more involved with the overall care of the patient; we're directing care, asking questions, making sure patients are getting therapy as needed, for example, or seeking their physician's advice, if warranted," says Lyons.

"Practitioners interact with patients in this population more than anybody on the team, usually," Brandt agrees. "The doctor doesn't see them as often as we do."

In fact, Wynne believes that the O&P profession has become so much more technologically advanced that the skill set now required for a practitioner includes expertise with computer programs and scanning technology. "Such advances have improved the patient experience and the quality of the device provided. Expertise in CAD is required—the central fabrication facilities have highly skilled and trained technicians that know these programs and are efficient in their use."

As with any new skill, the more opportunity one has to practice, the more proficient one is likely to become. Increased use of central fabrication allows clinicians more time to nurture and improve their computer and scanning skills through serving a larger volume of patients.

The rapidly evolving scanning technology alone may be driving more practitioners to embrace outsourcing: Boston O&P's central fab is creating all Boston Brace 3D and Boston Band orthoses from scans of the patients, says Wynne. "We teach scanning methods to clinicians, and so we're definitely seeing a change and a transition, with more people interested in utilizing the technology. Having an electronic history of the patient, it's simpler to send a scan of the patient to us for fabrication and allows [the clinician] to be much more efficient in the clinic. The feedback that we're hearing from the clinicians is that now they can spend their time clinically analyzing the fit and function of the device."

Another consideration may soon be pushing facilities toward increased CFab use, Snell points out. O&P's customer base is expanding as baby boomers age and demand for care increases.

"We're having more and more challenges getting good, experienced practitioners," he points out. "The schools are not turning them out fast enough, and the competition between facilities to recruit new graduates is sometimes intense. Right now, it's business as usual for us, but the more we get strapped for personnel, the more we'll need to outsource.

"I can hire more technicians and teach them those skills, but it gets a little expensive, and it gets a little crowded in the lab."

Do Patients Care Who Makes Their Devices?

"I don't think patients care that much about it, as long as the outcome is high quality," Snell says. "If we make a device in-house, competitors claim they send it to a specialty lab because only qualified people can do the job properly; if we don't make it ourselves and they do, they claim to have more control over quality and accuracy in-house. It's all in how you spin it."

"This is going to be one of the last barriers to fall in O&P," Brandt believes. "Most of our patients have no clue where the device is fabricated, but surveys show their assumption is that it's somewhere else—of course. They're aware that dentists don't make dentures themselves, and likewise, their surgeon isn't pounding the hip joint replacement out of metal in his basement lab the night before surgery.

"The value proposition to the patient is in the care we provide, the clinically sound device design, and the follow-through on outcomes measures."

Best-in-Class Outsourced Manufacturing
It's all about perception, Brandt says. The battle lines have been drawn for so long, and convictions so strongly held by those in favor and those opposed to increased use of central fabrication that the term CFab or central fabrication itself is outdated and doesn't accurately define the process of manufacturing limbs and braces, he claims.

His solution is to spin the label into one more appealing—as used by other professions: best-in-class outsourced manufacturing.

"Best-in-class manufacturing implies that I'm vetting people, and that I'm cutting some manufacturers out of the loop once in a while because they don't meet the standard," he explains.

On a related note, in a recent rebranding move, the former Snell Prosthetic & Orthotic Laboratory changed its name to Snell Prosthetics & Orthotics, de-emphasizing the laboratory or fabrication aspect of its service.

In further advances toward creating a more professional image, certain CFabs are standardizing their processes—possibly in anticipation of a long-discussed potential move by the federal government to implement manufacturing standards and establish oversight, as has already been done in the case of cranial remolding helmets.

"In anticipation of this oversight, these major fabrication labs are working to institute procedures and standards that encourage practitioners to recognize that their fabrication results are consistent and reproducible," Brandt notes, reflecting that Ability's practitioners, and ultimately patients, benefit from the consistency and reliability of these products, and the security of knowing manufacturing standards are in place.

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.