April 2018 O&P News

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THE ORTHOTIC & PROSTHETIC COMMUNITY NEWS SOURCE

Patient Advocacy: One Woman's Personal Campaign PG.12 Clinical Trials: Our Relationship With the Payor Goes Beyond Mere Reimbursements PG.14

A New Case Study:

The O&P Student

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Considerations for the Development of 3-D-Printed Upper-Limb Prostheses PG.18 PLUS

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Next Generation of Technicians PG. 32

O&P VISIONARY:

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Vol. 27 • No. 4 | April 2018

Departments & Columns 28 State by State

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A monthly column dedicated to the most important state and local O&P news.

29 Ad Index 30 Classified Ads 31 Meetings & Courses

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COVER STORY

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32 Tech Tips Mentoring the next generation of technicians.

A New Case Study: The O&P Student How are today’s O&P students being educated, and how do they expect to contribute to the O&P profession in today’s complex health-care environment? Five O&P graduate students—Alyssa Haus, Alexis Gagliardotto, Jovan Gonczar, Yona Cloonan, and Ryan Sharry—share their experiences and insights.

By Yelena Mazur

FEATURES

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On the Move for O&P Advocacy More and more, O&P advocates are seeking to educate the general public about the importance of ensuring O&P patients have access to the most appropriate orthotic and prosthetic technology. Learn how amputee Nicole Ver Kuilen designed her own awareness event, a 1,500mile running, biking, and swimming journey down the West Coast.

Research & Presentations 14

Clinical Trials: Our Relationship With the Payor Goes Beyond Mere Reimbursements

By Michael Wininger, PhD

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Considerations for the Development of 3-D-Printed Upper-Limb Prostheses

26 O&P Visionary Rick Fleetwood calls for changes in reimbursement practices and greater participation in advocacy for the profession.

By Jorge M. Zuniga, PhD; Matthew J. Major, PhD; Jean L. Peck, OTR/L; Rakesh Srivastava, MS, CPO; James Pierce; and Nicholas Stergiou, PhD

O&P News | April 2018

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COVER STORY

A NEW CASE STUDY:

The O&P Student

By Yelena Mazur

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O&P News | April 2018

W

e’re all familiar with the common phrase, “Children are the future,” or something resembling the sentiment. If this is a common understanding, why are students of O&P predominantly left out of the conversation regarding the future of the profession?

Students are rarely questioned about their education, experience, or expectations. With a high demand for O&P research and data, it is surprising that students aren’t sought out and questioned about the necessary means to provide a prime environment and tools for producing optimum, credible, and perennial data. If we’re neglecting our students, what precedent are we setting for future patient care?

AOPA decided to capture this missing dialogue and perspective by interviewing five O&P graduate students who attended the 2018 AOPA Policy Forum in March.

COVER STORY

Alyssa Haus Alyssa Haus, 23, is a first-year student at the University of Texas (UT) Southwestern Medical Center master of prosthetics-orthotics (MPO) program in Dallas.

Determined to work in the health-care profession, she had originally thought physical therapy (PT) was her calling.

But after shadowing the PT profession during her undergraduate career, “I knew something was missing. It didn’t feel like a full fit,” she says. “I had a family friend who worked the front desk at an O&P clinic, and I decided to shadow the practice. From that experience, I knew that I wanted to work with patients, and working with my hands was an ideal fit for me. O&P was not something that they talked about in college as a career possibility.”

Haus, who is set to graduate in December of 2018, is currently taking a lower-limb course, biomechanics, a research course, and an interprofessional course that encourages students to interact and engage with various health-care specialties apart from their own, including PTs, physician assistants, clinical nutritionists, etc. All O&P courses have a lab component, and students are readily fabricating the devices they learn about in class. Haus also is taking a 30-hour elective lab skills course this semester, where she is able to witness her professors as practitioners in the UT Southwestern on-site facility; there she also is learning tips of the trade from technicians. She cites this easy access as a definite benefit of the program. “It’s great to actually learn from professors who are currently in the field and are up to date on their skills and active in practicing and evolving methods of patient care.”

A typical day for Haus begins with a class, lab, or clinical lab hours from 8:30 a.m. until noon. Following a brief respite, she attends another lecture or lab, or has clinical hours from 1:00 to 5:00 p.m. When most professionals are calling it quitting time, the day is far from over for Haus and her class

Alyssa Haus

of 11 students. There is much studying to be done, group article reviews to complete—not to mention the interminable assignments in lab.

Along with completing all of their coursework, O&P students must maintain a C or higher grade average in each course, have a GPA of 2.7 or higher, and demonstrate clinical competence and professional etiquette in order to receive their master’s degree. O&P-specific courses have two to three exams per semester, which can take the format of

written, oral, and practical exams. All final exams bear these three components to familiarize and prepare students for the style of the clinical board exams postresidency. “I’m hoping to learn more problem solving skills. It’s one thing to possess the book knowledge and hand skills, but I want to be able to problem solve for those unique patient situations.

It’s also important for an O&P program to prepare me to readily work with and access other health-care professionals,” says Haus.

Although Haus has a predilection toward pursuing pediatrics during her residency, she understands that keeping a general and broad focus would allow her to see and gain hands-on experience with the vast array of the O&P population.

She plans to start applying for residency programs this summer and encourages future students, who have not yet applied to a graduate program in O&P, to shadow O&P facilities and gain experience.

“There are many great schools, but the right fit is incredibly important to find,” she says. With her numerous clinical lab hours and hands-on experience, it’s safe to understand why Haus is keen on finding the perfect fit.

Student meeting at the AOPA 2018 Policy Forum

O&P News | April 2018

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COVER STORY

Alexis Gagliardotto Alexis Gagliardotto, 21, is into her third and final year of her O&P education, expecting to graduate in April of 2018.

Her class was the last to graduate from St. Petersburg College, which recently ended its bachelor’s program. She transitioned to Florida International University, which offers a one-year master’s program in O&P online.

A Florida native, Gagliardotto discovered the O&P profession during high school, while interning for Westcoast Brace & Limb Inc. on summer break.

“Literally the first day of my internship, I knew that’s where I needed to be,” she says. Gagliardotto had already accumulated 320 clinical hours by the completion of her undergraduate career.

Alexis Gagliardotto

A day in her O&P undergraduate schedule mirrors that of Haus’s master’s program. Students spend four days a week in classes, lectures, and labs, followed by a day of clinical rotation at an O&P clinic, which differs each semester. A few of her rotations were spent at a Hanger Clinic location and Shriners Hospitals for Children.

Although her current coursework is online, the master’s program still requires students to maintain one day of clinical rotations per week. In a class of 12 students, most are interning or working as fitters. “You can’t just be in an online

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O&P News | April 2018

program and not keep up with your clinical skills. The master’s program is quite unique—it heavily incorporates engineering dimensions and how that integrates with O&P. It’s about stepping back and seeing the bigger picture of manufacturing different O&P componentry and being able to handle and design different devices by applying the research aspect as opposed to just clinical skills.”

Being in an online degree program can be a double-edged sword, admits Gagliardotto. There’s risk of regression if you’re not motivated enough to garner the imperative technical and patient skills. Students are still expected to accrue between 60 and 80 clinical hours a semester. “I am with the clinician more times than not. It’s 50/50 between seeing patients and fabricating,” she says. During rotations, students are asked to identify the pathology of any given patient, demonstrate competency in using a specific device, and anticipate the best case scenario to obviate any possible complications. Students are graded on how they present a patient during rotation. All coursework exams are proctored online through a computer-based webcam.

Classes in Gagliardotto’s program include statistics, project engineering, and engineering project management, where students must design and facilitate an entire engineering project that serves as an added value toward a lucrative business model. Gagliardotto chose to redesign a lawnmower and overhaul the safety features. Although the program does not have an official capstone requirement, Gagliardotto took a capstone class during her years at St. Petersburg College, where students had to review all of their O&P clinical skills through exams.

Group projects are another requirement for the online-based degree. “I actually view this as a benefit to an online program. Not only are you constantly learning how to manage your time, but you’re forced to accommodate

your schedule with other students in the program who are out of state,” says Gagliardotto. “All these challenges resemble those in the health-care world. I’m going to have to coordinate with physicians and patient-care teams with different barriers and scheduling restrictions. Learning to work through these barriers now will help you in the long run since patient care can get messy and complicated with more people involved.” Students regularly work in groups to complete critically appraised topic reviews, a process that requires keen discernment with detailed assessments in literature reviews of O&P research.

Gagliardotto hopes that her current skillset will serve as a launch pad to the residency programs she is applying to—a list that includes the Orlando Department of Veterans Affairs—Partners of Nemours Children’s Hospital, where she recently had an interview. “I prefer to undergo residency in a structured hospital setting, even though I just learned today that only 12 percent of residency sites are hospital based,” she says. Her goal is to complete a year in orthotics and a separate year in prosthetics; a dual 18-month residency in O&P does not meet the state licensure requirements for Florida.

Gagliardotto is already looking ahead into expanding her skillset with an interest in anaplastology, the fabrication of prosthetic facial parts for burn victims, cancer patients, and others. This particular profession is highly specialized and would require more education. The prospect of additional schooling doesn’t phase Gagliardotto, whose unremitting enthusiasm and insight could challenge any myopic approach to health care.

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COVER STORY

Classmates are not only forever friends, but they’re the first professional contacts a young clinician may make—and those relationships are invaluable, especially for nascent professionals trying to penetrate the health-care industry.

Jovan Gonczar Jovan Gonczar, 31, will be walking across the stage this spring when she receives her graduate degree in O&P from Eastern Michigan University. For some, health care is a profession; for Gonczar, it’s a lifestyle.

For several years, this emergency medical technician licensee worked in an organization helping children and adults with disabilities learn how to ride bicycles in order to stay mobile and safe in their communities. Along with being a health director of a children’s camp, she held an internship working on lifestyle management of stroke patients and spent time shadowing their PTs. Once she was exposed to the O&P industry, she knew she had found her niche.

Gonczar has already accepted a 12-month orthotic residency position with Wright & Filippis, the largest O&P company in Michigan. “I’m fortunate enough that Wright & Filippis has many patient-care clinics around the state so I can experience a diverse population firsthand,” she says.

She credits her dynamic O&P program with preparing her for residency and the future. Classes focus on specific and specialized areas of the body, components, and methodology in order for students to discern how to approach each patient with a variety of factors. Classes focus on spinal orthotics, lower-limb orthotics and prosthetics, gait, research

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O&P News | April 2018

Jovan Gonczar

methods, and advanced techniques— where different guest speakers, including O&P clinicians, address the students on specialty areas in O&P. Lectures encourage hands-on experience as students examine each other’s range of motion and conduct manual muscle testing.

Mornings begin with several hours of lecture, followed by a patient model demonstration in the afternoon.

Students evaluate the patient and may take a cast to develop in the plaster lab while simultaneously fabricating. Typically there are modifications to be done on a prosthesis.

After a full day, Gonczar tackles her co-authored capstone project. “It’s an anatomical model of the shoulder, implementing pressure sensors on different bony prominences, to be used as a

teaching model for students,” she says.

“Palpation is a really important skill to master, and this model gives you feedback that you’re palpating the correct area.” Providing students with the best tools will only serve them and their patients in the long run. Undoubtedly, a practitioner cannot provide a service that he or she is unfamiliar with.

It is with this open mindset that Gonczar was not only able to accrue more clinical hours, but also discover new methods and cross-cultural techniques by spending several weeks in Mexico and five weeks in Ecuador. “Our program director put me in contact with Marlo Ortiz, a practitioner in Mexico, who was willing to open and share his approach to O&P care. I learned about Ecuador through a previous student who had gone through that rotation,” she says. Gonczar is aware that not everyone has the means to garner experience abroad, but it’s not the place that matters, it’s the overall experience, she says. She advises future students to proactively form connections and seek additional opportunities to foster personal development.

As with any profession, networking is a lifeline. Classmates are not only forever friends, but they’re the first professional contacts a young clinician may make—and those relationships are invaluable, especially for nascent professionals trying to penetrate the health-care industry. Like Gagliardotto, Gonczar serves on the Student-Resident Committee for the American Academy of Orthotists & Prosthetists. She praises the committee’s efforts to engage with students and provide a well-rounded view of O&P outside of the classroom.

For students, guidance and mentoring are the preferred currency.

There is no rest for this health-care professional. After completing her orthotic residency, Gonczar plans to take the board exams and become a certified orthotist, concurrently applying to complete a prosthetic residency.

COVER STORY

Cloonan also believes kinesiology should be required as a prerequisite because simple body mechanics prove rudimentary to O&P. Yona Cloonan, PhD If you’re reading this article and surreptitiously racking your mind for your own “A-ha” moment, be advised that there’s a notable difference between the uncertain and the indolent. The uncertain can be a beautiful place to experience growth while you map out your path. For Yona Cloonan, PhD, one sees a nonlinear trajectory.

Cloonan, 42, was exposed to O&P at an early age after her brother was born with cerebral palsy. “I knew he had an orthotist and had to wear braces, and yet the reality and the proximity were just too close to home for me to separate his special patient-care needs from my own,” she says.

Cloonan has a PhD in epidemiology and has served on the faculty at the University of Pittsburgh for five years.

She now adds “first-year O&P graduate student” to her academic career at said university. A concatenation of factors persuaded Cloonan to pursue the O&P track. “There’s incentive with the population I’m interested in, pediatrics. I grew up knowing kids with spina bifida, and with my brother who has cerebral palsy. When I was doing research for my former graduate program, I would come across those populations a bit. Even with positional plagiocephaly, I was curious about whether cranial helmets actually work. The way I see it, I’m still in health sciences, I don’t have to waste or forfeit my research degree, and I can apply it while I’m currently executing evidencebased practice,” says Cloonan.

The ultimate deciding factor to pursue O&P stems from the numerous enervating hours Cloonan has spent

Yona Cloonan, PhD

staring at a computer screen. In graduate school Cloonan would take classes, attend to her research assistant job, and then relish getting her hands dirty through pottery classes. Pottery curtailed the mundane; however, postgraduate life proved less than gratifying. “Before I would just sit behind a computer and each row was data, and each row of data was a person,” she says. “I can’t do that anymore. I want to see the person, interact with the person, and witness the immediate outcome instead of possibly waiting years for a piece of paper.”

Although interaction with patients commences next semester, the 24 students in her class practice casting on each other for experience and feedback.

Cloonan’s coursework features transtibial prosthetics and lower-extremity orthotics classes, full days spent fabricating in the lab, and lectures provided by visiting practitioners. She will be expected to complete a capstone project before graduation and will need to fulfill a clinical internship in the spring of 2019.

With an extensive academic background, Cloonan staunchly supports the university’s requirement of prerequisite courses, which include anatomy, physics, basic sciences, statistics, and a minimum of 250 observation hours before applying at the graduate level. The prereqs help determine whether a certain program is right for a specific student, she says. Cloonan also believes kinesiology should be required as a prerequisite because simple body mechanics prove rudimentary to O&P. After all, how does one begin to assess gait? She also understands that a substantial amount of know-how will be gleaned from an intensive residency program, which she hopes to find in Pittsburgh.

Cloonan does not want to focus on pediatrics alone, fully aware that may limit or hinder the general scope of an O&P career. “I don’t want to specialize because I understand how that can trap you. I also have taught and love teaching. Whether I mentor future students or provide assistance in the lab, I’m open to variances,” she says.

Cloonan’s well-rounded history and years in academia propel her to provide feedback about a lack in general diversity within the O&P program, as well as the high costs of O&P education. “There should be more funding opportunities for students; it is really expensive even though I receive in-state tuition,” says Cloonan. These concerns are worth investigation for O&P programs that strive to attract the most qualified student pool.

Regarding the AOPA Policy Forum, Cloonan says, “I think that it’s a great benefit to the student attendees to learn about policies impacting the field and changes that are being proposed and pushed by AOPA. It also was a great opportunity to network with other students and O&P organizational leaders.

I think that having students go with other delegates from their states provides an excellent opening to discuss internship or residency opportunities in an open and frank manner.”

O&P News | April 2018

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COVER STORY

It’s important to recognize the diverse experiences at different residency programs, according to Sharry.

“Some places require you to commit to a permanent position afterwards while others make no guarantees and stress the unlikelihood a position will be available postresidency,” she says. “Some offer the 18-month dual residency or just the oneyear option of either prosthetics or orthotics.” Sharry will have to take all of these factors under consideration as she heads toward her own residency experience.

She is eager to work with her hands and witness the newfound independence of her future patients. She remains focused on gaining and perfecting her skillset to provide optimal care for those who will come to depend on her expertise.

For O&P students, hands-on experiences serve as preparation for residency opportunities.

Ryan Sharry Ryan Sharry, 22, is no stranger to the sometimes precarious position of O&P in academia. A first-year student at the Georgia Institute of Technology graduate program for O&P, she is facing challenges as the university’s School of Sciences makes changes to its interdepartmental O&P program. “We [the O&P program] unjustly got deactivated.

We are not closed as a program, but they are not accepting students for the fall,” she says. While nothing is official, “they’re saying it’s just a necessary pause to figure out how we’re going to readjust as a program.”

Sharry says a recent high turnover in faculty has the School of Sciences weary to house the O&P program under its jurisdiction, let alone provide future funding or support. Sharry, who has a bachelor’s degree in biomedical engineering, hopes that the O&P program moves to unify under the Engineering School, which has already proven its support through collaborations with the O&P program.

Despite the unknown future of the O&P program, Sharry believes her current O&P education excels in providing students with superior knowledge and skills. Students are required to complete 500 clinical hours and an O&P-based research project, and to excel during interview simulations that mirror a case study. During these simulations, students must interact with a

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O&P News | April 2018

Ryan Sharry

patient model and conduct a patient evaluation, including muscle testing.

There are checkpoints and requirements that must be met before a student may advance in the program. It’s an automatic “fail” if students do not introduce themselves or forget to wash their hands.

Sharry has accumulated clinical hours with Hanger Clinic and is presently at ProCare. “I know some students who work at a late-night pizzeria somehow, but my schooling is a full-time job,” she says.

For O&P students, hands-on experiences serve as preparation for residency opportunities. Sharry recently participated in a roundtable discussion with residency directors at a meeting of the American Academy of Orthotists and Prosthetists.

The Road Ahead Despite various backgrounds and perspectives, students and practitioners share a common anxiety concerning the health-care model. Practitioners worry about what’s next for patient care whereas students share trepidation about being equipped with the best knowledge and skillset to prepare them for any given scenario.

In reality, their concerns are the same, and their goals are similar: O&P is about improving the quality of life for each individual. Going forward, it will be necessary to set the best in education standards to promote ideal practices. If O&P is to succeed as an undoubtable and credible profession, recognized by the entire health-care industry, it is the O&P student who lays the foundation.

Students have much to learn from their future cohorts, and those in the field must design and maintain the best possible outcomes in O&P. Pragmatically, the day you stop learning and being a student is a day to announce your retirement. Now, for the sake of present and future O&P patients, get back to work.

Yelena Mazur is membership and meetings coordinator for AOPA.

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On the Move for O&P Advocacy Athlete takes on 1,500-mile triathlon to send the message that prosthetic componentry should be accessible

N

icole Ver Kuilen is no stranger to facing challenges and overcoming obstacles. In fact, it is central to her existence—as an athlete, as an advocate, and as a person living with limb loss. She has just completed a 1,500-mile triathlon down the West Coast; along the way, she shared her own story and advocated for legislative changes to improve health-care coverage for prosthetic services.

Ver Kuilen was diagnosed with bone cancer when she was 10 years old. A few months after her first chemo treatment, her medical team determined that her leg would need to be amputated to save her life.

Learning to use a prosthesis is a challenge, but children are resilient, and Ver Kuilen was soon ready to get moving.

That summer, she was faced with an obstacle that she didn’t know how to overcome. “All I really wanted to do that summer was go play in the water with my friends, but I learned that my leg wasn’t waterproof,” says Ver Kuilen.

Growing up near the Great Lakes in Michigan, Ver Kuilen was looking forward to the summer traditions: playing in the water with her friends and visiting the water parks. Even showering became a limitation. Her family wrote to its insurance provider to request approval for Ver Kuilen to receive a waterproof prosthesis so that she would not have to face these types of limitations for the rest of her life.

O&PNews News | | April April2018 2018 12 12 O&P

From left, Natalie Harold, MSPO, Nicole Ver Kuilen, David Boone, PhD, MPH, Tom Fise, and Sen. Ben Cardin (D-Maryland)

Insurance denied the request. “They wrote back and said [a waterproof device] is a convenience item, and it’s not medically necessary; so, we didn’t really push it because we thought, ‘No,’ meant, ‘No,’” says Ver Kuilen. This was her first experience with being denied access to the prosthetic care she wanted and felt she needed.

When she was 16, she again encountered a challenge in accessing a device she felt she needed. Engaging in a high level of activity was causing a lot of breakdown to her prosthesis—but Ver Kuilen was denied by her insurance company for a running prosthesis, despite her need for better technology to stay active.

“It wasn’t really until this past year that I just got fed up with the system and the fact that I had been dealing with

the same barriers over and over again for 16 years,” says Ver Kuilen. She was in the process of having a new prosthesis built and trying to find something that insurance would cover that would allow her to continue running half marathons and competing in bike races. “After jumping through all the hoops, 26 appointments and a year later, I basically had to settle for the same technology that I’d had for the past five years,” she says.

Motivated by her own challenges with access to appropriate prosthetic technology and care, combined with a growing awareness that so many others are unable to access the prosthetic care they need, Ver Kuilen launched ForrestStump.org and began planning a 1,500-mile journey: running, biking, and swimming down the West Coast.

Ver Kuilen’s teammate and clinical support during the Forrest Stump journey, Natalie Harold, MSPO, says, “I have to commend Nicole for the idea of Forrest Stump, because the whole goal wasn’t out of a place of selfishness. She had faced the same barriers over and over for 16 years, but she didn’t set out to get attention or raise money for herself. It was all bigger in scope.”

Harold is new to the O&P profession but wants to see more people living with limb loss gain access to the appropriate technology for their prosthetic needs.

“We’re not advocating for every amputee to get a running blade because that is not appropriate for every amputee,” she explains. “We’re only asking that the technology that is available be accessible, when appropriate, to all amputees.”

Ver Kuilen and Harold joined David Boone, PhD, MPH, and University of Washington O&P student Justin Rheault for Hill visits during the 2018 AOPA Policy Forum.

Nicole Ver Kuilen’s Call To Action Visit www.MobilitySaves.org for a video debrief, where you’ll learn more about the Forrest Stump project, the “1,500 Miles” documentary in progress, and athlete Nicole Ver Kuilen’s experience in meetings with members of Congress on Capitol Hill during the 2018 AOPA Policy Forum.

Here’s a sneak peek at Ver Kuilen’s call to action: “I’ve been an amputee for 16 years, and nothing resonates more with me than the fact that I had my amputation on Martin Luther King Jr. Day. In a speech that he gave, ‘The Fierce Urgency of Now,’ he spoke about us (citizens) getting more involved. For me as an amputee, I don’t want to wait any longer to have access to prostheses.

“I think we can all band together to use our collective voice. My voice alone is very small, and in the amputee world, there are only 2 million of us, which is a very small percentage compared to the number of total people out there. So we need more people to advocate, to help lift my voice and the voices of other amputees.

“I want to invite people to come with me to Washington, D.C., as part of Forrest Stump, as part of AOPA, to advocate for prosthetics and orthotics—to push policy forward that is going to open up access to technology and care that will really empower people in their lives.”

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Research & Presentations

Clinical Trials: Our Relationship With the Payor Goes Beyond Mere Reimbursements

By Michael Wininger, PhD Introduction Clinicians are reimbursed for their services when they provide approved treatments for patients with covered indications, i.e., symptoms or diagnoses that are recognized by the payor as valid reasons for prescription. Payor policy is determined by panel review of the best available information regarding treatment efficacy. There are five main sources of information on which policy is written: clinical science, meta-analyses, professional guidelines, expert guidance, and stakeholder opinion. Stakeholder opinion is expected to be experiential in nature: a forum for the patient, the family member, the nonprofit, etc., to speak to the human element of medicine.

The four remaining forms of information are mostly or entirely empirical.

And these branches of information all share a common root: the clinical trial.

A View From the Outside As a case study, consider the implantable cardioverter defibrillator (ICD), a biomedical device with a long history of coverage determination review by CMS. The ICD was first approved for implantation by the U.S. Food and Drug Administration (FDA) in 1985, and the first CMS coverage determination letter was published in 1986, with several reviews to the national coverage determination (NCD) over the subsequent 30 years.

Table 1 A Brief History of CMS Coverage Determinations for the Implantable Cardioverter Defibrillator 1985 FDA approval of first implantable defibrillator 1986 Coverage for life-threatening ventricular tachyarrhythmias 1991 Ventricular fibrillation not due to transient or reversible cause 1999 Demonstrated or risk of developing ventricular tachyarrhythmia 2003 Previous myocardial infarction, low ejection fraction, wide QRS interval 2004 Clarification of device investigational device exemption Category B 2005 Expansion of device-eligible patient categories 2018

14 O&P News | April 2018

Clarification of eligibilities, exceptions to waiting periods, ending registry requirement

Research & Presentations

In the late 1980s and 1990s, a series of large-scale, multicenter randomized clinical trials was designed in order to test the safety and efficacy of the ICD in various subpopulations. As these trials completed in the late 1990s and 2000s, CMS reviewed its coverage determination, which included specification of the ICD’s investigational device exemption (IDE). As this wave of clinical trials ebbed, the ensuing 15 years brought guidelines development by professional societies, additional clinical trials, and meta-analyses.

The trend is obvious: In a period when clinical trials are abundant, national coverage determinations undergo regular review and revision; once the clinical trials have subsided, experts are able to establish consensus practice guidelines, integrate plural data pools through reflective meta-analyses, and carry out more focal clinical trials to refine the knowledge base.

Connection to O&P There are 345 national coverage determinations listed by CMS; only two (Prosthetic Shoe, 280.10; and Durable Medical Equipment, 280.1) pertain to prosthetics and/or orthotics (it is noted that 280.1 points to a more detailed Chapter 20 of the Medicare Claims Processing Manual “Durable Medical Equipment, Prosthetics, Orthotics, and Supplies, DMEPOS”).

By contrast, there are 45 NCDs for the cardiovascular system (plus many additional heart-related therapies listed in other categories), and 19 NCDs for the renal system (plus many additional items in other categories). Per clinicaltrials.gov, there are nearly 14,000 clinical trials registered matching to “heart OR cardiac” as condition or disease, and nearly 7,500 trials registered matching to “kidney OR renal.” There are fewer than 500 trials matching to “prosthetic OR prosthesis NOT valve NOT eye NOT dental,” and most of these appear to pertain to prevention or management of

Table 2: Field Developments Cited in the CMS National Coverage Determinations (NCDs) Precipitating NCD Reviews 1999-2005

1996

MADIT Clinical Trial

1997

CABG-Patch Clinical Trial

1999

MUSTT Clinical Trial

2002

MADIT-II Clinical Trial

2002

DAVID Clinical Trial

2002

CAT Clinical Trial

2006

ACC/AHA/ESC Guidelines

2003

AMIOVIRT Clinical Trial

2008

ACC/AHA/HRS Guidelines

2004

DEFINITE Clinical Trial

2009

IRIS Clinical Trial

2004

COMPANION Clinical Trial

2012

2004

DINAMIT Clinical Trial

2013

2005

SCD-HeFT Clinical Trial

2013

AHA/ACCF/HRS Guidelines Eight-agency Appropriate Use Criteria ACCF/AHA Guidelines

2013

Uhlig Meta-Analysis

2014

Expert Consensus Statement

2014

Colquitt Meta-Analysis

2015

ESC Guidelines

2016

DANISH Clinical Trial

2017

AHA/ACC/HRS Guidelines

2017

Golwala Meta-Analysis

surgical joint replacement, not artificial limbs. Here we see further demonstration of the association between clinical trials and Medicare footprint.

What Can We Do? In order to get the attention of CMS, a clinical trials framework is needed within the orthotics and prosthetics community. CMS explicitly references the canonical Levels of Evidence in its own decision memos, expressly prioritizing multisite clinical trials in its review, itemizing the design aspects that they feel strengthen or weaken studies.

Precipitating NCD Reviews 2018

By using these principles as a guide, we will position ourselves to be maximally relevant and impactful with CMS and the broader scientific community.

By promoting well-designed and wellexecuted studies, we will demonstrate the worthiness of our innovations as part of the formulary of treatment options.

Who Can Do It? Integration of clinical trials into O&P requires evolution, in terms of both culture and infrastructure. The clinical scientists among us will readily embrace a clinical trials enterprise and can adapt easily.

O&P News | April 2018

15

Research & Presentations

Table 3: Design Considerations That Increase or Decrease Influence in CMS Review Enhancements

Detriments

Prospective design (cf. retrospective)

Differential measurement of outcomes (detection bias)

Masking (“blinding”) of participants or study personnel

Differential compliance or reporting rates (attrition bias)

Incorporation of a control group

Study population does not generalize

Demonstration of statistical support

Co-morbidities pose competing risks

Randomized allocation of patients to study arm

Treatment interacts with other interventions

But we’ll need to recruit the tinkerers, the gadget geeks, the technicians, the designers, and the purist clinicians among us to add an extra dimension to their mindset: Can you make your invention ruggedized for deployment in a patient trial?

Can you refine your technique so that a uniform approach reduces variability in the treatment effect? Can you introduce a research element into your clinic visit in a way that balances both the patient’s need for treatment and also the field’s need to gain evidence of treatment safety and efficacy through empiric means?

We’ll need to attract diverse professionals into the field, including data management specialists, statisticians, regulatory experts, and those with expertise in quality assurance and human rights.

Training Because the clinicians are the drivers of clinical science, the graduate training programs are the most logical venue for instilling the fundamentals of clinical trials. The standards put forth by the National Commission on Orthotic and Prosthetic Education for the MSPO degree require an understanding of the

16 O&P News | April 2018

research process and of using research findings to influence clinical practice; as well as formal training in research methods and completion of a research or capstone project. The methodologies associated with a clinical trial are niche, and more commonly taught in the context of an MPH or an MS in biostatistics. But it is conceivable that the basic elements of clinical trial design can be delivered in a brief, but cogent and informative, module as part of a research methodology course.

Randomization, stratification, batch effects, survival analysis, interim analysis procedures, and concepts related to conditional power can be introduced to students as introductory material; more sophisticated concepts could be packaged in an elective course.

One particularly intriguing opportunity would be that of the transitional MSPO model. For active clinicians in the field seeking to enhance their education and professional credentials, the transitional master’s provides a unique occasion to engage a class of certified clinicians—typically with many years of experience—together in a research project that takes on the structure of a

multisite clinical trial. The transitional program’s distance learning format actually facilitates the creation of a distributed network of clinician-researchers, executing a uniform protocol, managed centrally through the institution.

The Two-Way Street The U.S. Department of Health and Human Services not only reviews evidence from clinical trials, but maintains policy to promote their completion.

Consider 42 CFR 405.201, wherein investigational device exemptions are described. CMS’s National Coverage Determination 310.1 considers IDEs as routine costs in clinical trials; this provision is specifically intended to ensure that clinical trials continue to escalate the level of evidence so that policy can be refined through evidence-based medicine. Clinical trials are considered the essential tool for providing definitive medical evidence of treatment efficacy.

At the highest level of regulation and oversight, the clinical trial is the recognized standard.

At ground level, it may be easy to dismiss the clinical trial as an extravagance more suited for other medical disciplines. For that matter, our relationship with the payor can seem narrow: Claim gets filed, claim gets reimbursed.

But clinical trials are not only accessible, they are essential. And they are a vehicle by which our relationship with the payor can become bidirectional: Payor creates policy, we change policy through rigorous scientific study. Orthotic and prosthetic devices should join defibrillators at the heart of trials-based medicine.

Michael Wininger, PhD, is a faculty member in the University of Hartford’s Master’s and Transitional Master’s of Science in Prosthetics & Orthotics Program, Yale School of Public Health (Department of Biostatistics), and is a statistician of medicine for the U.S. Department of Veterans Affairs Cooperative Studies Program.

He also is lead statistician on the Efficacy and Safety of the Implantable Cardioverter Defibrillator Implantation in the Elderly clinical trial (“the I-70 Study”), NCT02121158.

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Research & Presentations

Considerations for the Development of 3-D-Printed Upper-Limb Prostheses

By Jorge M. Zuniga, PhD; Matthew J. Major, PhD; Jean L. Peck, OTR/L; Rakesh Srivastava, MS, CPO; James Pierce; and Nicholas Stergiou, PhD

Introduction The development of 3-D printing for the manufacturing of prostheses and orthoses has resulted in cost-reduction strategies, better accessibility, and customization of prosthetic designs. The widespread use of 3-D printing and the existence of myriad prosthetic designs available on the Internet allow clinicians and researchers from different disciplines to manufacture their own devices.

Given the dearth of studies discussing the practical application of 3-D-printed upper-limb prostheses, the current paper describes the technical considerations for the implementation of these devices in rehabilitation and research settings.

Specifically, considerations on remote fitting procedures, durability, regulatory implications, and bench testing results are discussed.

Background Advancements in computer-aided design software and additive manufacturing techniques (i.e., three-dimensional or 3-D printing) offer the possibility of designing, printing, and fitting prosthetic hands and other assistive devices at a very low cost. Previous studies 1-5 have described low-cost prosthetic hands, arms, and shoulders

18 O&P News | April 2018

with practical and easy fitting procedures that can be performed remotely.

Importantly, in children the durability of the 3-D-printed prostheses is challenged continuously due to their activity levels and outgrowth of the prostheses.6 Therefore, the cost effectiveness of 3-D printing makes repairs and upgrades of prostheses substantially more affordable.6 In general, previous publications1-4,6-8 have presented different aspects of the development of 3-D-printed prostheses for children, and the consensus is that 3-D printing is a promising manufacturing method for the development of these devices. There is a lack of information, however, with respect to the fitting procedures, assembly, durability, and regulatory implications. The U.S. Food and Drug Administration (FDA) recently published guidelines for the industry outlining technical considerations associated with the 3-D-printing processes and recommendations for testing and mechanical characterizing 3-D-printed devices.9 However, the literature still lacks a comprehensive review that can provide practical technical considerations for the implementation of 3-D-printed upper-limb prostheses in a clinical or research setting.

Research & Presentations

The current review aims to address this knowledge gap and also to: 1) provide preliminary findings for remote prosthetic fitting methodologies; 2) describe printing specifications; 3) discuss the current regulatory framework; and 4) provide basic mechanical characterization of 3-D-printed prostheses for pediatric patients.

Figure 1

Technical Considerations The Cyborg Beast 3-D-printed hand prosthesis was the first open-source design described in the scientific literature and will be used as a reference in the current review.2 Currently there are 58 different 3-D-printed prosthesis designs; 51 are available online and seven are reported in the scientific literature.8 The majority of the designs that are available on the Internet can be downloaded as a stereolithographic or source files.

Remote Prosthetic Fitting Procedures

Once the files of the devices are created or downloaded, they need to be properly scaled to the dimensions of: 1) the patient’s residual limb for generating an appropriately sized socket; and 2) the nonaffected limb for facilitating bilateral length symmetry. This step requires the supervision of a board-certified prosthetist, orthotist, or hand therapist, familiar with fitting upper-limb prostheses.

Anthropometric Measurements for Remote Prosthetic Fitting

If scanning options are not possible, the majority of the current open-source prostheses can be fitted by acquiring a few simple anthropometric measurements (Figure 1). Proprietary computer-aided design software such as Autodesk Fusion 360 (Fusion 360, Autodesk Inc., San Rafael, CA) or open-source image editing programs such as Tracker (Tracker, Open Source Physics, Arlington, VA) can be used to extract all anthropometric measurements from photographs (Figure 1). The remote fitting procedure

Template photographs for remote fitting procedures of 3-D-printed partial hand prosthesis (A, B, and C) and arm prosthesis (D). Dashed red lines indicate measurement boundaries over wrist and elbow joints. A. Wrist extension (A1. Nonaffected, A2.

Affected), B. Wrist flexion (B1. Nonaffected, B2. Affected), and C. Top view of hands and forearms (C1. Nonaffected hand length, C2. Nonaffected hand width, C3. Nonaffected forearm length, C4. Nonaffected forearm width, C5. Affected partial hand length, C6.

Affected partial hand width, C7. Affected forearm length, C8. Affected forearm width. D. Top view of the entire arms (D1. Nonaffected hand length, D2. Nonaffected hand width, D3. Nonaffected forearm length, D4. Nonaffected forearm width, D5. Nonaffected upper arm length, D6. Nonaffected upper arm width, D7. Affected forearm length, D8. Affected forearm width, D9. Affected upper arm length, D10. Affected upper arm width).

involves the application of photogrammetric methods to extract all the required measurements from photographs of the upper limbs using open-source software (Figure 1). After the application of photogrammetric methods to extract all the required measurements, proprietary computer-aided design software (e.g., Autodesk Fusion 360) or open-source modeling software such as Blender (Blender 2.77, Blender Foundation,

Amsterdam, Netherlands) can be used to modify and scale the 3-D model of the prosthesis. Importing and processing calibrated images into a modeling or computer-aided design software is required to properly scale the 3-D model of the prosthetic design. Calibration of the image and confirmation of the accuracy of the measurements can be confirmed by performing several measurements over the ruler included in the photographs.

O&P News | April 2018

19

Research & Presentations

A crucial step of the remote fitting procedures is the scaling and modifications of the digital model of the prosthesis performed by superimposing the prosthetic design over a 2-D image (Figure 2). Similar to the standard prosthetic fitting performed in a clinic, this step also requires the supervision of a clinical team to ensure that the prosthesis is scaled appropriately for each individual’s upper-limb morphology.

After the digital prosthetic design is superimposed over a 2-D image (Figure 2) and is examined in detail by the clinical team, the design can be exported as a stereolithographic file and 3-D printed.

3-D-Printing Specifications and Materials The most common method for 3-D-printed prostheses is fused deposition modeling. Fused deposition modeling is a form of additive manufacturing that involves melting thin layers of plastic over each other to form a 3-D structure.10 The two most common 3-D-printed filament materials used to manufacture upper-limb prostheses are polylactic acid filament and acrylonitrile butadiene styrene filament.10 After selecting the printing material, the files of the prosthesis need to be sliced and nested before 3-D printing. Slicing is the process that converts 3-D models into a format understood by 3-D printers. The model is “sliced” into 2-D cross-sectional layers that can be placed by the extruder.

The slicing software often develops a G code, which is a set of numerical values representing positions in the system-based reference frame from which the extruder traces and recreates the design.

Due to the inherent anisotropic characteristics of fused deposition modeling, orientation of the different 3-D-printed prosthesis components over the building tray can play an important role in the durability of the prosthesis.10 As characteristics and mechanical properties of 3-D-printed parts are dependent on printing orientation, it is important to

20 O&P News | April 2018

Figure 2

A. Illustration of an image imported as a plane and overlaid under the Cyborg Beast palm model scaled at 140 percent for a 16-year-old research participant. B. Overlaid of a 3-D-printed arm prosthesis model scaled at 99 percent for a 7-year-old child with a transradial reduction in the left arm.

consider the direction of operational loads on each component. The 3-D-printed parts using fused deposition modeling are much more likely to delaminate and fracture when placed in tension in the direction of build height compared to the orthogonal axes. For this reason, we recommend to 3-D print prostheses using a horizontal axis. There are only a few exceptions to this rule specific to the layer height and dimension of the printed part. Lower layer height (higher resolution) typically results in a part being printed with smoother surfaces and less likelihood to delaminate or fracture.

The 3-D-Printed Hand Prosthesis Cyborg Beast 2 A modified version of the 3-D-printed transitional hand prosthesis named “Cyborg Beast”11 (Figure 3) is used as a reference design for the current review.

The new version, Cyborg Beast 2, was designed using the modeling software program Autodesk Fusion 360 and manufactured in the 3-D-Printed Prosthetic, Orthotic, & Assistive Devices Laboratory located in the Biomechanics

Research Building of the University of Nebraska at Omaha.

For manufacturing, we used a combination of a desktop (Ultimaker 2, Ultimaker B.V., Geldermalsen, The Netherlands) and an industrial (Uprint SE Plus, Stratasys, Eden Prairie, MN) 3-D printer. Specifically, the plastic pins to secure all the different components of the prosthesis, as well as the fingers and thumb, were made of acrylonitrile butadiene styrene filament using the industrial 3-D printer. The palm, socket, forearm brace, and leveraging structure were made of polylactic acid filament.

The elastic cords placed inside the dorsal aspect of the fingers provide passive finger extension. Finger flexion was driven by nonelastic cords along the palmar surface of each finger and is activated through 20 degrees of wrist flexion. The result was a composite fist (flexing the fingers toward the palm) for gross grasp. The finger and thumb were oriented in opposition to facilitate cylindrical grasp and tip pinch.

A BOA dial tensioner system (Mid power reel M3, BOA Technology Inc., Denver, CO) allowed tension regulation

Research & Presentations

of the cables controlling finger flexion.

A brace leverage structure was included in the proximal aspect of the forearm to increase torque development and stability. Furthermore, a thermoplastic socket embedded in the palmar aspect of the hand prosthesis was added to facilitate fitting of the device. The prosthesis is also customizable to each child’s limb size and aesthetic requirements, such as colors and theme (e.g., comic characters). Most of the devices currently available online have a very similar configuration.7,8,12

Figure 3

The 3-D-Printed Arm (Transradial) Prosthesis

The hand was designed to have five fingers with two degrees of freedom (Figure 4). The finger and thumb were oriented in opposition to facilitate cylindrical grasp and tip pinch. Silicone finger pads were added to provide increased friction for grasping activities. A rotation mechanism placed on the wrist allowed full pronation and supination, and a pivot system with internal components allowed wrist rotation without twisting the line activating the flexion of the fingers. The rotation mechanism of the wrist consisted of an inner circular disc/shaft with a center opening (see magnetic adjustable wrist mechanism in Figure 3D). A circle of embedded magnets with matching polarity was placed around the disc. A bivalve circular sleeve with embedded magnets, aligned to match the disc magnets, is placed over the disc. The magnets are placed with opposing polarity to ensure mutual attraction. The disc and sleeve rotate independently and fixed in various positions by the attraction of the magnets. The magnets are sealed in a protective sleeve for safety. Elbow flexion and extension can be performed using a simple hinge mechanism. A BOA dial tensioner system allowed the regulation of the tension of the cables controlling the finger flexion. A Velcro strap secured the prosthesis to the arm, thus harnessing is often not needed for suspension.

The 3-D-printed partial hand prosthesis (Cyborg Beast 2). A. The hand prosthesis in the open position. Elastic cords placed inside the dorsal aspect of the fingers provide passive finger extension. B. Finger flexion was driven by nonelastic cords along the palmar surface of each finger and was activated through 20- to 30-degree wrist flexion of the residual functional joint. The red arrow shows the direction of wrist flexion to close the fingers and produce a functional grasp. C. The transradial arm prosthesis in the open position. Elastic cords placed inside the dorsal aspect of the fingers provide passive finger extension. D. Finger flexion was activated through 10 to 20 degrees of elbow flexion of the residual functional joint. The red arrow shows the direction of elbow flexion to close the fingers and produce a functional grasp. The wrist can be manually adjusted.

Figure 4

Cycling and compression failure load testing. A. Side view of cycling testing. B. Front view of cycling testing. C. Wrist joint angle and distance between tips of the first and second digits for cyclical testing. For joint angles, 180 degrees represents neutral position, with the longitudinal axis of the hand segment aligned with the forearm segment axis. D. Force versus displacement profile of the compression failure test with instance of first digit and cradle failure noted. E. Dorsal view of the prosthesis after failure. Red circle indicates the area of failure. F. Palmar view of the prosthesis after failure. Red circle indicates the area of failure.

O&P News | April 2018

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Research & Presentations

Current FDA Recommendations/ FDA Guidance One of the most useful and groundbreaking features of 3-D printing is its ability to produce complex geometries both quickly and at low cost for the manufacturer. As 3-D-printing technology matures and continues to permeate varied industries and products, it is apparent that some level of regulation must be developed to ensure consistent quality and reproducibility across fabrication types, manufacturers, and materials. According to 21 CFR Part 812 (Part 890.3420), the FDA’s product classification listings, external limb prosthetic components and accessories are defined as physical medicine devices and are generally considered Class I devices.

Class I devices are considered low risk.9 The use of upper-limb 3-D-printed prostheses for research purposes may or may not require an investigational device exemption (IDE), depending upon if the FDA-approved device is used within approved labeling or not. If used outside of labeling, an abbreviated IDE is required as described in Title 21 of the Code of Federal Regulations Part 812.

A recent FDA guidance document titled “Technical Considerations for Additive Manufactured Devices”9 serves as a first step toward defining government policy regarding the use of 3-D printing for medical devices. In sections 2.1a to 2.1e of this review, a general description of the FDA recommendations is provided, followed by comments regarding their implications specific to 3-D-printed prostheses and the numerous production methodologies, such as selective laser sintering, fused filament fabrication or fused deposition modeling, stereolithography, and powder bed and polyjet.

In general, the FDA recommends9 that all medical devices fabricated using additive manufacturing processes (either entirely or in part) be validated and tested with the similar procedures as performed

22 O&P News | April 2018

on traditionally manufactured devices with adaptation of protocols to ensure proper functionality. The overall requirements for this additional evaluation depend almost entirely on the intended end use of the product; some common factors listed include whether it is an implant, load bearing, and/or available in prespecified standard sizes or patientmatched. Based on these parameters, a series of recommendations for design, production, and testing is then provided.

These recommendations stem from areas of importance to the additive manufacturing process, such as materials, design, printing, and postprinting validation; printing characteristics and parameters; physical and mechanical assessment of final devices; and biological considerations of final devices (including cleaning, sterility, and biocompatibility). For example, an external assistive device would require far less material regulation, biocompatibility testing, and dimensional accuracy than an additive manufacturing-produced vascular stent.

Despite the lesser requirements placed on prostheses, there are still a number of intensive and important inspection tools and process tasks that are recommended for all design and manufacturing stages.

Design

Starting with the design of a device, the FDA recommends9 that a full production flow diagram be created to ensure repeatability in the process of product development and engineering. This flow diagram would include all critical steps, from device design to the postprocessing of the final part identified and documented. During design, it also is highly recommended to develop feasible size ranges and feature sizes based on the end-user requirements as well as the additive manufacturing machine capabilities. Because the relative scale of additive manufacturing medical devices can be modified so easily as compared to traditionally manufactured parts, it is important that versioning history be

recorded, as well as specific device scales and other identifying information on the device itself. This policy prevents future third parties from improperly modifying or adapting the additive manufacturing device due to lack of information.

Materials

Once a design has been completed, it is important to properly characterize and select suitable materials for fabricating the device. As with any type of manufacturing method, the FDA recommends9 documenting safety procedures, and chemical, mechanical, and physical properties of the materials used.

For 3-D-printed prostheses, necessary material properties include chemical composition, molecular formula, purity, chemical structure, molecular weight, molecular weight distribution, glass transition temperature, and melting temperature. Because material recycling is not commonly used with fused deposition modeling additive manufacturing processes, no additional analysis into material properties should be required.

Printing Characteristics/ Parameters

Equally as important as material properties, the printer and parameters used in the production of 3-D-printed prostheses also affect durability, surface finish, interlayer adhesion, strength-to-weight ratio, and many other part characteristics. Due to the anisotropic mechanical properties of nearly all additive manufacturing processes,10 it is important to optimize physical part orientation when printing. Additionally, the infill density (the density of the interior reinforcing lattice structure in fused deposition modeling) can significantly affect strength, flexibility, and opacity of finished parts.9 Many additive manufacturing machines incorporate a supporting external lattice (or support structure) to aid in the creation of “floating” geometries that could not otherwise be produced. If not carefully placed,

Research & Presentations

these supplementary supports can cause structural damage and issues with surface finish. Finally, layer thickness can significantly affect surface finish (causing pronounced interlayer striations), interlayer adhesion, and production speed.

By justifying the print parameter choices for a balance between speed, strength, and quality, the opportunity exists to create optimized additive manufacturing devices and workflows.9 Physical/Mechanical Assessment

The FDA suggests 9 that a series of mechanically destructive and nondestructive tests be performed to determine ideal printing parameters. The results of such an analysis can be used to optimize parameters. To test additive manufacturing parts nondestructively, many potential tests are proposed, 9 including ultrasound, computed tomography, X-ray (for simple geometry), confocal microscopy, and hyperspectral imaging. Each of these methods can return valuable information such

as part porosity, structural integrity, dimension accuracy, and density. In addition to this battery of assessments, the FDA recommends that tensile test coupons be destructively analyzed to document the impact of the additive manufacturing process on mechanical properties. Parts also can be manually inspected for conformance to the intended design constraints.

Biological Considerations

the cleaning process should account for the complex geometry of the device under worst-case conditions (e.g., greatest amount of residual manufacturing materials for cleaning validation, and a combination of largest surface area, greatest porosity, and most internal voids for sterilization validation). In general, the cleaning protocols should follow similar precautions to those already established by the FDA9 and used for standard prostheses and orthoses.

Because the focus of the FDA Draft Guidance 9 is to determine additive manufacturing medical device requirements, the interactions that parts have (mechanically, chemically, etc.) with the patients’ physiology must be documented and verified before use. Cleaning protocols also must be established, especially for devices with complex geometries, such as engineered porosity, honeycomb structures, channels, and internal voids or cavities that cannot be produced by traditional manufacturing methods. The FDA recommends9 that

Bench Testing of a 3-D-Printed Partial Hand Prosthesis There is a lack of quantitative parameters that address the durability of 3-D-printed prostheses. Cyclical and compression failure loading was performed in an early version of the Cyborg Beast 2 partial hand prosthesis to provide a basic understanding of the device mechanical characterization. The 3-D-printed prosthesis was manufactured for a 12-year-old boy using polylactic acid filament at a 120 percent scale and at 40 percent infill.

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Research & Presentations

Bench Testing Methods

Cyclical testing of the prosthesis was conducted to determine acute changes in performance from repeated flexion and extension. An image of the testing setup is displayed in Figures 4A and 4B. The prosthesis was fit onto a limb surrogate consisting of a steel rod representing the forearm and a wooden model of the hand, which were joined by a threemillimeter rubber pad. Both the forearm and hand surrogate were covered with soft foam. The Velcro strap of the prosthesis forearm cradle was fixed to the forearm surrogate and the hand surrogate filled the prosthesis hand cradle.

The forearm surrogate was secured to a fixture that did not permit longitudinalaxis rotation of the prosthesis. Hooks were threaded into the hand surrogate and protruded through the prosthesis hand cradle. The hooks were attached to a steel cable that ran through a pulley located directly inferior to the wrist joint and was placed into tension by linear actuation of a hydraulic-driven materials test machine (Instron, Norwood, MA).

Cable tension flexed the wrist joint, and extension position was reset manually with the cable relaxed. The prosthesis was subjected to 50 cycles of flexion/ extension from a starting position of approximately 15 degrees extension.

The linear stroke displacement occurred over 10 seconds and was set such that the prosthesis’s first and second digits initially mated when in wrist joint flexion. For each cycle, initial and final wrist joint angle were measured with a digital goniometer, and distance between tips of the first and second digits was measured with digital calipers. The BOA cable system was tensioned once at the start of testing so that the digits were in full extension apart from the distal phalanges, which were in approximately 45 degrees of flexion and provided slight resistance when extended.

Using the materials test machine, the compression failure load and mode were determined by subjecting the prosthetic

24 O&P News | April 2018

hand (i.e., components distal to the wrist joint) to a compressive force at a linear actuation displacement rate of 1 mm/s.

Prior to testing, the hand without a surrogate model was secured to the loading surface with the hand in a pronated position in an orientation where the loading vector approximately passed through the palmar plane and was preloaded to 10 N. The prosthesis was compressed between two flat surfaces with a roller-bearing plate beneath one surface to minimize shear forces. The prosthesis was observed for signs of failure, at which point the test was concluded. Instantaneous linear compression force and stroke displacement were recorded during testing.

Bench Testing Results

Wrist joint angle at the start and end of each cycle, and the distance between the first and second digit at the start of each cycle, are displayed in Figure 4. Through the 50 cycles of flexion and extension, the prosthesis consistently rotated approximately 36 degrees at a rate of 3.6 degrees/second into 21 degrees of flexion, and the first and second digits always met (i.e., closed pinch) at the end of each flexion phase. Upon return into wrist extension, distance between the first and second digits decreased sharply and then plateaued after seven cycles, suggesting that the BOA cable should be re-tensioned regularly to ensure that the digits extend fully with wrist extension.

Overall, the prosthesis demonstrated highly repeatable performance when tested over a small number of cycles.

The prosthetic hand ultimately failed at 1,746 N, which was characterized by sequential catastrophic failure of the first digit and then hand cradle (Figure 4).

The first digit failed at the joint housing, allowing for separation of the digit from the hand (Figure 4). The hand cradle failed by shattering on the dorsal side with a diagonal line fracture and separation of the first digit section from the palmar mesh, which pulled apart the radial side wrist joint pivot.

Conclusions The 3-D-printed prostheses are characterized by being inexpensive and easy to manufacture, and fitting procedures can be performed remotely.

The remote fitting procedures require simple anthropometric measures of the upper limbs extracted from photographs. Beyond the widely reported cost effectiveness of this type of manufacturing process, a promising use of 3-D-printed prostheses is to familiarize and engage patients who have rejected or abandoned their standard prosthesis.

A recent FDA guidance document titled “Technical Considerations for Additive Manufactured Devices� serves as a first step toward defining government policy regarding the use of 3-D printing for medical devices.

The FDA recommends that all medical devices fabricated using additive manufacturing processes be validated and tested with the similar procedures as performed on traditionally manufactured devices with adaptation of protocols to ensure proper functionality. Upper-limb 3-D-printed prostheses are usually classified by the FDA as Class I devices and generally are considered low risk.

Jorge M. Zuniga, PhD, is an assistant professor in the Department of Biomechanics at the University of Nebraska at Omaha, and also is associated with the University of Chile. Matthew J. Major, PhD, works in the Department of Physical Medicine and Rehabilitation at the Northwestern University Feinberg School of Medicine, and also is affiliated with the Jesse Brown VA Medical Center. Jean L. Peck, OTR/L, works at the CHI Health Creighton University Medical Center and as an adjunct faculty at the Department of Occupational Therapy at Creighton University. Rakesh Srivastava, MS, CPO, is president and chief executive officer at Innovative Prosthetics & Orthotics.

James Pierce works in the Department of Biomechanics at the University of Nebraska at Omaha. Nicholas Stergiou, PhD, is assistant dean of the Division of Biomechanics and Research Development in the Center for Research in Human Movement Variability at the University of Nebraska at Omaha.

Research & Presentations

References 1. Zuniga JM, Carson AM, Peck JM, Kalina T, Srivastava RM, Peck K. The Development of a Low-Cost ThreeDimensional Printed Shoulder, Arm, and Hand Prosthesis for Children.

Prosthetics and Orthotics International. April 2016;41(2):205-209.

2. Zuniga JM, Katsavelis D, Peck J, et al. Cyborg Beast: A Low-Cost 3-D-Printed Prosthetic Hand for Children With Upper-Limb Differences. BMC Research Notes. Jan. 20, 2015;8(1):10.

3. Zuniga JM, Peck J, Srivastava R. Anthropometric, Range of Motion, and Strength Changes After Six Months of Using the Cyborg Beast, an Open-Source Wrist-Driven 3-D-Printed Prosthetic Hand for Children. Midwest Chapter American Academy of Orthotists & Prosthetists.

2015.

4. Zuniga JM, Peck J, Srivastava R, Katsavelis D, Carson A. An OpenSource 3-D-Printed Transitional Hand Prosthesis for Children. JPO: Journal of Prosthetics and Orthotics.

2016;28(3):103-108.

5. Gretsch KF, Lather HD, Peddada KV, Deeken CR, Wall LB, Goldfarb CA. Development of Novel 3-D-Printed Robotic Prosthetic for Transradial Amputees. Prosthetics and Orthotics International. June 2016;40(3):400-403.

6. Tanaka KS, Lightdale-Miric N. Advances in 3-D-Printed Pediatric Prostheses for Upper-Extremity Differences. J Bone Joint Surg Am. Aug. 3, 2016;98(15):1320-1326.

7. Burn MB, Ta A, Gogola GR. Three-Dimensional Printing of Prosthetic Hands for Children.

The Journal of Hand Surgery. May 2016;41(5):e103-109.

8. Ten Kate J, Smit G, Breedveld P. 3-D-Printed Upper-Limb Prostheses: A Review. Disability and Rehabilitation.

Assistive Technology. Feb. 2, 2017:1-15.

9. FDA. Technical Considerations for Additive Manufactured Devices.

Available From: http://www.fda.gov/ downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm499809.pdf. 2017.

10.Chiulan I, Frone AN, Brandabur C, Panaitescu DM. Recent Advances in 3-D Printing of Aliphatic Polyesters.

Bioengineering (Basel, Switzerland).

Dec. 24, 2017;5(1).

11. Zuniga JM. Cyborg Beast. 2014; http://www.thingiverse.com/thing: 261462.

12. Diment LE, Thompson MS, Bergmann JHM. Clinical Efficacy and Effectiveness of 3-D Printing: A Systematic Review. BMJ Open. Dec. 21, 2017;7(12):e016891.

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O&P News | April 2018

25

O&P Visionary

Rick Fleetwood

Veteran O&P professional calls for changes in reimbursement practices and greater participation in advocacy for the profession

A

s “O&P King for a Day,” I would love to make many changes and would take advantage of every minute of this opportunity to correct and enhance the O&P service arena. Where does this desire come from? Before receiving this wonderful opportunity, I worked in the field for 44 years with one company, Snell Prosthetics & Orthotics—Arkansas.

Frank Snell, CPO, LPO, FAAOP, took care of the patients, and I was responsible for the running of the business; it has been an amazing relationship, and the respect I have for the Snell family is unwavering.

It is this very experience that has prepared me to accept the honor of being O&P King for a Day—because, as we know, admins and clinicians must work together. If there is a failure on either side, the whole delicate balance of care collapses.

OK, the clock is ticking and I only have one day to correct the injustices or implement new changes for the betterment of the profession. Where do I begin?

26

O&P News | April 2018

Correcting the Injustices There are a number of injustices that this profession is subject to, and, as King for a Day, I see a few that need immediate attention.

First, we need to examine payment for services rendered. We are held more and more accountable for the care we provide to the patient, and also for justification for that care. So, as other professions have already done, I would immediately implement the following strategy.

Since the clinician is evaluating the care as requested by the physician, our notes pertinent to the delivery of what the physician ordered shall and must be accepted. The O&P professional who fits and evaluates the patient is often in the best position to ensure that the patient benefits from the order as intended. Thus, the O&P practitioner’s notes hold weight equal to the physician’s notes because they are seeing firsthand the true outcome of the prescription. This I ordain immediately; O&P shall not be second class. (See? I’ve only been King for one day, and look what we have accomplished!)

Next, why are experts in other professions paid for their time in evaluations, fittings, and deliveries on new and old patients—yet competent, credentialed O&P professionals are not? As of today, we shall be respected as health-care O&P professionals and shall be reimbursed accordingly for services rendered. Our time and talents are just as valuable as those of other health-care professionals with whom we work to provide service.

In addition, bartering for items and services should be limited to third-world countries. When we send in a bill for service rendered, all parties know what to expect regarding what they are receiving and being charged. There will be no more occasions where we are importuned—or expected—to discount our services and products/items delivered. We will be paid for value received—not one penny less nor one penny more. Bartering—so much off Medicare, for example—is an unnecessary process that only adds to the cost and diminishes fair reimbursement to the provider.

Finally, government has a responsibility to the citizens it represents. When

O&P Visionary

we (O&P) in good faith take care of those citizens, we also have a right to be compensated for services rendered correctly and properly. So, if challenged and found to be wrong in their decisions to withhold funds, payors—government or private-sector entities—shall be required to pay interest for loss suffered and harm done to O&P businesses.

Failure to deliver just compensation in a timely fashion is illegal, and the absence of consequences or penalties for such failures and false charges also is illegal.

Payors should be held accountable for this injustice, just as O&P entities are held accountable. So, as of today, I hereby decree that any claims not found to be false shall be compensated with interest for days when payment was not correctly received.

Enhancing the O&P Field As O&P King for a Day, I realize that other rulers may influence our everyday existence. We call them U.S. representatives and senators. They have smaller state counterparts called governors, legislators, directors of Medicaid, chiefs in the U.S. Department of Veterans Affairs, etc. Those who give me counsel are few in number. However, I wish to hear from all O&P populations: These other rulers are having a profound effect upon our profession, yet my people are not

Rick Fleetwood shakes hands with Sen. Chuck Grassley (R-Iowa)

joining with me to fight for our beloved O&P field by actively donating, visiting, lobbying, and supporting our cause. All too often, just the same few stand up for what we do. Now is the time to become extremely active in every way you can to be an advocate for who we are and what we do.

As O&P King for a Day, I would make it mandatory for everyone to serve for the protection and well-being of our profession. No longer can you just stand back and let someone else do it because you lack the time, money, or knowhow—enjoying every victory that has been won by so few and giving nothing back in turn. As King for a Day, I hereby decree that everyone who serves in this profession must advocate for the profession by giving of your time, talents, and funds so that we may accomplish more as we all march together to advance our field. While most in this profession give to their churches, their schools, and various charities, they give nothing to the very profession that puts food on the table and helps to provide funds to donate to other causes. We have won some battles, but the big ones are yet to come. I fear some may wait until it is too late. But I pray that better reasoning will convince everyone in the O&P field of the importance of supporting such a cause, in the event that reality continues to limit my power to decree it.

Finally, as O&P King for a Day, I realize that my people are aging in greater numbers, and I fear for their well-being.

Therefore, today I hereby authorize the opening of new O&P schools to provide additional professionals to meet the challenge of the increased numbers that are to be served. I want to ensure the accessibility of services for our patient population and the ability to provide that service is met. In so doing, we need to also make sure that those who are stepping up to serve will be compensated for becoming part of the O&P family.

We must raise the bar regarding what is expected, what we provide, and how we

Rick Fleetwood, Anita Liberman-Lampear, MA, and Scott Schneider at the AOPA 2016 National Assembly Wine Auction Fundraiser

provide said service. By enhancing our service and capabilities, we will enhance our role in the medical community and enhance our service to those we serve.

Oh, if it were only true that I could be O&P King for a Day! Would I really want to? Yes, I would love being King, and I love this profession. So, as long as there is breath in this ole King, I will be out there fighting for right. However, my time is running out, and I hope that other O&P professionals will rise to the occasion and help to overcome all the new and difficult challenges we will face.

I am particularly praying that the next generation is getting ready to stand up and become part of the group that will make sure our O&P kingdom continues to flourish and grow even stronger.

So, my fellow subjects, are you ready to meet the changes, and can you help to enhance our field to ensure its continuance? No king, no single person or group, can answer the call. We as a profession must rise up every day and protect who we are and what we do.

Will you?

Rick Fleetwood is chief executive officer of Snell Prosthetics & Orthotics—Arkansas.

O&P News | April 2018

27

STATE NEWS

State by State The latest news from the states, and a recap of the AOPA State Representatives meeting

Each month, we talk to O&P professionals about the most important state and local issues affecting their businesses and the patients they serve. This column features information about medical policy updates, fee schedule adjustments, state association announcements, and more.

The following state reports highlight successful results from Capitol Hill visits during the 2018 AOPA Policy Forum.

Iowa Rep. Steve King (R-District 4) was added as a co-sponsor for the Medicare O&P Improvement Act (H.R. 2599) as well as the Injured and Amputee Veterans Bill of Rights (H.R. 2322). Sen. Chuck Grassley (R-Iowa) is one of four senators to sign on to a March 13, 2018, letter to CMS Administrator Seema Verma to insist that CMS advise its contractors about Section 50402 of the Bipartisan Budget Act of 2018—the provision assuring legitimate inclusion of the prosthetist/ orthotist notes in the medical record.

“I would like to thank Rep. King and Sen. Grassley for their continued support of good O&P legislation. They fully understand the positive impact that these bills and directives will have on the O&P care that so many Medicare beneficiaries and veterans receive,” said Todd Eagen, president of OPGA.

28

O&P News | April 2018

Illinois Sen. Tammy Duckworth (D-Illinois) was an original co-sponsor for the Wounded Warrior Workforce Enhancement Act (S. 1467) and a co-sponsor of the Medicare O&P Improvement Act (S. 1191). She is one of four senators to sign on to a March 13, 2018, letter to CMS Administrator Seema Verma to insist that CMS advise its contractors about Section 50402 of the Biparti- Michael Oros, CPO, LPO, and Rep. Peter Roskam (R-Illinois) san Budget Act of 2018.

“Attending the Policy Forum was an Committee. He is one of four senators invaluable experience. I was honored to sign on to a March 13, 2018, letter to have the opportunity to speak with to CMS Administrator Seema Verma to legislative staff about the issues facing insist that CMS advise its contractors our profession and, more importantly, about Section 50402 of the Bipartisan our patients,” said Sheila Pach, an Budget Act of 2018.

O&P student. “As a student, I was “It was an exhilarating day on happy to convey my gratitude for Sen. Capitol Hill. Our first meeting took Duckworth’s support of the Wounded place at Sen. Cardin’s office, where we Warrior Workforce Enhancement Act, met with staffer Josh Izaak,” said June which addresses funding needs for O&P Dunn, CFo, of D&J Medical. “I had education. I was lucky enough to also the good fortune to run into the senabe paired with other members of the tor, himself, just moments before, and Illinois O&P delegation, Michael Oros, he was willing to oblige Mary Walsh CPO, FAAOP, and Jim Kaiser, CP, LP, who advocated for the Medicare O&P Improvement Act and the Veterans Bill of Rights during our meetings.”

Maryland Sen. Ben Cardin (D-Maryland), who spoke during the second day of the Policy Forum, has been a supporter of AOPA legislative initiatives as a co-sponsor of the Medicare O&P Improvement Act (S. 1191) and in his role on the Senate Finance

Sen. Ben Cardin (D-Maryland)

STATE NEWS

[a resident at D&J Medical] and me for a photo opp. We were able to thank Sen. Cardin for his support, and educate Mr. Izaak on key legislation that affects the O&P industry during our meeting. We were able to advocate for each issue with personal stories of daily events in our own business, and advocate for access to quality care for all of our patients that so desperately deserve it. Josh was already very educated on O&P legislation and assured us that Sen. Cardin is going to continue to support us,” she said.

New York During the Policy Forum, Rep. Tom Reed (R-District 23) was added as a co-sponsor for the Medicare O&P Improvement Act (H.R. 2599).

Virginia Sen. Mark Warner (D-Virginia) is one of four senators to sign on to a March 13, 2018, letter to CMS Administrator Seema Verma to insist that CMS advise its contractors about Section 50402 of the Bipartisan Budget Act of 2018.

AOPA State Representatives Meeting The AOPA State Representatives Group met in Washington, D.C., on March 7 during the 2018 AOPA Policy Forum to discuss the local and state issues facing O&P practices and their patients. In response to requests during the meeting, the following sections have been added to each state page on the AOPA Co-OP: • A section titled Congressional Support for O&P Issues, which outlines every member of Congress from each state currently supporting an AOPA legislative initiative.

• A Policy Forum Update section.

• A section on Insurance Fairness laws in states that have laws, and information about ongoing efforts to introduce bills in states where efforts are underway.

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Publisher Thomas F. Fise, JD Advertising Sales RH Media LLC Editorial Services Content Communicators LLC Design & Production Marinoff Design LLC Printing Sheridan SUBSCRIBE O&P News (ISSN: 1060-3220) is published monthly by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314.

To subscribe, contact 571/431-0876, fax 571/4310899, or email landerson@AOPAnet.org. Periodical postage paid at Alexandria, VA, and additional mailing offices.

ADDRESS CHANGES Postmaster: Send address changes to: O&P News, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314.

AOPA is currently recruiting members who are interested in participating in the AOPA State Representatives Group for the following states: Connecticut, Colorado, Florida, Idaho, Kansas, Maine, Massachusetts, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, Rhode Island, South Dakota, Utah, Vermont, West Virginia, and Wyoming.

“Even though the effort was ultimately voted down in committee, we are confident that this is only the beginning of our efforts in Virginia,” said Dan Ignaszewski, director of government relations at the Amputee Coalition.

EDITOR'S NOTE: To submit an update for publication, please email awhite@aopanet.org. For up-to-date information about what’s happening in O&P in your state, visit the AOPA Co-OP and join the conversation in the AOPA Google+ Community.

Copyright © 2018 American Orthotic and Prosthetic Association. All rights reserved.

This publication may not be copied in part or in whole without written permission from the publisher. The opinions expressed by authors do not necessarily reflect the official views of the publisher, nor does the publisher necessarily endorse products shown in O&P News. The O&P News is not responsible for returning any unsolicited materials. All letters, press releases, announcements, and articles submitted to the O&P News may be edited for space and content. The magazine is meant to provide accurate, authoritative information about the subject matter covered. It is provided and disseminated with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice and/or expert assistance is required, a competent professional should be consulted.

ADVERTISE Reach out to the O&P profession and more than 13,500 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net.

O&P News | April 2018

29

CLASSIFIEDS

CLASSIFIEDS

UNIVERSITY OF VIRGINIA CERTIFIED PROSTHETIST ORTHOTIST (CPO) AND CERTIFIED ORTHOTIST (CO) The Prosthetics and Orthotics Division in the University of Virginia’s School of Medicine seeks a certified prosthetist and orthotist (CPO) and a certified orthotist (CO) to consult, provide, and fabricate orthotic and prosthetic devices for adults and children with musculoskeletal impairments throughout Central Virginia. The successful candidates will be responsible for managing comprehensive orthotic and/or prosthetic patient care. This includes patient assessment, formulation of a treatment plan, implementation of the treatment plan, and follow-up care and practice management.

Candidates for both positions should have either a bachelor’s degree with completion of an NCOPEaffiliated certificate program and completion of NCOPE-affiliated residency program; or an associate degree with at least 10 years of direct P&O experience. Qualified candidates must be certified through the American Board for Certification in Orthotics, Prosthetics, & Pedorthics and have one year of postcertification experience. Some experience with foot/ankle and pediatrics is required. Also, candidates should be knowledgeable with DME billing codes, insurance compliance, and current trends in the prosthetic and orthotic industry.

Successful candidates for the CPO position should also possess interpersonal skills to help build referral bases. For these candidates, a history of prior practice management is preferred, and supervisory and/or office management skills are a plus.

Applicants should complete a staff application through the Jobs@UVa website, and provide a cover letter, resume, and a list of three references. To apply for either position, visit https://jobs.virginia.edu, click on University Staff, and search for posting # 0622645 for the CPO position or posting # 0621917 for the CO position.

For more information about the division, please visit https://med.virginia.edu/orthopaedic-surgery/ orthopaedic-divisions/orthotics-and-prosthetics/.

Visit: https://jobs.virginia.edu This position is restricted and contingent upon continued funding.

The University of Virginia is an equal opportunity and affirmative action employer. Women, minorities, veterans, and persons with disabilities are encouraged to apply.

30 O&P News | April 2018

PRACTICE SALES & APPRAISALS

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Recruit Qualified Candidates! Contact Bob Heiman at 856/673-4000 or email bob.rhmedia@comcast.net.

RESOURCES

2018 AOPA CODING PRODUCTS

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Ensure each member of your staff has a 2018 Quick Coder, a durable, easy-to-store desk reference of all of the O&P HCPCS codes and descriptors.

• 2018 Coding Suite (includes CodingPro single user, Illustrated Guide, and Quick Coder): $350 AOPA members, $895 nonmembers 2018 CodingPro CD-ROM (single-user version): $185 AOPA members, $425 nonmembers • 2018 CodingPro CD-ROM (network version): $435 AOPA members, $695 nonmembers • 2018 Illustrated Guide: $185 AOPA members, $425 nonmembers • 2018 Quick Coder: $30 AOPA members, $80 nonmembers.

Order at www.AOPAnet.org or call AOPA at 571/431-0876.

CALENDAR

Meetings & Courses

2018 APRIL 11 AOPA Webinar: Enhancing Cash Flow & Increasing Your Accounts Receivable. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

APRIL 26-28 New York State Chapter Annual Meeting (NYSAAOP). Rivers Casino & Resort, Schenectady, NY. For more information, visit www.NYSAAOP.org.

APRIL 30-MAY 1 Mastering Medicare: Essential Coding & Billing Techniques.

San Antonio. Register online at bit. ly/2018billing. For more information, email Ryan Gleeson at rgleeson@ AOPAnet.org.

JUNE 13 AOPA Webinar: Audits: Know the Types, Know the Players, and Know the Rules. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

AOPA National Assembly.

Vancouver Convention Center.

For general inquiries, contact Ryan Gleeson at 571/431-0876 or rgleeson@AOPAnet.org, or visit www.AOPAnet.org.

JULY 11 AOPA Webinar: Administrative Documentation: The Must Haves and the Sometimes Needed. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

JULY 23-24 Mastering Medicare: Essential Coding & Billing Techniques.

St. Louis. Register online at bit. email Ryan Gleeson at rgleeson@ AOPAnet.org.

AOPA Webinar: Outcomes & Patient Satisfaction Surveys.

Register online at bit.ly/2018webinars.

For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

SEPTEMBER 12 AOPA Webinar: Coding: Understanding the Basics. Register

AOPA Webinar: Medicare As a Secondary Payor: Knowing the Rules. Register online at

online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.

NOVEMBER 12-13 Mastering Medicare: Essential Coding & Billing Techniques.

Las Vegas. Register online at bit. ly/2018billing. For more information, email Ryan Gleeson at rgleeson@ AOPAnet.org.

NOVEMBER 14 Evaluating Your Compliance Plan & Procedures: How To Audit Your Practice. Register online OCTOBER 10

at bit.ly/2018webinars. For more information, email Ryan Gleeson at

AOPA Webinar: Year-End Review: What Should You Do To Wrap Up the Year & Get Ready for the New Year? Register online

rgleeson@AOPAnet.org.

DECEMBER 12

information, email Ryan Gleeson at

New Codes, Medicare Changes, & Updates. Register online at

rgleeson@AOPAnet.org.

bit.ly/2018webinars. For more

at bit.ly/2018webinars. For more

information, email Ryan Gleeson at

ly/2018billing. For more information,

AUGUST 8

MAY 9

SEPTEMBER 26-29

OCTOBER 18-20

rgleeson@AOPAnet.org.

International African-American Prosthetic Orthotic Coalition Annual Meeting. Embassy

AOPA Celebrates Healthcare Compliance & Ethics Week

Suites Downtown Medical

November 4-10, 2018

Center, Oklahoma City. For more information, contact Tony Thaxton Jr. at 404/875-0066, email thaxton.jr@ comcast.net, or visit www.iaapoc.org.

NOVEMBER 4-10 Health-Care Compliance & Ethics Week. AOPA is celebrating Health-Care Compliance & Ethics Week and is providing resources to help members celebrate. Learn more at bit.ly/aopaethics.

O&P News | April 2018

31

TECH TIPS

Guiding the Next Generation of Technicians Effective mentoring requires explaining the basic elements and the underlying philosophy of the craft

By Tony Wickman, CTPO

I

’m getting too old for this. Yes, it happens to the best of us. We get old, our hands get tired, our eyesight weakens, and eventually—if you’re lucky—you retire. If you do it well, you leave behind a whole new crop of younger, smarter, more skilled technicians to replace you. Of course, in order to do that you will need to find some people to mentor and pass your skills on to.

It’s hard to mentor young people, but you need to make it a priority. We all have work to do, which takes time, and we all have a lot of responsibilities to manage, but making mentoring a priority will pay dividends way before you retire, if you do it right.

There is a difference between mentoring and training. Training someone just involves the transfer of skills, but mentoring means guiding a person into a lifelong pursuit, leading them into a certain mindset, and making sure they are comfortable in their surroundings.

The hardest part is picking the right candidates. Finding people that share your passion for the work is important.

32 O&P News | April 2018

The people you mentor need to be able to pursue the job as a career. They need to be able to find great reward in this field, and they need to have a great curiosity for it. The people who come into the field and just see it as “a job” won’t really stick it out. You know the type—they seem to be the majority of new hires. They come into the job and just do what has to be done to keep from getting fired (if you’re lucky) and then move on to something else. Training people just to have them move on is frustrating and expensive, but when you find a great candidate, you want to make sure that you focus as much energy on that individual as you can.

Once you have a great candidate, the next step is to teach him or her what you know. Don’t keep secrets, and don’t just tell trainees what to do—tell them why! I have always made it a priority to use the correct terminology when discussing a job with a trainee and to make sure the trainee understands the reasons we do the things we do. It’s just like math; it isn’t enough to know the

answer to the problem, they have to know the formula you used to get the answer. That’s the only way they will be able to solve problems when you aren’t around. If you can transfer the basic elements and the underlying philosophy of the craft to someone else, they will be able to take what you know and grow into a better technician than you were, and that is the goal.

I hear lots of horror stories about trying to teach millennials, and there may be some truth to those rumors. But for the most part, I have found that if someone is interested in the task, he or she will be eager to learn. Yes, today’s young people may need a few more pats on the back than we were used to, but complimenting people for the good work they do is a much more effective motivator than barking at them when they make a mistake. I know I have probably forgotten what a pain I was to train—most of us have—but if you just think back to the people who trained you, the ones you learned the most from were probably the ones who encouraged you to do your best, not the one who threw a hammer at you.

So there it is. Find good people, take them under your wing, encourage them to grow, offer them a safe place to fail, and make sure they know you’ve got their back. If it all works out, they will become an asset to your organization— and the O&P profession as well.

Tony Wickman, CTPO, is president of Freedom Fabrication in Havana, Florida.

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