Michael Barbella, Managing Editor12.03.21
Cai can finally see out his family’s car windows.
Such implicit capabilities are rarely cause for celebration, but Cai is something of an anomaly himself, having struggled with early onset scoliosis for most of his childhood.
Afflicting one in 10,000 children, the condition is characterized by a complex spinal curvature (85 degrees in Cai’s case). Early onset scoliosis can resolve on its own in children under age 2, but severe cases—like Cai’s—can lead to heart and lung problems that worsen over time.
Cai’s health definitely would have deteriorated, had surgeons not anchored magnetically controlled growing rods to the boy’s spine three years ago. Unlike traditional growing rods, the magnetically controlled devices are lengthened through an external remote control. He’s returned to the Children’s Orthopaedic Center at Children’s Hospital Los Angeles every three months to have the rods extended magnetically. The outpatient procedure takes less than five minutes.
Last year, Cai underwent a second surgery to replace the rods with longer versions. The new devices will allow him to grow as tall as he can over the next few years before he undergoes a final spinal fusion.
“These rods have been wonderful for him,” his grandmother Tracey said in a feature story on the hospital’s website. “They don’t hinder him from doing anything and he doesn’t think even twice about them. I just marvel at what Dr. Andras is able to do and that this procedure is available.”
Such procedures and products are necessary to treat a patient population that generally is overlooked by the $50.6 billion orthopedic implant industry. Major manufacturers have mostly ignored the pediatric patient population when developing new technologies due to the high cost of product development, relatively small market, and complex nature of the devices themselves (they must fit a body that is still growing).
ODT’s feature “Minor Adjustment” details the challenges companies face in developing pediatric orthopedic implants, and highlights some of the most recent innovations in this slighted market. David Bailey, president, and Fred Hite, chief operating officer/chief financial officer of OrthoPediatrics Corp., were among the industry experts interviewed for the story. Their full input is provided in the following Q&A:
Michael Barbella: Please discuss the trends in pediatric orthopedic device design and how these trends have changed (if at all) in the last several years.
David Bailey and Fred Hite: Over the last decade there has remained very little focus on pediatric orthopedic device development beyond OrthoPediatrics and a few other companies with one or two products. Historically patients were treated more conservatively by pediatric orthopedics surgeons, but in the last decade we have certainly seen a shift to more surgical care due to a number of socioeconomic factors. This combined with FDA's interest in streamlining the approval of devices specifically designed for children were two of the many reasons that building an entire company around the unmet need in pediatrics made sense.
More pediatric deformities are being treated with orthopedic surgery than historical casting procedures.
Two products have received HDE [humanitarian device exemption] approval, the first in 25 years, from the FDA—tethering and Apifix internal brace for treating scoliosis.
Barbella: In what ways are pediatric orthopedic devices different than adult products (other than size)?
Bailey and Hite: The bones of children are different than adults in many ways beyond simply being smaller. For example, pediatric devices must be designed to avoid the growth plates in children and accommodate bones which can be up to 30 percent more curved. Further, many pediatric orthopedic conditions do not present in adults so pediatric devices must be designed to treat a wide range of indications including skeletal deformities, cerebral palsy, and osteogenesis imperfect. The challenges facing pediatric orthopedic surgeons are extremely complicated and wide ranging, so adult products often do not work for these children.
Barbella: Why is the array of pediatric orthopedic devices so much more limited than that of adult products? Why aren’t there more devices being produced specifically for kids?
Bailey and Hite: Adult OEMs focus on the much larger adult hip, knee, and trauma markets and view the pediatric market as too small. Until recently, no other company specifically focused on this market. It also takes a large number of products to fully service this market. Pediatric orthopedic surgeons do a lot of surgery, but they don’t do one surgery a lot. The pediatric orthopedic market is a large niche market comprised of a lot of niche products, which is an entirely different model than the large OEMs prefer. Beyond that, no other company has a sales force selling into this market, and selling into this market requires a high degree of clinical knowledge specific to pediatric orthopedics that no other selling organization possesses.
Barbella: What are the challenges in designing/developing a pediatric orthopedic device vs. an equivalent adult product? How does OrthoPediatrics Corp. overcome these challenges?
Bailey and Hite: Pediatric devices must be designed with pediatric anatomy in mind such as avoiding the growth plates in children, accommodating for the multiple sizes and shapes of pediatric bones, and making the devices easily removable. The devices also must account for the unique pathologies surgeons are presented with, many resulting from conditions such as cerebral palsy. Beyond the implants, most of the systems we develop require very specific instrumentation, which in a lot of cases can make all the difference in how well surgery goes.
From the beginning, OP has partnered with pediatric orthopedic surgeons to develop systems, now 35, that are made just for them and their patients. We believe it is critical that we never try to simply make an adult product smaller. So we start working directly with the surgeons to design our device from the ground up with the specific focus on the unmet needs in pediatrics.
Barbella: Does the orthopedic sector present a particularly difficult challenge for those developing pediatric devices - as opposed to cardiovascular products, for example)? Why?
Bailey and Hite: There are probably other sectors of pediatrics such as cardiovascular products that present more challenges, especially from a regulatory perspective, however pediatric orthopedics also has challenges. Our patients' bones are always growing, so the development of devices that can grow with a child is a real struggle. Also, in pediatric scoliosis surgery developing devices that can treat very young children with deformed spines as well as trying to avoid spine fusion altogether are really the holy grail in the field.
Barbella: How are the market needs for pediatric patients identified? Does OrthoPediatrics work directly with surgeons to identify these market needs?
Bailey and Hite: We certainly work with the top key opinion leaders in our field to identify and define the unmet needs in our space. Also having a dedicated salesforce and engineering team that truly understands pediatric orthopedics is a huge asset. Great ideas for products can come from anywhere, however, we believe that a company with hundreds of customers and associates that are exclusively focused in this area is key to our identifying the unmet needs.
Barbella: Is there a specific area (part of the body) that designers are specifically focused on when developing pediatric implants? If so, why are these specific areas chosen?
Bailey and Hite: We focus on the largest procedure areas or where we feel we can make the biggest impact on the lives of children. So far this has been in the areas of pediatric trauma, limb deformity, and scoliosis, and we still have work to do to meet unmet needs in these focus areas.
Barbella: What kinds of future growth opportunities exist in the pediatric (orthopedic) device market? Is it expected to grow as robustly as the adult market?
Bailey and Hite: With the advancement of instruments and implants specific for kids, surgeons today have more options to surgically treat pediatric trauma, limb deformities and scoliosis, which enables faster growth than the adult market. These technologies among many other factors are leading to more pediatric surgery overall. In the future, we believe there will be further blue ocean opportunities in pediatric orthopedics that can drastically change the lives of children.
Such implicit capabilities are rarely cause for celebration, but Cai is something of an anomaly himself, having struggled with early onset scoliosis for most of his childhood.
Afflicting one in 10,000 children, the condition is characterized by a complex spinal curvature (85 degrees in Cai’s case). Early onset scoliosis can resolve on its own in children under age 2, but severe cases—like Cai’s—can lead to heart and lung problems that worsen over time.
Cai’s health definitely would have deteriorated, had surgeons not anchored magnetically controlled growing rods to the boy’s spine three years ago. Unlike traditional growing rods, the magnetically controlled devices are lengthened through an external remote control. He’s returned to the Children’s Orthopaedic Center at Children’s Hospital Los Angeles every three months to have the rods extended magnetically. The outpatient procedure takes less than five minutes.
Last year, Cai underwent a second surgery to replace the rods with longer versions. The new devices will allow him to grow as tall as he can over the next few years before he undergoes a final spinal fusion.
“These rods have been wonderful for him,” his grandmother Tracey said in a feature story on the hospital’s website. “They don’t hinder him from doing anything and he doesn’t think even twice about them. I just marvel at what Dr. Andras is able to do and that this procedure is available.”
Such procedures and products are necessary to treat a patient population that generally is overlooked by the $50.6 billion orthopedic implant industry. Major manufacturers have mostly ignored the pediatric patient population when developing new technologies due to the high cost of product development, relatively small market, and complex nature of the devices themselves (they must fit a body that is still growing).
ODT’s feature “Minor Adjustment” details the challenges companies face in developing pediatric orthopedic implants, and highlights some of the most recent innovations in this slighted market. David Bailey, president, and Fred Hite, chief operating officer/chief financial officer of OrthoPediatrics Corp., were among the industry experts interviewed for the story. Their full input is provided in the following Q&A:
Michael Barbella: Please discuss the trends in pediatric orthopedic device design and how these trends have changed (if at all) in the last several years.
David Bailey and Fred Hite: Over the last decade there has remained very little focus on pediatric orthopedic device development beyond OrthoPediatrics and a few other companies with one or two products. Historically patients were treated more conservatively by pediatric orthopedics surgeons, but in the last decade we have certainly seen a shift to more surgical care due to a number of socioeconomic factors. This combined with FDA's interest in streamlining the approval of devices specifically designed for children were two of the many reasons that building an entire company around the unmet need in pediatrics made sense.
More pediatric deformities are being treated with orthopedic surgery than historical casting procedures.
Two products have received HDE [humanitarian device exemption] approval, the first in 25 years, from the FDA—tethering and Apifix internal brace for treating scoliosis.
Barbella: In what ways are pediatric orthopedic devices different than adult products (other than size)?
Bailey and Hite: The bones of children are different than adults in many ways beyond simply being smaller. For example, pediatric devices must be designed to avoid the growth plates in children and accommodate bones which can be up to 30 percent more curved. Further, many pediatric orthopedic conditions do not present in adults so pediatric devices must be designed to treat a wide range of indications including skeletal deformities, cerebral palsy, and osteogenesis imperfect. The challenges facing pediatric orthopedic surgeons are extremely complicated and wide ranging, so adult products often do not work for these children.
Barbella: Why is the array of pediatric orthopedic devices so much more limited than that of adult products? Why aren’t there more devices being produced specifically for kids?
Bailey and Hite: Adult OEMs focus on the much larger adult hip, knee, and trauma markets and view the pediatric market as too small. Until recently, no other company specifically focused on this market. It also takes a large number of products to fully service this market. Pediatric orthopedic surgeons do a lot of surgery, but they don’t do one surgery a lot. The pediatric orthopedic market is a large niche market comprised of a lot of niche products, which is an entirely different model than the large OEMs prefer. Beyond that, no other company has a sales force selling into this market, and selling into this market requires a high degree of clinical knowledge specific to pediatric orthopedics that no other selling organization possesses.
Barbella: What are the challenges in designing/developing a pediatric orthopedic device vs. an equivalent adult product? How does OrthoPediatrics Corp. overcome these challenges?
Bailey and Hite: Pediatric devices must be designed with pediatric anatomy in mind such as avoiding the growth plates in children, accommodating for the multiple sizes and shapes of pediatric bones, and making the devices easily removable. The devices also must account for the unique pathologies surgeons are presented with, many resulting from conditions such as cerebral palsy. Beyond the implants, most of the systems we develop require very specific instrumentation, which in a lot of cases can make all the difference in how well surgery goes.
From the beginning, OP has partnered with pediatric orthopedic surgeons to develop systems, now 35, that are made just for them and their patients. We believe it is critical that we never try to simply make an adult product smaller. So we start working directly with the surgeons to design our device from the ground up with the specific focus on the unmet needs in pediatrics.
Barbella: Does the orthopedic sector present a particularly difficult challenge for those developing pediatric devices - as opposed to cardiovascular products, for example)? Why?
Bailey and Hite: There are probably other sectors of pediatrics such as cardiovascular products that present more challenges, especially from a regulatory perspective, however pediatric orthopedics also has challenges. Our patients' bones are always growing, so the development of devices that can grow with a child is a real struggle. Also, in pediatric scoliosis surgery developing devices that can treat very young children with deformed spines as well as trying to avoid spine fusion altogether are really the holy grail in the field.
Barbella: How are the market needs for pediatric patients identified? Does OrthoPediatrics work directly with surgeons to identify these market needs?
Bailey and Hite: We certainly work with the top key opinion leaders in our field to identify and define the unmet needs in our space. Also having a dedicated salesforce and engineering team that truly understands pediatric orthopedics is a huge asset. Great ideas for products can come from anywhere, however, we believe that a company with hundreds of customers and associates that are exclusively focused in this area is key to our identifying the unmet needs.
Barbella: Is there a specific area (part of the body) that designers are specifically focused on when developing pediatric implants? If so, why are these specific areas chosen?
Bailey and Hite: We focus on the largest procedure areas or where we feel we can make the biggest impact on the lives of children. So far this has been in the areas of pediatric trauma, limb deformity, and scoliosis, and we still have work to do to meet unmet needs in these focus areas.
Barbella: What kinds of future growth opportunities exist in the pediatric (orthopedic) device market? Is it expected to grow as robustly as the adult market?
Bailey and Hite: With the advancement of instruments and implants specific for kids, surgeons today have more options to surgically treat pediatric trauma, limb deformities and scoliosis, which enables faster growth than the adult market. These technologies among many other factors are leading to more pediatric surgery overall. In the future, we believe there will be further blue ocean opportunities in pediatric orthopedics that can drastically change the lives of children.