Michael Barbella, Managing Editor11.30.21
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. Paul Gonsalves, president, Global Orthopedics, Orthofix, was among the industry experts interviewed for the story. His 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.
Paul Gonsalves: A critical factor in the design of pediatric implants is the accommodation of the growth plates in pediatric patients. Growth plates are open until 12 to 14 years old in girls and 14 to 16 years old in boys. Any disturbance to the growth process may result in limb length discrepancy, bone misalignment and diseases that may need to be treated further at a later stage. For this reason, companies are focusing on developing specific devices that take into account these requirements. To do this we are not just downsizing adult hardware, but actually completely redesigning systems in order to better address specific pathologies and the unique shape of pediatric bones.
One additional area that is extremely important is the pre-operative planning phase for pediatric patients. Our recently developed OrthoNext digital platforms enables surgeons to accurately plan the surgery and position templating devices on the radiological images in order to visualize the implant in relation to the anatomy. This software is designed to streamline the selection of the precise size of device to ensure the best fit and optimal positioning for the patient’s body prior to the surgical procedure. In addition to new software technologies, remote patient management through telemedicine or dedicated patient apps and custom-made implants are becoming more and more important. These technologies offer pediatric patients the best services in order to achieve the best outcomes. At Orthofix we believe this will be one of the biggest differentiators among companies in the future and that is why we are focusing our research in this area. Our R&D department has a specific group of people fully dedicated to software development and new digital tools to enhance our solutions beyond traditional hardware implants.
Barbella: In what ways are pediatric orthopedic devices different than adult products (other than size)?
Gonsalves: The shape of a pediatric bone is completely different than an adult one. In addition to size, the angles and presence of the growth plates must be taken into account. For example, a standard surgical treatment for an adult fracture is the usage of a rigid intramedullary rod. In a pediatric patient, this approach may affect the functionality of the growth plates. The shape of the rod must be designed to avoid the growth plates in order to minimize potential impact on the child’s growth. Additionally, the growth plates and the reduced weight of pediatric patients in general can be used as an advantage in developing specific innovative treatments that are not possible for adults. For example, in 2004 Orthofix introduced the eight-Plate Guided Growth System, a minimally invasive device to correct knee and ankle deformities by “modulating” the growth plate in pediatric patients. This innovation completely changed the approach to a common pediatric condition. Now the use of the eight-Plate system has become a standard of care.
Recently, the FITBONE intramedullary lengthening nailing system manufactured by Wittenstein and distributed by Orthofix, received the FDA clearance and CE Mark approval for the first intramedullary lengthening nail indicated for pediatric use. The FITBONE system is used to lengthen the lower limb in patients suffering from limb-length discrepancy. While previously available for adult application, it is the first time such a device has been approved for pediatric use. We are proud to be the first company to offer surgeons and their pediatric patients a new option for limb lengthening. The FITBONE intramedullary limb-lengthening system is an invaluable addition to our comprehensive portfolio that includes both internal and external fixation devices for limb reconstruction.
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?
Gonsalves: While the overall numbers of pediatric surgeries may be growing, it is still difficult to set up economies of scale. Each patient is specific and the potential design variation of each product is huge. Considering the need for a vast array of options, it is not easy to match the right design for each patient. The overall result is that there is a tendency to adapt a patient to the device instead of the other way around. In adults the approach is more standard and variations are more limited. This is one of the reasons why we at Orthofix believe the adoption of the new technologies is fundamental to treating pediatric patients.
Barbella: What are the challenges in designing/developing a pediatric orthopedic device vs. an equivalent adult product? How does Orthofix overcome these challenges?
Gonsalves: At Orthofix we have more than 40 years of pediatric product development experience. One of our first products was the Orthofix Limb Reconstruction System, an external fixator used to lengthen bones in patients with achondroplasia. Over the years, many things have changed including new regulations and requirements that have added additional steps in the product development cycle and registration phase. Fortunately, we have an organization that can react quickly to changes and adapt to the new rules. We also collaborate with surgeons in the development and design of new products to ensure we are meeting the needs of pediatric patients and offering the best possible products for trauma and limb reconstruction.
Barbella: Does the orthopedic sector present a particularly difficult challenge for those developing pediatric devices as opposed to cardiovascular products, for example? Why?
Gonsalves: There are new requirements that we must follow during the development and manufacturing of devices. Beginning in May 2021, the new MDR (Medical Device Regulation) went into effect in Europe. This new set of rules states that all the new medical devices released in the market will require a preclinical trial before a CE Mark certificate will be issued. This means that the development process will be much longer and more expensive. To conduct a preclinical trial with pediatric patients will be very difficult. Apart from this, the number of pediatric cases is limited, and it takes longer to retrieve data to modify or create improvements to a design. This is why the new technologies are going to play an important role in shortening the development time and creating products designed for specific patients.
Barbella: How are the market needs for pediatric patients identified? Does Orthofix work directly with surgeons to identify these market needs?
Gonsalves: We have an international team of leading surgeons working in pediatric orthopedics to help us stay updated on new trends. They provide us different perspectives on the new technologies that are entering into the market. For example, no one would have ever imagined the potential role that new software and digital devices may play in the surgical field. With dedicated software programs that were internally developed (OrthoNext and Hex-ray), we are able to pre-plan the surgery before it actually happens. The surgeon is enabled to plan the surgical steps and the size of the implant in order to create the best combination for the patient.
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?
Gonsalves: One of the most important parts of pediatric device design is how well the patient will be able to tolerate the implant. Physiology and long-term sustainability are always a central area in our product development. Companies have always been focused on the surgical step because historically the implant is something very tangible that can be easily analyzed and improved. However, the surgical phase is just one of three steps that involve the patient. Before the surgery we have the preoperative phase, where the best implant for the patient must be selected, followed by the surgery phase, and then lastly, the postoperative phase which is critical to achieving the best outcomes. At Orthofix we are committed to supporting our surgeons and patients and their families not only during the surgical phase but also before and after. That is why we have developed specific tools, such as edugames, activity kits for children and patient apps, to monitor and support patients and surgeons during all the stages of the healing process. For parents the decision to have surgery for a child is a big one. Having patient resources such as websites, activity sheets and games is a great way to provide children and their parents with additional support. Research shows that parents search out the best treatments for their child. Orthofix has developed the first edugame, mySuperheroAcademy, designed to educate pediatric patients treated by TL-HEX System before and after surgery (see also https://www.tlhex.com/carehexcellence/). This results in adding value to surgeons by reducing the overall time needed to educate patients and their families with regards to surgery (see also https://www.juniortho.club/patient-support/). To emphasize this approach we have launched a dedicated brand—JuniOrtho—that represents our commitment as a company in the pediatric area.
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?
Gonsalves: In general, the pediatric market is expected to grow twice as fast as the adult orthopedic devices market. This may be attributed to the increase in fellowships and courses dedicated to pediatrics and to the fact that many surgeries, previously managed by generalists, have now been moved to dedicated pediatric orthopedic surgeons. Based on scientific literature, the surgical approach in pediatric trauma is now more common than in the past due to the better results, faster patient recovery and enabling children to return to school and to normal life. At Orthofix, we believe strongly in medical education, and we have developed specific training courses, both online and in person, to support surgeons in their daily practice. We actively collaborate with the scientific societies, POSNA in U.S. and EPOS in Europe, to tailor dedicated activities to better address surgeons’ educational needs.
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. Paul Gonsalves, president, Global Orthopedics, Orthofix, was among the industry experts interviewed for the story. His 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.
Paul Gonsalves: A critical factor in the design of pediatric implants is the accommodation of the growth plates in pediatric patients. Growth plates are open until 12 to 14 years old in girls and 14 to 16 years old in boys. Any disturbance to the growth process may result in limb length discrepancy, bone misalignment and diseases that may need to be treated further at a later stage. For this reason, companies are focusing on developing specific devices that take into account these requirements. To do this we are not just downsizing adult hardware, but actually completely redesigning systems in order to better address specific pathologies and the unique shape of pediatric bones.
One additional area that is extremely important is the pre-operative planning phase for pediatric patients. Our recently developed OrthoNext digital platforms enables surgeons to accurately plan the surgery and position templating devices on the radiological images in order to visualize the implant in relation to the anatomy. This software is designed to streamline the selection of the precise size of device to ensure the best fit and optimal positioning for the patient’s body prior to the surgical procedure. In addition to new software technologies, remote patient management through telemedicine or dedicated patient apps and custom-made implants are becoming more and more important. These technologies offer pediatric patients the best services in order to achieve the best outcomes. At Orthofix we believe this will be one of the biggest differentiators among companies in the future and that is why we are focusing our research in this area. Our R&D department has a specific group of people fully dedicated to software development and new digital tools to enhance our solutions beyond traditional hardware implants.
Barbella: In what ways are pediatric orthopedic devices different than adult products (other than size)?
Gonsalves: The shape of a pediatric bone is completely different than an adult one. In addition to size, the angles and presence of the growth plates must be taken into account. For example, a standard surgical treatment for an adult fracture is the usage of a rigid intramedullary rod. In a pediatric patient, this approach may affect the functionality of the growth plates. The shape of the rod must be designed to avoid the growth plates in order to minimize potential impact on the child’s growth. Additionally, the growth plates and the reduced weight of pediatric patients in general can be used as an advantage in developing specific innovative treatments that are not possible for adults. For example, in 2004 Orthofix introduced the eight-Plate Guided Growth System, a minimally invasive device to correct knee and ankle deformities by “modulating” the growth plate in pediatric patients. This innovation completely changed the approach to a common pediatric condition. Now the use of the eight-Plate system has become a standard of care.
Recently, the FITBONE intramedullary lengthening nailing system manufactured by Wittenstein and distributed by Orthofix, received the FDA clearance and CE Mark approval for the first intramedullary lengthening nail indicated for pediatric use. The FITBONE system is used to lengthen the lower limb in patients suffering from limb-length discrepancy. While previously available for adult application, it is the first time such a device has been approved for pediatric use. We are proud to be the first company to offer surgeons and their pediatric patients a new option for limb lengthening. The FITBONE intramedullary limb-lengthening system is an invaluable addition to our comprehensive portfolio that includes both internal and external fixation devices for limb reconstruction.
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?
Gonsalves: While the overall numbers of pediatric surgeries may be growing, it is still difficult to set up economies of scale. Each patient is specific and the potential design variation of each product is huge. Considering the need for a vast array of options, it is not easy to match the right design for each patient. The overall result is that there is a tendency to adapt a patient to the device instead of the other way around. In adults the approach is more standard and variations are more limited. This is one of the reasons why we at Orthofix believe the adoption of the new technologies is fundamental to treating pediatric patients.
Barbella: What are the challenges in designing/developing a pediatric orthopedic device vs. an equivalent adult product? How does Orthofix overcome these challenges?
Gonsalves: At Orthofix we have more than 40 years of pediatric product development experience. One of our first products was the Orthofix Limb Reconstruction System, an external fixator used to lengthen bones in patients with achondroplasia. Over the years, many things have changed including new regulations and requirements that have added additional steps in the product development cycle and registration phase. Fortunately, we have an organization that can react quickly to changes and adapt to the new rules. We also collaborate with surgeons in the development and design of new products to ensure we are meeting the needs of pediatric patients and offering the best possible products for trauma and limb reconstruction.
Barbella: Does the orthopedic sector present a particularly difficult challenge for those developing pediatric devices as opposed to cardiovascular products, for example? Why?
Gonsalves: There are new requirements that we must follow during the development and manufacturing of devices. Beginning in May 2021, the new MDR (Medical Device Regulation) went into effect in Europe. This new set of rules states that all the new medical devices released in the market will require a preclinical trial before a CE Mark certificate will be issued. This means that the development process will be much longer and more expensive. To conduct a preclinical trial with pediatric patients will be very difficult. Apart from this, the number of pediatric cases is limited, and it takes longer to retrieve data to modify or create improvements to a design. This is why the new technologies are going to play an important role in shortening the development time and creating products designed for specific patients.
Barbella: How are the market needs for pediatric patients identified? Does Orthofix work directly with surgeons to identify these market needs?
Gonsalves: We have an international team of leading surgeons working in pediatric orthopedics to help us stay updated on new trends. They provide us different perspectives on the new technologies that are entering into the market. For example, no one would have ever imagined the potential role that new software and digital devices may play in the surgical field. With dedicated software programs that were internally developed (OrthoNext and Hex-ray), we are able to pre-plan the surgery before it actually happens. The surgeon is enabled to plan the surgical steps and the size of the implant in order to create the best combination for the patient.
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?
Gonsalves: One of the most important parts of pediatric device design is how well the patient will be able to tolerate the implant. Physiology and long-term sustainability are always a central area in our product development. Companies have always been focused on the surgical step because historically the implant is something very tangible that can be easily analyzed and improved. However, the surgical phase is just one of three steps that involve the patient. Before the surgery we have the preoperative phase, where the best implant for the patient must be selected, followed by the surgery phase, and then lastly, the postoperative phase which is critical to achieving the best outcomes. At Orthofix we are committed to supporting our surgeons and patients and their families not only during the surgical phase but also before and after. That is why we have developed specific tools, such as edugames, activity kits for children and patient apps, to monitor and support patients and surgeons during all the stages of the healing process. For parents the decision to have surgery for a child is a big one. Having patient resources such as websites, activity sheets and games is a great way to provide children and their parents with additional support. Research shows that parents search out the best treatments for their child. Orthofix has developed the first edugame, mySuperheroAcademy, designed to educate pediatric patients treated by TL-HEX System before and after surgery (see also https://www.tlhex.com/carehexcellence/). This results in adding value to surgeons by reducing the overall time needed to educate patients and their families with regards to surgery (see also https://www.juniortho.club/patient-support/). To emphasize this approach we have launched a dedicated brand—JuniOrtho—that represents our commitment as a company in the pediatric area.
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?
Gonsalves: In general, the pediatric market is expected to grow twice as fast as the adult orthopedic devices market. This may be attributed to the increase in fellowships and courses dedicated to pediatrics and to the fact that many surgeries, previously managed by generalists, have now been moved to dedicated pediatric orthopedic surgeons. Based on scientific literature, the surgical approach in pediatric trauma is now more common than in the past due to the better results, faster patient recovery and enabling children to return to school and to normal life. At Orthofix, we believe strongly in medical education, and we have developed specific training courses, both online and in person, to support surgeons in their daily practice. We actively collaborate with the scientific societies, POSNA in U.S. and EPOS in Europe, to tailor dedicated activities to better address surgeons’ educational needs.
