Low ROI, Unique Patient Needs Thwarting Pediatric Implant Market

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. Nick Deeter, founder and CEO of WishBone Medical, was among the industry experts interviewed for the story. His full input is provided in the following Q&A:
 
Michael Barbella: Discuss the trends in pediatric orthopedic device design and how these trends have changed (if at all) in the last several years.
Nick Deeter: Pediatric orthopedics is still a very new segment within the industry; pediatric-focused orthopedic device companies have only existed in the last 15 years. This niche industry breeds developments to disrupt the status quo of using adult implants in children. Still to this day, adult products that are not cleared by the FDA for pediatric use are often altered on the spot in the OR to fit the child. 
In recent years, the FDA has recognized that children have their own unique physiological needs and has taken major strides to help make a push to prioritize them. Additionally, trends are moving away from casting and internal fixation with plates and screws, which allows for quicker healing and accurate alignment—ultimately creating a better experience for recovering patients and their families.
 
Barbella: In what ways are pediatric orthopedic devices different than adult products (other than size)?
Deeter: For plates, we incorporate a number of design elements to ensure that growth plates are not disrupted, including screw hole positioning and threads which angulate screws away from the physis. WishBone plates are designed to be soft-tissue friendly with lower profiles and contoured edges—along with low-profile screws. 
The composition of adult bones is much different from children’s—adults’ are hard and more calcified, while kids’ bones are pliable, and they have open growth plates that are more susceptible to injury. As a result, the fracture types are equally different.  Pediatric implants are also specific to pathologies that are more prevalent in children, such as hip dysplasia, angular- and rotational deformities. 
 
Barbella: What are the challenges in designing/developing a pediatric orthopedic device vs. an equivalent adult product? How does WishBone Medical overcome these challenges?
Deeter: Companies like WishBone must pay close attention to growth plates while considering the cases heavier-set children. While implants need to accommodate smaller bones, they also need to withstand adult-like loading. 
 
Barbella: Does the orthopedic sector present a particularly difficult challenge for those developing pediatric devices as opposed to cardiovascular products, for example? Why?
Deeter: Orthopedics is the last healthcare industry to make a full transition to single-use, sterile packed solutions, and with that, manufacturers and customers are still facing the financial and logistical challenges inherent to reusable cases and trays. Reusable cases and trays are extremely costly to produce—making for a capital-intensive business model and restricted inventory. Companies operating on such are only able to equip a small number of hospitals and little to no surgery centers. WishBone Medical’s single-use, sterile packed procedure kits bypass these obstacles completely.  
 
Barbella: How are the market needs for pediatric patients identified? Does WishBone Medical work directly with surgeons to identify these market needs?
Deeter: WishBone’s product systems are developed alongside surgeons. We create strategic relationships with key opinion leaders (KOLs) to conceptualize and design solutions based on their teams’ everyday challenges and patients’ actual needs. WishBone KOLs present us with collections of patient data that guide product development from start to finish. 
 
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?
Deeter: WishBone’s ultimate goal is to offer surgeons a comprehensive product portfolio with anatomically appropriate solutions from head to toe. Our team is striving to create innovative offerings for deformity correction of long-bone and trauma, from plates and screws and external fixation. 
 
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? 
Deeter: There are unlimited growth opportunities in this market, including innovation around resorbable implants, precision and minimally invasive surgical solutions, patient-specific implants, total joint replacement, and convenience kits.