On our recent tour of the medical device space in Northeast Indiana, we stopped off at OrthoPediatrics, a company that’s literally reshaping the lives of children for the better. It was founded in 2006 as the only company in the world to be exclusively devoted to pediatric orthopedics. Since then it has developed a series of products for spinal correction, long bone trauma and deformity, and for ACL reconstruction.
OrthoPediatrics designs devices that are not only scaled down in size from adult orthopedic implants, but are specifically tuned to the requirements of little patients and their surgeons. For example, most adult orthopedic implants are made of titanium to encourage growth of tissue around the implant, but for kids the use of stainless steel is often preferred in order to prevent that effect and to make explantation easier.
The company’s offices in Warsaw, IN, known as The Orthopedic Capital, are housed inside a remodeled car dealership which was made to resemble the surgical kits that OrthoPediatrics ships out to hospitals. Stepping through the front doors, the first thing you see is a photo of Dr Peter Armstrong, Chief Medical Officer, with one of his patients, a boy named Gideon. The young boy in the picture was born without arms and with two clubbed feet. Dr. Armstrong corrected Gideon’s feet so well that the now twenty-some year old uses them as his hands, draws incredibly well, and lives a normal life, girlfriend and all. That photo, combined with a nearby drawing Gideon made of his girlfriend, is essentially the company’s mission statement that’s so obvious it doesn’t need an interpretation.
The firm has an impressively fast pathway through the FDA’s regulatory process, receiving clearances within sixty days of submitting new products. This compares to about a year-long wait for most other companies’ orthopedic products, and is explained by the FDA’s interest in seeing pediatric solutions get to market as soon as possible. So far, OrthoPediatrics has eighteen surgical systems, including instruments and implants, that received FDA’s 510(k) clearance, and more are on the way.
The company works closely with orthopedic pediatric surgeons (there are about 3,000 of them worldwide) to meet the needs they’ve identified during their clinical practice. Because they treat rather different pathologies compared to adult ortho surgeons, who are often strictly hip and knee folks, the company has to do a lot of its own research and “get into the minds” of these doctors in order to build better products, according to Mark Throdahl, OrthoPediatrics’ President and CEO. To help with research and design, the company obtained exclusive rights to the Cleveland Museum of Natural History’s Hamann-Todd Human Osteological Collection, the world’s largest academic repository of human bones. They’ve scanned a number of specimens from the collection and have used the data to develop new products.
Mark’s firm started building simple devices at first, initially focusing on providing a variety of screws and plates that can fix damaged bones in children of different sizes. Over time they progressed into building innovative products that have unique advantages over existing devices, such as lower profiles, to entirely new products, such as an ACL reconstruction system that can be used on very young children. Because OrthoPediatrics focuses on innovation and design of new implants and related tools, they leave the high precision manufacturing to nearby firms that specialize in that field.
One of the projects OrthoPediatrics is currently working on is addressing osteogenesis imperfecta, a genetic disorder in which children’s bones are brittle and tend to break frequently. They have an implant in the works that would provide long term support for the tibia while expanding by itself as the leg grows. There are a number of projects that are still in a conceptual, proof-of-concept stage, and things have been progressing through the company’s R&D pipeline to yield about one new FDA cleared major system per year.
The firm works with pediatric surgical centers and spends a lot of effort training surgeons in using their products, having put on over 240 workshops over the past year in different hospitals. They sponsor CME courses to get more surgeons ready to use their systems and have a committee of teaching surgeons that help with the company’s educational programs. They sell their products worldwide, with 20% of sales going overseas to about thirty countries, and offer various educational resources in other countries as well.
We were very impressed by OrthoPediatrics’ short ten year history during which they’ve become a gold standard for pediatric ortho products worldwide. They’ve single-handedly created a new niche industry that’s separate from the huge ortho market obsessively focused on hips and knees of older folks. In this time they’ve trained hundreds of surgeons in a variety of techniques and are continuing to train more while developing improved and entirely new solutions.
Here’s a video made by OrthoPediatrics in which you can learn more about the company: