Makers of a pediatric ear tube and device for monitoring endotracheal tube positioning each received $50,000 from the Sheikh Zayed Institute for Pediatric Surgical Innovation, the latest move in the battle to tackle the shortfall in pediatric devices.
The problem is stirring global stakeholders to action, including the government of Abu Dhabi, which funded the institute with a $150 million gift in 2010. It's based out of Children's National System hospital in Washington, DC.
The winners of the third annual award were announced at the conclusion of a symposium in downtown DC on the challenges and opportunities facing pediatric devices.
|John Vaughan, AventaMed chief technology officer|
John Vaughan is the chief technology officer of Ireland's AventaMed, whose investigational ear tube is designed to eliminate the need for general anesthesia among young children suffering from an ear infection who are in need of a tympanostomy tube (also known as a grommet).
"What we've invented is a device that will place the tube quicker and simpler," he said in an interview following the award ceremony.
The $50,000 will go toward funding clinical trials of the device, which has the potential to greatly simplify 1 million procedures per year in the U.S. alone. Benefits of the device include a reduction in parental anxiety and cost savings to the healthcare system.
"The piece you get your funding on is how much you can save taking from an operating theater into an in-office setting," Vaughan said. He added that data shows in 1 in 10,000 children die under general anesthesia, and said research has suggested putting children under the age of three to sleep could result in cognitive and learning disabilities.
AventaMed was originally funded by the federal agency Enterprise Ireland and $1.5 million in angel funding. It's looking to soon hold a Series A funding round and file for 510(k) and CE mark approval by the end of 2016, Vaughan said.
|Donald Prough, Prospira founder|
Galveston, TX's Prospira also received $50,000 for its device to track the positioning of endotracheal tubes using optoacoustic imaging. A misplaced or dislodged endotracheal tube (used to ventilate the lungs) can be fatal, Prospira founder Dr. Donald Prough told FierceMedicalDevices.
Pediatric patients and infants are high risk, especially when being transported between hospitals, because they have a short trachea.
Prough will use the money to expand clinical studies of the device at Akron Children's Hospital. He also said the award will help him attract more funders. He needs about $500,000 to develop a manufacturing prototype that he can submit for FDA's 510(k) clearance.
Unsurprisingly, the challenges of funding pediatric device innovations were discussed during the daylong symposium. The small market size of most pediatric devices make them a tough business proposition, and engineering challenges like miniaturization and the need to avoid interfering with growth plates can make them expensive to develop.
Panelists at the symposium recommended utilizing nontraditional sources of financing, including government funding and VC firms with a philanthropic bent. They said so-called family offices, which manage the money of wealthy families, are showing increased interest in the pediatric device space.
Other challenges are legal and regulatory. Since the FDA hasn't granted pediatric indications to most devices (since they aren't generally designed to be used on children), doctors must use them off-label, which increases the liability risk when a mistake is made. And mistakes are more likely when the device is too large to be used optimally on children.
Also discussed was the FDA's new focus on taking input directly from patients and their families, as evidenced by the formation of a patient-centric advisory board.
"One of the biggest takeaways from the meeting was that you can apply for a 510(k) with patient advocacy data," Vaughan said. He plans to include data gathered from a focus group showing that parents value AventaMed's device because as he put it "there is a natural fear of putting your child under general anesthetic."
Six other pediatric devices companies made presentations for the funding during the symposium.
One of the judges was Justin Shaka of last year's winner, REBIscan. It is developing a device to diagnose lazy eye at an early stage. Shaka said he is still waiting for FDA clearance 28 months after filing his submission, demonstrating the challenges of developing pediatric devices.
- here's more, including a list of the finalists