Real world challenges in taking a medical device from adults to pediatrics to revolutionize the way clinicians clear occluded feeding tubes.
Feeding tubes are required when critically ill or severely compromised patients are unable to swallow food or medication. Patients requiring long-term feeding assistance typically use a surgically placed gastrostomy (G), jejunostomy (J) or a gastrostomy-jejunostomy (GJ) tube. For short term feeding assistance, nasoenteral (NE) tubes are normally used. In the United States (USA), approximately 7 million feeding tubes are placed each year. The problem is that these tubes often become clogged at reported rates from 12.5% to >35%. This results in millions of clogged tubes each year. When tubes remain clogged, patients can go without nutrition and medication for hours or even days. The interruption in nutrition and medication negatively impacts recovery. Healthcare practitioners spend significant time trying to clear clogged tubes, often spending more than 20 minutes per clog.
Actuated Medical, Inc. (AMI)* has developed the TubeClear device. TubeClear aims to reduce interruptions to feeding and medication regimens for the patient, reduce the time healthcare practitioners spend on hardware issues, and save significant time and money by quickly restoring patency to occluded feeding tubes. TubeClear is comprised of a reusable Control Box paired with a single use Clearing Stem. The healthcare practitioner attaches a Clearing Stem to the Control Box and inserts the Stem a few centimeters into the tube. Then the healthcare practitioner turns on the Control Box and manually directs the Clearing Stem further into the tube. The Clearing Stem has a specially designed tip that moves in a forward and backward motion that chips away at the clog to restore patency. TubeClear helps the healthcare practitioners to rapidly clear the tube without the expense and risk of tube replacement. The system is FDA cleared and CE Marked specific to NE, NG, G and J feeding and decompression tubes for adult patients.
For the pediatric market, clogged feeding tubes can occur more often due to the narrow diameters. The lack of nutrition and medication quickly exhausts the patient’s energy reserves and the patient may develop dehydration with electrolyte abnormalities more quickly than in adults. When a tube cannot be cleared by standard practice, it is replaced which then puts the patient at risk for surgical intervention, tube misplacement and dislodgement.
But, as commonly found, there were challenges to successfully transitioning an adult device to the pediatric market. Often the adult device is too big, too strong, or simply inappropriate for pediatrics. In this case, even though TubeClear is considered by the FDA to be “a non-significant risk device” there was still concern with moving TubeClear into the pediatric market.
The challenge to expand TubeClear’s indications to the pediatric population is threefold:
- The first was scale. Pediatric tubes are inherently smaller and the Clearing Stems now had to work in a much smaller tube. This is largely an engineering challenge.
- The second is regulatory. Rightly so, FDA assesses safety and efficacy in pediatric patients differently than in adults. AMI needed to comply with FDA requirements for pediatrics, which in some aspects can be more stringent than for the adult population.
- Third is market size. While there is certainly a medical need, the market is relatively small. Because developing a medical device is expensive, medical device firms typically look for a large market to offset their up-front R&D investment. Sadly, this combined with the regulatory burden often keeps larger firms out of the pediatric market.
To receive FDA clearance, AMI needed to investigate several factors. Among them was to investigate the behavioral response in a pediatric clinical study setting – a factor that was not required for clearance in the adult population. AMI needed a research partner at a recognized children’s hospital, which brought the team to CHOP and the PPDC. After reading a paper by a CHOP nurse, as well as a press release announcing the PPDC, AMI contacted our team to conduct the clinical study necessary to expand TubeClear’s indications. Since then, AMI has been working closely with the PPDC team to design a safe and informative study with submission to CHOP’s Medical Device Committee and internal IRB.
While the PPDC continues to work closely with AMI to assist in the indication expansion of TubeClear, the following are some key takeaways from their experience thus far:
- There are unique regulatory challenges with the pediatric market including a much higher bar for FDA clearance.
- Smaller market size makes it financially difficult to invest heavily into up-front R&D. Finding outside funding sources is critical to commercializing a pediatric device.
- Finding the right clinical research team is critical to your success. Start the process early.
*Actuated Medical, founded in 2006, is located in Central Pennsylvania with the vision to Improve Patient Outcomes by developing medical devices that move in such a way as to enhance the intervention. Their innovations enable healthcare practitioners to perform faster, easier, and safer procedures by integrating electronically controlled Innovative Motion® technologies. As a business, they constantly look for new opportunities that fit their scientific and technological skill set. When the right opportunity is discovered, they seek R&D funding from SBIR grants from the NSF and NIH – in 2014, Actuated Medical received a Small Business Administration Tibbetts Award for SBIR Excellence. To learn more about Actuated Medical or the TubeClear device, please visit ActuatedMedical.com.