To date, 40+ projects have been assisted by the PPDC! Below is a list of some of our assisted projects, and we invite you to read about their journeys into the pediatric market:
InfraScan, Inc.: The Infrascanner
Clinical expertise and advanced technology come together to provide the best possible care to save the brain following traumatic brain injury.
Traumatic brain injury (TBI) is one of the most debilitating medical conditions, as it can lead to potential lifelong complications. It is also the leading cause of death in children. The quality of treatment provided following a moderate to severe TBI is extremely important due to the way in which TBIs evolve. Traumatic brain injuries progress through several phases. The first stage is the primary injury phase. This is the damage that is directly caused by the impact or blow to head; this initial injury may be relatively small in size and have limited permanent effect on the brain tissue. The second phase is the secondary injury phase. As the brain reacts to the initial injury it goes through a cascade of changes which can result in swelling, brain bleeds (hematoma) and chemical imbalances. All of these are injurious to brain tissue. The final magnitude of injury to the brain is the combination of the primary and secondary injury. “Time lost is brain lost”. Early detection and treatment of secondary injury is critical to limit permanent brain damage. The Infrascanner handheld, hematoma detector was developed to aid clinical personal in the detection of developing hematomas. Early detection means early treatment, usually resulting in surgery for large and growing hematomas. Computed tomography (CT) scans are used to identify and track hematomas but with the addition of the Infrascanner, scans can be done frequently at the patient bedside reducing the exposure to radiation and movement of the patient yet providing clinicians with current information. This helps clinicians identify and track developing hematomas so that they can intervene in a timely manner.
Britton Chance from the University of Pennsylvania and Claudia Robertson from Baylor College of Medicine invented a Near Infrared (NIR) system for detection of brain Hematomas and tested it successfully in 305 patients at Baylor College of Medicine. An entrepreneurial team formed a company, InfraScan, Inc., around this technology in Collaboration with Drexel University. Office of Naval Research and later the Marine Corps funded the technology development. Subsequently the Infrascanner handheld brain hematoma detector was developed, winning an Excellence in Design gold award in 2007 and in 2009 the system was featured as a transformational technology in Better World Report. The company also attracted $1.8M in funding from BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania, from Ben Franklin Technology Partners of Southeastern Pennsylvania, and from Philadelphia Industrial Development Corporation.
Severe TBI has become one of the most common battlefield injuries. The newly released Infrascanner Model 2000 was developed based on input from the US Marines. A rugged, compact design was created to support the rigors of military emergency use.
InfraScan, Inc. is in the process of bringing the scanner to market throughout the world. The European CE regulatory approval was obtained in 2008 and US FDA clearance for use in hospitals on adults was obtained in 2013. With support from PPDC a study is currently underway in CHOP to expand the FDA clearance and to show the efficacy and safety of the Infrascanner in children. Infrascanner provides the unique portable solution for helping clinicians detect and treat emerging hematomas in time to limit permanent brain damage.
Actuated Medical, Inc.: TubeClear
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.
Little Sparrows Technologies: Bili-Hut
Solving the global problem of providing phototherapy to treat neonatal jaundice anywhere.
About 8% of all newborns have severe neonatal jaundice. It's one of the most common conditions affecting infants, and the incidence jumps to 80% for preterm newborns in the first week of their lives. An estimated 6 million newborns worldwide do not receive treatment for severe jaundice because they lack access to effective phototherapy devices. Annually, jaundice causes an estimated 30% of newborn deaths in underdeveloped areas, and many survivors suffer lifelong neurological disability as a result of the disease.
The Bili-Hut is a portable, high-intensity phototherapy device for treating newborns with neonatal jaundice. Little Sparrows offers a three-pound, collapsible enclosure that uses low-energy-requiring LED lights, enabling use with either line power or alternative sources such as a 12-volt battery. With funding from the PPDC combined with other funding sources, including the Saving Lives at Birth Grant Competition, Little Sparrows is refining the device and is seeking FDA approval.
OtoNexus Medical Technologies: Otitis Media Detection Device
Changing the way clinicians diagnose middle ear infections to decrease the amount of unnecessary antibiotic prescriptions and reduce healthcare costs.
OtoNexus Medical Technologies, Inc. is commercializing a Doppler ultrasound medical device to rapidly and accurately diagnose middle ear infections, called Otitis Media (OM), in children and adults. 17.6 Million patient visits each year are coded to OM at a cost of more than $5 Billion/year, yet clinical studies show a 50% error rate in diagnosis. Otitis Media is the #1 reason for antibiotic prescriptions in children, as well as the #1 cause for surgery in children. Current diagnostic methods are decades old, and cannot distinguish the type of infection behind the eardrum.
With funding in part from the PPDC, OtoNexus is developing a handheld device to quickly and accurately detect both the presence and type of fluid behind the eardrum in one second or less. This would provide, for the first time, objective, definitive diagnostic data which could lead to increased accuracy, earlier and better treatment, reduced antibiotic use, and reduced healthcare costs.
RasLabs, LLC: Polymer-based Liner for Prosthetic Sockets
Developing an adjustable prosthetic liner to revolutionize the fit and function of prosthetics.
RasLabs believes in developing, fabricating, and distributing customized products that have the power to heal and save lives. They produce Synthetic Muscle, electroactive polymer (EAP) based materials and actuators that contract and expand at low voltages. This EAP material could improve the interface between a child and his/her prosthetic limb. Without using gears or motors, the material contracts or expands like muscle, in response to low-voltage electricity. Using this biomimetic material to line the socket of a pediatri-sized artificial leg or other limb could provide a more snug fit of the prosthetic device during normal daily use, and improve a child's experience using it. With funding in part from the PPDC, as well as support of the Synthetic Muscle Project from the US Department of Energy, MassChallenge, CASIS, and the US Department of Defense, the prosthetic liner device is in early development.
Figure 1. Simple demonstration of sensing using an analog multimeter.
Most polymers, once cooled, do not move or change shape. Ras Labs Synthetic Muscle™ are electroactive polymers (EAPs) that undergo controlled motion and shape-morphing with electric input. Synthetic Muscle™ incorporated into self-adjusting EAP based pads for prosthetic liners and sockets will allow amputees and children born without fully formed limbs to go about their active lives without needing to adjust the fitting of their prosthetic device(s) throughout the day. The purpose of this development is to resolve major issues facing amputees, such as prosthetic slippage and the inconvenience of removing or adding prosthetic sockets to maintain fit. For pediatric patients, this is of paramount importance because of the brain mapping that occurs with full function during childhood, and for all children to comfortably and easily enjoy the full freedom of motion.
Ras Labs Synthetic Muscle™, comprised of electroactive polymers (EAPs), expand and contract at low voltages, and can create a dynamic prosthetic liner or socket to maintain proper fit for the amputee throughout the day (prototype stage). In addition, these polymers offer impact resistance and pressure sensing, and have the potential to combine these properties in one integrated solution. The pressure sensing property of these polymers potentially allows Ras Labs’ prosthetic pads to adjust to the shape of the patient’s residuum without manual adjustment.
When mechanical pressure is applied to Ras Labs’ electroactive polymers, the change in resistance can be recorded. This allows Ras Labs to use these EAPs as resistive sensors in addition to their contractile properties for multiple applications. As resistive sensors, these electroactive polymers have the potential to advance prosthetic technologies by creating self-adjustable dynamic prosthetic liners and sockets. Multiple pads can be placed in the prosthetic liner or socket as different sensor zones to detect changes in pressure. This detection can lead to an automatic adjustment of the prosthetic pads by contracting or expanding to maintain proper fit and can also give feedback to patient on the use of the device in static and dynamic states. Feedback from the device can help the patient and prosthetist adjust rehabilitation practices to improve the patient’s locomotion and balance, and automatic adjustment of dynamic prosthetic pads would enhance proper fit and comfort of prosthetic devices for the amputee patient. The sensing the sensing properties of Ras Labs’ Synthetic Muscle™ through compression and impact. Based on preliminary results, Ras Labs Synthetic Muscle™ can register pressure at different magnitudes by a change in resistance. In the compression sensing tests, the polymer senses that a large amount of force is being applied over a set period of time. For the impact sensing tests, the polymer registers the blunt impact by showing a spiked decrease in resistance followed by an exponential climb to a stable state.
Ras Labs is collaborating with United Prosthetics, Inc., which is taking care of the majority of the Boston Marathon victims, including pediatric patients, is assisting with prototyping, and has offered to help with human clinical trials. The addition of the sensing properties of Ras Labs Synthetic Muscle™ to its shape-morphing actuation properties has the potential to greatly advance prosthetic devices. Due to a combination of activity and dehydration, the amputee’s residuum can undergo volume changes throughout the day causing improper fit and discomfort. These changes can eventually lead to skin and tissue degradation if the patient does not manually adjust his or her prosthetic device to maintain a proper fit. Dynamic fit is crucial to maintaining a proper fit of the prosthetic device, and the goal of Ras Labs is to increase the patient’s level of comfort and proper fit by incorporating Ras Labs EAPs polymers into prosthetic liners and sockets (Figure 2). A combination of contractile actuation, impact attenuation, and pressure sensing from Ras Labs Synthetic Muscle™ to create dynamic self-adjusting prosthetic pads and liners can enable amputees and children born without fully formed limbs to go about their active days without constant manual adjustment of their devices.
Figure 2. Current prototype incorporating Ras Labs Synthetic Muscle™
based EAP system into an adjustable prosthetic liner.