At first, the ventilation solution seemed too simple.
Rush Bartlett, a Biomedical Engineer and Post Doctoral student in the interdisciplinary Stanford University Biodesign Program, had been observing doctors in the Intensive Care Unit at Stanford Hospital for several months. Within Biodesign, Rush teamed up with Ryan Van Wert, a Pulmonary and Critical Care physician in the last year of his fellowship training. After several months of observations the attention of the team was increasingly drawn to patients on ventilators.
In the Biodesign Program, doctors and engineers spend six months working in teams observing medical care looking for problems to solve. Once they record several hundred clinical needs, they utilize a proven diligence process to narrow the list down to only the most compelling problems to solve.
By taking a step back and simply observing how care was provided in the ICU, Rush and Ryan noticed that patients with breathing tubes were almost always sedated with powerful medications to the point of being in a coma. This is current standard of care to manage the extreme discomfort caused by the breathing tube, which was like having a snorkel shoved down your throat.
The first Eureka moment happened when the team noticed that not all patients who were ventilated needed the sedation. Equally sick people who were ventilated through a tracheostomy did not require sedation (a tube through a hole in the bottom of the throat) because a tracheostomy tube does not trigger the gag reflex.
The second Eureka moment happened while the team was observing a bronchoscopy, the insertion of a fiber optic camera down the throat and into the lungs to look for disease. Very little sedation was needed during bronchoscopy even though the fiber optic camera passed through the same sensitive parts of the throat that the breathing tube did. The key difference was that prior to a bronchoscopy physicians were using tweezers and cotton balls to dab a little topical anesthetic to key spots in the back of the throat to numb the gag reflex.
At that point the solution was obvious, what patients with breathing tubes in the ICU needed was a way to constantly numb the throat. Like an epidural for the throat. Continuously numbing the throat would mute the gag reflex and lessen the need to keep people in drug-induced comas.
The implications were significant. Non-sedated patients recover faster. They don’t experience delirium, a costly and potentially devastating side effect of these medications. They are also less at risk for hospital-acquired infections and can avoid lengthy physical rehabilitation after the ICU. Sedation of patients with breathing tubes is such a problem that the American Board of Internal medicine called it one of the top five unmet needs in the ICU in the recently released Choosing Wisely Campaign.
“I guess we just approached the problem differently. For so long people have been trying to make different sedatives with fewer side effects but what actually happens is they just have different side effects,” Bartlett said. Sedative drugs cost between $400-$800 per day and up to 60% of heavily sedated patients in the ICU develop delirium which costs $3.6 billion annually to treat. “If you can reduce the cost of drugs by half, reduce hospital acquired complications, and help people get well more quickly, that generates huge value,” he added. “If you cut a five day ICU visit by two or three days, you start to see very big numbers,” as much as $30 billion in annual savings could be achieved by the U.S. health system, Bartlett said.
Rush and Ryan developed the Wyshbone Catheter, a device that continuously applies the topical anesthetic Lidocaine to the throat to reduce endotracheal tube discomfort. “Lidocaine is a well-studied anesthetic medication. It’s used intravenously for heart conditions, and in many over the counter medications in low concentrations. It’s used every single day for bronchoscopy procedures,” Ryan said.
Bartlett and Van Wert were 2013 E-Team finalists for Awair and the Wyshbone catheter. They said the early funding and recognition were indispensable moving forward.
“Funding is critical, you cannot advance a venture without funding,” Bartlett said. He also credited the E-Team workshop and OPEN conference with very rewarding networking opportunities, both with the instructors and peers.
“The E-Team program helped us to take a step back and look at our overall approach,” he said. “However, talking with other E-Team members, sharing ideas, and sharing experiences we found to be even more valuable than the instruction in the classroom.”
Bartlett said Awair has nearly finalized the Wyshbone design of the device and is preparing for quality and regulatory testing. Awair is on the lookout for partners and potential investors. Despite the huge development costs of the medical device industry, Bartlett sees an immediate market for Wyshbone with hospitals seeking to provide better care at lower cost in the ICU.
For other entrepreneurs, Bartlett recommends experience as the best teacher. “The only sure way to fail is to not try or to give up when facing adversity. Trying may not be a guarantee of success, but without lots of effort you will never create an impact.”