An Innovative Partnership

ENT – or ear, nose, and throat – sounds like a small part of the body, but it’s a big area of medicine. The specialty (also called otolaryngology) encompasses everything above the shoulders except the eyes and brain, and includes the airway and the organs for taste, smell, hearing, and speech.

As a surgical specialty, ENT doctors are both physicians and surgeons. This dual role creates many challenges, from the need to operate through small, tortuous openings like the ear and the nose, to helping patients with life-altering diseases that lack good treatment options, like certain kinds of hearing loss.

Challenges in Care

The drive to address these challenges has fueled a longstanding collaboration between the Stanford Department of Otolaryngology and the Stanford Byers Center for Biodesign. Stanford Biodesign teaches a proven process for solving important unmet healthcare needs through technology innovation.

“As surgeons, we tend to be very needs-oriented. We see a problem and we want to fix it,” said Peter Santa Maria, MD, PhD, an assistant professor of otolaryngology at Stanford Medicine.

Robson Capasso, MD, chief of sleep surgery and a global advisor at Stanford Biodesign, added, “We are always looking for technologies that improve care by making procedures less invasive, risky, or expensive, or move them from the OR to outpatient.”

A Multi-Faceted Collaboration

As part of this collaboration, ENT doctors learn and practice the biodesign innovation process by participating in Stanford Biodesign programs. These include the two-quarter graduate-level Innovation Course that residents and fellows can join, and a Faculty Fellowship for ENT faculty members interested in health technology innovation.

To help move faculty-initiated projects forward, Capasso and Santa Maria lead an Otoinnovation lab, where they use Biodesign-developed screening tools to help faculty members decide which ideas to pursue, based on their potential to reach patients and improve care. “We also provide mentoring, connections to funding sources, and contacts to other experts including some outside the US that can help lead early-stage clinical trials,” said Capasso.

The ENT department also devotes significant time and effort to hosting teams of Biodesign trainees so that they can directly observe the delivery of care. In this capacity, Capasso, Santa Maria, and others allow trainees to shadow them in the OR and clinic. They also serve as mentors, advisors, and principal investigators on the projects that stem from those observations.

“I do whatever needs to be done,” said Santa Maria. “For some teams I am a mentor, while for others, I am a hands-on clinical partner.” In addition to providing subject matter expertise, Santa Maria and others provide insight on issues that are essential to the adoption of a new technology, such as how it will integrate with the existing workflow in the clinic.

Another key piece of the collaboration is support from the Otolaryngology Department. “The collaboration with Biodesign significantly increases translational research opportunities for the faculty,” said Capasso. “This is only possible because our department leaders not only support translational research, but they help ensure we have protected time to serve as mentors and trainers.”

Developing Solutions

The collaboration is making a difference. Multiple teams of Biodesign trainees are currently tackling compelling ENT clinical needs. These projects include:

• Ear-Buddy: Matt Oldakowski and Josef Bartunek, two 2016-17 global trainees, are working on a non-invasive solution for a pediatric ear disease called otitis media with effusion, or “glue ear.” It’s one of the primary reasons children get ear tubes, the most common childhood surgery in the US.
  
  “Ear tube surgery doesn’t always work and may need to be repeated,” said Oldakowski. During his team’s clinical immersion, he described meeting a patient about to undergo ear tube surgery for the sixth time. “We were struck by the intense burden of so many surgeries on the patient, as well as the cost to the healthcare system,” he said. With Santa Maria as the clinical lead, the team is testing a non-invasive device that helps ventilate children’s middle ears as they swallow, with the goal of reducing the need for surgery.


•  Auricle: Francis Wong and Jay Dhuldhoya from the 2019-20 Innovation Fellowship are working on a device to restore hearing in adults with severe high frequency hearing loss. Over 1 million adults in the US have this condition, which makes speech incomprehensible even with hearing aids.
  
  Describing one of the clinical observations that motivated the team to address this need, Wong recalled, “We saw a patient in his early sixties who had been coming to the audiology clinic for years. From the moment he was called in to the consulting room, it was obvious that he had real difficulty understanding speech and even communicating with his wife. His best option was a cochlear implant, but that comes with some risk of losing residual hearing, and he was struggling with the decision because he knew there would be no turning back.” Working with Santa Maria and other ENT faculty, the team recently started a clinical study and completed several proof-of-concept cases.


• Nasus Medical: 2018-19 Innovation Fellows Ashley Seehusen, Adam Gold, and Shira Koss are developing a device that will improve at-home treatment for patients with chronic inflammation of the nasal and sinus cavity lining (rhinosinusitis) by delivering the medication further up the nasal passageway.  The team, which is now a company-in-residence at Fogarty Innovation continues to receive clinical feedback and support from several department members and has developed prototypes have shown promise in early human clinical trials.


• Spirair: this project out of the 2019-20 Innovation Fellowship, led by Brandon McCutcheon and James Kintzing, is developing a new approach to correcting nasal septal deviation that can be performed in an outpatient setting. The team is working on the project with associate professor of otolaryngology Jayakar Nyak, MD, PhD.


• Marisleep: This company, founded by Stanford Biodesign global trainee Hirofumi Taki, is developing a digital device to resolve hypopnea and sleep apnea without patient contact.

Improving Care

"Our department has a long history of working with engineers and other sciences to solve problems," said Santa Maria. He referenced Stanford professor emeritus Rodney Perkins, who pioneered new surgical procedures for the ear before turning to technology innovation to help patients with hearing problems that could not be fixed through surgery.

While Perkins ultimately started multiple companies, not all faculty members are interested in this path. The collaboration gives doctors like Capasso another way to be involved. “I find it gratifying to play a meaningful role in driving innovation as an advisor,” he said. “Working with Biodesign taught me to think about bigger picture of how you actually improve healthcare. How do you understand everyone’s roles and incentives and what is important to different stakeholders in the healthcare system? Biodesign gives you a framework for all that.”

Capasso continued, “It’s changed the way I think about the problems I see in the clinic. Our primary goal is to keep our patients safe and make sure they are receiving the best care possible. But, at the same time, we can work to improve patient care through innovation.”

_{All quotations are from interviews conducted by the authors unless otherwise cited.}