Earlier this year I had the opportunity to meet with Neil Ray, CEO of Raydiant Oximetry and hear a bit of his journey in developing a truly life changing photonics-based device.
Ray is a pediatric anesthesiologist who has been in clinical practice for almost 20 years. In this role he cares for mothers during the child birthing process in the hospital as well as newborn babies. "We have a lot of access to monitoring modalities for patients, but there's no monitoring modality available for the fetus," says Ray. "This is a very sort of stressful time for everyone involved."
Within the developed world, there is a trend of doing a growing number of C-sections eventually deemed as medically unnecessary. A big driver is the monitoring, which currently has an accuracy of a coin toss at predicting fetal distress. To address this issue, Ray came up with the idea of using pulse oximetry technology, essentially extending its scope to monitoring the baby during childbirth.
Pulse oximetry works on the concept that oxygenated blood is red and when deoxygenated blood is blue. As such, the pulse oximetry technology placed on your finger can tell how much oxygen is circulating in your blood by conducting a color analysis of your blood. The blood in your arterial system pulsates because your heart pulsates, so pulsations are very easy to identify. By identifying those pulsations, you can measure arterial blood oxygenation.
Ray’s device measures fetal arterial blood oxygenation through the maternal abdomen. “We're shining light through the maternal abdomen and bouncing out the baby. We get a very bright signal from the mom, and a much smaller signal from the baby,” he says. “We can separate those signals because the heart rates are different. Mom has a certain heart rate, which tend to be slower than the baby's heart rate. Because we always know what mom's heart rate is, we can isolate the signal coming from the baby, do the color analysis and tell you how much oxygen is in the baby's blood.”
Ray is trying to solve a difficult problem. Every human admitted to a hospital is immediately fitted with pulse ox, and it makes the whole monitoring situation much easier for a nurse to have multiple patients. The only patients in a hospital not monitored for pulse ox is the baby in the womb. Doctors can hear the ultrasound, and it sounds perfectly healthy, but it doesn't mean the blood is getting to the brain. As a results obstetricians do not know if the baby in distress. The doctors only know if it has a healthy heartbeat. And because they're afraid of a scenario where they might make the wrong call, and the baby is damaged during childbirth, they have turned to C-sections. This situation has created a need to improve the state of the technology and monitoring and cut through the complexity with a solution. Ray’s creation is an enormous jump forward in technology – and it will save lives, while preventing false negatives.
Because Ray's background is neither scientific or engineering-centric, there was a lot of research and development work necessary to properly develop this technology. Ray had a really difficult time finding a U.S. university willing to do the R&D work. "It was expensive, and American universities have very high overhead indirect costs (around 50%), timelines were slow, and the universities were very concerned about IP encumbrance," he says. "They've got a mission, if they develop something, they own that IP, making it challenging to get access to co-developed IP."
This changed when Ray attended the Med Tech Summit in Dublin where he learned about Tyndall National Institute and its Biophotonics Institute. This also led to Ray meeting Patrick Morrissey, head of photonics operations at Tyndall and the center manager for the Irish Photonic Integration Center.
While Ray’s project is a solid fit for Morrissey’s group – investment is a key challenge when bringing a product like this to market. Not only is the technology still somewhat invisble to investors, scaling is an issue, especially when people try to relate and compare photonics with semiconductors. “Obviously, the semiconductor industry is huge, and investors see photonics as a bit of a cottage industry that is a bit invisible,” Morrissey says. “Obviously we disagree because photonics has fantastic opportunities with a huge number of applications.”
Ray acknowledges, it's also hard for women's health care companies and devices that are oriented towards pediatrics, children's health care, to get funding. “When you look at the medtech ecosystem, it tends to fund ideas and cancer cardiology orthopedics," says Ray. "We're working on something that traditionally hasn't been very cherished and been ignored. When you think of women's health care companies, research dollars that go into women's health care research, venture funding. It's less than 2-3%."
Ray is trying to solve a difficult problem. Every human admitted to a hospital is immediately fitted with pulse ox, and it makes the whole monitoring situation much easier for a nurse to have multiple patients. The only patients in a hospital not monitored for pulse ox is the baby in the womb. Doctors can hear the ultrasound, and it sounds perfectly healthy, but it doesn't mean the blood is getting to the brain. As a results obstetricians do not know if the baby in distress. The doctors only know if it has a healthy heartbeat. And because they're afraid of a scenario where they might make the wrong call, and the baby is damaged during childbirth, they have turned to C-sections. This situation has created a need to improve the state of the technology and monitoring and cut through the complexity with a solution. Ray’s creation is an enormous jump forward in technology – and it will save lives, while preventing false negatives.
The ability to establish a proof of concept for technology based on the insights learned from the Tyndall team has been instrumental in pushing Raydiant forward including its ability to successful raise $12 million of Series A financing. And it has also received grants from the National Science Foundation and the National Institute of Health.
Although progressing, the technology is still a few years away from the commercial use. And it's because we've been able to get all these multidisciplinary teams together, ultimately combining Tyndall’s modeling abilities, professionals with medical industry experience, people in machine learning, and people who understand this part of the hospital.
“We've been able to build collaborative team to do something special. The use of light as a diagnostic modality or treatment modality is very exciting to me," says Ray. "When you think historically, the med tech industry has been oriented towards mechanical engineering to address disease – you inflate something, you vacuum something, you use electricity – but we haven't addressed it with light. Yet, everyone's walking around now with an emitter and receiver on their wrist, right. And those devices are just moving from being kind of consumer type things to real help monitors, preventative medicine type scenarios."
