The NSF I-CORPS Program enabled a thorough, comprehensive, and structured customer discovery initiative. This involved coursework along with more than 100 interviews with relevant stakeholders. The knowledge gap to be filled was whether near-infrared spectroscopy (NIRS) based non-invasive intracranial pressure (ICP) sensing is commercially viable. The key objectives were to explore hospital reimbursement strategies, clarification of the beachhead market within neurocritical care centers (operating room, intensive care unit, etc.), the viability of use-cases in rural hospitals, and the attractiveness of markets and regulatory processes abroad.

Intellectual Merits: Cerebral perfusion is important for brain health and is altered in traumatic brain injury, hydrocephalus, and stroke. Of particular importance for adequate perfusion is intracranial pressure (ICP) and maintaining ICP at a healthy level is paramount for patient outcome. However, continuous ICP monitoring is invasive, requiring pressure transducers to be placed into the brain. There is a need for a non-invasive alternative that minimizes the risk of complications and allows accurate ICP monitoring in patients for a broader set of indications. We have recently developed a non-invasive alternative to ICP sensing, which is based on placing an optical sensor on the forehead of patients.

Broader Impacts: The proposed technology has clinical and overarching societal impact due to its proposed accessibility. Current ICP sensing is not only prone to infections and overall risks to the wellbeing of patients, but is also expensive, requires surgery, and is only ever done in patients with extreme injury. We are not aiming to replace current practices to treat elevated ICP, but aim to aid clinical decision making with a device that is rapidly accessible due to its ease of use as well as reduced cost compared to invasive sensors. The impact of such a device is potential earlier detection of elevated ICP, therefore enabling a path towards early intervention and thus improving patient outcome.

Findings: Adoption insights: The technology adoption process is multidisciplinary and depends on the health system. Requires buy in from various clinicians to then get approved by tech adoption committees. Tech needs to be flexible to physician needs: ability to be continuous, have alerts, and able to be integrated into existing systems. Certain settings are more open to new tech adoption than others, consider collaborating with private practice settings and teaching hospitals and places with many residents. Finally, to get adopted the tech should be low maintenance (not be bulky and should not require lots of calibration). Would need to consider ease of use and how labor intensive the device is. If the device is bulky, hard to use, expensive, inaccurate, or the company isn’t transparent about the limitations of the technology, the device is likely to fail.

ICP value insights: Non-invasive ICP could help avoid unnecessary invasive testing. Current imaging takes a while, and this could be a faster way to get necessary data. The boundaries of utility of non-invasive ICP are not known due to the high threshold of obtaining the measurement. But Non-invasive ICP would revolutionize the field. Continuous monitoring is important for tracking changes in physiological states. ICP is unlikely to replace certain tests altogether, but it could be useful in tandem with other measurements. ICP is tracked by anesthesiologists in the operating room. In settings such as the battlefield or when an EMS team is responding to a call, a portable, non-invasive ICP device could help triage patients and determine who should be taken to a facility, where, and how quickly. Although having an ICP measurement likely wouldn’t change an EMS team’s existing protocols, it could be very useful in rural settings. In areas where resources for treating conditions related to ICP are low, this device could provide clinicians with guidance. Patients who don’t live in a medical hub with extensive resources often have to travel large distances just to get their shunts evaluated. If a device to check ICP could be used by more local hospitals, this could save healthcare costs and resources. It’s broadly applicable. Would use this device to screen patients in situations where it’s unclear if non-invasive monitoring is necessary, or if no prior history is known and the patient presents with altered mental state. This would mostly be used to screen patients at risk or where risk is high and they need continuous monitoring or patients who are fragile and at risk of complications. ICP would serve as an additional tool, and provides additional information to the transport team. This would affect how the patient is transported, where they are transported, and what kind of team is ready to receive them. In unclear cases (ex. Where the patient sustained an injury a few days prior), ICP could help further assess the patient for a brain bleed. The ability to have ICP in the field clarifies ambiguity. 

Last Modified: 08/17/2024
Modified by: Jana M Kainerstorfer