Neurolife Case

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University of Texas *

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Mechanical Engineering

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Apr 3, 2024

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1. What problem is Neurolife solving? What conclusion does Neurolife make about invasive ICP monitoring? What premises or claims do they use (if any) to support this conclusion? How are these claims supported? The problem NeuroLife is solving is to address shortcomings in the current methods of monitoring intracranial pressure (ICP) in patients who have experienced traumatic brain injury or are suffering from conditions such as hydrocephalus, stroke, or brain tumors. The current standard of invasive ICP monitoring involves risks such as infection, bleeding, and damage to brain tissue. NeuroLife offers a non-invasive solution to monitor ICP that eliminates these risks and improves patient outcomes, while also providing an opportunity for more widespread and regular monitoring. NeuroLife concludes that invasive ICP monitoring is problematic due to its associated risks and challenges—these challenges include: ● surgical complications ● infections ● lack of consistent real-time monitoring They propose that a non-invasive, continuous monitoring solution be more cost effective and provide better care to patients. To support its conclusion, NeuroLife cites: ● High patient demand: Given the estimated 1.5 million traumatic brain injury (TBI) cases and 50,000 deaths annually in the US alone, along with conditions like stroke, hydrocephalus, and brain tumors, there is a clear need for an improved monitoring solution. ● Inherent risks of invasive methods: They point out the risks involved with the current invasive ICP monitoring practices, including infection, bleeding, and brain tissue damage. ● Improvement in patient outcomes: Non-invasive monitoring can potentially improve patient outcomes through constant real-time data, and this can lead to more timely and effective interventions. 2. Does Neurolife appear to rely on any informal fallacies to make their argument? Explain. Based on the case, it seems like NeuroLife doesn’t rely on informal fallacies to make their argument. This is because their argument is based on valid premises such as the high demand for non-invasive ICP monitoring due to the inherent risks associated with

invasive procedures and the potential for improved patient outcomes with continuous, real-time monitoring. 3. What is the underlying technology or conceptual principle underlying Neurolife’s solution? What evidence supports its efficacy? Why or why not is the evidence credible? The underlying technology behind NeuroLife's solution is their iSCAN, which uses proprietary software to analyze signals from existing, standard clinical monitors like ECG, NIRS, etc. to provide real-time, non-invasive monitoring of ICP. To support the efficacy of this evidence, NeuroLife states that their technology has been evaluated through five separate feasibility studies with more than 100 patients, demonstrating successful results. However, without detailed information on the design, implementation, and results of these studies, it’s hard to say with complete certainty how credible they are. For utmost credibility, the technology should go through rigorous peer-reviewed clinical trials and earn approval from regulatory bodies like the FDA (which is unclear if NeuroLife has). Additionally, patient outcomes would be further enhanced with long-term studies and add to credibility. 4. What is a provisional patent and, prima facie, what might its value be to NeuroLife? What do you think of the provisional patent's value? A provisional patent is a patent application that is filed with a patent office to establish an early filing date for an invention. It allows the inventor to use the term "patent pending” for about a year, during which they can further develop the invention and assess its commercial viability. For NeuroLife prima facie, the value of a provisional patent includes: - The early filing date, because by establishing a priority date, they can claim the rights to an invention early and have proof that they were working on tech ahead of the competition. - The extended development period—the one year period gives NeuroLife the ability to refine their invention and conduct more research in order to assess the market and commercial viability. - Licensing and investment opportunities, which demonstrates the diligence towards protecting their IP and their edge against competitors. This can bring in more potential investors, partners, or licensees.

5. What current medical technology or solution competes with Neurolife’s solution for non-invasive assessment and diagnosis? What evidence does Neurolife offer regarding the competing technology’s viability and efficacy? Is this evidence credible? Current emerging competitive technologies for NeuroLife include: ● Near infrared spectroscopy (NIRS) or Diffuse Optical Imaging (DOI): Developed in 1977, this technology has been experimentally applied to ICP monitoring. This technology often confuses scalp blood flow with brain blood flow. Several NIRS peer-reviewed articles show no significant difference in the “brain” blood flow of brain dead subjects compared to live subjects. ● Dynamic Magnetic Resonance Imaging (dMRI): This experimental technology integrates the principles of fluid dynamics and human physiology to estimate ICP. The technology is being pioneered by Dr. Noam Alperin, of Alperin Noninvasive Diagnostics. According to Dr. Alperin, multiple MRI exams are required to overcome the wide variability in this technology. MRIs are expensive, bulky, labor intensive and cannot be used for continuous bedside measurement. ● Evoked Otoacoustic Emissions (EOAE): Dr Jean-Pierre Lin, a pediatric neurologist, is developing this technology at St. Thomas’ Hospital in London. Otoacoustic technology depends on the communication between the CSF space and the middle ear canal. Many healthy individuals lack this communication due to a normal anatomic variation. As a result, published reports were only able to detect EOAE in 50% of subjects. ● Ultrasonic optic nerve sheath diameter (ONSD): This technique uses ultrasound to measure the diameter of the optic nerve sheath and correlates observed sheath size changes to elevations in ICP. ONSD requires serial measurements and fails to provide an absolute ICP reading. While this technique has shown promise in children, it has shown limitations in adults, particularly in patients with ICP greater than 30mm Hg. Additionally, this technique is labor intensive, requires highly trained operators, and is not suitable for continuous ICP monitoring. This evidence seems credible because it references and draws from many other knowledgeable sources and published reports, and also aligns with similar research on the subject. However, there seem to have been many constraints mentioned with the collection of this data. As mentioned earlier, credibility can be improved with more detailed information, more peer-reviewed clinical trials and federal approval, and more assessments of patient outcomes.

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