Posted by malikza on Sunday, October 23, 2016 in News.

Patient Perspective

• Designed monitoring system must be able to detect shunt failure before patient develops neurological symptoms by reducing time spent at elevated intracranial pressure
• Design must conduct non­invasive, continuous monitoring of intracranial conditions to understand shunt function even when it is not failing
• Design must incorporate a remote communication system that is able to inform patient/parents and doctors of shunt function and intracranial conditions with minimal error
• Design must not hinder shunt flow
• Design must be safe, and should not introduce new side effects
• Design must be biocompatible
• Shunt/monitor must be painless beyond post­op recovery period
• Design must be resistant to physiological environment variability
• Must have an inconspicuous design that allows normal childhood activities
• Design should be able to predict/warn of impending failure before the shunt actually fails

Provider Perspective

• Providers must be willing to switch to this technology due to proven clinical benefit over the current design
• Means to detect shunt function should be straight­forward without need for manual computation
• Design must be easily autoclavable/sterilizable
• Design must not enable transmission of infection from abdomen to brain or introduce other complications
• Design should be easily integrated into surgical flow and be easily removable
• Monitoring system should provide a way to determine or screen out false
• positives

System Perspective

• Design must be compliant with FDA regulations
• Design must be profitable with significant margin (profit/revenue) in order to bolster acceptance by physicians and insurers
• Manufacturing system should be scalable to mass production in order to improve its cost effectiveness
• The monitoring system and the procedure associated with its installation should be reimbursable by insurance of all types
• Implementation and use of the new technology should decrease future cost to the system associated with shunt failure symptoms via earlier failure detection