LAB 2 WRITE-UP
Device Image and Description
This is a pulse generator that stimulates the vagus nerve to prevent against epileptic seizures.
Technical and Clinical Feasibility
The device is very feasible to produce. The technology for the VNS, and the brain sensor is already used today. We would be adding Bluetooth technology to the VNS generator and brain sensor and connect it to an app that stores information and sends out the notifications. An app would need to be designed in order to manage the device. The brain sensor being used to detect the signs of a seizure is the challenging part of the design because if it does not produce accurate detections of seizures it could send false readings to the VNS generator and app. Overall, the technology involved in this device has already been developed.
Clinical success is likely, but not entirely conclusive. The VNS generator currently in place works. A VNS generator connected directly with the brain sensor was tested in a clinical setting and was successful; however, our device would alter this slightly as the brain sensor and VNS generator would be connected through Bluetooth instead of direct wiring.
Our prototype is a more personalized prevention method that stimulates the vagus nerve only when the patient is experiencing the symptoms of an epileptic seizure, reducing the likelihood of side effects of vagus nerve stimulation.
Based on the current market costs of the materials such as titanium, gold, and silicone, we estimated the price of materials to be around $500. Since the software of the pulse generator already exists, only the software of the pulse generator that interacts with the brain sensors needs to be programmed, so we estimated the cost of this to be anywhere around $1,000 to $4,000. Altogether, the cost to create this design should be, at most, somewhere around $4,500.
Since the price of the current vagus nerve stimulation device alone is around $12,000 (ResearchGate and Depression-guide.com), the anticipated sale price of one of our designed vagus nerve stimulation devices would be about $14,000 since our device has the added benefit of direct interaction with the brain as well as personalized stimulation to the vagus nerve when the patient is exhibiting symptoms of the onset of an epileptic seizure.
An estimated 20,000 people with refractory epilepsy were advised to receive surgery to treat their epilepsy in the United States. This number was calculated based on statistics presented in Joseph Sirven’s paper “Evaluation and management of drug-resistant epilepsy” and Philippe Ryvlin’s paper “Epilepsy surgery: eligibility criteria and presurgical evaluation.” Based on this number and the anticipated average sale price of $14,000, the market size for this is $280 million per year at 100% penetration into the market. At 5% penetration, the market size is $14 million per year.
The technology for the device is already made and we would only be slightly altering it. It is very likely that the current technology would work.
Other clinical testing has been done on similar products and although the clinical feasibility for our product is inconclusive, the results of the current clinical success make it likely for our device to reach this stage.
This is due a market size of $280 million per year.
The results of customer validation were inconclusive, but did not necessarily result in making the product not worth trying.
Competition exists but improvements are being sought out. Our product will be an improvement to the other solutions currently available.
While there are current patents for vagus nerve stimulation devices, our prototype's design and function are fairly different from the current devices.
Based on these scores, our prototype has a score of 48 on the fundability worksheet, which is a decent score when only looking at six categories. Therefore, this score should warrant funding for this prototype.