EPITECH Detecting absence seizures
SECTOR PRODUCT DEVELOPMENT ProduCt report, MSc02 ID2, JUNE 2017
Title page Title ‘Epitech’ - Monitoring absence seizures
Angela Lise Frank
Project module Sector Product Development Project period March 28th - June 13th Project team Epitech (Ma2-ID2)
Halldóra Auður Jónsdóttir
Supervisior Christian Tollestrup Co. supervisior Poul Henrik Kyvsgaard Hansen
Maria Brændstrup Kristensen
Pages 20 Editions 8
Marie Cathrine Soele Madsen
Steffen Andreasen
| 1
Abstract Epilepsy types characterized by non-convulsive seizures, e.g. absence epilepsy, is an untreated topic to a large extent, as there are no current products, addressed to the private home, on the market. Development of products, technologies, and software addressing this subject creates great amounts of unutilized potentials regarding monitoring and data collecting of absence seizures. Parents of children with absence epilepsy are always monitoring and registering their children’s seizures, which is a stressful task as the seizures can be frequent and short, and because they are hard to detect. The registered data is the key for the neurologist to determine the right diagnose and pre-
Table of content Absence epilepsy Epitech Epitech overview Large scale Notification and feedback Customization User scenario Instruction guide Exploded view Budget Business model
2 |
3 4 6 8 9 10 12 14 16 18 20
scribe the correct medicine and dosis, which is crucial regarding potentially curing the disorder. The possibility to get seizure free lies before the child steps into puberty, where there is a risk of the absence epilepsy evolving into convulsive types of epilepsy, which can not be cured. This project introduces the development process of the design proposal, Epitech, which detects absence seizures with EEG-technology. The design is driven by comfortability for longterm use, which gives the parents and the epileptic child an opportunity for more freedom in the form of privacy and relieving the pressure of observing.
Absence epilepsy In U.S.A. and Europe around 700.000 children have absence epilepsy. Absence seizures are hard to detect, because the child becomes absent, which can look like daydreaming or other normal behavior. The child can have up to 200 seizures a day, lasting from 2-50 seconds. It is important that these children get the right medicine, because they have 65% chance of being cured after being seizure free for two years before reaching puberty, and avoid the risk of their epilepsy evolving into far worse types. Epilepsy is a complex neurological disorder, which requires skills and experience for the neurologist to find the right treatment, which consists of very strong medicine. The neurologist bases the treatment on clinical data (EEG) and seizure reports made by the families, containing as much data about the seizures as possible. Because this type of seizure is so difficult to detect, families spent all their time, energy and resources observing their child. Even when the family is really trying their best, a study shows that they only detect 6% of the absence seizures. This is not optimal ground for the doctor to determine treatment.
| 3
Epitech Epitech is a monitoring device for children with absence epilepsy, detecting over 90% of seizures using the electroencephalography (EEG) monitoring method. The brain activity is measured by two dry sensors placed on the forehead. Epitech sends a notification to the relative adults in the Epitech application, to make them aware of the seizure. In the application they have the opportunity to add seizure data to each seizure, which is saved as seizure reports in the cloud, accessible for the relative adults and the neurologist during consultations. Epitech is a home monitoring device, that helps the relatives to detect the seizures in periods where correct seizure data is necessary for the neurologist to determine or evaluate treatment. Furthermore, it is for helping the worried parents in periods or situations, where they would have the need of being notified when a seizure occurs. Epitech is designed to fit children and the demands required during their daily life scenarios. It ensures optimal detection and comfortability, having soft ear fittings useful during physical activity, and a night band during sleep. It can be used in every situation during the day, except bathing.
4 |
| 5
* The charger is only on conceptual level and not further developed
6 |
Epitech overview Epitech nightband Extra battery and battery charger While one battery unit is in use, the other can be charged.
Adjusting sliding mechanism Following the instruction guide, the parents is able to adjust the length of the sensor arm, making it fit to the head size of the child.
Control unit Contains all electrical components: Actiwave - recording the EEG. It also has a backup battery. 4G unit - sending the data real time. (simcard the parents has to buy themselves and insert) Microchip - containing the detection software (algorithm) and bluetooth. LED light indicator - indicating: seizures, low battery and incorrect sensor connection.
Dry sensors Hygienic silver dry sensors, only requiring contact with the skin.
Frame Flexible frame in PC/ABS, which quality is holding the construction tight, but not putting uncomfortable pressure on the head of the child.
Battery unit Holding battery for minimum 16 hours.
Ear fittings Soft silicone-rubber with internal metal wire that makes it possible to adjust to all ears, ensuring fixation during all activities.
| 7
Large scale
Seizure
Epitech is used with additional products and services. The products and services together with the connections is presented on this page.
1
1. When the child has a seizure, the dry sensors read abnormal brain activity. 2. The abnormal brain activity is recognized by the software as a seizure. All data is sent as a seizure report to the cloud.
2
3. From the cloud, a notification is sent to the adult, through the Epitech application on their smartphone. Through the application the adult has the opportunity to add data regarding each seizure. 4. The seizure data is saved as seizure reports, available for the adults and the neurologist during consultation.
8 |
Seizure Start: 3:50 Timespan: 36 s
3 4
ADD DATA
Notification and feedback When a family buys the Epitech package, they have to setup the contact persons. This is done by each contact person downloading the application, and inserting the device number and a code in the application. Through the Epitech application, the contact person receives notifications regarding the device and the detection of seizures. Inside the application, it is possible to customize different alarm modes, so they fit to the contact persons need regarding alarming more or less noticeable, in the current situation. The most important notification is the seizure alarm. Here it is possible to see the starting time of the seizure, as well as the seizure timespan. Other important notifications can occur if there is low battery or the sensors have incorrect connection. All three notifications is also shown as visual feedback on the product with light, so it is not necessary to look at the smartphone if the adult is with the child. Furthermore, it is possible to check system functionality by running the debug mode from the app.
Seizure Start: 3:50 Timespan: 36 s
ADD DATA
* The mobile application is only on conceptual level and not further developed.
| 9
Epitech
10 |
Customization Children down to the age of 5 associate colors with emotions and positive feelings with bright colors such as red, blue, pink, green and purple. In these colors children are capable of relating emotional responses like happiness, strength and excitement (California State University, Department of Child Development). In this age children start expressing their identity through clothes, accessories and toys. Epitech is a device that in the usage period is going to be a part of the identification of the child. For this reason the child is given the choice of choosing the colors on their own device. It is designed so the child still has possibilities of wearing other head accessories.
| 11
User scenario
1
The father adjusts the device for the first time, so it fits his son, using the instruction guide.
3
The mother is cooking dinner, when her smartphone starts vibrating. Her son is having a seizure
12 |
2
4
The child is playing outside in the garden.
The mother walks to her son, and comforts him.
In the Epitech application, she adds seizure data. ‘He was playing in the garden’.
5
6
7
The child and parents are soundly asleep, while the device is monitoring the child.
8
The father helps him put on the nightband and clicking on the battery and control unit before nighttime
At the consultation the neurologist looks at the seizure reports, and afterwards choose the suitable medicine.
| 13
Instruction guide Epitech day
a
b
1. Measure the head (a), mark 10% above the nose. Measure the diameter (b), mark 5% of the distance from the previous mark.
14 |
3. Adjust the length of the device so the end sensor is on top of the mark from step 1.
2. Place the device on the head of the child
4. Adjust the earpiece for a better fixation
Epitech nightband
5. Take off the control unit from the day device by sliding and pulling.
6. Charge the battery and take the second battery from the product package.
7. Place the second battery on the Epitech nightband.
7. Place the nightband like on the illustration, making sure that the sensor is in the correct placement.
| 15
Exploded view Batteries Actiwave Circuit board MCU (Micro Controller Unit) 4G chip Simcard holder Battery unit bottom (right) Battery unit bottom (left)
Ear support (right) Dry sensors
Sensor arm
16 |
Battery unit (right)
Battery unit (left) Control unit (right)
Back frame
Control unit (left)
Control unit bottom (right)
Control unit bottom (left)
Ear support (left)
| 17
Budget
In the U.S. there is approx. 100,000 people with absence epilepsy. Of those, it is expected that 50% can use the design proposal (size, not being absence free, etc.). Another 50% of those is assumed to buy the product within the first three years of production (25,000). Unfortunately, there are new cases of absence epilepsy every year. Where it is expected to sell, to 5,000 over the course of the three years. The initial investment is mostly affected by the manufacturing of production molds, the molds are in the 104 SPI mold class. This means it is suited for medium use,
18 |
which is graded under 100,000 cycles. A total of 15 molds are made, costing a total of $ 225,000. Another steep development cost is the team, who should do the final development, this team is consisting of two mechanical engineers and two software developers, costing a total of $ 108,000 including a prototype. It is expected to sell 10,000 units/year for the first three years, which provides the company with a breakeven after 22 months, including 7 months of development.
Production cost
Overall budget
One Epitech set: 1 x Controlunit 2 x Battery units 1 x Control unit bootom left
$ 118.77 $ 4.01 $ 0.07133
1 x Control unit bottom right 2 x Ear suports 1 x Headband
$ 0.07133 $ 0.668 $ 1.2
Prices for 30.000 units Material costs $ 3,815,199.3 Production cost $ 187,000 Total production cost $ 4,002,199.3 Tooling cost $ 225,000 Development cost $ 101,725 Prototyping $7500 investment $334,225
Total $ 124.79066
Total $4,336,424.3
1 x Connector 1 x Head band
$ 0.07115 $ 0.75
Costs (unit)
$144.54
Sales price (unit price) piece
$350 per
1 x Carger
$ 1.5615
Total $ 2.38265
Breakeven time in 21.8 months (including 7 months development)
Set total
Total profit 30.000 units sold
$ 127.17331
$6,163,575
| 19
Business model
RELATIONSHIP
MONEY Data GOODS VALUE
Subscription Delivery
Self-service Customer support
Asset Payment
Asset Payment
Delivery
Delivery
User data
InteraXon
Notification Freedom
Delivery
Epitech Seizure Data Correct medicine
Delivery
Reduced Expenses
Epitech
Freedom
Parents Cured child
Insurance
Less worries
Seizure Data Seizure free
Effective consultation
Doctor 20 |
Reduced Expenses
Epileptic child