BME100 f2016:Group6 W8AM L2

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BME 100 Fall 2016 Home
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6
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Name: Andee Wallace
Name: Suleica Garcia
Name: Sarah Unger
Name: Astha Chourasia
Name: Charlotte Burke


Device Image and Description

Figure 1 shows the inhaler wristband and blood oxygen monitor prototype. The part labeled 'A' is the inhaler canister, easily replaceable by the user. This will be encased fully in the silicone of the bracelet in a form-fitting manner, with openings at the top of the canister for replacement and at the bottom for use. The part labeled 'B' is the blood oxygen monitor, a small chip that will be able to register pulse and blood oxygen, as well as many other factors. Part 'C'is the adjustable part of the wristband, which will be held together using either a buckle or a plastic loop similar to those used on animal flea collars.

Figures 2 and 3 are prototypes of the mouthpiece for the inhaler. This will be attached using silicone with a simple hinge for easy rotation. It will lie close against the wrist, using the hole labeled 'E' to keep the nozzle of the inhaler from accidentally discharging during daily activities. The hole labeled 'D' will be where the nozzle will engage for speedy use. The user will have to physically disengage and rotate the mouthpiece in order to discharge the inhalant.

Technical and Clinical Feasibility

Technical Feasibility
1: The biggest challenge facing the device is the need for a clear, accurate and constant reading of the patient's oxygen level. Blood oxygen levels are more difficult to measure through the wrist, as opposed to a finger, because the reading has to compete with a strong pulse, making it harder to get an accurate blood oxygen level reading. The only current technology available for measuring oxygen levels is through the finger, whether by a wire attachment or clip designed specifically to attach to the finger. In order to make the device serve our intended market and meet the intended goal, we would need extensive research to enable oxygen levels to be read constantly and through a wristband without any attachments.

a) The face of the device would display the date, time and live pulse and bloody oxygen level readings. The face of the device would incorporate pulse oximeter technology in order to provide current and continuous readings. The monitor and device would be wireless and use Bluetooth to pair with the user's smartphone to display a history of readings, as well as the current readings. The app itself would be designed to better secure a pediatric market by giving parents a way to access their child's vitals while they are away or asleep. Additionally, a vibration monitor system will be incorporated into the face of the device to alert the patient and/or parent when the vitals drop below a designated level, determined individually with the assistance of a pulmonologist.

b) The greatest challenge with the device is the technology needed to give live and constant pulse and blood oxygen level readings. The current technology enables a pulse oximeter to measure a single, current blood oxygen level when prompted. In order to fit the new device, new technology would be needed to allow a pulse oximeter to continuously measure and report blood oxygen levels. Additionally, blood oxygen levels are currently measured by readings taken by a device attached to the finger. Ideally, new technology would allow blood oxygen levels to be measured on an individual's wrist without the need of a finger attachment.

c) Without the technology necessary to obtain a reading from the wrist, the device would be much bulkier and run a higher risk of breaking or not being used. The finger band needed to gather readings would need to be attached to the band itself in order for the readings to display on the face of the band, limiting movement and restricting the use of the hand in daily life. This could ultimately lead to either the destruction of the wire connection or the frustration of the patient, both resulting in the removal of the device.

Following the development of the new technology necessary to obtain wrist readings, the device would run the risk of having pauses or breaks in current monitoring. During these freezes, a user could suffer low oxygen levels and the device would be unable to alert them. This risk would prevent the user from benefiting from the alert system in the device, but would still allow them to benefit from the convenience of their inhaler on their wrist.

Clinical Feasibility
3: Clinical studies using preventative devices similar to ours have proved to be successful in the past. The device used in the clinical study in 2002 was much simpler than our idea because of the technology available at the time. However, with our technology integrated into a wrist band device, there is a lot of promise in a potential trial. There would be no risks to the patient's health because the device does not interfere with the manual admission of the inhaler, which is currently the standard in asthma treatment. A device aimed towards helping monitor asthma in children would help both the children by increasing their understanding of the illness, as well as the parents who could monitor their children. There is a clear path to success because we could track how well the device and alert system work by monitoring alerts using the Smartphone application, as well as receive feedback regarding the accessibility of the inhaler directly from trial participants.

a)This device would be very capable in a clinic because it is designed to be used for asthma prevention, as opposed to a possible cure. Children who suffer from chronic asthma can be monitored throughout the day using the device to send their vitals to a health physician, as well as their parents. The children would wear the device on their wrist similar to a watch. The software in the face of the watch would allow the device to connect the information gathered by the monitor to an app which would allow parents or doctors to monitor the child's vitals on their smartphones or computers. In the clinic we would monitor the accuracy of the vitals taken by the device and whether it can help the children have easier access to the attached inhaler. We would also be testing the compatibility of the app with any type of phone so that there are no risks for a lack of data or receiving it late.

b)The device itself has no risks because it doesn't involve any new drugs and it is not invasive. One possible risk would be if a child took the wrong dose of their inhaler. Although the dosage taken by the child is not directly tied to the monitoring device, an incorrect reading could lead to the misuse of the drug, such as a higher dosage than necessary. Another risk would be a malfunction with the app resulting in data not being transferred correctly or in the time needed to perform treatment. However, the app is meant for prevention so the device would not be causing any additional health issues for the child.

c)A clinical study would prove very successful because there have already been similar clinical trials using a similar device for asthma prevention. One clinical study proved to be successful in freeing activity limitation using a device called a Healthy Buddy which many of the children in the trial liked because it was fun and it helped remind them to take their medicine (Guendelman, P. S., 2002). The trial lasted 90 days and its main goal was to find out if keeping track of asthma symptoms could help the family and physicians better the child's asthma care. The children were taught how to use the device with proper techniques answering different questions by a nurse that could access their asthma symptoms.

Market Analysis

Value Creation
By increasing the quality of life of a young chronic asthma patient, the prototype expects to help turn medication into a convenience instead of a hurdle for children. Because the parents of the said children will be able to track the blood-oxygen levels of their child, they would ultimately be able to properly act upon asthma attack threats beforehand. This would increase the ability for young asthma patients to participate in various activities traditionally considered "unfit" for the disease-ridden. Inhalers have been the prominent method of medication for asthma patients for a while, but most have failed to recognize the instability of treatment due to the low chances of relief and the inability to have immediate access to an inhaler during times of distress. As a result, the patients often use a higher dose than needed because of the lack of a blood-oxygen level monitor and the increased time between the start of an attack and the treatment due to the time required to locate an inhaler. With the introduction of a preventative method prototype with a monitor to regulate medication and inhaler attached, the customers would eventually be saving money and decreasing health risks over a period of time.

Manufacturing Cost
Total Expected Cost of Production: $165

Inhaler portion: $30. Patients without insurance can expect to pay between $30 and $60 for their medication along with the inhaler. The cost varies depending upon the dosage and brand of medication.

Regular silicone wristband plus silicone inhaler casing: $35. To insure that the inhaler and the medication canister are secure attached to the wristband, a silicone casing will be provided to prevent fallout and damage. This is expected to cost around $15. A simple yet sturdy silicone wristband conjugates the major portion of the device. It is expected to be completely flexible for added comfort, yet robust enough to carry a monitor and medication, costing around $20.

Blood-Oxygen Monitor: $100. Although a bit ahead of its time, the main portion of the device, the blood-oxygen level monitor, is expected to cost around the same price as the "Withings Pulse O2" device. An added feature, along with the phone application, is expected to be an alarm altering the patient of low blood-oxygen level.

Sales Price
For a marginal profit, the device is expected to sell for around $199.99, as compared to the $165 cost of production.

Market Size
The device is primarily geared towards children with chronic Asthma, therefore consisting of 8.6% of the American children population. Because the large population size of Asthma patients is constantly growing, the device plans to receive a significant amount of interest due to its innovative design. The asthma medication industry lacks a single effective inhaler-type device for all branches of disease indication, side effects and complications during drug inhalation, and lack of awareness, therefore further restraining the market growth. The inventive idea of attaching medication to a monitor with set alarms of blood-oxygen levels of the patient makes the inhalation of the product significantly convenient and eliminates the possible complications, ultimately acting as more of a preventative device rather than simply a relief device for asthma attacks. In terms of value, the inhaler industry is account to over 69.9% share of the global respiratory inhaler device market by 2015, and is expected to remain the dominant method of medication. However, the introduction of the wristband style product is expected to drive demand for digitally operated inhaler devices over the forecast period. The device's manufacturing and sales price stays at a stable inexpensive cost, therefore gathering an even bigger consumer market. Because of the high demand for new inhaler technology and its fairly inexpensive sales/market cost, the device would receive a score of 2 on the Fundability Worksheet. If the product was geared more towards adults with chronic asthma, the score would increase, but not by a significant amount.

Fundability Discussion

Customer Validation
The customer validation with this product would be preliminarily rated at a 2, the product is still in the early stages and is not fully prepared for customers to be willing to purchase or invest, however many asthma patients have expressed curiosity and interest in this product. It will be particularly desirable among younger children, considering the freedom this innovation can provide.
Market Size
The market size rating has been determined to be a 2, because the product is viable and would have a large market, however adults would not find it very practical. The driving force behind having an inhaler wristband is the irresponsibility and rash behavior typically exhibited in children, however this product could very well work for adults with developmental delays as well.
IP Position
IP position is a 3, because the device does not directly infringe on any existing patents. Although there are patents for wristbands which incorporate inhalers and software developed to connect a vibrating monitor system with a smartphone app, these technologies have not been combined nor do they include a blood oxygen monitoring system. Therefore, this device would likely qualify for a patent with little resistance.

Technical Feasibility
Technical feasibility is a 1, simply because blood oxygen monitoring would be inaccurate through the wrist and would require an investment to develop. Although some technology does exist, the specific ones needed for this design would require some work.
Clinical Feasibility
The clinical feasibility of this innovation is rated at a 3 because the technology required that is interacting with the body is pre-existing and would require little to no testing. Inhalers are used daily, and this product is more of an engineering innovation than a health innovation.
The value proposition will easily displace any competition. Because the asthma medication market is generally dominated by top inhaler companies such as Propeller Health, with only the basic inhaler method, having a wristband monitor along with medication technology should easily serve as a new and improved design. This gives this category a score of 3.

Using these scores as well as the scores listed in the previous lab, this product scores a 108 on the fundability criteria worksheet. Without two factors, reimbursement and regulatory pathway, this score is very promising. An actual product that was funded scored a 432, so it is safe to assume that if upon further research of this innovation those categories are each rated at least a two, our product will appear very fundable despite its areas of pitfall.


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