BME100 f2016:Group2 W1030AM L2

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OUR TEAM

Name: Danielle Mara
Name: Lauren Gustafson
Name: Joel Reynoso
Name: Maribel Diaz
Name: Merin Jacobs
Name: Your name

LAB 2 WRITE-UP

Device Image and Description

Cartridge Wristband



This prototype design shows a wristband with a rectangular prism attached to the bottom of the band. This is where the inhaler is attached, and it will be a cartridge where the vapor will be released with a push. The design is similar to that of current inhalers, with compressed medication that releases due to pressure build-up. It will hold the same medication that is currently used, but on a smaller scale. It provides a brief relief from an asthma attack and alerts authorities of the user's whereabouts through the GPS function of the watch. The watch portion will also allow for connection to a smart phone and will work in conjunction with an app that can contact emergency personnel in the case of a severe asthma attack. The watch will contain a sensor to detect heart rate, steps, and the many other functions that current fit watches have.

Technical and Clinical Feasibility

Technical Feasibility

What is the technology needed?
-->Refillable/exhangeable cartridges that will hold the asthma medication
-->A way to release the medication. A pressurized container
-->Activity tracker/sensor to detect the condition of the wearer
-->Wireless technology to connect the wristband to a smartphone
-->Water/temperature resistance technology for the band
-->Material for the band, possibly rubber where the medication is released
-->Magnetic charging port

What are the challenges?
-->Making the high pressure container safe
-->Not making the band too bulky
-->Having the button release the medication quickly
-->Having the vent/opening easily and quickly accessible
-->Making the inhaler not rely on the watch
-->Making the refillable cartridges readily available for sale
-->Creating a slim/non-bulky charging port

What could go wrong?
-->The pressure to release the dosage could not function correctly or the pressure might not be powerful enough
-->App might not notify the ambulance/police/emergency contacts of alerts
-->Could run out of battery life quickly
-->Emergency app button might be set off by accident
-->Pressure might be set off by high or low temperatures

Clinical Feasibility

Will it work in the clinic?

-->This device will be using albuterol to treat the emergency asthma attack. Albuterol is the most commonly used drug to treat the emergency onset of bronchospasm, which is an asthma attack. Albuterol is clinically proven to treat the onset of asthma most effectively in an emergency situation, therefore, that is why this medication will be used in the emergency asthma inhaler wrist device.

The clinical study would have to include subjects that have mild to severe asthma. The subjects should be able to represent the total population of asthma sufferers. The subjects would have to do a range of physical activity in various locations to test the effectiveness of the drug and its convenience to the "wearer"of the wristband. The clinical trials could range in time length from 2 months to 6 months.

What are the clinical risks?

-->Dosage size: 1 mL of albuterol sulfate inhalation solution 0.083% contains 0.83 mg of albuterol in isontonic, sterile, aqueous solution

  • effective dosage: 2 mg albuterol, so requires at least 2.41 mL of solution. Device must have capacity of around 2.5 mL

-->Side-effects: nervousness, shaking, headache, nausea, dizziness, raise in blood pressure,

-->Rare side-effects: chest pain, irregular heartbeat, rapid breathing, confusion

Have similar products been in a clinical trial? How long was the trial?

-->V-meds:

V-meds is a device used to treat respiratory aliments such as reduced lung capacity. This device uses Nano Mist and homeopathic therapy to help improve breathing in contrast to prescription Corticoid inhalers which often have adverse side-effects. The device is modeled after an electronic smoking device using coils and a battery to heat and administer medicines such as menthol. The company primarily used testimonies and reviews of the product as their trials. They conducted no formal clinical trial. The information and statements regarding the Nano Mist have not been evaluated by the Food FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.


-->Nebulizer:

A nebulizer is primarily used for children and older patients. It is used as a substitute for an inhaler because most children cannot simultaneously inhale and press down on the canister to administer the albuterol. The nebulizer has less side effects than the albuterol inhaler, but it is less efficient. A nebulizing treatment usually takes 5 to 10 minutes, which therefore would not give immediate relief in a random asthma attack. There was a clinical study to test the effects and results of the nebulizing treatment. It was conducted over 60 days and 77% of users reported positive results after treatment.


-->Inhaler:

Most common inhalers use the drug albuterol to calm the bronchospasm in an emergency asthma attack. Once administered, the drug works instantly. There have been many clinical trials to test the effects of albuterol in an asthma attack, such as in the clinical trial "Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma". In this clinical trial, they tested the effects on the albuterol, placebo puff, acupuncture, and no intervention on asthma treatment. It was observed that the albuterol treated the asthma attack the quickest and the most efficient. This clinical trial was conducted for 23 months with 60 subjects.

Citations

"Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma — NEJM." New England Journal of Medicine. Web. 13 Sept. 2016.

"Albuterol Inhalation Solution - FDA Prescribing Information, Side Effects and Uses." Albuterol Inhalation Solution - FDA Prescribing Information, Side Effects and Uses. Web. 12 Sept. 2016.

"Albuterol Sulfate Inhalation : Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD." WebMD. WebMD. Web. 12 Sept. 2016.

"Nebulized Hypertonic Saline for Bronchiolitis: A Randomized Clinical Trial." Pubmed.gov. Web. 11 Sept. 2016.

Wechsler, Michael E., M.D., and Et.al. "Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma — NEJM." New England Journal of Medicine. New England Journal of Medicine, 14 July 2011. Web. 13 Sept. 2016.

Wu, S., C. Baker, and Et.al. "Result Filters." National Center for Biotechnology Information. U.S. National Library of Medicine, Oct. 2014. Web. 13 Sept. 2016.



Market Analysis

Value Creation

What value does your prototype create for the customer?

This emergency inhaler wristband allows for the user to have a more convenient, accessible, and reliable treatment for a random or exercise induced asthma attack.

This novel device has advanced technology to administer an emergency dose of albuterol in a random or exercise-induced asthma attack. The technology includes GPS tracker, high pressurized cartridge with albuterol, LED lights, button to release medication and alert emergency responders, and pedometer, calorie tracker, heart rate monitor, and Bluetooth capacity.


Manufacturing Cost

In order to determine the cost to produce our product, we analyzed the cost of production of a few similar products that essentially make up our product, including a sport watch, a smart watch, and an inhaler. The cost of production of a Fitbit Flex, including manufacturing and materials, is $17.36. This product includes a GPS, Bluetooth, calorie tracker, pedometer, LED lights, and heart rate monitor. But, the Fitbit Flex doesn't have all of the features that we will include in our product, so we also analyzed the cost of production of a 38 mm Apple Watch Sport in order to factor in a watch with a touch screen. The cost per unit of manufacturing this watch is $83.70. To factor in the inhaler portion of the wristband, we analyzed the cost of an inhaler. An albuterol inhaler sale price is around $75-$80. Typically the cost of production of a product is about 1/3 the sale price, so we can estimate that the cost of production for the inhaler is about $27. Since our product is somewhere between the Fitbit and Apple Watch, we took the average cost of production between the two, $50.53, and added that to the cost of the inhaler, $27.00, and were able to estimate a cost of production of about $77.53


Sales Price

Using the same rule that was used to determine the cost of production above, (3 x production cost = sale price), we set our sale price at $230.00, just slightly under three times the cost to produce the product.


Market Size

About 25 million adults in the U.S. suffer from asthma. Of those, 65% of them have persistent severe asthmatic problems. The are the patients who would be willing to pay for a device that would treat emergency attacks because they are more susceptible to frequent and more life-threatening attacks. This puts us at 16.25 million people who may be interested. We must factor in that not everyone with severe asthma can afford a device like this, but also that many asthma patients with less severe symptoms may also be interested. Our market size is then about 16 million customers times $230 per unit, giving our product a final market size of about $3.68 x 10^9, or $3.68 trillion.


Works Cited

"Asthma in the US." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 03 May 2011. Web. 21 Sept. 2016.

"Asthma Severity among Adults with Current Asthma." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 17 Feb. 2015. Web. 21 Sept. 2016.

@benlovejoy. "Component & Manufacturing Cost of 38mm Apple Watch Sport Is Less than $84 – IHS Teardown Analysis." 9to5Mac. N.p., 01 May 2015. Web. 21 Sept. 2016.

Media, IHS Electronics &. "Teardown: Fitbit Flex." Electronics Industry News & Analysis. N.p., 17 Oct. 2013. Web. 21 Sept. 2016.

"Proventil Coupons and Discounts." InternetDrugCoupons.com. Script Relief, LLC, 2015. Web. 21 Sept. 2016.




Fundability Discussion

Customer Validation: 2

Market Size: 3

Competition: 3

IP Position: 2

Technical Feasibility: 1

Regulatory pathway: 2

Clinical Feasibility: 2

Reimbursement: 2

Total score = 288

Using the fundability worksheet, determine if your prototype should be funded. Justify why or why not.

This device still has the potential to be vital in emergency situations where patients cannot bring a rescue inhaler and it irradiates the problem of forgetting one's inhaler as well. This product has not been surveyed to gather information about possible interest in purchasing the device. Since millions of people suffer from asthma in the United States alone, there is a very large market size. There is very little competition with the wearable emergency inhaler, but there are wrist devices that can be used to detect or prevent an asthma attack, but they do not treat the onset of bronchospasms in an emergency situation. The competition's devices only alert the athlete to cease activity; they cannot dispense medication. The IP Position is thus because there are little patents that are similar to this device. There are patents for wearable exercise watches and inhalers but none for the combination. The technical feasibility is low due to the fact that one must entirely create the dispense cartridge and that would require lots of research and testing. The regulatory pathway score is a seen above because the clinical data is essential, but many clinical tests have been done for other similar devices such as the inhaler, nebulizer, and fitness wristwatch. The clinical feasibility is stronger because this medication, albuterol, has been proven to treat the onset of a asthma attack. The clinical trials must discover how much medication is needed and how to administer it effectively and safely. The reimbursement is as shown because emergency inhalers are reimbursed and this device could be reimbursed in a similar manner, but with few minor adjustments such as the private purchasing of the wristband.

Although this device could be vital in helping with emergency asthma attacks, the device should not be developed because it would not outweigh its expense to the customer and it is not as easily accessible to all asthma patients unlike the inhaler.