BME100 f2016:Group3 W1030AM L2

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Contents

OUR TEAM

Name: Nya Griffin
Name: Nya Griffin
Name: Lauren Hudson
Name: Lauren Hudson
Name: Ravyn Ogden
Name: Ravyn Ogden
Name: Kaycee Bischoff
Name: Kaycee Bischoff
Name: Maddie Howell
Name: Maddie Howell

LAB 2 WRITE-UP

Device Image and Description

The implanted chip has been cut in half for this picture to reveal the reservoirs that contain the epinephrine This is what the chip looks like from the outside. The two ports will be used to release/refill the epinephrine. One will release the drug when activated; the other will be used as a port to refill the chip with epinephrine if empty/expired. This picture just shows that the chip is 21.21 x 21.21 x 10 mm (about the size of a nickel).



Technical and Clinical Feasibility

Technical Feasibility

a. What are the technologies needed?

•The implanted device needs a means to relay information/signals to the external device; much like BlueTooth.


•The implanted chip needs a way to release the epinephrine; we were thinking like a “gate” that opens when the button on the external device is pushed. Upon receiving the signal, the implanted devices releases the drug all at once.


b. What are the challenges?

•Ensuring that the internal temperature of the body does not shorten the shelf-life of the epinephrine


•Creating a mechanism that releases the epinephrine instantaneously, as opposed to a slow release over time by other implanted drug delivery systems


c. What could go wrong?

•System could malfunction


•Body could reject implanted chip (allergic to materials, not bio-compatible)


Clinical Feasibility

a. Will it work in the clinic?

Clinical trials

https://clinicaltrials.gov/ct2/show/NCT00828542?term=implanon&rank=2 Clinical trial for Implanon birth control (Implanon is an implantable birth control device that releases hormones) consisted of two groups one group that was given oral hormonal birth control and another that received the implanted device. To monitor the success of the device in comparison to the pill, blood samples were taken periodically overtime and certain metabolic variable associated with birth control were monitored.

https://clinicaltrials.gov/ct2/show/NCT00636493?term=implantable+drug+delivery+device&rank=1 This study assessed the efficacy of a device inserted in the eye that releases steroids to combat retinal vein occlusion. This device was deemed safe and effective.

https://clinicaltrials.gov/ct2/show/NCT01432522?term=epi+pen&rank=2 This study compared the absorption and circulation of epinephrine administered through intramuscular injection and that of epinephrine administered by intranasal spray.


b. What are the clinical risks?

-Since this is a life saving device, people’s lives have to be put in danger in order to test if this device is effective. One way to test the effectiveness of the device, would be to test it thoroughly on animals. Also, one of the clinical trials did not induce an allergic reaction to test the effectiveness of their drug (epinephrine delivered intranasally). They instead compared the absorption of epinephrine into circulation of both their device(the intranasal spray) and an epi pen.

- Subject age, many children who would be using the device are ineligible for a clinical trial.


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

-Intranasal epinephrine delivery spray (another epi pen alternative): The clinical trial went from July 2010- September 2011.

-Implanon device (Implanon is an implantable birth control device that releases hormones.): The clinical trial lasted from July 2007 to February 2008.

-Fluocinolone Acetonide Implant for Retinal Vein Occlusion (This device is inserted into the eye and releases steroids to combat retinal vein occlusion) : The study lasted from October 2002-May 2009.




Market Analysis

Value Creation
The prototype offers the customer peace of mind and preparedness knowing that they are always protected in the event of a severe allergy attack. Rather than keeping track of multiple Epipens (often sold as a two-pack), the prototype offers a still cheaper, more reliable way of treating anaphylaxis. Our product offers both financial and emotional value.

Manufacturing Cost
-Most companies for not forthcoming in how much it costs to produce similar products. We will make the market price for our product similar to the market price of other products. -Popular insulin pumps like OneTouch and MiniMed range from 4500 and 6500 dollars. However, most insurance plans cover these devices for most the cost. Most people still have copays. ( http://health.costhelper.com/insulin-pump.html ) - It costs consumers $5 to half of the total cost of the pump for people with insurance

-The life-saving dose of epinephrine contained in an Epi-pen is worth approximately $1 http://www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business

-The cost of the Implanon birth control implant varies widely  from $5-$25 to $400+ depending on insurance, which suggests that the cost to produce the implant is relatively low. https://www.getthefacts.health.wa.gov.au/condoms-contraception/types-of-contraception/implanonreg https://www.plannedparenthood.org/learn/birth-control/birth-control-implant-implanon

Sales Price
The price of the device would be $500. Although insulin pumps are vaguely similar to our design, they include much more internal technology than our design. Therefore, the price of our product would not be as high as an insulin pump. The price would be closer to the price of Implanon, which is an implantable birth control device that slowly releases progesterone, which costs $400+ and this price includes the implantation of the device. Our device is slightly more complicated than Implanon because the epinephrine needs to be released all at once.

Market Size
Because “3.6 million people were prescribed an Epipen in 2015” and our price per device is $500, 3.6 million potential customers multiplied by $500 would yield a market size of $1.8 billion. http://www.wsj.com/articles/mylan-faces-scrutiny-over-epipen-price-increases-1472074823



Fundability Discussion

Customer validation - 2 Market size - 3 Competition - 2 IP position - 2 Technical Feasibility--2 Clinical Feasibility--1

Our fundability score is 48. Our prototype should be funded because there are many people who are looking for an alternative to Epi Pens. Our product offers many benefits that Epi Pen does not offer such as increased convenience (through its unique delivery system) and peace of mind (from the fact that it’s always with the customer).    



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