BME100 f2016:Group5 W8AM L2

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OUR TEAM

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LAB 2 WRITE-UP

Device Image and Description

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The patch would be a 2x2 inch square, featuring rounded corners. The patch would appear as a single application but would consist of thin layers of adhesive gel to attach the patch to the patient's skin, a membrane to regulate the passage of drugs to the patient, and a separated compartments of fludrocortisone and hydrocortisone. The patch would release a consistent dosage of hormones throughout the placement of the patch, adhering to the adrenal insufficiency.



Technical and Clinical Feasibility

Technical Feasibility
Creating such a device as our patch for Addison's disease could be possible. Other hormone patches have been made but nothing involving Addison's disease, for example nicotine patches and our Addison's patch will have similar a similar build, except it will be providing hydrocortisone and fludrocrotisone. Our patch will have different compartments to release the two different hormones, hydrocortisone and or fludrocortisone. Finding methods to release different dosages of the steroidal hormones based on the patient's needs would be a difficult challenge we would come across because hydrocortisone tends to be more needed than fludrocortisone. Also, each patient differs in dosages between either hormone. Specific materials needed to create our patch are: a backing film in order to contain the hormones, an adhesive layer that sticks to the skin, and a release membrane to regulate the dosage of steroids given to the patient. We will also need to research where the best place on the body would be to apply the patch.

http://www.mylan.com/en/products/packing-and-delivery-systems/transdermal-technology http://www.madehow.com/Volume-3/Nicotine-Patch.html#ixzz4KFHy3yMv


Score:2

Clinical Feasibility
Initially, dogs suffering from hypoadrenocorticism would be tested for a pre-clinical testing. Dogs' symptoms include dehydration, irregular heart rates, weakness, and depression and are treated with cortisol medication. Eventually when the patch is used on humans, humans are at risk of skin redness/burning/itching/peeling, thinning of skin, blistering skin, stretch marks, nausea, heartburn, headache, dizziness, menstrual period changes, (insomnia), increased sweating, and acne due to the change of hormones.

Score:2

http://www.dog-health-guide.org/addisonsdiseasedog.html http://www.rxlist.com/hydrocortisone-side-effects-drug-center.htm

Tobacco patch: Started with lass than 30 people o find out if the product was safe. 70-100 people are tested to see if the patches are working and are effective.

Market Analysis

Value Creation
Consumers of the patch would be able to apply two patches throughout the day rather than taking oral pills multiple times and would also be able to avoid the uncomfortable and time consuming steroid injections. The patches would also be more convenient for the patients who need both, hydrocortisone and fludrocortisone, by featuring both hormones in each patch, having settings to release either one of the hormones or both depending on the patient's needs.

Manufacturing Cost
The manufacturing cost of one patch of 30 mg would cost just about $1.00. The cost of Hydrocortisone for one patch is $0.70 and the raw patch is about $0.25-$0.35 per patch depending on who we buy from. https://www.medicalmega.com/medical/3m-healthcare/1624W.html?gclid=Cj0KEQjw6uO-BRDbzujwtuzAzfkBEiQAAnhJ0MUkpDlAD3Htzn4cGUkmhPqqg1QAUOqs44-ztQ6hg3caAoDY8P8HAQ

Sales Price
The patches would be sold in monthly dosages (30 per pack) at around $70. At this price the patch is on the higher side of medications for Addison's but is still valuable due to the ease of medication. Addison's patients normally pay around $40 per month for the medication but some pay up to $150 giving our product a great sales position.


Market Size
There are about 33,000 currently with Addison's Disease in America. This is a small amount of patients but they have to take the medicine every day of their lives.

Score:1.5

Fundability Discussion

The patch would probably be funded because the design is simple and would be somewhat easy to test in clinics. However, the market size is fairly small and the number of patients is very small.