BME100 f2017:Group2 W0800 L1

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Lab 1: “ Needs Identification”

Introduce the Fundability Worksheet from Medicoventures. Identify an existing health care issue. Report on the impact of the issue on society (why it’s important) Identify your customers for validation. Review current solutions to the chosen health care issue. Available resources: Google Scholar, Patent Searches, News Searches (Lexis Nexis), Journal Searches Describe advantages/disadvantages to each current solution. Identify the unmet needs (financial, technological, etc.) Score relevant portions of the fundability worksheet Customer validation. Competitors Intellectual Property (IP)


  • Cite appropriately all resources used in completing this analysis.*

Describe the health care issue you will develop a solution for.  Include a description of the pathology your device or technology that will treat/prevent/diagnose. The health care issue that our group is developing a solution for is a complication of diabetes, specifically diabetic peripheral neuropathy. Estimates put the worldwide diabetic population at 300 million people by 2025. 60-70% of patients with diabetes deal with diabetic neuropathy during their lifetime with this serious metabolic disease. However, this product can also expand to the elderly, athletes, pregnant women and many other groups of people who are at risk of skin infections from cuts, ulcers, and other skin breaks. Diabetic peripheral neuropathy is a complication of diabetes that involves nerve damage. The nerves are damaged usually near or in the extremities such as the feet, and this can be very dangerous to people with diabetes. When diabetics have a hard time feeling pain in their feet, it can create problems that may lead to amputation. Diabetics who have peripheral neuropathy can get cuts and ulcers on their foot, and since the patient cannot feel the pain, the wound goes untreated. This leads to infections, and if the infection is not treated, amputation is often necessary. The device that our group is creating is a Thermal Bio Gel that covers the entire foot. This Thermal Bio Gel is easily put on like a sock. It will be thin, breathable, and have sensors that can detect a skin break. Thermal Bio gel will alert the user when a breakage is found in the gel. This will allow the user to search their foot for a cut that could potentially become infected. The Biogel also provides protection to the user’s foot, to prevent cuts from happening which reduces all risks of an infection.  This product is going to have a heat feature, which dilates the blood vessels and increases circulation in the foot. This will decrease the chances of an infection, while keeping the health of the patient at a maximum.    

Customer Validation: Create a list of 20 specific customers that you would contact to validate your device/technology (physicians, individuals, organizations etc).

1.  Endocrinologist: (An endocrinologist is a doctor who specializes in treating metabolic disorders, such as diabetes) 2.  Diabetes victims. 3.  People who have specifically developed diabetic neuropathy. 4.  A Board Certified Neuromuscular Neurologist: Someone that is trained to understand and read testing on nerve damage and each category of diabetic neuropathy, including symptoms.

Aguillar, Maria M.D. Phone: 480-301-8000, Mayo Clinic, Scottsdale Bosch, E. Peter Phone: 480-301-8000, Mayo Clinic, Scottsdale Akanas, Valerie M.D. PhD Phone: 213-975-9950, Los Angeles.

5.  Athletes: who are on their feet so much, and are prone to cuts because of friction inside of their shoe from running/doing other high movement activities. 6.  People who have been found to have Hypercoagulation (thickened blood)      7.  People with Peripheral artery disease. (which leads to poor circulation in the lower extremities such as feet and legs 8.  A podiatrist: a doctor that specializes in treating many foot and ankle problems, including infections, bunions, and many other injuries to the foot. 9. People with Deep Vein Thrombosis (clotting disorder that makes them prone to getting blood clots) 10. People who have varicose veins, which leads to poor circulation in the area. 11. Physical Therapists that will be interested in recommending a product to their patient that will help with blood flow and reduced foot ulcers/skin breakdown so that they can perform at their best during their therapy. A trusted physical therapist that works at Haven of Lake Havasu City (nursing home) has already provided validation for the idea of this medical product. 12. People who have Raynaud’s disease, a disease that causes arteries in the hands and feet to narrow, leading to poor circulation. 13. Specifically the elderly who do not heal from infections as readily as the younger generation. They are also more susceptible to foot ulcers and cuts. Wounds take longer to heal due to the initial phase of blood vessels dilating to allow oxygen and vital nutrients to flow to the site of infection slowing because of age. 14. People with genetic and immune disorders that make it more difficult for them to fight off particular infections. Skin breakdown on the feet may be a more prominent problem due to cuts that occur from walking barefoot or wearing the wrong type of shoe. 15. Dermatologists that also help to prevent/treat different skin disorders including those that occur on the feet. 16. General practitioner, who would deal with infections and other problems that occur on the feet. 17. People who have chronic diseases that cause them to be in bed alot. This causes pressure on the heels and leads to ulcers and other skin breakdown on the foot. Pain in general is a symptom of pressure on the heel from being in bed a lot. 18. vascular surgeons. 19. Gynecologist, because they often deal with pregnant women who experience swelling in their feet and foot pain. They are carrying more weight so it can cause poor circulation in the feet. They are also more unable to see their feet or bottom of their feet to identify cuts or other skin tears. 20. Pregnant women because the pregnancy can cause swelling and pain in their feet. Fitting their feet in shoes can be a problem as well if it is too tight, and there are pressure points that can cause ulcers. Rubbing in their shoe due to swelling will also break down the skin.

Competitors: List current solutions for this healthcare issue. Create a column for each of the following:

Research team that has developed new insight into treating diabetic foot ulcers. They have discovered that the extracting skin cells directly from the ulcers and genetically reprogramming them and revert them to an embryonic state. They will then become a type that can heal much faster and more efficiently. If we can develop a more cost effective, more accessible, and simpler product that will help to prevent/treat foot ulcers, as well as other types of skin breakdown, then this could very possibly put us ahead of the above listed competitors. The above listed method would be very difficult and expensive. This method of healing foot ulcers may be very expensive, not as easily accessible, and you will also have to go through a lot of paperwork and getting the insurance company to cover the procedure. Their method will also have to take time in order for the insurance company to put it on the list of things that they will cover. TENS Pros E-SOCK Conductive Stimulation Sock . It increases blood flow and is extremely effective for treating all sorts of foot and ankle disorders such as Arthritis, Diabetic Foot Pain, Muscular Sprains and heel and ankle injuries. This is a great product, but it will not tell the user any useful information. We want to increase blood circulation, prevent cuts, ulcers, and other skin breaks, but also to introduce technology into a wearable product for the feet. We want this technology to detect breaks in the skin and be able to send this information through near field communication to a smartphone or other near device. This product also does not do anything for foot ulcers, cuts, and other skin breaks.

Advantages (with reference to other solutions): Disadvantages (with reference to other solutions and the ideal solution) Include unmet needs and categorize them (financial, technological, etc.).


Disadvantages The product will be slim, fitting, and comfortable, making it more convenient for daily activities. The customer would have to physically put on the product every day. Being able to wear the slim fitting product in a shoe will make it less noticeable. They may have to find shoes that will have enough space for the product to fit inside the shoe. Finding a shoe that will provide the extra space necessary is an easy and affordable task as opposed to the health risks that come from not using the product. The customer has to feel that the product is worth their money, with it will be so new to the market. (financial) Finding inexpensive material to use for the product is much easier now that it was 10-20 years ago. If their skin does not react well with the material, this will cause irritation and may cause the customer to not want to wear it. (comfortability) Stretchable materials are more readily available with recent innovations in micro wires and sensors that can be put in different materials. We will need to find a more inexpensive material to use for our product. (technological) Will not have to be hooked up to a machine. If we aim for a more technological approach, we will have to find an inexpensive but also compact and convenient way to implement the technology into our product. (technological) It will be able to detect skin breaks through bio gel technology and send information to a smartphone in order to alert the user of a current break in the skin. Another app on the user’s phone and will have to have the phone present in order to receive the alerts.  (accessibility) Product will prevent ulcers and skin breakdown from occurring, as well as increasing blood circulation that will allow oxygen and vital nutrients that carry away waste to reach the site if an infection does occur. It will also relieve pressure from a bony prominence, such as a heel, which causes poor blood flow to the area. Although improved circulation does lower the risk of an infection, this method does not completely fix the problem of an infection. If an infection does happen to occur the proper medicine from a physician is still needed. (technological) The biogel will protect the foot from receiving cuts from sharp objects. It is not completely impenetrable. (technological)

Given the above (a and b) describe why your device/technology is more marketable.     Our group’s technology is marketable, because it is different than what is out there. Our product targets a complication of diabetic neuropathy in a way that other products have not. There is not yet a product that will detect a skin break on the feet of someone with diabetic neuropathy. This product can be cost effective, and has a huge market, because of the large audience that will be interested in our product . The return on this investment is to the moon, and if done right that investment can be made reality. Investors can see the profit that this product can bring, which leads to big investments. With a lot of money to work with, research and testing could be done right, making the perfect Thermal Bio gel sock.

IP Position: Perform a patent search and describe existing patents related to your device/technology.     Few of many current patents on a diabetic neuropathy sock type device.

Therapeutic sock for diabetics Patent #: US 20070283483 A1 Compression sock that helps treat blood circulation, and also reduce risk of infection in the case of ulcers, contains silver fibers as an anti microbial. Claims on Coloring of parts of sock sections(bottom(having silver as component), ankle, heel, calf) method of manufacturing(the process and the way the sock is made). Adjustable sock for people with diabetes and injuries Patent #: US 20070271680 A1 Adjustable sock for diabetics, and others with foot injuries. adjustable to control how tight or loose one would like to wear the sock.  Made to help circulate blood. Claim on being adjustable. Device, method, and use for treatment of neuropathy involving nitric oxide Patent #: US 8241650 B2 “Sock” and/or non implantable device that is worn on and around the foot that comprises a nitric oxide (NO) eluting polymer, to allow instant treatment to areas of the foot they are in contact with. NO causes relaxation of arteries and blood vessels, helps with blood pressure and circulation. Claims on non implanted NO delivery devices(gives specific dosage), a device for treating neuropathy comprised of a proton donor, nitric oxide eluting polymer.

Using the information you have compiled, score the portions of the fundability worksheet listed below. Customer Validation (use a value of 1). Fundability worksheet score: 1 Competitors. Fundability worksheet score: 3 IP Position. Fundability worksheet score: 2

Works Cited

“What Kind of Doctor Treats Foot.” Foot HealthCare Associates. Web. 9 Sep. 2017. “What Kind of Doctors Specialize in Neuropathy?” Network for Neuropathy Support, 2015. Web. 9 Sep. 2017. “What is an Endocrinologist?” News Medical Life Sciences. Web. 9 Sep. 2017. “Wound Healing Among Seniors.” Advanced Tissue, 2017. Web. 9 Sep. 2017. “Doctors Develop New Method to Treat Diabetic Foot Ulcers.” Advanced Tissue, 2017. Web. 9 Sep. 2017. “Doctors Who Treat Neuropathy.” Network for Neuropathy Support, 2015. Web. 9 Sep. 2017. “Advisory Board.” US Neuropathy Centers. Web. 9 Sep. 2017.