BME100 s2018:Group4 W1030 L1

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OUR TEAM

Name: Jonathan Kendall-Jackson
Name: Amanda Tran
Name: Maren Eltze
Name: Cesar Carreto
Name: Your name
Name: Your name

LAB 1 WRITE-UP

Health Care Issue

We will be developing a solution for high blood pressure. Hypertension is the leading cause of both death and disability in the United States.(1) High blood pressure occurs when the force of blood pushing against the walls of the arteries as the heart is pumping blood is too high.(2) There are many causes of hypertension, many of which are genetic causes as well as environmental and lifestyle causes. Unhealthy living habits, including high sodium intake, lack of exercise, and excess drinking, are typically the reason for adults who have hypertension. Additionally, there are many prescription medications that can cause high blood pressure, such as birth control, hormone therapies, and cold relief medicines. People at risk for developing high blood pressure are people who are older, people who are overweight, and people who have a family history of hypertension or sensitivity to sodium. Hypertension is also more common in African American adults and is more likely to develop in men than women. High blood pressure has many negative consequences over time. Some of these complications include aneurysms, kidney disease, heart attack, heart failure, peripheral artery disease, and stroke.(2) When a person is diagnosed with high blood pressure, there are many healthy lifestyle changes that can be made to reduce their blood pressure naturally, and there are many medications that can be prescribed to reduce blood pressure as well. Some of these include diuretics, beta-blockers, ACE inhibitors, Angiotensin II receptor blockers, and many others.(3)

The device we will be designing will be a wearable technology that focuses on high blood pressure. The device will look similar to a smart watch, and the device will monitor heart rate and blood pressure. The device would have many features to track healthy living as well, including sleep and dietary tracking. Additionally, the main feature of the device is the administering of a prescribed medication for the individual in the form of al patch on the skin to treat hypertension by reducing blood pressure. The drugs would be administered transdermally and there are many different medications that have been approved to be transdermally delivered, including diuretics and clonidine. These patches will be prescribed by the patient’s doctor, and ideally, the patients will only have to change the patch every week. Additionally, another feature of the device is that it would be able to detect when a patient is having a heart attack, notify 911, and administer an emergency Aspirin, also in the form of a patch.

Customer Validation

1. Patients with high blood pressure (HBP).

2. Cardiologists.

3. Hematologist.

4. General Physicians.

5. Nurse Practitioners.

6. Registered Nurses.

7. Pharmacists.

8. Pharmacy Technicians.

9. Clinical Laboratory Technicians.

10. Emergency Medical Technicians.

11. Pharmaceutical engineers.

12. Biomedical engineers.

13. American Heart Association.

14. Ponoco Coated Products, LLC.

15. Software engineers.

16. FitBit R&D Department.

17. Destiny Innovations & Supply Inc.

18. Corium International.

19. Mylan Technologies.

20. HZO - Waterproof technology.

Competitors

Current solutions for high blood pressure monitoring and drug administration:


Monitoring: A) Automated Blood pressure monitors


Advantages:

-Allow the patient and healthcare provider to measure blood pressure

-Relatively easy to use (no formal training required), widespread use (commercially and at-home)

-Inexpensive (5)

-Some insurance companies cover the cost of the monitor (6)

-Usually accurate (5)


Disadvantages:

-Often large and bulky, pressure of blood pressure cuff may be uncomfortable

-smaller wrist options are available but still require the use of a pressure cuff (and are often less accurate)

-Need the accurate cuff size to get an accurate blood pressure reading

-Can be seen as a “hassle”, many may find it inconvenient with their schedule or forget to monitor regularly

-Hard to measure blood pressure on the go

-Patients may not accurately use blood pressure monitor at home

-Does not measure blood pressure over time (5)

-Does not alert the patient (5)


B) Watch (very new technology)


Advantages:

-Very easy to use

-Doesn’t require a large monitor or uncomfortable cuff

-Can use anywhere on the go

-May have more than one use (rather than just blood pressure monitoring)


Disadvantages:

-Expensive

-Not covered by insurance

Most relevant competitor:

-Heartisans Watch


High Blood Pressure (hypertension) treatments:


A) Healthy lifestyle changes


Advantages:

-Effective and noninvasive

-No negative side effects

-No or less medication needed

-Increases overall health (not just blood pressure)


Disadvantages:

-Hard to monitor

-Requires changing many aspects of life

a. Dietary habits b. Exercise c. Stress levels

-Results vary as some change lifestyle more than others

-May be hard to stay consistent

-Hard to integrate into work and social life, may collide with culture of the region

-Could be more expensive in the short term (healthy foods and possible exercise equipment/membership) than taking pills that are covered by insurance


B) Oral medication/pills (most common)


Disadvantages:

-Many people don’t take all of the medication they need

a)A recent study showed that only 20% of patients with resistant hypertension take all of the medication that they need (4)

-Inconvenient

a)Requires daily effort and remembering (most patients taking these medications are older, possibly more forgetful)


Advantages:

-Widespread use, often covered by insurance

-Easy to use, doesn’t require a lot of instruction or lifestyle change


C) Transdermal Patches


Advantages:

-Medication released continuously, rather than with peaks after a pill is taken (reduces risk of toxic side effects) (7)

-Doesn’t require daily pill taking - harder to forget

-Some blood pressure medication already approved for this method (Clonidine)


Disadvantages:

-Not many medications are approved to be transported into the body transdermally (7)

-Not all blood pressure medications approved for this

Relevant Transdermal Patch competitors (8)

-Catapres-TTS® (Boehringer Ingelheim, Ingelheim am Rhein, Germany)

-Clonidine Transdermal System [Aveva (Miramar, FL, USA)

-Barr Pharm Labs Div Teva (Montvale, NJ, USA)

-Mylan Technologies (Albans City, VT, USA)

-Watson Labs (Dublin, Ireland)


Why our product is a good alternative:

It combines the benefits of watch blood pressure monitoring with the ease of use of a transdermal patch allowing for easier and more effective blood pressure monitoring and treatment than the traditional alternative, which is using automated blood pressure monitors in conjunction with either healthier lifestyle choices and/or oral medication.

IP Position

Adhesive peel-forming formulations for dermal delivery of drugs and methods of using the same: US20050276842A1

-Patch that has a peel and stick design with a solvent solution with the drug. The design of the holding the drug in a solution is a process that may be considered for the product

Method and device for monitoring blood pressure: US6443906B1

-Watch that measures blood pressure at an artery. This technology is part of the fundamentals of the product design, so this technology may need to be incorporated with the design

Biosynchronous transdermal drug delivery for longevity, anti-aging, fatigue management, obesity, weight loss, weight management, delivery of nutraceuticals, and the treatment of hyperglycemia, alzheimer's disease, sleep disorders, parkinson's disease, aids, epilepsy, attention deficit disorder, nicotine addiction, cancer, headache and pain control, asthma, angina, hypertension, depression, cold, flu and the like: US20080220092A1

-A device that looks like a watch but its a dispenser to administer drugs like clonidine transdermally. This technology is critical for the design of the project but initials designs will use disposable patches rather than pressurize solution of the drug that’s in the patent.

Aspirin transdermal patch: WO2005084255A2

-“An aspirin transdermal patch having an outer layer, a vapor impermeable layer, a vapor permeable layer, an aspirin containing layer, adhesive portions, and a peelable liner.” This patient contains a method to deliver aspirin quickly through the skin. The product needs this feature in case when the device detects a heart attack. With it the device may buy the client time to get into an emergency room.

Watch with hidden compartment: US7333399B2

-A watch that opens up to have a storage unit inside. This feature is vital for the device since it will be what will hold the patches with the medicine inside of it. It needs to be modified though to allow the medicine to permeate through both the watch and skin.

Sustained/immediate acting ketoprofen patch and process for manufacturing the same: US6190690B1

-Status: Granted as of 20 Feb. 2001

-A patch design with a high permeable membrane to allow a drug to be released onto the skin of the patient. There is a non permeable membrane of the opposite side of patch to prevent the drug from leaking out the wrong way. The membrane has an adhesive that binds to the skin to prevent dismount from the patient. This patent contains a few aspects of the design of the product that is required to administer the drug which is the permeable and the nonpermiable membrane to allow a one way flow of the drug to the patient.

Fundability Worksheet

Customer Validation (use a value of 1): 1 - The portion of Customer Validation on the fundability worksheet receives a score of 1 because we will not have customer feedback to-date.

Competitors: 2 - This portion of the fundability worksheet receives a score of 2 because there are a few competitors that exist, however those that do exist do not have the combined technology of our product they only feature the specific components that are involved in our device.

IP Position: 1 - The entire product itself is not fully patented, but technology that the product requires do already exist. Luckily, since many patents are for individual components for the product, there is hope that the product could be patented because the technology will be modified and then combined into a product of its own.

Works Cited

1. Wedro, Benjamin, MD. “High Blood Pressure (Symptoms, SIgns, Causes, Diet, Medication)”. eMedicineHealth. Stoppler, Melissa, MD. 20 November 2017. https://www.emedicinehealth.com/high_blood_pressure/article_em.htm

2. National Heart, Lung, and Blood Institute. “High Blood Pressure”. 10 June 2016. https://www.nhlbi.nih.gov/health-topics/high-blood-pressure

3. American Heart Association. “Types of Blood Pressure Medications”. 6 November 2017. http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/MakeChangesThatMatter/Types-of-Blood-Pressure-Medications_UCM_303247_Article.jsp#.WmjMrJM-eu4

4. "Transdermal Patches | Cgmp-Compliant - Cherryville, North Carolina." Poconoctd.Com, 2018, http://www.poconoctd.com/transdermal-patches.html.

5. "Transdermal Patches | Mylan." Mylan.Com, 2018, http://www.mylan.com/en/products/packaging-and-finished-dosage-forms/transdermal-technology.

6. Judd, Eric, and David A. Calhoun. “Management of Resistant Hypertension: Do Not Give Up on Medication.” Nephrology self-assessment program : NephSAP 13.2 (2014): 57–63.

7. Parati, G, et al. “Advantages and Disadvantages of Non-Invasive Ambulatory Blood Pressure Monitoring.” Journal of Hypertension. Supplement : Official Journal of the International Society of Hypertension., U.S. National Library of Medicine, Dec. 1990, www.ncbi.nlm.nih.gov/pubmed/2127944.

8. “Blue Cross and Blue Shield's Federal Employee Plan.” FEP Blue, www.fepblue.org/en/wellness-resources-and-tools/wellness-resources/hypertension-mgmt-program.

9. Alkilani, Ahlam Zaid, et al. “Transdermal Drug Delivery: Innovative Pharmaceutical Developments Based on Disruption of the Barrier Properties of the Stratum Corneum.” Pharmaceutics, MDPI, Dec. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4695828/.

10. Pastore, Michael N, et al. “Transdermal Patches: History, Development and Pharmacology.” British Journal of Pharmacology, BlackWell Publishing Ltd, May 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4403087/.