BME100 f2016:Group1 W1030AM L1

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TEAM 1

Carlye A. Frisch
Kendra M. Gibble
Anna Rothweil
Nicholas C. Whitley
Gabrielle F. Wipper


Electronic pill dispenser with timed release, biometric safety lock, provided by pharmacists with prescription medicines inside, with alarm notifications for pharmacists or other medical personnel, for patients' home use, especially when purchasing high-risk medicines

In order to prevent overdose just as well as forgetting to take medicine, pharmacies will provide patients our safe pill dispenser when purchasing high-risk medicine. This will cost them an additional fee, either for rent and for cleaning or for buying the dispenser for life-time use.

Health Care Issue

"2.4 million Americans used prescription drugs non medically for the first time within the past year, which averages to approximately 6,600 initiates per day." (National Institute on Drug Abuse (NIH)) https://www.drugabuse.gov/publications/research-reports/prescription-drugs/trends-in-prescription-drug-abuse/how-many-people-abuse-prescription-drugs


Overdose.jpg Overdose2.jpg


Substance abuse: "Substance abuse refers to the harmful or hazardous use of psychoactive substances, including alcohol and illicit drugs. Psychoactive substance use can lead to dependence syndrome - a cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal state." (WHO) http://www.who.int/topics/substance_abuse/en/

The abuse of and addiction to opioids such as heroin, morphine, and prescription pain relievers is a serious global problem that affects the health, social, and economic welfare of all societies. It is estimated that between 26.4 million and 36 million people abuse opioids worldwide, with an estimated 2.1 million people in the United States suffering from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 addicted to heroin. The consequences of this abuse have been devastating and are on the rise. For example, the number of unintentional overdose deaths from prescription pain relievers has soared in the United States, more than quadrupling since 1999. There is also growing evidence to suggest a relationship between increased non-medical use of opioid analgesics and heroin abuse in the United States. https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-to-opioids-heroin-prescription-drug-abuse

https://www.priorityhealth.com/provider/clinical-resources/medication-resources/~/media/documents/pharmacy/cms-high-risk-medications.pdf

Competitors

Product name Advantages Disadvantages Source/Link
Med-Time XL automatic pill dispenser The product has an alarm and notifies the caregiver's phone if a dosage is missed. It is easy to mix up medications when refilling. The product is not tamper proof. http://www.epill.com/dispense.html
Med minder The cost for Med-Minder is covered by the patient's copay and it requires no batteries. There is no alarm to alert the patient when it is time to take their medication. There is no child lock or password required to access the medication. https://www.medminder.com/medminder-pharmacy/
Alert 1 Medication Reminder and Organizer Tamper proof, portable, and offers a rechargeable battery. The product is very bulky in size and does not notify the caregiver if a dosage has been missed. https://www.alert-1.com/products/medication-dispenser-reminder-and-organizer/206?utm_source=google&utm_medium=cpc&utm_campaign=Google-Shopping&gclid=CLaeosqm7M4CFUprfgodz0oN8g





Customer Validation

Patient
Anyone is a potential patient who consumes prescription pills, prescribed by a doctor or physician. Ideal for the elderly, undependable, irresponsible, mentally ill and forgetful people. The pill dispenser doesn't let taking in an overdose and contacts an emergency contact if the pills weren't taken in. It can also be connected to smartphone and computer through an application which reminds patients of taking the medicine, stores medical information etc. Patients taking high-risk medications and/or suffering from chronic diseases, even with ones affecting reliability, could use the pill dispenser and be treated at home safely this way.

"Drug addiction is a brain disease. Although initial drug use might be voluntary, drugs of abuse have been shown to alter gene expression and brain circuitry, which in turn affect human behavior. Once addiction develops, these brain changes interfere with an individual’s ability to make voluntary decisions, leading to compulsive drug craving, seeking and use." https://www.drugabuse.gov/related-topics/medical-consequences-drug-abuse

Either to prevent addiction and treat it, our pill-dispenser is the perfect tool to use.


Payer
The insurance companies of patients, to whom latter pay monthly fees. In case of patient not having a health insurance, the payer might be the payer itself again or kind of fund. The customers of insurance companies are in greater safety with the use of our electronic pill-dispenser. Lower chance of overdose or medical problems in connection with pill-taking. This means a decrease in the expenses of treating above mentioned problems.

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Physician
Doctors/physicians, whose patients would be in greater safety. Risks of using serious medicines gets lower, just as well as the responsibility of the physician prescribing. This way more effective treatment is possible, faster recovery.

"High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients." https://www.ismp.org/tools/highalertmedications.pdf


Provider
Pharmacies/hospitals. More work for their employees, but more benefits as well. Profits on cleaning fee, rental fee, refilling fee. A considerable percentage of US public health care expenses is made up of prescription drugs, which indicates their wide and everyday use.

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Purchaser
Pharmacies/hospitals/patients occasionally. Competitor companies mentioned in section "Competitors", because our product is willing to be cheaper and used in a different way.

IP Position

IP POSITION

List and describe the patent landscape and patent status. Will you own the space? Are there blocking patents you may end up infringing on?


0 No patentability or freedom to operate

1 No or weak patent applications or provisionals only

2 Non-provisional(s) filed and pending or issued patents, but weak

3 Strong, issued patents


The score for IP Position for this product would likely be a 0, but if the group can put together improvements enough to be called novel, this product could earn a 1.


4.1 Patent Landscape

The patent landscape in general is not promising. This area has a lot of competition, and the availability of new patents is small due to the coverage in the area. The product vision of this group, even with all the proposed improvements, may not produce something that can be patented because many of the improvements may be seen as obvious in light of the prior art. A novel product or a novel improvement is necessary to obtain a patent.


US5641091 Page 7 Part of Fig 13 Edited Compressed 96.jpg

Automatic pill dispenser II

U.S. Patent No. US5641091A

Legal Status: Expired-Fee Related

Application No. US08399912

https://patents.google.com/patent/US5641091A/en?q=automatic+pill+dispenser&q=patent

This system is really designed for people who forget to take their medicine. It holds the medication in small spaces that rotate to allow the person to pick up the pills through a small window. The unit has a round piece that rotates around a center, with multiple small spaces that will hold a dose of a patients' medications. The unit also has a "Pill Sample illustrator" that is attached and will show samples of the pills, as well as their names, nature and dosages.



US4695954 Page 1 Fig 1 Edited Compressed.jpg

Modular medication dispensing system and apparatus utilizing portable memory device

U.S. Patent No. US4695954A

Legal status: Expired-Fee Related

Application No. US06663916

https://patents.google.com/patent/US4695954A/en?q=automatic+pill+dispenser&q=patent

This "system, apparatus and method" (as it was patented as such) is for dispensing medications prescribed by a doctor or other qualified medical personnel. This particular patented system makes use of a portable memory device, for example one described within the patent materials is a magnetic card. It would store prescription information on the card as programmed by a pharmacy. The container has individual compartments where the pills would be placed. The portable memory device and the container are "transported together to a medication dispenser located near a patient." (To me this sounds like another physical building location like a pharmacy or doctor's office.) This dispenser naturally has a device to read the memory device. It makes medication within the individual compartments available to the patient at prescribed times. It "also includes apparatus for monitoring whether or not the patient is complying with the prescribed medication schedule. Patient compliance information is stored within the memory device." It also has a monitor which would allow medical personnel to "obtain a video display or printed record of the prescription information and patient compliance information within the memory device.


4.2 IP Risks

Our biggest risk in IP beyond the obvious lack of patents, is that the product may not be able to get a new patent issued. The product would have to show substantial non-obvious improvement over prior art, and it is not clear that the product vision of this group will meet that test.

Fundability Worksheet Scores

Competitors

1--Crowded market space, Differentiation will be difficult--However we think we have several different ideas that will differentiate us in the market (patentability is still a question whether it will be enough of an improvement)

Customer Validation

1--Conservatively--Hesitant interest to purchase or Not enough customer feedback to date--We believe there is not enough actual feedback, but there is a market need and customers have a wide variety of similar devices without our improvements. We are also beginning with a target market of the physicians and pharmacists, which is a slightly different entry.

IP Position

0 maybe a 1--No or weak patent applications or Provisionals only-- if we can differentiate enough to be a valid improvement