BME100 f2017:Group14 W0800 L1

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TEAM MEMBERS

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Name: Shae Diaz
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Name: Kennedy Miskin
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Name: David Asuncion
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Name: Sean Smits
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Name: Carlos Mendez-Arias

LAB 1 WRITE UP: NEEDS IDENTIFICATION

Health Care Issue

One in twenty people will have a one off epileptic seizure at some point in their lives. One in fifty will have epilepsy at some point in their lives. 1 out of every 100 people living in the United Kingdom currently have epilepsy (EpilepsySociety). While not all seizures are dangerous, first time seizures or the first seizure in six months, seizures that last more than 5 minutes, or a seizure shortly after having one is an emergency situation that requires intervention, like drugs(CDC). This intervention needs to be as soon as possible or can lead to other health problems. Currently there are only two drugs used to handle a seizure that has become an emergency situations; a drug inserted rectally or a drug given in an IV. The rectal drug is obviously invasive and uncomfortable, and the IV drug, Lorazepam, can be difficult to administer if the patient is moving. Our epilepsy epipen or “Lorazapen” would be a way to easily administer Lorazepam in an emergency situation without wrestling for an IV. This pen could also be prescribable, similar to an epipen, to be used by used by family members if a dangerous seizure were to suddenly occur. Currently the only option for family members is to insert diazepam and that can be uncomfortable for family members to do. Not to mention family members who may not know how to administer it. Lorazepam is already prescribed to patients with epilepsy in a pill form to take daily as a prevention measure, but this dose can be added to if a uncontrollable seizure were to happen. This easy access device will prevent injury to those in an emergency situation by allowing them to get medicine faster and create a viable, less invasive way to treat emergency seizures.

Customer Validation

"Physicians:"
Dr. Barry A. Hendin, MD - neurologist at Phoenix Neurological Associates
Dr. Sandra Kuniyoshi, MD PhD - neurologist at Banner Health
Dr. Jonathan S. Moray, MD - neurologist with New England Neurological Associates, P.C.
Dr. Michel Joseph Goumaz - neurologist in Geneva, Switzerland
Dr. David Treiman, MD - neurologist at Barrow Neurological Institute focusing on epilepsy
"Providers:"
Mayo Clinic in Rochester, Minnesota
John Hopkins Hospital in Baltimore, Maryland
Massachusetts General Hospital in Boston, Massachusetts
New York-Presbyterian Hospital in New York
UCSF Medical Center in San Francisco, California
The top five hospitals in adult neurology & neurosurgery
"Payers:"
Epilepsy Foundation - epilepsy advocates and sponsors of various incoming therapies
Milken Family Foundation
Finding a Cure for Epilepsy and Seizures
Citizens United for Research in Epilepsy
Epilepsy Research UK
"Purchasers:"
NeuroVista Corporation - medical device company focusing on epilepsy management and treatment
NeuroCrine Biosciences - biotechnology company focused on neurological disorders
Minerva Neurosciences - biotechnology company focused on central nervous system disorders
BioLert LTD - biotechnology company; working on seizure detection technology
Mylan N.V. - pharmaceutical company; owners of the EpiPen

[1]http://health.usnews.com/best-hospitals/rankings/neurology-and-neurosurgery

Competitors

Our device is more marketable because it provides a way for people to administer a dose of Lorazepam when they start having a seizure. The epipen makes it possible for patients and their loved ones to carry around a dose a lorazepam in case they need it. Our device is also less invasive and more comfortable for both the patients receiving and paramedics administering the rectal dosage of diazepam. Having an epipen makes it easier to inject lorazepam because there is no need to spend time finding a vein for an IV.

IP Position

After searching for pre-existing studies/experiments on the technology, it was discovered that various institutions and studies have already made advancements into the autoinjector “field” for the purpose of responding to those with seizures.

Fundability Worksheet

Customer Validation
Score: 1 “Not enough customer feedback to-date”
Currently, since our idea is new and hasn’t been released to the general public, we do not have enough customer feedback to determine how likely it is for patients in need to purchase our device. Therefore the score is a 1.
Competitors.
Score: 2 - “Competitors exist but clinical improvements are still being sought.”
As mentioned above, there are competitors such as IV Lorazepam, Rectal Diazepam, and IV Diazepam. These competitors, however, can be rather inconvenient/uncomfortable for patients and cause them to have some type of supervision. ::Our product will allow patients suffering with epilepsy to help combat seizures from anywhere. For this reason, it is likely our product will be popular, but it probably won’t eliminate the use of IV Lorazepam, Rectal Diazepam, and IV Diazepam. ::Therefore the score is a 2.
IP Position.
Score: 1 - “No or weak patent applications or provisionals only.”
Since our product uses similar technology as other products, but with a different end goal, there already are patents for these aspects of our medical device. For that reason, it may be difficult to receive a new patent for something so similar in design.
Therefore the score is a 1.