While the image provided is not incredibly detailed, it does provide a general idea of what our intended design is. Each electrode is wireless and connects to smartphone/tablet devices via bluetooth. It is a minimalist design. The extruding section of the electrode is intended to act as a grip for the patient or physician to grab in order to apply or remove the electrode from the body. The base of the electrode will adhere to the patient with either a cleanable suction cup mechanism or a disposable self-adhesive patch.
Technical and Clinical Feasibility
Our needed technologies include electrodes, bluetooth or radio-frequency identification (RFID) technology, application development software, and a tablet or smartphone in order to run our application. The primary challenge of developing our product is being able to effectively deliver electroshock therapy to a patient using wireless technology. If we are to develop our product in this minimalist fashion, we must make sure that the connection between our application and the electrodes is constantly strong. This is a challenge in that wireless FES technology is relatively uncommon, and the use of an application to deliver this kind of therapy deviates from most modern FES technology. Possible errors with our device include faulty or failed connections between the application and the electrodes, problems with each electrodes’ ability to deliver the appropriate amount of stimulation, or potential bugs in our application that will compromise the device’s ability to function properly. Clinical Feasibility
a. Will it work in the clinic? EMS is a very common practice in rehabilitative medicine and has been proven in a multitude of studies to be effective in treating disuse atrophy. Because of this existing research, the clinical feasibility of our product is high. While our product appeals to intensive care-patients in hospitals, it will likely work best in post-acute/rehab facilities that treat patients requiring extended hospitalization. http://www.ncbi.nlm.nih.gov/pubmed/23561945 http://www.ncbi.nlm.nih.gov/pubmed/14518784 http://www.ncbi.nlm.nih.gov/pubmed/25296344 http://www.ncbi.nlm.nih.gov/pubmed/25108833 http://www.ncbi.nlm.nih.gov/pubmed/23701811
b. What are the clinical risks?
Risks include potential pain or muscle damage to patient due to overstimulation of the muscle(1) and also the risk of pain and skin irritation.(2).
By taking advantage of the wireless technology and utilizing an application for a phone or tablet to monitor the output of the electrical charge, risk of overstimulation of the muscle can be reduced. Each electrode is applied on top of the skin and there no incisions or medications required it is very minimally invasive to the patient.
During the clinical testing it is important to determine the optimal use or placement of the electrodes for the patient.(2) To reduce the likelihood of misplacement of the electrodes it is important to include a easily understandable guide for applying the electrodes in the application for the phone or tablet of the caregiver and patient.
1.Gersh MR. Electrotherapy in rehabilitation. Philadelphia: FA Davis Co.; 1992, Ch. 1 and 7.
2.Kroon, J. D., Ijzerman, M., Chae, J., Lankhorst, G., & Zilvold, G. (2005). Relation Between Stimulation Characteristics And Clinical Outcome In Studies Using Electrical Stimulation To Improve Motor Control Of The Upper Extremity In Stroke. Journal of Rehabilitation Medicine, 37(2), 65-74. doi:10.1080/16501970410024190
Have similar products been in a clinical trial? How long was the trial?
Technical Feasibility Final Score: 2 - While FES technology has been existence for a long time, our shift towards an app-based device will require additional research and testing in order to ensure that our device works effectively.
Clinical Feasibility Final Score: 3 - Electrical stimulation technology has been in use for a long time by physicians and rehabilitation specialists. While technical feasibility is not a 3 due to new technologies, the use of electrical stimulation technology is extremely viable in intensive care units, long-term acute care hospitals, rehabilitation clinics, and in households.
By making the design wireless and utilizing an application it will provide more accessibility to more patients. This application will also allow caretakers to help and monitor a greater number of patients at the same time. With this application and the wireless electrodes, a patient can expect to reduce travel time and time in physical therapy.
Cost on site such as Newegg, pepin, a high quality electrode can be purchases in packs of 4 for $19.95. It is expected that most patients would require anywhere from 16 to 32 electrodes depending on the prescription. The bluetooth adapter used in each electrodes can be purchased retail for $9.99 from a site like Newegg. The price for the electrodes can range from $223.96 to $479.6. Certain application development companies have been know to charge anywhere from $150000 to $450000 to develop an applications.
The anticipated sale price for the electrodes can range between 500 and 600 dollars to cover the expenses of production. To cover the expense for the application design it can be purchased for $4.99.
The market size this product would be incredibly large. Patients can range from bedridden patient undergoing chemotherapy or is a comatose state to patients preparing for bariatric surgery. The largest market however would possibly be patients recovering from strokes. According to the 2016 Update Report by the American Heart Association ‘Yet each year, ≈795 000 people continue to experience a new or recurrent stroke... Approximately 610 000 of these are first events and 185 000 are recurrent stroke events.’(3) These number that have not changed since 2010. (4) According to the 2016 Update Report By the AHA, mortality rate due to stroke has decreased by 33%. This means there are more patients that will require extensive physical therapy.
(3)Mozaffarian, D., Benjamin, E., Go, A., Arnett, D., …, Turner, M. (2015).Heart Disease and Stroke Statistics—2016 Update: A Report From the American Heart Association. Circulation. 2015;CIR.0000000000000350, published online before print December 16, 2015 http://dx.doi.org/10.1161/CIR.0000000000000350
(4)Lloyd-Jones, D., Adams, R. J., Brown, T. M., Carnethon, M., Dai, S., Simone, G. D., . . . Wylie-Rosett, J. (2009). Heart Disease and Stroke Statistics--2010 Update: A Report From the American Heart Association. Circulation, 121(7). doi:10.1161/circulationaha.109.192667
We gave market size a rating of 3 because even focusing on a small portion of our possible market we can still generate profit after the production to the application and the electrodes.
Many products have been tested and are being sold. It is a very not invasive product