Technical Feasibility
a. The technologies needed include a micro computer, a battery, a GSR sensor, a heart rate sensor, an O2 sensor, an LCD screen, and a thermometer.
b. One challenge that this design faces is including all of these technologies into a small wristwatch-sized device. The cost of the device is difficult to determine due to the variability in technologies and manufacturing costs. Keeping the sensors separate and maintaining accuracy is another obstacle that the device must overcome in order to be successful.
c. Since the device is such a small device, the heat of the battery could fry the sensors and wiring. A hardware malfunction is entirely possible due to the device's small stature.
Clinical Feasibility
a.
b. Clinical risks include inaccuracy of the device as well as incorrect usage and reading of the results.
c. Clinical Trials Summary
Part
Image
Summary
Watch Body
Here is the main watch body where the computer, mobile interface, and heart rate sensors are housed. The body is intended to be Aluminum for a durable product as well as giving our customers something they will like to wear. On the very top there is a screen to display information about the sensors on board and on the fingers, as well as buttons to toggle the different options the device offers.
The watch strap is not show for clarity.
Watch Body
Here is another view of the watch as seen from below. The cylindrical extrusion is the heart rate sensor.
Interface
This is the connection between the sensors and the watch, data and electricity is sent to and from the watch and sensor via this link. It connects with the watch body magnetically on the oval ends.
Finger Sensor
Here is what will house all other sensors that will attach to the outer finger, including: Pulse Oximeter, Thermometer, and Galvanic Skin Response Sensors. All on 3 separate finger units.
Finger Sensor
The unit is attached with a cable over the top to not have any disturbing wires in the way and the ergonomic design guides the finger into an optimal position for accurate and precise readings.
Whole Assembly
When put together, all 3 components work seamlessly together to track your vitals and record them to your mobile device. Helping the customer keep track of trends in their vitals and symptoms so the customer can aide themselves and reduce chronic pain without medication.
The watch strap is not show for clarity.
Number
Title
Summary
What this means for us
NCT00910689
Drug and Non-Drug Treatment Of Severe Migraine (TSM) [1]
This trial consisted of a 4 treatments, combinations of drugs, placebos, and/or "behavioral management", in order to determine the most effective treatment option. It was found that the treatments with the behavioral therapy and biofeedback, both with drugs or with placebos, resulted in the largest decrease in pain and the highest quality of life at the end of the trial.
From these results, we can see that outside therapy, in addition or apart from drugs has been linked to decreases in overall pain.
NCT00108277
Respiratory Dysregulation and Breathing Training in Anxious Outpatients [2]
In this trial, patients with anxiety were either instructed to raise/lower their breathing, or were treated as normal. It was found that over a period of 1 month, the patients that underwent the breathing training, that is those who were instructed to raise/lower CO2, had a lower episodic anxiety scale than those who had normal treatment.
The results of this trial encourage us to include a CO2/O2 monitor for our product, as it has been found that tracking breathing can assist in decreasing anxiety and overall pain.
NCT00212264
Conservative Treatment of Postprostatectomy Incontinence [3]
This trial measured the occurrence of incontinence after surgery over a period of time with the three treatments being behavioral treatment, behavior treatment and biofeedback, and placebo. It was found that the patients who used biofeedback and behavioral therapy had the largest drop in occurrences of incontinence, suggesting that biofeedback had a large role in the significance of this decrease.
The results of this trial suggest that biofeedback can be used in several situations, and therefore widens the market to include patients who suffer pain but have side effects from surgery such as incontinence, as this trial presents. Therefore, our product can be used to assist in monitoring the results for people undergoing treatments such as these.
NCT00361270
Treatment of Veterans With Chronic Low Back Pain (CLBP) [4]
The trial measured the sleep quality as well as pain intensity of veterans as they underwent one of several treatments including hypnosis, audio aids, and biofeedback. At the end of the trial it was recorded that biofeedback led to the lowest pain on the BPI scale as well as a significant drop in PSQI, meaning it is easier for them to sleep, this being a result of lessened pain and discomfort.
This study suggests that biofeedback is a viable treatment option for chronic pain sufferers and can significantly improve several aspects of their life.
DOI: 10.1007/s10484-006-9028-0
A Pilot Study of the Efficacy of Heart Rate Variability (HRV) Biofeedback in Patients with Fibromyalgia[5]
This study looked at several aspects associated with fibromyalgia such as depression, pain, and improvement in functioning. It was found that biofeedback increased HRV and BPV, as well as lowering pain and depressive symptoms. Overall the study found that biofeedback had a significant impact on bettering the lives of fibromyalgia patients, that is the study participants.
The conclusion of this study suggests that biofeedback is a good treatment for chronic pain patients, especially those with conditions like fibromyalgia.
References:
[1] Holroyd KA, Cottrell CK, O'Donnell FJ, Cordingley GE, Drew JB, Carlson BW, Himawan L. Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ. 2010 Sep 29;341:c4871. doi: 10.1136/bmj.c4871.
[2] Wollburg E, Roth WT, Kim S. Effects of breathing training on voluntary hypo- and hyperventilation in patients with panic disorder and episodic anxiety. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):81-91. doi: 10.1007/s10484-011-9150-5.
[3] Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972.
[4] Treatment of Veterans With Chronic Low Back Pain (CLBP). (2016, April 22). Retrieved September 16, 2016, from https://clinicaltrials.gov/ct2/show/study/NCT00361270?term=biofeedback
[5] Hassett, A.L., Radvanski, D.C., Vaschillo, E.G. et al. Appl Psychophysiol Biofeedback (2007) 32: 1. doi:10.1007/s10484-006-9028-0
Market Analysis
Value Creation
An accurate, durable product that utilizes the newest methods in its assemblage. Starting the company with reliable management that pays employees fairly and doesn’t cut corners on cost to ensure a high-quality and trustworthy product.
Manufacturing Cost
$130 per unit- includes all sensors, hardware, software, and cosmetics.
$300K- application development
Sales Price
$150 per unit to clinics
$180 per unit to public/independent buyers
Market Size
$180 per unit to customer x 2% of chronic pain patients (2 million) = 360 million.
According to the Institute of Medicine of the National Academies[1], 100 million Americans suffer from some form of chronic pain each year. Even assuming such a low number of people actually go to a clinic to deal with their pain, the market size is a sizable and respectable number.
References
[1]"The American Academy Of Pain Medicine." American Academy of Pain Medicine. N.p., n.d. Web. 20 Sept. 2016.
Fundability Discussion
Technical Feasibility - 2; Already known technologies and sensors simply need to be assembled into one unit. Blutooth connection easy and simple to establish. Unknown interactions between sensors and wiring.
Clinical Feasibility - 3; Many clinical trials have been done on biofeedback using similar technologies, and those studies show success and improvement in chronic pain and other relevant ailments.
Market Size - 2; With a relatively small estimate of 180 million, the market size falls on the high end of 80-200 million. This gives investors a safe bet on the amount of people that need and will buy this product.
BME 100 Fall 2016
