Easy ECI Inc.
Easy-ECI Inc.
Jessica Brisbin
Alexandra Jefferds
Nichole McPherson
Nicholas Werner
Extracorporeal Counter-Irritation Device
1.0Executive Summary
1.1Objectives
1.2Mission
2.0Company Summary
2.1Company Summary
2.2Company Ownership
3.0Products
3.1Product Need
3.2Product Description
3.3Competitive Comparison
4.0Market Analysis Summary
4.1Market Segmentation
4.2Industry Analysis
4.3Main Competitors
5.0Strategy and Implementation Summary
5.1Strategy and Implementation Summary
5.2Phase Breakdown and Milestones
Phase 1
Phase 2
Phase 3
6.0Management Summary
6.1Management Summary
6.2Organizational Structure
6.3Management Team
1.0Executive Summary
Needle sticks are involved in many common minimally invasive medical procedures and often result in people experiencing pain, anxiety or discomfort. Approximately 7-22% of the population in the United States has belonephobia, or a fear of needles which can greatly increase the amount of physical and psychological stress experienced by the patient during these medical procedures.(9)Sometimes, traumatizing experiences with needle sticks at a young age can even trigger belonephobia. Counter-irritation to needle sticks has long been used by dentists during injections of Novocain to reduce pain by pinching the surrounding gum and lip prior to and during the injection. A study by Menegazzi et al. found that counter-irritation in the form of music significantly lowered the pain experienced by patients receiving laceration repairs; however had little effect on the anxiety experienced during the procedures. The authors indicated that further investigations into this form of pain and anxiety lowering counter-irritation are warranted.(7)Gammon et al. completed a study in 1940 which showed that counter-irritation administered through vibration delayed the onset of pain.(4)Thus the ECI device could potentially decrease anxiety and pain associated with common minimally invasive medical procedures such as injections, vaccinations, IVs and catheters.Easy-ECI Inc. is committed to providing a simple, effective product that reduces the anxiety and pain associated with injection and catheterization.
1.1Objectives
The objective of the ECI device is to reduce pain and anxiety experienced during needle sticks. Specifically for the patient the ECI device must apply extracorporeal counter-irritation device to the skin of the patient which is strong enough to lessen their perceived pain during a needle stick. Also the ECI device should distract the patient through the use of its colorful appearance, soothing music and flashing lights in order to minimize anxiety experienced. The ECI device seeks to make the medical procedure easier and less stressful for the user by calming the patient. for the user is to make the medical procedure occur more smoothly by calming the patient. The ECI device must not be too exciting however, that it rouses the child to move or the user to become distracted. For our clients, who are pediatric doctors, hospitals, and clinics, the ECI device must be easy to purchase, affordable, and easy to maintain. Our goal is to keep the costs of the device under thirty dollars.
1.2Mission
Easy ECI’s mission is to design inexpensive solutions for pediatric clinical care which can reduce suffering throughout the world. By providing high quality ECI devices at under thirty dollars, pediatricians and clinics worldwide will be able to better comfort and treat patients. The novelty price will ensure a maximum number of devices are sold globally and therefore shareholders employees will be rewarded for their support in our company. In this way Easy ECI strives to improve healthcare internationally as well as capitalize lucratively by focusing on the details. One device at a time Easy ECI will fill in the gaps in medicine. Our commitment to reduce pain and anxiety of the patients, doctors and healthcare personnel will maximize the quality of medicine on an individual level, thus elevate the acceptable standard of medical practice.
2.0Company Summary
2.1Company Summary
Easy ECIwill design, manufacture and market anoriginal medical device. Current company developmental activities consist of prototype validation and redesign.
2.2Company Ownership
The structure of Easy ECI consists primarily of fourbioengineers:
Jessica Brisbin
Alexandra Jefferds
Nichole McPherson
Nicholas Werner
Clinical consultation is handled by Director of the Research for the Center for Emergency Medicine at the University of Pittsburgh Medical Center:
Dr. James J. Menegazzi, PhD
Prototype validation consultation is carried out by a fellow at Children’s Hospital of Pittsburgh:
Dr. Daniel Thomas
Dr. Thomas’ clinicians, members of the pediatric emergency department
3.0Products
Easy ECIwill producea device to reduce the pain and anxiety associated with minor medical procedures: Extracorporeal Counter-Irritation Device (ECI).
3.1Product Need
Minor medical procedures such as injections, IV starts, and catheter insertions have the potential to cause patients great anxiety even the physical pain associated with the procedure is minimal. If a patient is anxious about an injection, the arm muscles may tense up, resulting in greater pain than would have been experienced otherwise. A patient dreading an impending procedure focuses a great deal of attention on the site, and anticipated pain often becomes the reality.
Topical anesthetics only affect the outermost layers of skin and do not permeate deeply enough to be of significant benefit during injections. Because the administration of a local (subcutaneous) anesthetic is itself an injection, there is no reason to perform this step for simple procedures such vaccinations, where the pain experienced is slight. Nonetheless, the anxiety associated with these procedures is real.
Consequently, there is a need for alternative forms of pain relief. Current techniques include hypnosis, tactile therapy, and diversion therapy.All of these approaches have their strengths and drawbacks, but all require the active participation of the clinician or another individual. There is a need for a small, noninvasive device that will decrease pain and anxiety efficiently.
3.2Product Description
The device consists of a small (3x2x1") box which contains three independent circuits: 1) A vibration mechanism to provide tactile counter-irritation, 2) Flashing lights to provide visual distraction, and 3) Music to provide auditory distraction. The three circuits are powered by a single 9v battery located on the exterior of the box. The circuits may be activated using a common toggle switch or individually using DIP switches.
The first circuit (vibration) consists of a small weighted motor and provides a gentle but tangible vibration. The body of the motor is embedded in the exterior of the box, and the shaft and weight project into the box. There is sufficient room within the box for the shaft and weight to rotate freely.
The second circuit (visual) consists of five red LEDs that light up sequentially (chase) in a circular pattern. The chasing motion of the lights is accomplished through the use of a 4011 CMOS NAND Gate and a 4017 CMOS Counter[1]. The LEDs are embedded in the exterior of the box, next to the motor described in the first circuit.
The third circuit (music) is composed of a craft store music chip attached to a small 8 speaker. The internal circuitry of the music chip is unknown.
The exterior of the box is equipped with a strap of double sided hook-and-loop fastener material. To attach the device to the patient’s arm, the clinician places the box on the arm, holds one tail of the strap tight against the arm, and then wraps the other tail over the first. The box itself is painted in blue, green and white to simulate an underwater scene; the motor body is painted to resemble a turtle shell.
Ongoing improvements to the ECI’s design include:
- Use of a strap made of material verified to be biocompatible
- Redesign of the box
- Use of off-the-shelf motor and music chip
3.3Competitive Comparison
A focus group of pediatric clinicians confirmed the need for a small, noninvasive device to reduce pain and anxiety in children during minor medical procedures. Currently, there are no similar devices on the market, though other strategies to reduce pain are used. The clinicians believe that the current design is feasible, though some cosmetic improvements would be beneficial. It was suggested that a redesign of the ECI include an animal-shaped case with legs that moved and that the bottom of the device feature cleat-like protrusions. Both of these features would enhance the vibration sensation. Such improvements would be cost-effective ways to further reduce pain and anxiety using this device.
4.0Market Analysis Summary
In 2006, The Washington Post reported that approximately 7-22% of the US population has belonephobia, or a fear of needles, which can greatly increase the amount of physical and psychological discomfort of the patient during simple medical procedures.(9) Needle phobia is a newly defined formal medical condition and has recently been included in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) within the diagnostic category of Blood-Injection-Injury Phobia.(3)(6)(2) The etiology of needle phobia is rooted in an inherited vasovagal reflex that causes shock with needle puncture. With repeated needle exposure, those with an inherited vasovagal shock reflex tend to develop a fear of needles.(5) Due to the modern reliance on injections and blood testing, and because persons with needle phobia typically avoid medical care, this condition is a significant impediment in the health care system. Based on this data, it is evident that the market is present for a device such as proposed by Easy-ECI Inc.
4.1Market Segmentation
Currently the market for this product is primarily domestic, however the device shows promise in the European marketplace. The device would be implemented in any pediatric care facility, including, but not limited to: hospitals, pediatric clinics, as well as offices of primary care physicians.
While third-world markets were investigated, it was shown that such a device is seen as an unnecessary luxury when essential medical equipment is difficult to acquire.
4.2Industry Analysis
Current solutions to this problem range in monetary value. Diversion and tactile therapy can be as inexpensive as free. However, the necessity of another trained individual’s presence for the procedure is not truly economically free. Due to this hidden economic cost, most patients do not opt for this treatment. Hypnotherapy can cost upwards of $300.(1) This high fee makes it difficult for children to receive this service.
Along with being relatively inexpensive ($30), the ECI device is applied shortly before and removed after the procedure, making it unnecessary for a third party to be present.
4.3Main Competitors
Currently there exists no other device on the market specifically employed to alleviate the pain and anxiety associated with needle sticks in children. However, medical professionals use other techniques to solve this problem. Some of the commonly used techniques used are: 1) hypnotherapy, 2) tactile therapy, 3) diversion therapy, and 4) local/topical anesthesia.
Hypnotherapy is sometimes used as an alternative to anesthesia and can cause the patient to be deeply relaxed. However it can wear off unexpectedly, requires the presence of a trained hypno-therapist, and is accompanied by high costs that are not covered by most insurance companies.
Tactile therapy can lessen the actual sensation of the needle stick but draws extra attention to the needle which can result in an increase in anxiety.
Diversion therapy averts the child’s attention away from the needle lowering anxiety, but does nothing to lessen the pain of the stick.
In the past, topical anesthesia was not widely used because it only affects the top layers of the skin, which is not deep enough for most procedures. It also does nothing to diminish anxiety.
5.0Strategy and Implementation Summary
5.1Strategy and Implementation Summary
The ECI device was created in order to reduce the pain and anxiety that is commonly associated with needle sticks through the use of counter-irritation. The development and manufacturing of the ECI device occurred over three phases. The first phase was primarily involved with researching and creating preliminary design specifications. The second phase consisted mainly of designing the device according to set specifications. The last phase was composed of verifying and validating through testing and analysis.
5.2Phase Analysis and Milestones
Phase 1
The initial phase is where the background research was conducted and the preliminary ideas of design were constructed. To begin, meetings were attended with the mentor, Dr. James J. Menegazzi. Through these initial meetings, design ideas and the actual problem at hand were discussed. Previous studies were researched and any relevant results were implemented towards the design of the ECI device. Product design specifications were then created in order to determine the proper design of the device. Theses specifications consisted of hazard analyses, risk analyses, design specifications, etc. The product design specifications allowed for the best possible construction of the prototype to maximize the effectiveness. Market analyses were conducted to determine the populations in need of this device. After a thorough understanding of the problem and the intended market, a final prototype design idea was formulated. Once the design was verified by Dr. Menegazzi, the prototype could move forward. The confirmation of a proper design was the first major milestone of this device.
Phase 2
This second phase began the actual construction of the prototype. The first prototype consisted of a hand assembled breadboard that contained all of the working components of the device. Once it was confirmed through this prototype that all of the components could be put onto one circuit, a second prototype was began. This second prototype consisted of an outer casing that enclosed all the working components. The casing allowed for the lights to be seen, the music to be heard, and for the vibrations to be felt. A Velcro strap was attached to the outer casing to allow the device to put attached to a subject. The creation of the second working prototype was another major milestone in the device construction. The verification of the device was another important step in the second phase. Several important aspects of verifying the device included the size, weight, and functionality of the device. The device passed these verification criteria being that it was six square inches, weighed less than eight ounces, and had all three working components (lights, music, and vibration). Another very important verification criterion concerned whether or not the device would actually reduce pain in a subject. Since clinical testing can not occur in this phase (for reasons mentioned in phase 3), testing upon members of the design team was done. These tests involved the snapping of a rubber band on the upper arm of group members. The members were snapped on various days and both arms. The snapping occurred with and without the use of the device to see if there was a reduction in reported pain while using the device. It was determined amongst the members that pain was reduced with the use of the device. This was an important preliminary verification of the ECI device.
Phase 3
In the final phase, the intention was to validate the device and also to work on improvements for future use of the device. After device construction, clinical testing of the prototype was considered. However, before any clinical testing could occur, IRB approval was necessary. In this phase, a bid for IRB approval was sent in through the help of the mentor. Upon approval from the IRB, clinical testing is set to occur. This clinical testing and the results obtained should prove to be the best validation for the device. The testing will be performed with the help of Dr. Daniel Thomas, who is a fellow at Children’s Hospital of Pittsburgh (CHP). He has stepped forward and has proposed a testing procedure that he will help run. The testing will involve children aged 5 to 8 at CHP. The children will be receiving a needle stick on the back of their hands. Two groups will be set and differentiated based on whether or not they are wearing the device during their procedure. The pain they incur will be reported using the color analog scale and this will be interpreted by the doctor. Results showing that there is a significant difference of reduction of pain experienced while wearing the device will be validation of the device and will be a great milestone. Even without the clinical testing, a form of validation was completed. Through the help of Dr. Thomas, a focus group consisting of doctors in the pediatric emergency department of CHP was held. The feedback of this focus group showed that the doctors felt the device could be of feasible use in the hospital. The approval of the focus group was a key validation point for the device and another milestone. In this final phase, future directions of the device were also considered. Options such as implementing a screen onto the device to prevent a view of the medical procedure and using a disposable tourniquet to hold the device onto the child’s arm were suggested. Once testing results are determined, then these future modifications can be attempted.