| Health & Safety | Heating/cooling feature must have sensors to detect potentially harmful temperatures on the skin. | The device must be able to properly modulate skin in order to provide effective therapy and avoid discomfort and injury to the user. | The device must be able to monitor the skin temperature of the hand, specifically the fingers. | The temperature of the skin must remain within the therapeutic range in order to provide a safe and effective therapy for the patient [3]. Monitoring skin temperature will ensure that the device will not cause damage to the patient's skin or tissue, as change in intramuscular and intra-articular temperature will not exceed that of skin temperature [4]. The fingers are the part of the hand most susceptible to temperature change than the rest of the hand [5]. |
| Health & Safety | Device electronics and batteries must be properly insulated from the user. | Insulating the electronics from the user will decrease the chance of any electrical shocks or injury due to component malfunction. | The device must not harm the user while the device is in use. | The device should remain within its programmed parameters in order to safely deliver the intended therapy to the user. |
| Health & Safety | Device must be capable of being shutdown at any time by the user. | If a component malfunction occurs, the user must be able to shut the device off to avoid injury. | | |
| Health & Safety | Device must be able to be calibrated by a licensed physician. | The device treatment protocol should be able to be set by the user’s physician through a simple software interface or physical hardware modification. | The device must be capable of being used by the patient outside of a clinical setting with minimal training. | Simple and intuitive design will allow patients to conduct the therapy outside of a clinical setting and without the need for a trained physician present. This will grant the patient therapeutic autonomy in personal locations. |
| Health & Safety | Device must display some sort of feedback system to the user while in use. | The user should be able to visually see when the device is on or in use. | The device must be able to transfer heat to, and remove heat from the hand in controlled cycles consistent with literature for alleviating pain and increasing range of motion. | Controlled heating has been shown to increase range of motion while controlled cooling has been shown to decrease pain. The application of cyclic heating and cooling for a set interval of time has been shown to achieve these therapeutic effects [2]. |
| Economic | Device must be affordable to users with low or nonexistent income. | Many of the potential users of this device are elderly and do not possess an active income. The cost of the device must not significantly impact the financial situation of the intended audience. | The device must be affordable for the target patient population. | The patient population must be able to afford the device without financial compensation of active income as the target population consists largely of elderly individuals. Almost half of all Americans aged 65 or older and one third of Americans aged 45-65 have been diagnosed with some form of osteoarthritis. |
| Social | Device must not be bulky or unsightly to the user or surrounding peers. | In order to avoid social anxieties related to the use of such a device in public, the device should be sleek and inconspicuous. | The device must be light enough to transport with one hand. | The average person can lift up to 10% of their weight in one hand without affecting their gait cycle [1]. |
| Social | Device must be quiet. | The device should not emit any loud noises to allow for use in quiet environments without disturbing nearby people. | Device must be quiet to nearby people. | The device should not emit any audible noise to allow for use in quiet environments without disturbing nearby people. |
| Manufacturing | The device must be able to be adjusted to fit hands of different sizes and shapes. | The device should fit the majority of the population’s hands without any issues. This will allow for the device to be useable by a much wider audience. | The device must fit on the majority of human male and female hands. | Female’s hands are on average smaller than male’s hands, while arthritis affects women more than men [6, 7]. A properly fitting device would be more effective at applying and removing heat from the patient’s hand. |
| Manufacturing | The device must be able to be manufactured using resources at TCNJ. | TCNJ has a machine shop, rapid prototyping lab, and a woodshop for students to prototype and manufacture projects | Manufacture of the device must be done within the scope of our budget and materials available. | Manufacturing capabilities for this device are limited to what is available and obtainable through TCNJ. Any choices that would require an amount of money outside of the budget will be avoided because the budget is limited to money provided by TCNJ and generous donations. |
| Ethical | Device human testing must be IRB approved. | Human testing protocol must be approved by IRB before testing of the device can be done on population. | The device must be able to be tested on humans. | Testing ensures that the device is functional and can heat and cool in cycles. Testing on humans ensures that the patient is able to feel the temperature changes. |
| Environmental | Device should use natural materials/fabrics where possible. | A more sustainable device design will decrease environmental impact. | Device must have sustainable considerations in terms of the materials and power system. | Natural materials and rechargeable batteries are preferable from an environmental standpoint. Having a device made of materials resilient to wear will allow the hardware of the device to last longer. |
| Environmental | The device must be able to be powered by rechargeable batteries or plugged into the wall. | Disposable batteries are hazardous waste and most end up in landfills | | |
| Sustainability | The device has to be made out of materials that are resilient to wear. | Materials that are resilient to wear would need to be replaced less often | | |
| Regulatory | The device must follow FDA device guidelines. | In order for the device to go into market, the device must be FDA approved | The device must be made with FDA considerations so it could be submitted for approval/clearance. | If the device does not comply with the FDA, it will not be approved or cleared and can not be marketed as an FDA approved/cleared device. Making this device with FDA considerations allows for the potential for it to eventually be submitted for approval or clearance. |