| Constraint Category | Constraint | Justification | Connection to Requirement |
Economic | The manufacturing process of the project cannot cost more than $500.00. | Each student gets $125.00 from the engineering department and this amount cannot be exceeded. | New |
| Global | N/A | N/A | N/A |
Environmental | The device should use the minimal necessary power source such as usage of batteries. | Improper disposal of batteries leads to contamination of air, soil, and water since they are made out of lithium. | Addressed by power source requirement 4. (Chapter 2.4) |
| Social | Results should easily be read – specifically by those who are 65+ years old (font size should be legible). | The device encompasses those who are visually impaired as well as the elderly. | Addressed by requirement 3 (Chapter 2.3) |
| Political | N/A | N/A | N/A |
| Ethical | Stored data cannot be shared with third parties. | Users must be informed that their results are being stored but not shared with anyone. | Addressed by data storage requirement 7.(Chapter 2.7) |
Health/Safety | Device must follow FDA requirements for sanitation. | Test strips are in contact with urine. Infectious pathogens can be transmitted if the device is not properly cleaned. | Addressed by sanitation requirement 5.(Chapter 2.5) |
| Patients cannot use pre-owned test strips. | This is forbidden by the FDA since it can lead to health risks as well as misleading and inaccurate test results. | Beyond project scope. | |
| The device must follow electrical safety standards IEC600601 | IEC 60601 must be followed by any medical device containing electrical components | Addressed by requirement 6(Chapter 2.6) | |
Manufacturability | Device is manufactured by a team of 4 only. | ChromaScan Health team consists of 4 individuals. | Not linked to requirement of device design – only limited by the senior design course. |
| The device must have the ability to be manufactured and go through the process of verification and validation testing using resources available to TCNJ students. | The resources will primarily come from the Engineering Department at TCNJ. | This is not linked to a requirement but has been taken into consideration when doing the specifications of the device. | |
| Devices must be designed and manufactured within the timeframe of the academic year 2023-2024. | The device must be presented by the end of the spring semester, so it must be manufactured before then. | Not linked to requirement of device design – only limited by the senior design course. | |
| Sustainability | Limit the amount of 3D printing material used. | Plastics are non-degradable | Not linked to requirement of device design but will be considered in the design. |