Needs Statement

A way for pill-medication users to improve accurate medication compliance in order to reduce accidental missed or repeated doses.

Principle Needs

  • To be cost effective
  • To be customizable to various medication dosages/frequencies
  • To be physically easy to use, including for people of limited dexterity
  • To clearly indicate whether a medication has been taken, including for people with poor vision and hearing
  • To maintain integrity of medication

Link to FRM-3

1. Functional Requirements

1Clearly indicate whether a medication has been taken
– User should be able to look at device and know if they have taken their medication.
2Easy to use for users with limited dexterity.
– The population that would benefit most from this technology is typically older with more health problems and is therefore more likely to have dexterity deficits.
3Cost-effective for user
– Medication costs are high, cost should not be a barrier to access this technology.
4Portable
– Many medications have to be taken at specific times of day, resulting in the need to carry them around. Thus, the design must be portable.
5Customizable to different medication frequencies/doses
– Some medications have to be taken at specific times of day or multiple times in a day. Device should be able to adhere to a schedule established by the user.
6Accuracy in telling if pill has been taken
– Inappropriately indicating that a pill has been taken when it hasn’t or vice versa would result in more confusion for the user and missed/repeated doses which could be dangerous depending on the medication.
7Easy for user with limited mental capacity
– Medication users may have limited reading or comprehensive ability, thus instructions should be easy to understand for most users.
8Instructions are visually easy to read
– Font should be large with high contrast in order to be more readable for people who are hard of sight which may be the case for many pill users, particularly elderly users.

2. Performance Requirements

1Device withstands mechanical damage (i.e. from carrying in a backpack)
– As previously mentioned, medications often need to be carried. The device not only needs to be portable, but its technology must be able to withstand the potential hazards of being transported without damage.
2Device can be cleaned in between medication refills
– Device has antibacterial properties, is safe to be washed by hand or dishwasher, and/or can be sterilized with UV, ethyl alcohol, or another method.

3. Biocompatability Requirements

1Device material does not interact with medication
– Chemical components of device does not leech into, degrade, or otherwise harm medication.
2Device material protects integrity of medication
– Provides protection from UV, temperature variance, physical damage, etc.

4. Regulatory Requirements

1Meets class 1 device regulations

5. Interface Requirements

1Communicates with a mobile app to receive dosage and frequency input from user (potentially)