PRE2023 3 Group7

Pill dispensing robot

Team and interests

Quinten Liu, 1842471, q.m.liu@student.tue.nl

Fenna Sigmond, 1696947, f.e.sigmond@student.tue.nl

Thijs Frints, 1441523, t.g.g.frints@student.tue.nl

Daniel Joaquim Ho, 1534254, d.joaquim.ho@student.tue.nl

Sven de Gruyter, 1857657, s.d.gruyter@student.tue.nl Sjoerd van de Goor, 1557815, s.v.d.goor@student.tue.nl

Interests:

• Medical Imaging
• Physical product
• AI
• Tangible / functional product
• Danger detection or prevention
• Healthcare or elderly care

Meetings

Minutes meeting 23-02-2024

Target Audience

People that are taking medication long term and have trouble taking and managing their medication. This target audience could be expanded depending on the outcome of the interviews.

Product Overview

A robot which dispenses pills on a specific schedule and can inform about and answer questions about medical usage, which may be interacted with by speech, and buttons, and which talks back and provides subtitles on the spoken texts using a screen.

Preliminary Functional Requirements

Software

• AI integration to understand speech
• AI integration to process natural language inquiries about medicine in the specific context of the patient
• AI integration to process natural language outputs to spoken language
• Software to memorize and on time inform about medicine intake
• Remember which medicine was taken
• Admin-client distinguishment in access to schedule

Hardware

• Easily swappable medicine cartridges for about 4 types of medicine
• Dispensing function
• Speaker, screen, microphone, buttons
• Small and light
• Probably stationary
• Non-intrusive

Informal planning

Week 1		Week 2		Week 3		Week 4
Literature review + summaries Relevant groups’ work	A A	Literature discussion Functional requirements Target audience & problem	A	Designing Preliminary software Components + feedback + order needed		Finalize components Software prototype 3D modelling of product
Week 5		Week 6		Week 7		Week 8
Software done Assembly done 3D Printing done		Iterate on software or add app Solve problems		Solve problems Prepare presentation Begin cleaning up wiki		Present Clean up wiki

A = All, Q = Quinten, F = Fenna, T = Thijs, D = Daniel, Sv = Sven, Sj = Sjoerd

State of the Art

Available Products on the Market

DoseControl device by MedControl Systems.

When it comes to the state of the art of medicine dispensing, there are currently two types of solutions: passive and active. The passive solutions are the standard pill boxes that allow the patient to sort the medication into smaller compartments based on which day the medication needs to be taken. Active solutions are the autonomous solutions that dispense meddication, notify the patient, and even notify the caregiver when medication should be taken. This project aims to implement an active medication solution.

The passive solution comes in a variety of options, usually being a plastic container with sub-compartments for the storage of medication. These are the more traditional pill boxes, where the user needs to sort the medication beforehand into the correct sub-compartments. This type of solution tends to only hold enough medication for a week, requiring the containers be refilled and medication sorted every week by the user, where human error could play a role. This solution does not include any form or reminders, rather a container of all the medication that should be taken at a specific time. This still requires the user to remember to take the medication.

Hero Smart Dispenser by Hero Health.

The alternative is an active device, of which there are two alternatives: DoseControl and the Hero Smart Dispenser. The first device, DoseControl, is a radial pill box that can remind the user to take their medication. The medication still needs to be sorted into their respective compartments, and the time of medication intake set. However, once that is done, the device will rotate the medication compartments such that the next compartment is aligned with the dispensing hole. The device then rings like an alarm clock, and can send a notification via the app if it is set up on the user or care givers phones. This is already an improvement to the pill boxes, but still requires the periodic refilling and organizing of the medication into the compartments. This device also does not have a form of confirmation that the medication has been taken from the device. This is a relatively affordable device, currently available in the EU. Similar devices from other companies are also available.

The Hero Smart Dispenser is a device that has 10 compartments for medication, meaning that it can store up to 90 days worth of 10 different medications. This device is setup to play an alarm noise when it is time to take medication, and dispense the medication according to the prescription. The device is also connected to an app, and both the caregivers and patients can receive notifications when it is time to take medication. The Hero dispenser also has a button on it, which the patient has to press in order for the medication to be dispensed. This also allows for a second notification to the caretaker informing them that the patient has taken the medication from the machine. The app that comes with this device tracks data such as dosages taken, missed, and when medication was taken. This dispenser makes it quite easy for the users to refill the medication, and easy for the caregivers to remotely check on the adherance of the patient. This device is only available in the US, with similar products also being available in the US. There is currently no equivalent in the EU. This device is available on a subscription basis, directly from Hero.

This project aims to create an active solution, similar to that of the Hero dispenser, with an application such that notifications, dosages, intake, and medicinal information can be given. The aim is to have the device be prescribed to patients via hospitals for long-term medicine intake in order to aid the patient and informal care givers.

Medical Adherance

The problem we are trying to address with our product is a lack of medical adherence, predominantly because of forgetfulness. While it’s important to justify the design choices of the product, consulting existing literature and state-of-the-art products in this domain will accelerate the project's development by using existing knowledge.

Effectiveness

One very crucial question to ask is how effective this type of technology has been in addressing medication adherence. In fact, low-cost reminder devices like pillboxes, pill bottle toggles and cap timers do not improve adherence in nonadherent patients, as found in a 50.000 patient data review by Niteesh et al in 2017. Unfortunately, this is the technology most used by people and the easiest to find on the market at the moment. Meanwhile, electrical medical adherence products (MAPs) are not very popular among patients. a review of many peer-reviewed studies testing the effectiveness of electrical MAPs assessed whether MAPs improve adherence and identifies and describes common features of electrical MAP devices. The conclusion was made with the data of 37 qualifying studies with a sample size of 4326 patients. The conclusion is that MAPs have a definite ability to improve adherence by up to 49%. And more specifically, devices that were integrated into the care delivery system and that were designed to record dosing events were most associated with improved adherence.

MAPs also all had 5 common characteristics overall:  

• recording dosing events and storing a record of adherence
• audiovisual reminders to cue dosing
• digital displays
• real-time monitoring
• providing patients with adherence performance feedback

Thus it can be concluded that the development and use of MAPs is by all means very relevant as they greatly improve the medication adherence of patients in general, even though they are not commonly used, while low-cost common medication adherence devices seemingly do not improve this statistic at all. Integrated delivery systems and recording dosing events are features that improve adherence the most.

[I'm not done I'm still adding stuff]

Goals of review:

• Find state of the art
• Find what was done; what worked, what did not work. Perhaps reach out to the members of groups of previous years to ask for further details
• Medical technology state
• Pill dispensing specifics
• Elderly technology interaction
• Privacy and ethics of the technology

Literature Review of already existing medicine dispensers

Existing Products, Specifications, and Research and Regulation

General Literature Review of comparisons, effectiveness, and ethics regarding MAPs

Literature research Sven

Literature Review Fenna

Robot Design

Block Diagram

Block diagram of the preliminary design of the pill dispenser

To get an idea of needed components and on the functioning of the robot, a Block diagram was made. This is mainly to get an idea of what is needed to create a prototype. In the block diagram can be seen that the following components are needed in the design:

• Raspberry Pi, this will be the main drive force of the robot. It will control all other components
• Button, the button will be used for multiple things. the user can press it to get medication out of the machine after a notification. It can also be used to get more information about medication.
• LED-Screen, this will be used to display information.
• Speaker, gives the same information as seen on the LED-screen, but then spoken out
• Servo motor, will be used to turn the dispenser and make sure that there is enough rotation to get the correct amount of medication out of the storage container.
• Pill storage, bigger tubes of multiple pills of the same medication.
• Dispenser, used to get all medication needed at a specific time out.
• Pill tray, a weighing plate that knows when medication is on it.
• Weight sensor, a sensor to check if the user really took the medication out of the tray and sends a notification if the medication is not taken out.

Stakeholders and their interests

Problem statement

The general problem we are trying to solve with our product and we’ll have to analyze surrounds the subject of medical adherence, the ability for a patient to keep following their medicine regimen. The problem is that medicine adherence is hard to keep high for certain people, be it voluntarily, because they don’t want to, or involuntarily, for example when the patient is forgetful. To identify the full problem statement, the most important stakeholders and their interests in the pill dispensing robot are identified using literature and interviews.

There are many stakeholders that share an interest in our problem, of which a handful are relevant and important to our product. These groups of stakeholders can be divided into three categories: User, Society and Enterprise.

Users

The most important stakeholder to a medical self help device are the patients using it, as they are the ones taking medication. The patients are people that have trouble taking medication on time, or could use help in managing their medication schedule. A device like ours does not address the group of people who do not want to take their medication, only people who are forgetful or find managing their medication hard. The device can assist with medication adherence, which will be done by making a schedule for the medication, alert the patient when to take medication, instructions for taking their medication, and answering questions they might have.

Another group of users of the device is informal caregivers. These users will interact with the machine by setting the device up for the patients in their homes, inputting the medical prescriptions into the device, and refilling the medication. They can also use the device to monitor the medical adherence of the patient. This device aims to help the caregiver provide care for the patient when they are not physically present by automating the task of reminding the patient to take their medication throughout the day. The device can help a general practitioner get a better insight on the medical administration of a patient.

Society

When it comes to the societal aspect of the device, a major stakeholder are governing bodies. The government, specifically the EU parliament is responsible for legislation and regulations regarding medical assistance devices such as this one. National governing bodies would also decide what reimbursement policies there are for this device in the context of healthcare programs and health services, which doesn’t influence the implementation of the product but vastly changes the access and availability of it to the average consumer (Forsberg et al., 2000). They thus play a key role in deciding how these devices can be implemented and will contribute to society.

Enterprise

The companies that decide to produce such devices need to design the product such that the users are kept in mind. The hospitals and pharmacies that are partnered with these companies can provide the device to the user should a medical professional deem necessary, as well as provide the medication for within the device. Health insurance companies could also incorporate such a device into their insurance plans for people who need it.

Ethical Aspects

Shift of responsibility

Something to consider when conceptualizing a medication adherence device like ours is what effect it might have on not only the patient, but the caretakers too. Several ethical considerations arise regarding the responsibilities of caretakers. One of which revolves around the responsibilities that are taken away from caretakers due to the use of such products, as well as the new responsibilities that may be imposed on them.

Caregivers play a crucial role in the medication adherence management of patients. Especially in those with polymedicated regimens and dementia patients. It’s currently important to train caregivers to understand the disease the patient has, as well as the importance of medication adherence in patients as to reinforce it to ensure optimal treatment and is thus recommended. (Segarra et al. 2022) This task can be very hard to perform consistently for some caregivers, especially if they deal with multiple patients. With the use of smart pill dispensers, some of the tedious work can be alleviated. They can automate medication dispensing and reminders, reducing the direct responsibility of caretakers to physically administer medications at specific times, especially helpful when they have to deal with complicated or frequent dosage. Though, this responsibility would not disappear. It would be shifted to the device, and possibly thus to either the programmers or company of said device.

In return, caretakers, or patients self-medicating, would need to bear new responsibilities related to the oversight and maintenance of the smart pill dispenser. Foremost, the caretaker still has to confirm the medication adherence of the patient by interpreting the data they receive from the device, like recognizing patterns in the periods of non-adherence and correlating it to a potential barrier causing it, communicating with the patient or a healthcare provider when needed. The caretaker also needs to maintain the device by refilling, programming the patient’s regimen into it and troubleshooting technical issues, which does ask for a different set of skills from the caretaker. Additionally, caretakers might become responsible for ensuring that sensitive health information is protected from unauthorized access or misuse in accordance with the wishes of the patient, as many devices have configurable privacy settings to consent on the sharing of health information with the device company.

So, with the introduction of a smart pill dispenser like ours, caretakers are relieved from the tedious task of memorizing or planning the medication regiment of one or more patients, and are instead tasked with maintaining the device and interpreting the medication adherence data. In general, caregivers given the option for a device like this will highly prefer to choose it (Forma et al., 2022), so the change of responsibility is generally seen as positive.

Interview preparation

Patient

1. Would you prefer to have this device be portable? Why or why not? (Stationary/portable)
2. How do you take your medication on holiday or days out?
3. Do you want to be able to take medication with you while on holiday? (Ability to take doses away from home)
4. Do you prefer physical buttons or touchscreen to interact with the device? (Buttons/touchscreen)
5. How many different medications should the machine hold? (Amount of different pills)
6. How often do you get more medication from the pharmacy? (Storage capacity)
7. How would you like to be notified to take medication? What notification method works best for you? (Notification)
   1. When the medicine is ready, the machine plays a noise and produce a light signal. It will also send a phone notification after 5 minutes if not taken. Would this be a nice way to be reminded?
8. Would you prefer to fill the machine with pre-packaged rolls or pills from a bottle? (refill)
9. How do you currently get your information about your medication? How would you like to receive information about your medication? (Information)
10. What are suggestions for the device that would make it better to use? (General/ending)

Caregiver

1. How does responsibility surrounding medicine intake currently work?
2. Do you check that the patient has taken their medication?
3. What would you like to be notified about? (Amount of monitoring/ validation)
4. How do you want to be notified that the patient has to take/ has taken the medicine? (Notification)
5. Would you prefer to fill the machine with pre-packaged rolls or pills from a bottle? (How to refill)
6. What is the current protocol for medicine intake? Which aspects should the device do? (Security)
7. What are suggestions for the device that would make it better to use? (General/ending)

Old Interview Questions From minutes

• How often do you forget to take your medicine a week?

• How do you currently store your medicine?

• How do you currently get the information about your medication?

• Are you away from home a lot for longer periods and therefore have to take your medication storage with you?

• Do you want to have more information with taking your medication, so for example, let you know that you need water with a specific pill?

• Do you want help with taking your medication?

• What would help you with taking your medication on time?

• Do you currently have problems with taking your medication?

• How do you spend most of your days, are you at home a lot?

• How do you get more medication currently?
• What do you still miss from the description of our proposed design?

Translated old questions for interviews

• Hoe vaak worden medicijnen vergeten door patiënten? En als dat vaak gebeurd, wat is dan de oorzaak?
• Hoe komt de medicatie terecht bij de patiënten? (bijvoorbeeld via mantelzorgers of halen ze die zelf op)
• Hoe komen de patiënten informatie over de medicijnen te weten?
• Komen er problemen voor bij het nemen van medicatie, en wat is hiervan de oorzaak? (bijvoorbeeld bij onduidelijke instructies,( pil nemen met glas water bijvoorbeeld.)
• Hoe en waar wordt de medicatie opgeborgen/bewaard?

• Als patiënten weg zijn van huis, hoe zorgen ze ervoor dat de medicatie op tijd en op een juiste manier wordt genomen? (voor een korte periode, zoals een dagtrip of bezoek, en voor een langere periode van huis)
• Is er behoefte aan een manier om medicatie op een overzichtelijkere/betere manier mee te nemen als patiënten van huis gaan?

(After a brief description of our design idea)

• Zou deze robot patiënten kunnen helpen met het nemen van medicatie op tijd en op de juiste manier?
• Zou deze robot patiënten en mantelzorgers kunnen helpen met de administratie van de medicijnen?
• Zijn er nog andere functies die handig zouden zijn voor een robot als deze?

Privacy Requirements

-       A patient can give their permission to use personal data, if they have received all the relevant information about the possible consequences and the reasons for data sharing.

-       Assumption of patient’s permission to share information

-       In the case that no Personally identifiable information (PII) is used, data can be shared

https://www.knmg.nl/actueel/dossiers/beroepsgeheim/medisch-dossier

-       Caregivers that need access to information to care have permission

-       Professional secrecy can expire for scientific research purposes

-       Caregivers can share information that is directly relevant to their work

https://www.regelhulp.nl/onderwerpen/kwaliteit/beroepsgeheim

-       Organizations outside of healthcare can obtain health data but must fulfill the confidentiality obligations

https://www.autoriteitpersoonsgegevens.nl/themas/gezondheid/gezondheidsgegevens-gebruiken-en-delen/gezondheidsgegevens-delen-met-derden#algemene-regels-gegevens-delen

For robot/app:

Compartmentalization of data can be done to avoid the necessary use of private data. The robot would have no access to PII and only to relevant information; the type of medication and doses. The caregiver or doctor connected with the robot would have that information and for example: connect the medical dossier to a number that would be shared with the robot. The only viewer of personal data would be the doctor/caregiver, already having the patients permission.

Norm for data security in healthcare called NEN 7510, publicly available in the Netherlands

-       Data can only be given and used when:

o  Caregiver needs to carry out an activity for which data is needed

o  There exists a healthcare relation between person and patient to which the data is connected to

o  Data is needed in support of an activity

https://www.nen.nl/zorg-welzijn/ict-in-de-zorg/informatiebeveiliging-in-de-zorg

For interview/survey:

-       Caregivers can give information not pertaining to a specific patient as long as no PII is given

-       With permission of the patient, caregivers can give more in-depth information (since our research does not pertain to the patient themselves it is most likely not necessary)

Time spent

Week 1:

All	1st meeting (2h)
Quinten	Researching SotA (2h); Finding and reading relevant papers regarding medication dispensers (3h); Finding and reading relevant papers regarding ethics and elderly care (2h)
Fenna	Research State of the Art (1h); Robot specifications (2h); Research Product Design (1h); Research Use Case (2h)
Thijs	Looking at already functioning medicine dispensers (1.5h); Reading papers on dispensing robots and summarizing them (4.5h); look at ethics for medication rules (0.5)
Daniel	Research what has been done/state of the art (3.5hr); Dispensing Specifications (1.5hrs); EU regulations, medical technology state, privacy and ethics of the tech (3.5hr);
Sven	Research on state of the art/dispenser mechanisms (1,5h); Research AI implementation by notifications (1,5h), naming requirements/specifications (1h)
Sjoerd	Setup wiki (2h); process annotations of first meeting (1.5h); Read documentation OpenAI and Google for insight into which we can use (3h)

Week 2:

All	Feedback Monday meeting and evaluation (1h), Meeting 23-2-24 (1h) see minutes
Quinten	Transfer and ordering of data to wiki (1h)
Fenna	Privacy Research (1.5h)
Thijs	preliminary design options research (2.5h)
Daniel	Identifying Stakeholders (1h), Interview Questions (2h), Data requirements (0.5h)
Sven	start identifying stakeholders and specifying the target audience (1,5h), translate and improve interview (1h)
Sjoerd	Create prototype AI implementation, with testing and prompt engineering, using API documentation (4h)

Week 3:

All	Feedback Monday meeting and evaluation (1h)
Quinten	Literature Review incorporation into stakeholders (3h);
Fenna
Thijs	Start making a design for the machine and block diagram of systems needed (6h)
Daniel	Cleaning up Interview Questions (1h); Incorporating Literature Review into Wiki (4h);
Sven
Sjoerd