5. Deployment and Commercialisation
At the beginning of the niCE-life project implementation, a survey of the available technical solutions on the market was performed (available in D.1.3.1 of the niCE-Life project [
2]). The results of the survey may be summarised as follows. There already exist many possibilities on how to track the movement of the patients, how to partially monitor them, and how to process all the data and alert the right personnel. Most of the systems use GPS tracking combined with an attachable device to a patient clothes/shoes/body as a vital component, which is an advantage when the patient has no intention to get rid of such devices and therefore can be monitored in a limited way also outside the house. These systems are therefore designated for patients, or elderly people, with not-so-serious diagnoses. If considering a strongly diseased patient with Alzheimer’s or Parkinson’s disease, such devices are not sufficient to monitor the patients’ behaviour, such as opening the doors and windows, turning on the gas, or other hazardous situations. Although some systems offer similar peripheral sensors, they are expensive. Many systems also offer smartphone and computer applications for reporting or monitoring purposes. However, none of the studied devices already obtained CE marking for medical devices valid in the EU.
Naturally, AP-NURSE tried to fill the gaps identified in the survey. The most challenging part of the development itself was the sustainability and introduction of the newly developed tool into the market. The successful work done serves as steppingstone for the further commercialisation of this system; however, several technical issues, precisely identified during the testing in real environment, need to be solved. The technical readiness level of AP-NURSE reached TRL-6 or TRL-7. Anyhow, to reach the market introduction, further TRL levels (TRL 7-9) need to be reached to finalise the tool.
To perform the first thought experiment, the Bratislava region was analysed. With a population of 686,349 as of 31 December 2020 [
5], the Bratislava region accounted for 12.4% of the total population of Slovakia. Approximately 15.5% of the population of the Bratislava region is in the post-productive age (above 65y). Regarding the demand for such devices and according to a web search, there are more than 25 retirement homes and care centres in the Bratislava region and 3 specialised geriatric clinics. It is important to note that almost every location in the Bratislava region could be reached by car in less than one hour, which allows for the establishment of just one technical support centre near the geographic centre of the region. Based on these facts, we assume the potential to implement the AP-NURSE solutions as relevant where the density of the relevant institutions and the number of frail elderly people allow for the sustainable and cost-effective first implementation of the AP-NURSE system. The further exploitation of the system can then be performed also in the more rural villages and regions with a lower density of inhabitants.
Respecting the nature and the current stage of the development of AP-NURSE solutions and the following aim to introduce the tool to the market, several important steps need to be performed as follows:
Implementation of small technical upgrades to the devices and information system based on the results from the pilot action.
Development of blueprints for mass production.
Final testing in the real environment.
Selection of the production company with an implemented QA system.
Certification according to the EU Medical Devices Regulation (MDR 2017/745).
Based on the steps defined above, the initial investment costs needed to introduce the AP-NURSE solution to the market and allow its sustainability were calculated to be EUR 150,000. Principally, two pricing strategies exist, differing in the need to cover initial investments by a loan or the availability of a starting grant. Based on the above-mentioned assumptions and that the investments costs must paid from the proceeds, it seems that at least eight parallel implementations with 50 devices each without the need of continuous support make the critical mass, allowing for the financial sustainability of the AP-NURSE tool in the Bratislava region. Further details can be found in the deliverable D.T4.2.4 of the niCE-Life project [
2].
6. Conclusions
This paper summarised the development and testing of the AP-NURSE intelligent monitoring device aimed to increase the quality of everyday life of patients suffering from Alzheimer’s and Parkinson’s diseases, frail elderly, and those who take care of such patients. The first part of the paper presented Slovakia’s demographic information. It highlights that population ageing is starting to be a significant issue, which will require measures for mitigating its consequences at local and European levels. It described the final design of AP-NURSE Home and Care, defines its versions, selects based on the needs of potential users, and provides details on the hardware and software implementation. Currently, there are four versions of the AP-NURSE Home platform (AP1-H, AP2-H, AP4-H, and AP6-H), four versions of the AP-NURSE Care M5Stack platform (AP1-M, AP2-M, AP4-M, and AP6-M), and three versions of the AP-NURSE Care Waspmote platform (AP1-W, AP4-W, and AP6-W).
In the next part, the procedure of laboratory testing was presented. A set of function tests, test cases, and sensor sensitivity tests carried out at the special testing room created at STU are described. For the AP-NURSE Home and Care versions, 25 function tests were defined. The results of function tests were evaluated as expected and unexpected. The function tests identified the excellent performance of the AP-NURSE Home, Care M5Stack, and Care Waspmote devices. The average success rate of AP-NURSE Home was 96%, and only three unexpected results were achieved, each caused by the low sensitivity of the noise sensor. The success rate of AP-NURSE Care M5Stack was 100%, and the success rate of AP-NURSE Care Waspmote was 94%, with two unexpected results caused by the limited performance of the MQ5 air quality sensor.
Subsequently, test cases were defined and performed for all AP-NURSE Home and Care versions. The tests were evaluated as passed, failed, or limited, while the keyword limited represents a case where the test could be successful under specific circumstances. The overall pass rate of the AP-NURSE technology, including the ones with limited performance, was 75%. Individual hardware platform pass rate was 64% for AP-NURSE Home, 83% for AP-NURSE Care M5Stack, and 80% for AP-NURSE Care Waspmote. It should be noted that the tests failed only in the case of AP1-H, AP1-M, AP1-W, and AP2-H devices; the tests for the remaining versions were all passed. In general, it should be concluded that the test cases showed valuable results, and the achieved success rate is acceptable. It was also found that all tests strongly depended on placement and sensor sensibility.
The last part of the paper dealt with testing the AP-NURSE technology in real environments. Two sites were selected for testing, the Social Care Centre in Bratislava (SCC) and the Social Care Home in Warsaw (SCH). This chapter described the installation procedure and performance evaluation based on local indicators. These local indicators were technology acceptance, usability, reliability, accuracy, and applicability. For each indicator, a specific evaluation procedure was defined. The data for the evaluation of indicators were gathered using a targeted LimeSurvey online questionnaire, caregiver forms collected regularly, and through the evaluation of notifications and raw data from the information system used for the management of AP-NURSE units. The results showed that the AP1 and AP4 devices met all the criteria and passed the evaluation procedure.
Nevertheless, there is a space for improvement for these devices. It will be necessary to improve their accuracy and reliability to exceed at least 95% for commercialisation. Unfortunately, the remaining devices failed the evaluation. However, after some modifications and upgrades, these devices can be further tested and used in practice.
The most important finding of the testing was that most caregivers in both pilots had positive thoughts about the AP-NURSE system. In the online questionnaire, they claimed that AP-NURSE “eased the control of clients”, “increased their safety”, “gives a better overview of what is happening in the centre”, “can promptly handle dangerous situations”, or “it shortens the reaction times of the staff in case of an event”. At the same time, they claimed that there were some outages of the system and would require sound notifications. All the required features will be implemented in the future.
The participation of the STU team in the Interreg niCE-life project stimulated the technical development, which has brought relevant results able to improve the quality of life of the vulnerable elderly population. Moreover, implementing the AP-NURSE system brought caregiving to the 21st century. Technically simple but logically advanced devices could decrease the response time of the caregivers and the stress of the Care Centre staff. The technical development performed was based on the actual needs acquired during the early stages of the project and was translated to the construction of AP-NURSE tools accompanied by a robust information system. The complexity of the needs was surprising for the STU team; thus, significant knowledge and experience were gathered and further developed. The identified needs in care centres outside the project focus served as motivation for several diploma theses offered to students and then successfully defended. Moreover, the enormous amount of raw data collected might be used in further research where techniques such as machine learning could be used to identify specific patterns in the sensor signals and thus might improve the effectiveness of detection of dangerous situations.
The system and tools implemented are thoroughly described in this paper and may serve as a steppingstone for the further commercialisation of this system. Several technical issues need to be solved but were precisely identified during the testing in a natural environment. We consider the technical level reached as TRL-6 or TRL-7. We strongly believe that after further improvement, the AP-NURSE tool developed in the niCE-life project will become a helpful tool and ease the everyday life of chronically ill people treated either in care centres or in their home environments as frail elderly in general.