WHAT IS iMonitor?

iMonitor is a Software Medical Device with CE marking. This web-based application allows rheumatologists to remotely monitor patients suffering from rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA ), thanks to an alert generating system, unique in the sector. The software has been adapted in many languages and is present in various countries around the world.
iMonitor is designed and developed with the aim of:

• Improving the management of patients suffering from rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA );
• Improving communication between the rheumatologist and his patients, during and between visits; 
• Optimizing the frequency of check ups on the basis of patient parameters measured through the tool and during visits.

HOW DOES IT WORK?

The platform allows you to create a direct communication channel between the rheumatologist and his patients in addition to traditional check-ups through a unique system of alert generation through the following steps:

1. The rheumatologist creates the patient profile;
2. The rheumatologist selects PRO (Patient Reported Outcome) questionnaires and sets the benchmark values for the alert system to go off;
3. The patient fills out the PRO questionaires which are sent to him at regular intevals; 
4. The system alerts the rheumatologist when the patients' values exceed the threshold values repeatedly or when the patients skip the questionnaire fill-out. 

INNOVATIVE ASPECTS:

iMonitor is based on the successful integration of two algorithms:

1. A medical algorithm for the evaluation of the parameters of disease activity on the basis of the data entered by the patient and the possible generation of alerts when the threshold values specified are exceeded ;
2. An algorithm for the patient data entry, validated from a medical point of view, to faithfully reflect the transposition in electronic format of paper questionnaires (PRO - Patient Reported Outcome).

Finally, iMonitor is also characterized by a simple and intuitive Interface which is user friendly, it respects European and local regulations on data privacy of registered patients and creates strong interaction between doctors and their patients.

THE PROJECT

The stand -alone Software Medical Device was developed for Pfizer in 2014 and Kelyon was responsible for managing the project in its integrity, starting from the design of the application.
Afterwards, Kelyon helped carry out the analysis and risk management for the software, which allows to identify the risks associated with the use of the app and to determine the classification of the latter, in relation to the linked risk level, in order to implement the procedures for assessing conformity to norms and regulations.
Medical devices are divided into four classes of increasing risk; iMonitor is included in Class I: "less critical devices, such as those non-active and non-invasive".

After the development phase, Kelyon supported the client through the validation phase, which provides for a verification by the intended user, thus the physician, that the device complies to all medical requirements and that the underlying formulas and algorithms function properly from a medical standpoint.

Afterwards, Kelyon oversaw the CE marking phase for the device and then implemented the Master Version in English and the subsequent localization of software for adaptation to the different countries in which it was deployed.

Kelyon, in addition, offers post development and installation service including Cloud Hosting of recorded patient data, users support via Help Desk through phone or e-mail, Vigilance which includes a set of activities aimed at reducing the chance of recurrence of the same incidents, Maintenance and Management of the new versions of the software, when necessary, through change management processes.

All services offered by Kelyon are delivered with the utmost attention to patient data security and privacy, in compliance with applicable laws on data protection.

www.imonitor-med.co.uk