Nowadays Laboratory Automation is a fundamental aspect of clinical analysis laboratories and hospitals, thanks to it we have a 15% decrease in headcount cost [1], a 34% reduction in timing for test results [2], a 10% increase in the overall number of tests [2], and a 46% shorter sample collection time [3]. Inpeco is the world leader in Total Laboratory Automation (TLA) and provides solutions focusing on safe test results and productivity for clinical laboratories worldwide. Within this context, the object of this thesis work will outline from the project management point of view the R&D development and subsequent release of a software component named DMS Driver Tosoh G11 v.1.0. The latter once available for commercialization will allow the connection of Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 to the flagship product for Inpeco, FlexLabTM Automation System. The development process will be divided into four phases, defined by Gate. In order, scoping (Gate 1), feasibility (Gate 2), development and specifications testing (Gate 3), and final testing (Gate 4). During Gate 1, the purpose of the project will be defined, taking into consideration the expectations of end users with respect to functionality, timing, and quotations. In Gate 2, analysis of the project will be conducted by the Project Manager and the Team assigned to the project to confirm its feasibility. Gate 3 will mark the beginning of actual Driver development, which will be continuously tested against specifications. Finally, Gate 4 will involve testing against Design Input Requirements and Risks Mitigation Methods. Throughout the various Gates, continuous oversight of the ongoing documents will be conducted to ensure proper project monitoring and progress. Furthermore, the thesis examines how the project's development planning evolved based on the available resources and time. So, we will see how the realignments have been functional and led to the achievement of the release goal within the initially set deadlines. In addition, we will analyse how risks that could have turned into problems have been mitigated with the use of project management tools and the project has continued as planned. The thesis will close by evaluating the benefits that the Project Manager role brought to the project and describing the future improvements to the design and development process that Inpeco is working on.
Oggi l'automazione da laboratorio è un aspetto fondamentale nei laboratori di analisi clinica e negli Ospedali. Grazie ad essa abbiamo una diminuzione del 15% nei costi del personale [1], una riduzione del 34% dei tempi per i risultati dei test [2], un aumento del 10% del numero complessivo di test processati [2] e un tempo di raccolta del campione più breve del 46% [3]. Inpeco è leader mondiale nella Total Laboratory Automation (TLA) e fornisce soluzioni mirate alla sicurezza ed alla produttività dei risultati dei test per i laboratori clinici di tutto il mondo. In questo contesto, l'oggetto di questo lavoro di tesi delineerà dal punto di vista del project management lo sviluppo e il successivo rilascio di un componente software denominato DMS Driver Tosoh G11 v.1.0. Quest'ultimo, una volta disponibile per il mercato, consentirà il collegamento dell’analizzatore Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 al prodotto di punta per Inpeco, il sistema di automazione FlexLabTM. La gestione del progetto sarà suddivisa in quattro fasi definite da Gate. In ordine, definizione dello scopo (Gate 1), analisi di fattibilità (Gate 2), sviluppo e test delle specifiche (Gate 3), e test finale (Gate 4). Entro il Gate 1, sarà definito lo scopo del progetto tenendo conto delle aspettative degli utenti finali, in termini di funzionalità, tempistica e quotazioni. Nel Gate 2, l'analisi delle richieste sarà approfondita dal Project Manager e dal Team assegnato al progetto per confermarne la fattibilità del progetto. Il Gate 3 segnerà l'inizio dello sviluppo effettivo del Driver che sarà testato secondo le specifiche tecniche. Infine, il Gate 4 si tradurrà in test sulla base dei requisiti iniziali e ai metodi di mitigazione del rischio. In tutti i vari Gate sarà condotta una revisione continua dei documenti prodotti per garantire il monitoraggio e l'avanzamento del progetto. Inoltre, la tesi esamina come la pianificazione dello sviluppo del progetto si è evoluta in relazione alle risorse e al tempo disponibile. Quindi, vedremo come i riallineamenti sono stati funzionali e hanno portato al raggiungimento del rilascio entro le scadenze inizialmente stabilite. Analizzeremo come i rischi che avrebbero potuto trasformarsi in problemi, sono stati mitigati grazie all'uso di strumenti di project management garantendo al progetto di continuare come previsto. La tesi si concluderà valutando i benefici che il Project Manager ha portato al Team e descrivendo come Inpeco sta cambiando il processo di gestione del progetto.
project management role in ivd software design and development process
VITTORINI, FRANCESCO
2022/2023
Abstract
Nowadays Laboratory Automation is a fundamental aspect of clinical analysis laboratories and hospitals, thanks to it we have a 15% decrease in headcount cost [1], a 34% reduction in timing for test results [2], a 10% increase in the overall number of tests [2], and a 46% shorter sample collection time [3]. Inpeco is the world leader in Total Laboratory Automation (TLA) and provides solutions focusing on safe test results and productivity for clinical laboratories worldwide. Within this context, the object of this thesis work will outline from the project management point of view the R&D development and subsequent release of a software component named DMS Driver Tosoh G11 v.1.0. The latter once available for commercialization will allow the connection of Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 to the flagship product for Inpeco, FlexLabTM Automation System. The development process will be divided into four phases, defined by Gate. In order, scoping (Gate 1), feasibility (Gate 2), development and specifications testing (Gate 3), and final testing (Gate 4). During Gate 1, the purpose of the project will be defined, taking into consideration the expectations of end users with respect to functionality, timing, and quotations. In Gate 2, analysis of the project will be conducted by the Project Manager and the Team assigned to the project to confirm its feasibility. Gate 3 will mark the beginning of actual Driver development, which will be continuously tested against specifications. Finally, Gate 4 will involve testing against Design Input Requirements and Risks Mitigation Methods. Throughout the various Gates, continuous oversight of the ongoing documents will be conducted to ensure proper project monitoring and progress. Furthermore, the thesis examines how the project's development planning evolved based on the available resources and time. So, we will see how the realignments have been functional and led to the achievement of the release goal within the initially set deadlines. In addition, we will analyse how risks that could have turned into problems have been mitigated with the use of project management tools and the project has continued as planned. The thesis will close by evaluating the benefits that the Project Manager role brought to the project and describing the future improvements to the design and development process that Inpeco is working on.| File | Dimensione | Formato | |
|---|---|---|---|
|
2023_05_Vittorini.pdf
accessibile in internet per tutti
Descrizione: Executive Summary + Tesi di Laurea Francesco Vittorini 04/05/2023
Dimensione
5.59 MB
Formato
Adobe PDF
|
5.59 MB | Adobe PDF | Visualizza/Apri |
I documenti in POLITesi sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
https://hdl.handle.net/10589/206973