醫療器材軟體開發專案之時程風險管理-以A公司為例

Abstract

本研究藉由A公司之醫療器材軟體開發專案作為時程風險管理以建立整體流程。醫療器材有別於一般資訊設備，一旦故障或失效，即有可能對病人造成傷害、甚至發生無法彌補之缺憾，必須以非常嚴謹的確效及評估產品之安全性及效用；須嚴謹考量安全性及其功能失效時之安全設計。各國醫療器材主管機關紛紛要求業者必須導入軟體開發生命週期程序，必須符合醫療器材生命週期管理標準IEC 62304:2006+AMD1:2015之規範，亦需將其驗證的相關活動留下紀錄以作為產品上市審查之依據。為達上述要求，勢必延長專案開發時程及增加專案管理的複雜度與風險。因此本開發專案為醫療器材軟體範疇且具有開發週期長、參與開發及驗證人員多及首次開發此產品等種種因素，具有相當大之潛在時程風險。

因此，本研究在風險管理方面建構一連串的流程與活動，透過個案分析來提出可以進一步對時程風險評估的改善方法，並以蒙地卡羅模擬分析提供專案的可能完成時程範圍和可能發生的機率，使決策者可以根據團隊之產品熟悉度、團隊經驗程度、團隊效率及公司對此專案的支持度等種種考量下，綜合可承受之風險，使決策有據可循，提高決策品質。此模擬分析亦可提供給客戶參考作為合約談判之用；本研究依其影響及發生機率分為四大類並提出對應之主要策略，所建議之策略再依據實際公司之環境作調整；亦讓客戶充分了解此專案的風險因子，共同與客戶加強風險管理及應變措施提高專案成功率與滿意度。本研究之成果提供醫療器材產業業者及軟體開發人員，作為時程風險管理之風險評估與流程設計之參考。

This case study is to build up the overall process flow of schedule risk management by look into depth the medical device software project development of A company. The medical device software needs to consider very carefully the safety design in response to the safety or function failure. There are more and more governmental bodies in charge of medical devices requesting medical device manufacturers to obey the software development life cycle processes i.e. the IEC 62304:2006+AMD1:2015 standard, so as to record the evidence of the validation activities for premarket approval. To meet such requirements, the schedule of project will have to be extended and the complexity and risk of project management will have to be increased.

This project has following features: (a) the scope is of medical device software; (b) relatively long development schedule; (c) many project members and (d) the first product to this A company. Due to the listed above factors, it has high risk to the schedule management to this project.

It is therefore, to construct a series of processes and activities to propose an improvement methodology of the project schedule risk management; also to use Monte Carlo simulation addresses the estimated schedule range and the probability. Based on the above and combining the factors of team experience and team efficiency, the decision makers will be able to make sound decisions.

This simulation analysis can also serve as reference to customers for contract negotiations. In response to risk, it has been divided into 4 categories and its corresponding strategies, then adjust by the actual environmental factors of each company. This can also be used to raise the customers’ full awareness of risk factors of a project. In this connection, we can work together with our customers to enhance the risk management and counter measures in order to increase the satisfaction and likelihood of success. The achievement of this case study is to establish a reference to schedule risk management and process design flow for medical device manufacturers and medical device software development personnel