研發邁向商品化之路-醫療器材以Q公司為例

The Road From R&D To Commercialization- An Example of「The Q Medical Devices Inc」

王俊富(Chun-Fu Wang)

指導教授 ： 林義貴

國立交通大學/管理學院/管理學院工業工程與管理學程/碩士(2020年)

摘要

本個案描述新創公司創立後邁向商品化的歷程，一名有豐富生產管理經驗的處長工作上所面臨的情境問題。這幾年間，精準醫療(Precision Medicine)和預防醫學(Preventive medicine)的觀念愈來愈提升，癌症的早期治療存活率有70%，愈早發現，成功治療的機率就愈高，因此癌症篩檢也朝著提早發現的方向努力進行。個案公司於2011年12月成立，為一專業而創新之生醫多重基因標記晶片及次世代之數位即時聚合酶鏈鎖反應 (digital real-time Polymerase Chain Reaction, dqPCR)檢測系統之供應商。個案公司專注於研發將在臨床中應用的創新精準腫瘤醫學、疾病診查和生殖治療解決方案，從而改善患者生活品質，不會造成經濟負擔。因此個案公司開始由研發型公司轉型成為一間具有生產營運之公司，在轉型過程中會遭遇到不同的問題。
本論文個案公司在產品品質尚未達到穩定階段時必須要面對實務上的問題，品質和營收上孰重孰輕?沒有現金的流入公司運轉財務上會有一定的困難，而品質不穩定影響的是公司聲譽及賠償問題，另外在面對認證專案時程落後、單一供應商管理問題、部門組織調整之問題，個案公司是如何克服是本論文探討之重點。個案公司預計在2022年首次公開募股(IPO)，所以產品商品化必須取得之認證ISO13485、TFDA、CE、GMP…等，必須盡早取得，研發轉商品化勢在必行也必須成功。

關鍵字

供應商關係管理 ； 企業風險管理 ； 破窗理論 ； 專案管理 ； 衝突管理 ； 商品化

並列摘要

This case describes situation when a director with excellent experience in production management, faced problems of start-up company’s products in process to commercialize. In the past few years, the concepts of Precision Medicine and Preventive Medicine have been increasing. The early treatment survival rate of cancer is 70%. The sooner it is discovered, the higher the chance of successful treatment. Therefore, cancer screening toward early detection direction. In this case, company was established in December 2011. It is a professional and innovative supplier on biomedical multi-gene marker chips and next-generation dqPCR((digital real-time Polymerase Chain Reaction) detection systems. The company focuses on the development of innovative precision oncology medicine, disease diagnosis and reproductive treatment solutions that will be applied in the clinic to improve the quality of life of patients without causing financial burden. Therefore, company began to transform from a research and development company into a company with production operations, and encountered different issues during the transformation process.
In this thesis, the company must face practical problems when the product quality has not yet reached a stable stage. How to judge quality and revenue which is more important? No cash flow into the company will have financial difficulties in operating, and the unstable quality will affect the problem is the company's reputation and compensation. In addition, in the face of the delay of the certification project schedule, the issue of single supplier management, and department reorganization, how to overcome those issues are the focus of this thesis. The case company is expected to have a successful IPO in 2022, so the certifications ISO13485, TFDA, CE, GMP, etc. that must be obtained for the commercialization of products must be obtained as soon as possible, and the R & D to commercialization is imperative and must be successful.

並列關鍵字

SRM ； Break Pane Law ； Enterprise Risk Management ； Project Management ； Conflict Management ； Commercialization

參考文獻

一、中文部份

1.陳彩稚 (2012)，《企業風險管理 初版》，前程文化。

2.鄧家駒 (2005)，《風險管理 四版》，華泰文化。

3.鄭燦堂 (2010)，《風險管理-理論與實務 二版》，五南文化。

4.宋明哲 (2018)，《風險心理學-人本風險管理 二版》，五南文化。