本文管理個案為一家中型規模的醫療器材生產製造商，製造及販售「一般外科電
燒刀」所使用之一次性配件及製造 AED 使用的一次性配件。行銷地區以歐美市場為
主。經過三十年的努力，「一般外科電燒刀」之開發已算嫻熟且已朝自動化方向來生
產製作，但是在不同電燒領域產品開發的過程中，遭遇到一些瓶頸。
「一般外科電燒刀」在外科手術中，屬於非常基本的外科器械，雖然普遍應用於
手術過程中以提供切割與止血之功能，但這種普遍使用的泛用型器械價格也在各國醫
療保險費用支出不斷被要求減少醫療浪費與節省成本的政策下，泛用型器械的售價不
斷下探，進而導致公司獲利能力持續下滑。公司經營者所思考的是，若要讓公司永續
營運，需要因應科技發展而開發新的產品應用，才能讓公司穩定的獲利，並且長久經
營下去。
經由本案例的分享與探討，以便讓有志於讓台灣醫療器材業的各個夥伴在全球醫
療器材市場上中爭取最大發言權，進而站於有利的市場位置。在這經營過程中，如何
將公司的資源與技術跟隨世界先進各國的醫療器材法規變化趨勢加以因應與整合，以
達到快速達成客戶需要的優勢來創造公司永續經營的機會。

This is a case study of a medium-sized manufacturer of medical device that
manufactures and sells disposable accessories used with “Electrosurgical Pencils” and
disposable accessories used in the manufacture of AEDs. And these products are mainly
marketed in the European and the US markets. After 30 years dedicated in this field, the
development of “Electrosurgical Pencils” has been well-accomplished and has been
produced with implementation of automation. However, some bottlenecks have been
encountered in the process of product development for different electrosurgical products.
The “Electrosurgical Pencils” is a very basic surgical instrument in surgical operation.
Although it is commonly used in surgery to provide cutting and coagulating function, the
price of this commodity type of instrument keeps approaching to a lower range due to the
policy of reduce of medical waste and reduce of cost. This has led to continuous decline in
profitability for this company. What the owner of this company considers are it is needed to
develop new products in response to the development of new technology so the company
can continuously grow and enable to make stable profits.
Through the sharing and discussion of this case, it helps all partners from medical
device field in Taiwan are able to speak up in global medical device industry and then stand
in a favorable market position. In this business process, it is very important to know how to
integrate the company's resources and technologies with the changing trends of the medical
device regulations in the world's most developed countries in order to achieve the rapid
development of the company's sustainable business opportunities.

1. 中華民國衛生福利部 藥事法。
2. IDEA 物語(2002)(作者：湯姆．凱利/譯者：徐鋒志)大塊文化出版社。
3. 2017 醫療器材產業年鑑 經濟部技術處。
4. 21 CFR Part 820, TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND
DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN
SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 820 QUALITY
SYSTEM REGULATION
5. ISO 13485: 2016, Medical devices -- Quality management systems --
Requirements for regulatory purposes
6. ISO 14971:2007, Medical devices -- Quality management systems --
Requirements for regulatory purposes
7. ISO/IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
8. James M. Morgan and Jeffrey K. Liker (2006), the TOYOTA product
development system, New York, Productivity Press.