電燒隱形冠軍──大瓏企業

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2013 / 5月

文‧張瓊方 圖‧林格立


台灣中小企業比率接近98%,其中有許多名不見經傳、卻在各領域居領導地位的「隱形冠軍」,大瓏企業就是其中之一。大瓏在醫療器材──電燒刀的全球市占率高達25%,是當今最大供應商,小兵立大功,其影響力不容小覷。


大瓏企業位於土城頂埔科技園區的生產基地,正好被電子代工產業龍頭鴻海集團與正崴科技包夾其中,相對而言,大瓏似乎顯得「默默無聞」,殊不知它可是醫療耗材──電燒刀全球最大供應商。

「隱形冠軍」是德國經濟學家赫爾曼‧西蒙在1986年提出的概念,指的是檯面上可能默默無聞,卻在小領域中領先群倫,居全球市場領導地位的企業。

無可取代的冠軍

2012年,經濟部為提振經濟發展,改善產業結構,參考德國經驗,積極推動「中堅企業躍升計畫」,發掘74家台灣本土的「隱形冠軍」,協助其在既有基礎上,發展關鍵生產技術,在國際市場上站穩無可取代的地位,大瓏企業也名列其中。

事實上,在醫療器材──電燒刀領域裡,大瓏已是獲得各界肯定的優質企業,這些年先後拿下第11屆小巨人獎、第16屆研發創新獎、第18屆「國家磐石獎」,與第22屆「國家品質獎中小企業獎」。今年3月下旬,總統馬英九與新北市長朱立倫還曾聯袂走訪大瓏企業,給予讚賞和鼓勵。

冷門卻專精

大瓏之所以「隱形」,與產品冷僻有很大關係。醫療專業用的電燒刀,可能沒有幾個人知道,但它卻是開刀房裡不可或缺的耗材。

各類外科手術為了讓傷口漂亮,一般用傳統手術刀劃開第一刀,接下來細部切割幾乎都以電燒取代,其優點在於一邊開刀、一邊止血。

電燒原理基本上是靠高壓,接連發電機箱的電燒刀,在人體產生高壓高頻的切割凝結功能,再藉由回流護片,將電流傳導回機器上。「有些人手術後身上出現燒焦的痕跡,就是因為回流護片沒貼好,」大瓏企業總經理齊忠明指出。

電燒刀依科別的需求不同,刀頭會有不同的設計,有針狀、塔形、球形,還有環狀。而同樣是骨科,髖關節、膝蓋和肩膀需要的刀就不相同。甲狀腺開刀使用的電燒刀也很特別,由於附近血管很細,開刀時會先夾起來凝結,然後再切割,藉以避免流血。

一隻外科電燒刀,包含刀頭、刀筆以及接連發電機的電線。大瓏企業董事長劉惠珍指出,開刀房使用的電燒刀,防水是第一要件,此外,掌控切割與凝結的開關也非常重要,「彈力要容易控制,不能太輕也不能太重,否則醫生按久了手會酸;彈力還要維持一致,按500下都一樣。」

外銷全球,法規優先

大瓏的「隱形」,也與捨本地市場,直接放眼全球市場有關。

「台灣市場太小,」劉惠珍表示,目前只有長庚和秀傳向大瓏購買拋棄式電燒刀,「因為健保的關係,台灣許多醫院選擇採用可重複使用二、三百次的電燒刀,但國外人工昂貴,消毒後再使用成本更高,多使用拋棄式耗材。」

大瓏與菲利浦、嬌生、柯惠等美國大廠合作,產品外銷以歐美為主,除了澳洲、紐西蘭、日本、韓國、泰國、巴西、墨西哥等國直接銷售外;經代理廠商經銷販售更是遍布全球。

「醫療器械是一個高度受法規管制的行業,」劉惠珍指出,醫材產業法規嚴謹且驗證時程冗長,讓她吃足苦頭,但也因此更加確立遵守法規的重要性。

既然要走全球市場,大瓏設立專門的法規部門,拿到所有系統認證與產品查驗登記。舉凡歐盟、日本厚生省、美國的FDA、巴西的衛生署,每年都會派員來查廠。

從門外漢到業界冠軍

令人驚訝的是,這家台灣少數行銷全球的醫療器械公司創辦人,一開始卻是個不折不扣的門外漢。

現年59歲的董事長劉惠珍,當年自輔仁大學法律系畢業後,又在美國取得MBA碩士學位。雖然都與醫療產業關連不大,但站在市場的角度觀察,劉惠珍在醫療器材產業上嗅到了商機。

她一開始以600萬元起家,從組件加工出發,生產醫療器材所需電線。繼而在大廠協助輔導下,逐漸取得各零件的製造能力。

從照本宣科的OEM,漸漸具備為客戶設計產品能力的ODM,再到自行設計、取得專利、貼大廠廠牌的OBM,大瓏逐漸站穩腳步,取得無可取代的重要地位。

聚焦在專一領域、不斷地精益求精,是大瓏的經營哲學。

電燒刀在醫療用品中屬於侵入性的第二、三等級,必須要消毒滅菌。

早期大瓏產品運送到客戶端後,後續還需經過檢驗、包裝、消毒程序,劉惠珍決定要提昇產品的附加價值。

2011年,大瓏設立潔淨程度一萬等級無塵室之塑膠射出廠房;生產線也比照高科技產業,人員進入前要徹底洗手,從頭到腳穿戴無塵衣、帽、鞋套,戴口罩。並設立微生物實驗室,專門負責監控環境中的含菌量。

經過合作大廠的認證,大瓏現在生產的產品,到達客戶端已不需檢驗、消毒,可以直接入庫。

雖然與電燒刀領域全球市占達76%的美國柯惠公司合作,但大瓏不以此為滿足,近年進而推出自有品牌──E Surgical,在澳洲、紐西蘭、日本、韓國等亞太地區,及法國銷售,逐漸從「隱形冠軍」中嶄露頭角。

提高效能,立足台灣

1987年創立,走過25個年頭,大瓏企業從電線加工開始的「門外漢」,一步一腳印地走向世界級的醫療器材產業;從一個不到十個人規模的小公司,成長到四百七十多位員工的中小企業,儘管過程艱辛,但立足台灣,與同胞一起打拚的信念卻始終沒有動搖。

「經營事業一定要有理想,」學商出身的劉惠珍認為,台灣人純樸、善良、素質好,是很好的創業環境,因此,在自己熟悉的家鄉創業,一直是她的目標。「如果為了事業,去到一個人文法治都不熟悉的地方,我認為不值得。」憑著這股信念,劉惠珍想盡辦法讓自己在台灣生存下來。

大瓏企業的生產過程秉持MIT原則,除少數台灣沒有的塑料需要仰賴進口外,舉凡不鏽鋼、銅、塑膠等基本材料,大瓏都在台灣取得;四百多位員工也清一色是本地勞工。

「既然你不出走,那就應該與台灣的同胞一起打拚,」劉惠珍認為,勞力密集產業不論出走到哪裡,終究還是要面臨工資高漲問題,「與其追逐勞力便宜的地方,不如把心思放在如何精進上面。」

劉惠珍指出,要留在台灣發展、生存,首先要提高效能,把勞工成本省下來,以材料成本來競爭。大瓏將需要使用大量勞力的部分自動化,讓員工多功能,不是只做單一的動作。並增加高附加價值的產線──如骨科,骨科微創的刀比較長,刀頭有各種不同的形狀與長度,需要較多人力投入。

為了精簡人力,大瓏花了相當長的時間自動化,並在全球註冊專利與商標。

如今大瓏已經可以做到每5秒鐘生產一枝電燒刀,一部機器一年可以生產380萬枝(一枝約30元台幣),預計到2015年產量可達到千萬枝。

有共鳴的幸福企業

年營業額10億元台幣的大瓏,或許稱不上大企業,但卻在其能力所及的範圍內,發揮影響力,不僅每年將公司營業額的千分之一、公司獲利的2%,捐做公益,更以追求員工福利、成長為企業的目標。

三年多前工廠遷移至土城新廠,特別留一層樓設立景觀優美的員工餐廳、咖啡廳與健身房。

「營造好的工作環境,員工才不會迷思電子產業,或為了他廠多一點點錢跑掉,」劉惠珍表示,公司每年有一次減重比賽,追蹤BMI(身體質量指數),還配備健身房、淋浴間,成立瑜珈、書法、慈幼等8個社團,以凝聚公司同仁的感情。

「經營事業不能只是目標導向,員工心靈成長也很重要,」劉惠珍說,為凝聚向心力,大瓏每季都舉辦季會,選一個星期五下午,生產線停工3小時,全體員工在九樓餐廳聚會,像今年第一季主題設定為「共鳴」,就請來九天民俗技藝團團長許振榮到廠演講,激發全體員工的「共鳴」。

打造台灣精品醫材網

「醫療領域是良心事業,一定要有所執著,不斷學習,也要有所創新,才能永續,」劉惠珍指出,大瓏雖聚焦於冷僻的外科電燒刀領域,但仍有些精密器械需研究開發,例如電燒心臟就是一個有待突破的領域。

「現在有很多專利被國外大廠綁住,」劉惠珍表示,心血管疾病是當前與未來很重要的領域之一,大瓏正著手開發屬於心臟領域的重複使用器材,如開刀房裡心臟的電擊器。「單次使用成本很高,醫院多希望能重複使用,」她解釋。

此外,大瓏還進一步將觸角延伸至電子操控機台──E box研發上,目前已有初步成果。

大瓏不以電燒刀界的「隱形冠軍」為滿足,在退休交棒之前,劉惠珍還有夢,她希望以大瓏為中心點,結合、扶植其他規模較小的廠商,聯手打造台灣精品醫療器材網路,行銷全球。

讓冠軍不再隱形,劉惠珍若能美夢成真,非但是大瓏之福,也是台灣醫材產業之福。

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近期文章

EN

New Deantronics,“Hidden Champion” of Electrocautery

Chang Chiung-fang /photos courtesy of Jimmy Lin /tr. by Scott Williams

Roughly 98% of Taiwanese businesses are SMEs. Though essentially unknown, many are “hidden champions” that occupy spots at the top of their industries. Medical devices manufacturer New Dean­tron­ics is a case in point. It is the world’s largest maker of electro­cautery instruments, accounting for 25% of the global market. Though a relatively small company, it is enormously influential in its field.


New Dean­tron­ics’ manufacturing headquarters sits squeezed between OEM giants Fox­conn and Fox­link in ­Dingpu High-Tech Industrial Park in New Tai­pei City’s Tu­cheng District. A relative unknown compared to its larger neighbors, the company is actually the world’s largest manufacturer of electrocautery devices.

Top dog

The idea of the “hidden champion” was proposed by German economist and author Hermann Simon some 15 years ago to refer to inconspicuous companies that are highly successful leaders within their own small fields.

Inspired by the concept, the Ministry of Economic Affairs launched a program in 2012 aimed at stimulating economic growth and revamping our industrial structure by promoting the development of medium-sized companies. The program has identified 74 Taiwanese “hidden champions,” New Dean­tron­ics among them, and aims to help them develop the kinds of manufacturing technologies that can solidify their international positions.

In the case of New Dean­tron­ics, the company is already widely acclaimed for its excellence within the field of electrocautery. Over the last few years, it has received the 11th annual Rising Star Award, the 16th annual R&D Innovation Award, the 18th annual National Award of Outstanding SMEs, and the 22nd annual National Quality Award (SME Award).

Highly focused

The main reason New Deantronics has remained relatively “hidden” is that its product is fairly obscure. But even though few people outside of the medical field have heard of electrocautery pens, the devices are operating-theater essentials.

Generally speaking, surgeons use traditional scalpels, which cause less scarring, for their first incisions, then use electro­cautery for almost all of the fine cuts thereafter. The technique’s advantage is that it reduces bleeding during surgery.

Electro­cautery uses electrical current at high voltage and frequency but low power to cut or cauterize tissue. “Patients sometimes leave surgery with burn marks as a result of poorly placed dispersive electrodes,” explains Arthur Chi, general manager of New Deantronics.

Electrocautery pens come in a variety of shapes and sizes that differ based on how they will be used. Pen tips come in a variety of configurations, such as needle, ball or ring shapes. They can even vary within a given field of medicine. For example, orthopedic surgeons used different pens on hip, knee and shoulder joints.

At the most basic level, an electro­cautery pen consists of a tip, a body, and a wire that connects it to the power supply. New Dean­tron­ics founder and president Jane Liu notes that those used in operating theaters must be waterproof, and that the button used to switch between their cutting and coagulating functions is crucial. “It has to have just the right amount of resistance, neither too little nor too much, or it will tire out the physician’s hand during surgery. In addition, the force required to depress it has to remain consistent even after many uses.”

Supplier to the world

New Dean­tron­ics’ “invisibility” is also related to its decision to forgo the local market in favor of focusing directly on the world market.

“The Taiwan market is just too small” says Liu. In fact, ­Chang Gung and Show ­Chwan Memorial Hospitals are currently the only local hospitals buying New Dean­tron­ics’ disposable electro­cautery pens. “The way the National Health Insurance system is structured encourages Taiwanese hospitals to buy electro­cautery pens that can be reused 200 to 300 times. In contrast, the high cost of labor abroad makes it quite costly for hospitals in other nations to sterilize and reuse pens. They therefore tend to prefer disposables.”

The company exports primarily to the US and Europe via agreements with Royal Phil­ips, Johnson & Johnson, and Covidien. It also sells directly to Australia, New Zealand, Japan, South Korea, Thailand, Brazil, and Mexico, and has extended its reach to the rest of the world through agents.

“The medical devices industry is highly regulated,” says Liu. She adds that while she’s felt her share of frustration with the stringency of regulations and the duration of certification processes, the aggravation factor makes her even more careful about adhering to them. To that end, the company has established a legal department specifically to handle the certification of its systems, and the testing and registration of its products.

From outsider to industry leader

Surprisingly, Liu was an industry outsider prior to founding what has become one of the few Taiwanese medical device companies with global reach.

The company’s 59-year-old founder received her undergraduate degree in law from Fu Jen Catholic University before pursuing an MBA in the United States. Though she didn’t have a strong personal connection to the healthcare industry, she saw opportunities in the medical devices sector when she examined it from a market perspective.

After founding her company with just NT$6 million, she began manufacturing wiring for medical instruments. She then gradually moved into manufacturing components with the help and guidance of larger firms.

New Dean­tron­ics’ approach to business has been to focus on a single field and to seek constantly to improve.

Electro­cautery pens are invasive devices that must be sterile. In its early days, New Dean­tron­ics had its customers handle the testing, packaging and sterilization of its products after delivery. Liu later decided to increase her company’s value-added by moving these functions in house.

The company built an ISO Class 7 compliant clean room in 2011 so that it could injection mold its plastics in a sterile environment. Workers entering the production area now must first thoroughly wash their hands, then don cleanroom clothing from head to foot (including a hat, gloves, and a mask) before going inside. The company has also built a microbiology laboratory specifically to monitor the bacteria in its production environment.

Now certified by the company’s large partners, New Dean­tron­ics’ products no longer need to be inspected and sterilized on delivery, and can go straight into inventory.

In spite of having already achieved great success—it is partnered with Covidien, the world’s top electro­cautery brand with 76% of the global market—New Dean­tron­ics has no plans to rest on its laurels. In fact, the company introduced its own brand—E Surgical— just a few years ago and now distributes it in Australia, New Zealand, Japan, South Korea and France.

Rooted in Taiwan

Since its 1987 founding, New Dean­tron­ics has slowly grown from an industry outsider into a world-class medical device maker, from a small startup with fewer than 10 workers into a medium-sized enterprise with more than 470 employees. The road was long and arduous, but Liu’s faith never wavered.

Her objective has always been to run a business here in Taiwan, where she understands the environment. “If pursuing my career had meant going to a place where I didn’t know the culture or laws, it wouldn’t have been worth it to me.” She therefore did her utmost to make things work in Taiwan.

New Dean­tron­ics’s production processes adhere to her “Made in Taiwan” principle. With the exception of a few plastics that can’t be sourced from Taiwanese suppliers, Liu acquires all her basic materials, the stainless steel, the copper, and the plastic, in Taiwan. Her 400-plus employees are all Taiwanese as well.

“If you’re running your business here, you should hire Taiwanese,” says Liu, who argues that labor-intensive businesses end up having to deal with rising labor costs no matter where they go. “You’re better off putting thought into how to move your business forward than you are chasing from place to place in search of cheap labor.”

Over the years, the company has automated the portions of its production that were labor-intensive, freeing its employees from repetitious tasks and enabling them to fulfill a greater variety of functions. It has also increased the value-added of its production line by, for example, manufacturing the many different lengths and shapes of electrocautery tip required by minimally invasive orthopedic surgeries. That, in turn, has required contributions from a greater number of employees.

New Dean­tron­ics has devoted considerable effort to automation, and has generated a number of patents around the world as a result. Its production machine can now produce an electrocautery pen every five seconds, and as many as 3.8 million pens per year. The company plans to add two more machines and increase their annual production to 10 million units by 2015.

Building a medical devices network

While the company’s annual revenues of roughly NT$1 billion are hardly those of a large firm, it is very influential within its area of expertise.

“Working in healthcare is about helping others,” says Liu. “To sustain your business over the long term, you must have drive, learn continually, and be innovative.” Even though New Dean­tron­ics operates in a relatively non-competitive industry, it still needs R&D. Liu notes that cardiac electro­cautery is ripe for a breakthrough.

The treatment of cardiovascular disease is an important area and will continue to be so in the future, but Liu notes that foreign firms control many key patents. New Dean­tron­ics is therefore seeking to develop its own technologies for reusable cardiological devices, such as defibrillators for the operating theater. “Having to dispose of something after a single use is very expensive, and hospitals are looking for reusable options,” explains Liu.

The company has also been exploring the development of power supplies/control panels for their electrocautery pens, and that research is already beginning to bear fruit.

Liu isn’t content with having created a company that is merely the “hidden champion” of the electrocautery pens industry. Before she retires, she hopes to bring other small medical device makers together under her company’s umbrella, creating a Taiwanese network of device manufacturers that can market its products to the world.

If she succeeds in her ambitions, Taiwan’s entire medical devices industry will reap the rewards.

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