惟精惟一的探索

從工業內視鏡到醫療內視鏡
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2020 / 9月

文‧曾蘭淑 圖‧林旻萱


因母親罹癌逝世,心中的不捨與不平,成為改變的契機,激發了德盟檢視儀器總經理曾湘德,從生產工業內視鏡轉而研發醫療內視鏡,成為目前台灣唯一垂直整合研發、設計、製造到維修的高階內視鏡廠商。


走進德盟儀器公司,滿牆盡是獲得台灣SGS、GMP品質認證,以及歐美品質認證的證書。掛著一副又黑又大眼鏡的總經理曾湘德,直接點出企業生存之道:「如果只做其一,客人不買單,要突破企業現有的困境,唯有客製化一途。」

但是,從生產探管長達120公尺、可以探勘地底隧道的工業用內視鏡,到外徑只有0.8mm,用於探照人體鼻淚管、泌尿管或腦腫瘤的醫療內視鏡,這一路的轉折與心路歷程,就如曾湘德所說,是不斷突破的過程。

工欲善其事,必先利其器

2007年,原本住在德國的曾湘德,經德國一家前三大的內視鏡廠商向他反映,原本只能用眼睛看的工業用內視鏡,如果可以拍照或是錄影,或是投放在螢幕上看,可以讓年紀偏大的工程人員使用起來更方便,這項建議引發曾湘德研發的動機。

他因此開發出了鏡頭可以轉彎、又能拍照錄影的工業用內視鏡,用於檢測汽車引擎的燃燒室,是否燃燒完全,如奧迪、保時捷、博世等汽車大廠都是他的客戶。他又接到蘇俄米格戰鬥機的訂單,開發出米格機專用的內視鏡,得以伸進引擎發動機內檢查,作為維修的證據,可以發現飛機葉片是否因小石子撞擊而有了裂痕,避免一架飛機的折損,大受客戶肯定。

這十多年間,德盟根據客戶的需求,開始接受來自全球客製化內視鏡的訂單,不同款式、尺寸多達三萬多種的內視鏡,可以伸進坦克與潛艇的排煙管與油筒中;也生產了抗輻射與水壓力材質的內視鏡,放進核能電廠的設備去檢查,檢查暗管是否耗損,避免小小瑕疵所造成不可估量的損失。

開發醫療內視鏡

2012年曾湘德的母親因為鼻咽癌第三期,半年後病逝,引發他思考:「我的工業用內視鏡,可以看到飛機引擎室的葉片是否因小石子的撞擊而有裂縫;可以鑽進完全暗黑的潛艇引擎室,察看是否燃燒完全,為何我不做可以看到惡性腫瘤的醫療內視鏡?」

因為曾湘德的母親,不想麻煩別人,吃了好長時間的止痛藥,等到發現時已癌症三期,當時還在國外出差的他,反省治療情景,如果可以及早發現,如果母親開刀與化療時可以清楚「照」到腫瘤而加以根治,或許情況會不一樣。

「電腦斷層可以證明有惡性腫瘤以及腫瘤所在的座標,但是手術開刀打開時,人體內的惡性腫瘤並沒有坐標,醫生的肉眼不容易判定惡性腫瘤在那裡,如果腫瘤擴散出去,更不容易查覺。」曾湘德解釋,以腦腫瘤為例,與正常腦組織的邊界不清,手術時為了要避免傷及無辜的組織,又要保全重要的神經構造,不得不妥協無法完全切除,所以極易復發,造成治療上的層層困難。

剛好2012年長庚集團下的長庚醫學科技公司委託德盟研發醫療內視鏡,開啟了曾湘德長達六年的研發過程,甚至耗盡他在工業用內視鏡所賺來的錢。

因為醫療用品有別於一般工業產品,從接受經濟部旗下的塑膠產業技發中心生醫部的輔導,申請工廠認證、衛福部的GMP工廠認證及上市許可,一系列漫長的過程,這當中有員工不堪轉型的陣痛而離職,而德盟全力發展醫療內視鏡的同時,也讓工業內視鏡的研發停擺了六年。

觀其微,觀其妙

這當中的努力,從一系列的獲獎與品質認證,讓曾湘德可以肯定繼續走下去的決心,3.5吋的醫療內視鏡套組,輕巧易攜帶,可以用於偏鄉醫療的緊急手術,2016年與2019年得到「台灣精品獎」,未來配合5G頻寬更是發展遠距醫療的利器。2017年德盟又拿到亞洲除了日本之外的醫療內視鏡維修中心的認證。

由於歐美生產的耳鼻喉科內視鏡,從主機、相機、光源機,再加上內視鏡,整套設備依廠牌的不同要50~100萬元不等,目前只有具規模的耳鼻喉科才有此備配。

德盟開發的耳鼻喉科軟式鏡,亮度與影像效果不輸歐美品牌,價錢卻只要20萬元,讓窮鄉僻壤的耳鼻喉科可以使用,檢查中耳炎、耳朵的息肉、喉嚨閉鎖等症狀,甚至是鼻咽癌。2019年6月在耳鼻喉科頭頸外科醫學會發表後,引發耳鼻喉科醫師團購。

研發團隊還開發出放置內視鏡的「泡消架」,朝向消毒清洗自動化的方向研發,讓護理人員更方便使用,免除消毒不完全的疑慮。

命運的安排,看見腦腫瘤

一開始,德盟的醫療內視鏡用於研究教學上,例如成大醫學院等醫學系教授委託德盟,開發供學術使用的子宮鏡、膽道鏡、喉頭鏡,希望能進一步解決臨床上遇到的問題。

真正讓曾湘德感受到醫療內視鏡的威力,是長庚醫院為一位二個月大的嬰兒切除腦部腫瘤的手術,當醫師使用德盟的醫療內視鏡,清楚地照到腫瘤,加以切除,並將取出的腫廇進行病理切片,再次確認是惡性腫瘤時,開刀房一陣歡呼。

全程記錄的曾湘德解釋,在微創內視鏡手術中,醫師靠肉眼無法判定是腫瘤,必須施打5ALA顯影劑,經德盟的內視鏡系統特殊光動力波長一照,吸收顯影劑的腫瘤細胞會呈現粉紅色,讓醫師可以準確切除。

其實內視鏡只能看到腫瘤在那裡,但對醫師而言,還要有相對應的工具來切除它。面對這個困境,德盟進一步把它轉換為商機,再開發「腦神經外科腫瘤切除輔助工具」,為符合醫師的使用習慣,目前已改良至第七代,例如原本考量伸進人腦只要8公分的長度,納入實際手術時情境的考慮後,增長至15公分。

這支看起來像一把精密的工具夾,重量約300公克,開刀時可以向右或向左轉90度,按住或夾住腫瘤後,讓醫師進一步切除,預計在取得衛福部認證後,2021年就可上市。

曾湘德去(2019)年起已在研發磁導式內視鏡,即有導航功能,更可以協助定位發現腫瘤,預計2022年可以完成;目前已成功研發拋棄式的內視鏡,避免重覆感染。

「我當初投入醫療內視鏡,只是一股想幫助人的傻勁,安排我設計的內視鏡可以看到腫瘤。」他再強調說:「這是命運的安排,當時我並沒有想到要挑戰全世界工業技術的限制。」配合政府輔導醫療器材業往微創及人工智慧(AI)發展,醫療內視鏡產業可以成為台灣醫療產業的亮點。

八年來投入醫療內視鏡的研發,協助醫院完成不少成功的手術,曾湘德感觸特別深:「我現在對醫療很了解,很有把握,假如我的母親是現在發現惡性腫瘤的話,我可以用內視鏡找到腫瘤,加上手術、質子治療,結果一定可以不一樣。」 

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EN

From Industrial to Medical Endoscopes

Adronic Inspection Instruments’ Journey of Exploration

Esther Tseng /photos courtesy of Lin Min-hsuan /tr. by Scott Williams

John Tseng, CEO of Adronic Inspection Instruments, was both saddened and indignant when his mother passed away from cancer. But those emotions became an impetus for change, leading him to shift his company’s focus from producing industrial endoscopes to developing medical ones. Currently Taiwan’s only vertically integrated maker of top-tier endoscopes, Adronic develops, designs, manufactures and services the devices in house.


The lobby of Adronic Inspection Instruments’ facility is decorated with the company’s many SGS Taiwan and GMP quality certifications.

Company CEO John Tseng says it has relied on a process of continual innovation to transition from making 120-meter-long endoscopes, used to inspect tunnels, to medical endoscopes as small as 0.8 millimeters in dia­meter, used to examine human nasolacrimal canals, ureters, and brain tumors.

Honing one’s tools

When Tseng was living in Germany in 2007, a neighbor who owned an industrial endoscope maker suggested that enabling industrial endoscopes to make videos would make them easier for older workers to use. Tseng thought it was a good idea and began working on it.

He subsequently developed an industrial endoscope with a lens that could be aimed, and that could record video. Designed to inspect the combustion chambers of automotive engines and determine whether fuel had fully combusted, the device won Tseng customers in the auto industry, including firms like Audi, Porsche, and Bosch. He even received an order involving Russian MiG warplanes, which resulted in him developing an endoscope designed to examine the interiors of their engines to check for evidence of maintenance.

Adronic spent a decade developing and producing more than 30,000 endoscopes of different shapes and sizes, tailor-made to meet needs as unusual and specific as examining the interiors of exhaust pipes and fuel tanks of military tanks and submarines. The company also produced radiation- and water-resistant endoscopes used to check for pipe wear at nuclear power plants, ensuring that small defects would not lead to immeasurable harm.

A fated transformation

In 2012, Tseng’s mother was diagnosed with Stage III nasopharyngeal carcinoma. Her death six months later caused Tseng to reflect: “My industrial endoscopes are capable of looking inside jet engines to check for fractures in the turbine blades caused by impacts from small stones. They can penetrate into the pitch-black engine compartments of submarines to see whether fuel has fully combusted. Why can’t I make a medical endoscope to spot malignant tumors?”

Not wanting to be a bother to others, Tseng’s mother had treated her symptoms with analgesics for a long time before seeing a doctor. As a result, her cancer was already at stage three when it was finally discovered. Tseng, who in those days was still working abroad, couldn’t help but wonder whether his mother’s outcome would have been different if the cancer had been found sooner, or if the doctors had been able to clearly image the tumor at the time of her surgery and chemotherapy.

Coincidentally, Chang Gung Medical Technology, part of the Chang Gung Medical Foundation, happened to commission Adronic to develop a medical endoscope in 2012. The move initiated a six-year-long R&D process that absorbed all of the company’s earnings from its indus­trial endoscope business.

A series of awards and quality certifications earned along the way reinforced Tseng’s conviction that he was on the right track. The company’s 3.5-inch medical endo­scopes, which are portable enough to be easily used for urgent surgeries in remote locations, earned Taiwan Excel­lence Awards in both 2016 and 2019, and in the future will be used in conjunction with 5G technology for telemedicine applications. Meanwhile, the company earned certification as a medical endoscope maintenance center for the Asia region (excluding Japan) in 2017.

Spotting brain tumors

Adronic’s medical endoscopes were initially used in research and education. For example, faculty members from National Cheng Kung University’s College of Medi­cine asked Adronic to develop hysteroscopes, ­biliary endo­scopes, and laryngoscopes for academic applica­tions in hopes of making progress towards resolving problems in clinical settings.

But it wasn’t until doctors at Chang Gung Memorial Hospital used an Adronic endoscope to image and excise a brain tumor in a two-month-old baby that Tseng fully appreciated the device’s power. When the tumor was subsequently examined and reconfirmed to be malignant, the surgical team was even more relieved to have removed it.

Tseng recorded the entire event, and explains that doctors can’t tell with their naked eyes which tissue is cancerous. For this microendoscopic surgery, they injected the baby with a photosensitizing imaging agent called 5-ALA that makes cancers appear pink, then used the Adronic system’s photo­dynamic detector to spot the tumor and remove it.

Endoscopes can identify tumors’ locations, but surgeons still need other tools to remove them. Observing this difficulty, Adronic realized it could take its own corporate trans­formation farther by developing tools to assist in the removal of brain ­tumors. 

In 2019, Tseng began working on magnetic endoscopes, which are better able to identify the precise location they are imaging, and expects to complete develop­ment in 2022. The company has already developed disposable endoscopes, which eliminate the risk of spreading infections from one patient to another.

“When I first went into medical endoscopes, I did it with the ordinary, simple-­minded idea of helping people. But fate turned my efforts into something more, and I ended up designing endoscopes capable of spotting brain tumors.” With the govern­ment now steering medical equipment makers towards the development of micro and AI-­assisted devices, medical endoscopes may well become another leading light in Taiwan’s medical devices industry.

Tseng says that his eight years researching and developing medical endoscopes that have helped hospitals complete innumerable successful surgeries have provided him with a much better understanding of healthcare. “If my mother’s cancer were discovered now, I could use endoscopy to find the tumor. With that information to guide surgery and proton therapy, she would have had a different outcome.”                            

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