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Editorial

As MedTech World heads towards its inaugural event in Hong Kong, our third edition this year explores a city that continues to deliver on opportunity. Strategically positioned as a super-connector between mainland China and the global market and home to a growing ecosystem of skilled talent and innovation, Hong Kong has no doubt a pivotal role to play in the future of medical technology.

The use of increasingly smart technology to improve healthcare is a recurring theme throughout this issue. For years, emerging technologies such as AI hovered in a state of anticipation - surrounded by bold predictions and buzzwords. Now, they are beginning to emerge from their chrysalis, shedding layers of hype that reveal practical applications that prove reality can be just as compelling. On page 10, we look at the future of robotics in care. Earlier this year, UBTECH revealed its long-term vision for humanrobot symbiosis at a showcase launch event in Shenzhen. We explore the potential of the UWORLD U1, the world’s first full-size, mass-produced ultra-bionic humanoid robot, to support home care as an emotionally responsive companion, promoting both physical and mental well-being. Elsewhere, SmartCare CEO Justin Cheng reflects on the company’s journey from a research initiative at the Hong Kong University of Science and Technology (HKUST) to an AI-driven platform helping to transform patient-centred care. By reducing clinicians’ administrative burden and improving the patient experience, SmartCare offers a practical glimpse at how AI is making a difference. Read the interview beginning on page 18. With all that said, on to a round of thank yous. Firstly, to Dr. Dylan Attard - whose own journey with MedTech World is a reminder that meaningful communities are built over time. What started as a single gathering in Malta five years ago has grown into a global platform that has quietly built a strong foundation of trust, collaboration and engagement across the MedTech community. Behind that growth is a clear sense of purpose - one we hope is reflected throughout this edition’s pages. Great design, compelling storytelling, and thoughtful translation have made this an issue worth keeping. We hope it finds a well-deserved space on your bookshelf. Katy Micallef, Editor MedTech World Magazine

隨著 MedTech World 即將在香港迎來首屆亞洲盛會，本年度第三期雜誌聚焦在這座持續創造機遇的國際城市。香港憑藉其連結中國內地與全球市場的戰略地位、以及日益成熟的人才與創新生態圈，正逐步成為推動全球醫療科技發展的重要樞紐。

本期內容的一大主軸，是智慧科技如何持續改變醫療服務。多年來，人工智慧（AI）等新興技術始終伴隨著市場期待與各種想像；如今，它們正逐漸走出概念階段，從熱門話題走向實際應用，證明了真正的創新不只是願景，而是正在發生的現實。

在第 10 頁，我們將與您一起探索醫療服務機器人的未來。今年稍早，UBTECH 在深圳發表了「人機共生」的長期願景，並正式推出全球首款量產全尺寸超擬人仿生人形機器人 UWORLD U1。我們深入探討這款機器人如何作為具備情感互動能力的陪伴者，為居家護理帶來新的可能，同時兼顧身心健康支持。此外，SmartCare 執行長 Justin Cheng 分享了該企業如何從香港科技大學（HKUST）的研究計畫，發展為以 AI 為核心、推動以病人為中心醫療服務的平台。透過減輕醫護人員行政負擔、提升病人體驗，SmartCare 展現了 AI 能如何真正為臨床服務創造價值。精彩專訪請見第 18 頁。

最後，也想藉此機會表達感謝。首先，感謝 MedTech World 執行長暨共同創辦人 Dr. Dylan Attard。他一路走來的歷程，正說明了一個有影響力的產業社群是需要時間、信任與持續投入才能建立。五年前，MedTech World 從馬爾他的一場小型聚會起步，如今已發展為串聯全球醫療科技生態圈的平台，在業界建立起穩固的信任、合作與交流網絡。而支撐這一路成長的是始終如一的使命感，我們也希望這份精神能夠透過本期每一篇內容傳遞給讀者。

同時，也感謝所有參與本期製作的團隊成員。從版面設計、內容策劃，到故事撰寫與翻譯，每一個環節都凝聚了許多心力，才成就了這本值得珍藏的雜誌。希望您喜歡本期內容，也期待它能在您的書架上，佔有一席之地。

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MedTech World

Contributors Wara Samar Senior Content Writer

Katy Micallef Editor

Duncan Barry Content Writer

Jacob Sammut Photographer

Faye Paris Senior Editorial Designer

Anita Tseng Translation

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Contents

Cover Story

Turning science fiction into clinical reality 將科幻變為臨床現實 In this cover story, Arman Nadershahi, CEO of Endiatx, speaks about autonomous medicine, the data flywheel powering it, and why disrupting endoscopy is just the opening move.

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Meet the robot born for companionship

為陪伴而生的機器人 UBTECH on the launch of UWORLD U1, the world’s first full-size mass-produced ultra-bionic humanoid robot.

Stop Selling Start Mapping

別急著賣產品，先建立利害關係人地圖 Podymos discuss stakeholder mapping, AIdriven hyper-personalisation, and why bad messaging is like sailing with the anchor still down.

From HKUST Lab to the world stage

從香港科技大學實驗室走向世界舞台 How SmartCare is redefining the patient journey with AI.

From bank notes to lab notes: Powering precision at the point of care

重新定義臨床決策：即時分子診斷創新之路

The scientific architecture behind Verge HealthTech Fund Verge HealthTech Fund 的科學投資邏輯 Investing in tech that delivers scalable, affordable, and accessible healthcare solutions.

A closer look at The VitaPCR™, Credo Diagnostic’s first breakthrough platform.

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MedTech World | Contents

Healthcare without hospital walls

打破醫院圍牆的健康管理

Shaping the future of healthcare 塑造醫療照護的未來

Dr Renzo De Gabriele, Permanent Secretary, Office of the Deputy Prime Minister and Ministry for Health in Malta on Malta’s Digital Health and Health Data Strategy 2030.

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How wearable technologies, AI and community-based screening are reshaping preventative healthcare in Hong Kong.

Engineering a new era in soft-tissue surgery

開創軟組織手術的新時代 An exclusive interview with Aliform on developing technologies for the controlled release of fibrotic skin tethering in reconstructive and aesthetic surgery.

Contents | MedTech World

The future of stem cell therapy 幹細胞治療的未來

Sino-South Vanya Pharmaceutical Cell Medical Technology (Shenzhen) on its approach to regenerative medicine.

Beyond approval: Maintaining global compliance in the post-market era

Listening before it’s too late 提前聽見心臟的警訊 Why the future of cardiac care will be defined by timing, not treatment.

核准之後：後市場時代如何維持全球法規合規 Alira Health on bringing the patient perspective into healthcare decision-making.

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A note from the

CEO and co-founder Welcome to the fourth edition of MedTech World Magazine, released alongside our flagship event in Asia, taking place in Hong Kong from 26 to 28 August.

Hong Kong is a city that embodies ambition. As one of the world’s leading financial centres and a gateway to the Greater Bay Area and the wider Asia-Pacific region, it offers unparalleled access to markets, talent, investment, and innovation. It is where global ideas meet regional opportunity, making it the ideal home for MedTech World in Asia. Healthcare innovation is moving faster than ever before. From artificial intelligence and robotics to digital health, precision medicine, and advanced diagnostics, new technologies are changing how care is delivered, creating opportunities to improve outcomes for patients around the world. At the same time, Asia is emerging as one of the world’s most influential regions for healthcare investment, research, manufacturing, and commercialisation. The future of MedTech will increasingly be shaped by collaboration across borders, bringing together entrepreneurs, investors, healthcare providers, policymakers, and industry leaders to solve healthcare’s greatest challenges. This is where MedTech World has an important role to play. Our mission has always been to create the environments where meaningful connections happen and where ideas become partnerships, investments, and real-world impact. By bringing together leaders from across the global healthcare ecosystem, we aim to strengthen Hong Kong’s position as a meeting point for innovation and to help connect Asia’s rapidly growing MedTech community with opportunities across Europe, North America, the Middle East, and beyond. This event reflects that vision. The progress of our industry depends not only on breakthrough technologies but also on the strength of the global community behind them. Thank you for joining us at this important milestone. Together, we have an opportunity to accelerate innovation, improve patient outcomes, and strengthen the partnerships that will define the next chapter of healthcare, both across Asia and around the world. Enjoy the event. Dr. Dylan Attard MD, MRCSI, MEnt. CEO AND CO-FOUNDER, MEDTECH WORLD 8

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歡迎閱讀《MedTech World Magazine》第四期。本期雜誌配合 MedTech World 亞洲旗艦盛會同步推出，活動將於 8 月 26 日至 28 日在香港舉行。

香港是一座充滿企圖心的城市。作為全球領先的國際金融中心之一，同時也是連接粵港澳大灣區及亞太地區的重要門戶，香港擁有無可比擬的市場、人才、資金與創新資源。這裡是全球創新理念與區域發展機遇交會之地，也因此成為 MedTech World 亞洲盛會的最佳舞台。

醫療科技正在以前所未有的速度演進。AI、機器人、數位健康、精準醫療及先進診斷等技術，不斷改變醫療照護的樣貌，也為提升全球患者的健康成果開創更多可能。與此同時，亞洲正快速崛起，成為全球醫療投資、科研創新、製造能量與商業發展的重要樞紐。展望未來，醫療科技的進步將更加依賴跨國合作，唯有串聯創業者、投資人、醫療機構、政策制定者與產業領袖，才能共同推動創新，回應醫療領域最重要的挑戰。這正是 MedTech World 所肩負的重要使命。

我們致力於打造一個促進深度交流的平台，讓有價值的連結得以建立，讓創新構想轉化為合作夥伴關係、投資機會，以及真正落地的成果。透過匯聚全球醫療生態系的領袖，我們希望進一步鞏固香港作為醫療創新交流樞紐的地位，並協助亞洲快速成長的醫療科技社群，與歐洲、北美、中東及其他地區建立更多合作契機。本次活動正體現了這項願景。醫療科技產業的進步，不僅取決於突破性的技術創新，更建立在全球醫療社群緊密合作的基礎之上。

感謝各位與我們共同見證這個重要時刻。我們攜手合作，將有機會加速醫療創新、改善患者治療成果，並深化那些將引領亞洲乃至全球醫療照護邁向下一個時代的重要夥伴關係。

祝您在本次活動中收穫豐富、滿載而歸。 Dr. Dylan Attard MD, MRCSI, MEnt. 執行長暨共同創辦人 MedTech World

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Meet the robot born for companionship

Medtech World’s Duncan Barry speaks to UBTECH MICHAEL TAM, Chief Brand Officer of UBTECH, President of Consumer Robotics Innovation Business Group, and General Manager of UWORLD, as the company launches UWORLD U1, the world's first full-size mass-produced ultra-bionic humanoid robot. The company has had more than 10,000 orders and launched an initiative to donate 100 humanoid robots in support of mental well-being programmes.

Speaking to Medtech World, UBTECH’s Michael said that on June 30, 2026, UBTECH hosted its 2026 Global Launch Event in Shenzhen, where it introduced its long-term vision for humanrobot symbiosis and officially unveiled the UWORLD U1 series of full-size ultra-bionic humanoid robots, the first in the world designed for mass production. The lineup includes three models: the U1 Lite semi-torso edition, the high-performance full-body U1 Pro, and the high-dynamic full-body U1 Ultra, with pricing set from 119,800 RMB. As of the day of the launch event, cumulative orders for the UWORLD U1 Series had surpassed 13,361 units. James Zhou, Founder, Chairman of the Board, and CEO of UBTECH, outlined the company's long-term vision for the evolution of human–robot collaboration. He described a three-stage progression: first, completing hazardous and repetitive work to free people from dangerous tasks; second, extending into everyday life through companionship and service applications; and ultimately, advancing toward increasingly seamless interaction between humans and intelligent robots.

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Michael said UBTECH is evolving beyond a traditional robotics manufacturer toward a platform company focused on AI-enabled robotics and intelligent infrastructure. He noted that the company has pursued a two-decade roadmap for growth. During the first phase (2012–2022), UBTECH focused on developing core technologies, helping bring humanoid robots from research laboratories into industrial deployment while building the company's commercial foundation. During the second phase (2023– 2033), the company is expanding into consumer robotics with the goal of making humanoid robots part of everyday life. The year 2026 marks an important step in the evolution of UBTECH from industrial and commercial applications toward consumer adoption. Backed by its self-developed full-stack humanoid robot technologies, broad application portfolio, and continued investment in innovation and talent, UBTECH has achieved multiple industry milestones. Building on its industrial robotics business, the company ranked first globally in revenue and sales volume from full-sized

embodied intelligent humanoid robots in 2025, and launched UWORLD in 2026, extending its robotics portfolio into the consumer market. During the launch, Michael Tam, Chief Brand Officer of UBTECH, President of Consumer Robotics Innovation Business Group, and General Manager of UWORLD, said human-robot companionship represents a new approach to supporting mental well-being. He added that companion robots have the potential to become an important new consumer category by providing personalized emotional support throughout different stages of life. He cited projections that China's ultra-bionic humanoid robotics market could grow from the tens of billions of RMB to the trillion-RMB level between 2026 and 2036. UWORLD integrates a fully proprietary end-toend technology stack, including biomimetic skin, embodied intelligence hardware, operating systems, emotion-driven large language models (LLMs), and system-level manufacturing. This integrated architecture is designed to address long-standing challenges in the real-world deployment of humanoid robots.

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MedTech World | UBTECH

The UWORLD U1 Series features 88 degrees of freedom and a proprietary dual-pivot biomimetic cervical spine, enabling it to replicate up to 90% of fundamental human movements. The system is powered by the world’s first emotionaware LLM designed for long-term companionship, capable of recognizing more than 20 finegrained emotional states with an accuracy rate exceeding 90%. Its biomimetic fast-and-slow brain architecture draws on cognitive neuroscience principles, enabling a 500-millisecond intuitive response system alongside deep reasoning capabilities powered by models with hundreds of billions of parameters. A biomimetic expression actuation system, driven by a proprietary controller, reduces speech-to-lip synchronization latency to within 20 milliseconds, creating a remarkably lifelike interaction experience. The Agent Memory OS, a cross-temporal memory system, is designed to establish a persistent digital life framework. A proactive care engine uses environmental awareness to enable wakeword-free interaction, allowing UWORLD robots to respond naturally to contextual cues and social situations. UWORLD also emphasises the principle that users retain ownership of their data and has established a three-layer privacy architecture consisting of local-first processing, minimal cloud dependency, and user-controlled hardware safeguards. Combined with highly lifelike interaction capabilities and an end-to-end safety framework, the system enables humanoid robots to evolve from functional tools into emotionally responsive companions. The U1 Series is designed to support a wide range of consumer and commercial applications, including daily companionship, emotional support, lifestyle enhancement, and social assistance, as well as reception and hospitality services, elder care, psychological support, tourism and exhibitions, research and education, and premium domestic service applications. At the launch event, UWORLD introduced the “Human-Robot Companionship Initiative.” China

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為陪伴而生的機器人

MedTech World 記者 Duncan Barry 專訪 UBTECH 品牌長、消費機器人創新事業群總裁暨 UWORLD 總經理 Michael Tam，探討公司正式推出全球首款量產全尺寸超擬人仿生人形機器人 UWORLD U1，以及推動心理健康支持計畫的最新布局。該公司已收到超過一萬份訂單，並發起捐贈 100 台人形機器人的公益計畫，以支持心理健康相關方案。 Michael Tam 在接受 MedTech World 採訪時表示，UBTECH 於 2026 年 6 月 30 日在深圳舉辦 2026 全球新品發表會，正式發布公司對「人機共生」的長期發展願景，並推出全球首款專為量產打造的全尺寸超擬人仿生人形機器人 UWORLD U1 系列。U1 系列共推出三款機型，包括半身版本 U1 Lite、高性能全身版 U1 Pro，以及高動態全身版 U1 Ultra，售價人民幣 119,800 元起。截至發表會當天，UWORLD U1 系列累積訂單已突破 13,361 台。

UBTECH 創辦人、董事長暨執行長 James Zhou 在會中說明公司對人機協作未來發展的長期藍圖。他指出，人形機器人的發展將歷經三個階段：首先接手高風險及重複性工作，讓人類免於從事危險任務；接著進入日常生活，提供陪伴與服務；最終邁向人類與智慧機器人更自然、更無縫的互動模式。

Michael Tam 表示，UBTECH 正逐步從傳統機器人製造商，轉型為聚焦 AI 機器人與智慧基礎設施的平台型企業。他指出，公司已規劃長達二十年的發展藍圖。第一階段（2012–2022 年）專注於核心技術研發，推動人形機器人從研究實驗室走向工業應用，同時奠定公司的商業基礎。第二階段（2023–2033 年）則積極布局消費型機器人，希望讓人形機器人成為日常生活的一部分。2026 年，也象徵 UBTECH 正式從工業及商業應用邁向消費市場的重要里程碑。

憑藉自主研發的全棧式人形機器人技術、多元應用布局，以及持續投入創新與人才培育，UBTECH 已創下多項產業紀錄。以工業機器人業務為基礎，公司於 2025 年在全尺寸具身智慧人形機器人市場的營收與銷量均位居全球第一，並於 2026 年推出 UWORLD，正式將產品版圖拓展至消費市場。

在發表會上，Michael Tam 表示，人機陪伴將成為支持心理健康的新模式。他認為，陪伴型機器人有望成為新一代消費市場的重要產品類別，能夠在

UBTECH | MedTech World

has more than 90 million adults living alone and 118 million empty-nest seniors, with an estimated 10% to 20% of individuals living alone meeting the clinical criteria for mental health disorders. In response, UWORLD announced plans to donate customised humanoid robots each year to support vulnerable groups, including children growing up apart from one or both parents, older adults living alone, and families facing difficult circumstances, with the goal of providing long-term emotional companionship and psychological support.

Combined with highly lifelike interaction capabilities and an end-to-end safety framework, the system enables humanoid robots to evolve from functional tools into emotionally responsive companions. 不同人生階段提供個人化的情感支持。他並引用市場預測指出，中國超擬人仿生人形機器人市場規模，預計將於 2026 至 2036 年間，由數百億元人民幣成長至兆元規模。 UWORLD 採用完全自主研發的端到端技術架構，涵蓋仿生皮膚、具身智慧硬體、作業系統、情感驅動大型語言模型（LLM），以及系統級製造能力，旨在解決人形機器人長期面臨的實際部署挑戰。

UWORLD U1 系列擁有 88 個自由度，並搭載自主研發的雙樞軸仿生頸椎，可模擬高達 90% 的人類基本動作。系統同時搭載全球首款專為長期陪伴打造的情感感知大型語言模型，可辨識超過 20 種細緻情緒狀態，辨識準確率超過 90%。

In 2026, UWORLD plans to donate 100 customised U1 Series humanoid robots. These units will incorporate 3D facial reconstruction and voiceprintbased identity replication technologies to recreate designated individuals, while integrating emotiondriven interaction models and dedicated long-term memory systems. Combined with multimodal situational awareness, the robots are designed to provide structured psychological support services.

其仿生快慢雙系統架構結合認知神經科學原理，可在 500 毫秒內完成直覺反應，同時透過數千億參數模型提供深度推理能力。搭配由自主控制器驅動的仿生表情系統，可將語音與唇形同步延遲控制在 20 毫秒以內，帶來更接近真人的互動體驗。

With the launch of UWORLD, UBTECH has established a robotics portfolio spanning industrial, commercial and consumer applications. The industrial Walker S Series has already entered mass production and commenced deliveries, while UWORLD is expected to become the company's second growth engine as it brings humanoid robotics to consumer markets.

在此次發表會上，UWORLD 同步宣布啟動「人機陪伴倡議」。目前中國約有超過 9,000 萬名獨居成年人，以及 1.18 億名空巢長者；估計約有 10% 至 20% 的獨居人口符合心理健康障礙的臨床診斷標準。因此，UWORLD 宣布未來每年將捐贈客製化人形機器人，協助包括留守兒童、獨居長者及困境家庭等弱勢族群，提供長期情感陪伴與心理支持。

UWORLD 亦搭載跨時間記憶系統 Agent Memory OS，用於建立具持續性的數位生命架構；主動式關懷引擎則透過環境感知能力，實現無需喚醒詞的自然互動，使機器人能依據情境及社交環境主動回應。

在資料隱私方面，UWORLD 強調使用者擁有自身資料的所有權，並建立三層隱私保護架構，包括本地優先運算、將雲端依賴降至最低，以及由使用者自行控制的硬體安全機制。結合高度擬真的互動能力與完整的安全防護架構，使人形機器人從功能型工具進一步發展為具備情感回應能力的陪伴者。

UWORLD U1 系列可應用於多元消費及商業場景，包括日常陪伴、情感支持、生活協助、社交陪伴，以及接待服務、高齡照護、心理支持、觀光展覽、科研教育及高端家庭服務等領域。

2026 年，UWORLD 預計捐贈 100 台客製化 U1 系列人形機器人。這些機器人將結合 3D 臉部重建及聲紋身分複製技術，重現指定人物的外貌與聲音，並整合情感互動模型及專屬長期記憶系統，再搭配多模態情境感知能力，提供更具結構性的心理支持服務。隨著 UWORLD 正式推出，UBTECH 已建立涵蓋工業、商業及消費市場的完整機器人產品布局。目前工業用 Walker S 系列已進入量產並開始交付，而 UWORLD 則預計成為公司第二成長引擎，加速人形機器人走向消費市場。

HONG KONG AUGUST 2026

Stop Selling. Start Mapping. CLAUDIA HOLY built Podymos on a single conviction: that MedTech companies are leaving adoption on the table by getting their marketing fundamentals wrong. She speaks to Wara Samar about stakeholder mapping, AI-driven hyper-personalisation, and why bad messaging is like sailing with the anchor still down.

There is no shortage of brilliant technology entering the medical device market. What there is, according to Claudia Holy, Founder and CEO of specialist MedTech marketing agency Podymos, is a persistent failure to communicate that brilliance in a way that moves people to act. Working exclusively within MedTech, Holy argues her team sees what generalist agencies cannot. "We work across so many MedTech companies that we see what works and what doesn't," she tells Samar. "A marketer sitting inside one medical 14

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device company sees what works for that company. We see what works across the whole sector... what resonates with healthcare professionals, how they are moving towards digital assets. That's where our real advantage is."

The mapping problem

Samar asks Holy to name the costliest mistake companies make at launch. She answers without hesitation: stakeholder mapping (or the absence of it). Before messaging, before content, before channels, organisations must know who

Bad messaging is like sailing with the anchor still down. Everything else becomes very, very painful.

別急著賣產品，先建立利害關係人地圖 Claudia Holy 創立醫療科技行銷公司 Podymos 的初衷源自於一個信念：許多醫療科技企業之所以難以推動產品的採用，並非因為技術不足，而是缺乏行銷的基本功。她在接受 Wara Samar 的專訪時，分享了關於建立利害關係人地圖（stakeholder mapping）、 AI 驅動的超個人化行銷，以及為何糟糕的訊息傳遞策略，就像船錨尚未收起時就試圖啟航。醫療器材市場從來就不缺乏創新技術，真正的問題在於許多優秀的產品未能以促使市場採取行動的方式被有效傳達。身為專注於醫療科技領域的行銷公司創辦人暨執行長，Claudia Holy 認為這正是專業的醫療科技行銷團隊與一般綜合行銷代理商之間最大的差異。

“我們與非常多的醫療科技公司合作，因此能夠清楚看見哪些策略有效、哪些無效，” 她向 Samar 表示， “ 一家醫療器材公司的內部行銷人員，通常只能看見哪些方法適用於自家公司；但我們洞察的是整個產業的趨勢，哪些內容能夠引起醫療專業人士的共鳴、他們如何透過數位內容獲取資訊，這就是我們真正的優勢所在。”

HONG KONG AUGUST 2026

MedTech World | Podymos

stands between their device and adoption, what questions those people will ask, and what evidence they need to say yes. "You'll end up bumping into a brick wall if you haven't mapped this out," she says. "Who are all the people you need to speak to in order to get your technology into a hospital? What do they need to see? Map this at the start of development. It tells you what clinical evidence you need, what health economic evidence you need. Once you know that, the marketer's job becomes simple." Messaging flows directly from that mapping. Founders, being close to their technology, tend toward complexity when buyers need clarity. Holy draws on StoryBrand, the framework built by Donald Miller on the principle that people don't buy the best product; they buy the one they understand the fastest. It gives Podymos a structure for stripping messaging back to what matters. But without the stakeholder map underneath it, even the sharpest messaging misfires.

Three places the funnel breaks

The journey from pipeline to sustained adoption, Holy says, breaks down in three consistent places. First: awareness. AI-generated content has flooded every inbox, meaning salience now demands hyperpersonalisation. Generic outreach no longer clears the noise. Second: the website. Holy cites the statistics that 80 per cent of a buyer's decision is made before 16

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they ever contact a company. "If you don't have content that answers the questions your customers have, and those questions are issues, fears and concerns stopping them from buying, you lose people before you knew they were there."

80% of a buyer's decision happens before they contact you. Without the right content online, you're invisible. Third: follow-up speed. Even when the website converts, slow responses to lead forms squander the moment. Holy sees agentic AI as a near-term fix, voice agents that immediately qualify and route inbound enquiries so no lead goes cold.

Regulation as competitive moat

MedTech's regulatory complexity, be it FDA or EU MDR, countryspecific promotional guidelines, or evolving digital rules, is often treated as a ceiling on marketing ambition. Holy reframes it as a differentiator. An agency that truly understands those frameworks does the maximum possible in each geography, rather than defaulting to cautious copy out of uncertainty. Podymos accompanies every client document with a regulatory summary: claims mapped to their source, content checked for compliance.

利害關係人地圖繪製的難題

當 Holy 被問及企業在產品發佈時最容易犯、也最昂貴的錯誤時，她毫不猶豫地回答：”缺乏利害關係人地圖。 “她指出，在規劃訊息傳遞策略、內容製作和選擇行銷渠道之前，企業必須先理解有哪些關鍵決策者會影響產品的採用、這些人會提出什麼問題，以及他們需要看到哪些證據才會同意導入新技術。

“糟糕的訊息傳遞策略，就像船錨尚未收起時就試圖啟航，導致一切都會變得非常艱難。”

“如果你沒有事先進行分析，繪製出利害關係人地圖，你遲早會碰壁，” 她說。 “為了讓你的技術順利進入醫院，你需要和哪些人溝通？他們在意什麼？這些都應該在產品開發初期就釐清。這樣的分析能告訴你需要蒐集哪些臨床證據、以及哪些健康經濟學證據，一旦這些基礎工作完成，行銷人員的工作就會變得簡單許多。” Holy 指出，訊息的傳遞是建立在利害關係人地圖上。許多創辦人因為過於熟悉自身技術，往往傾向於談論複雜的產品功能和技術細節，然而市場與買家需要的是清晰又容易理解的價值主張。為此，Holy 採用了 Donald Miller 所構建的 StoryBrand 框架，這個核心理念非常簡單：人們購買的未必是最好的產品，而是最容易理解的產品。這套方法論為 Podymos 提供了一套清晰的架構，協助客戶聚焦於真正需要被說明的訊息，摒除不必要的複雜內容。然而，即使擁有再出色的訊息傳遞策略，若沒有利害關係人地圖作為基礎，也無法有效觸及關鍵決策者，導致行銷成效大打折扣。

產品採用過程的三大斷點

Holy 指出，從潛在客戶開發到產品被持續採用的過程，企業最常在三個環節出現問題。

Podymos | MedTech World

購意向、並將詢問分配給最合適的業務或客服團隊，大幅縮短回應時間，確保每一個詢問都能獲得即時的跟進。

監管作為競爭護城河

"If your marketing partner doesn't understand the regulations, they'll try things you simply cannot do," she says. "But if they do, they'll enable everything you legally can. And that's a much bigger space than most companies realise." Founders are so close to their technology that it becomes very difficult to create messaging that is understood in seconds. If this messaging isn’t in place, your marketing costs will rise, conversion rates will drop, and ADOPTION WILL SLOW. Your device may gain some traction, just not nearly as much as it should. Looking ahead, Holy sees MedTech marketing accelerating online, driven by Answer Engine Optimisation pulling from websites and social channels before a sales conversation ever begins. Her closing message to every MedTech founder is the same one she delivers every day: get the stakeholder map right, get the messaging right, and everything else flows. Ignore it, and no matter how much you spend on the rest, you are sailing with the anchor still down.

糟糕的訊息傳遞策略，就像船錨尚未收起時就試圖啟航，導致一切都會變得非常艱難。第一個環節是品牌認知，隨著 AI 生成的內容大量湧現，市場上的資訊噪音已經變得前所未有地龐大，若企業想要脫穎而出，就必須提供高度個人化的內容與溝通策略。

第二個環節是企業網站， Holy 引述統計數據，在買家聯繫企業之前，往往已經完成 80% 的決策。”如果你的網站內容無法回答客戶內心的疑問，而這些疑問正是阻礙著他們採購的顧慮與風險，那你可能在察覺到這些客戶存在之前就已經失去了他們。”

“買家有 80% 的決策是在跟企業接觸之前。如果網站上缺乏正確且具有價值的內容，這間企業等於在市場上不存在。” 第三個環節則是後續跟進速度，即使網站成功吸引了潛在客戶、也完成了轉化，若企業沒有及時回應客戶的提問，也可能錯失商機。於此 Holy 認為代理式 AI 是目前能夠解決這項問題的重要工具，透過 AI 語音代理，企業可以快速回應潛在客戶的詢問、初步評估客戶的採

在醫療科技領域，無論是美國 FDA、歐盟 MDR、各國差異化的行銷規範，還是不斷演變的數位監管規則，往往被視為限制行銷發揮的天花板。Holy 反而認為這可以成為企業的競爭優勢，因為真正能理解這些框架限制的行銷團隊，能夠在各個市場法規允許的範圍內做到極致，而不會因為不確定性而採取過度保守的行銷策略。在 Podymos 的工作流程中，每一份客戶文件都附有監管摘要，明確標示各個主張的證據來源，確保所有內容都符合法規要求。

她表示 “如果你的行銷夥伴不了解這些規範，他們往往會避免做任何可能踩線的作法；但如果他們對於法規有充分的理解，他們便會幫助你在合法的範圍內發揮最大的可行空間，而這個空間往往比大多數企業能想像的還要大。”

“創辦人往往因為與自身技術過於接近，導致很難在短短幾秒內創造出清晰易懂的訊息。如果訊息傳遞不到位，行銷成本將隨之上升、轉換率下降，產品採用程度也會放緩。你的產品或許可能會取得一些市場動能，但沒有達到它應有的潛力。”

展望未來，Holy 認為醫療科技行銷會持續地加速數位化，同時，受到 Answer Engine Optimisation（AEO，答案引擎優化）的推動，網站與社群媒體內容會在銷售對話開始之前，成為客戶獲取資訊的來源。 Holy 向所有 MedTech 創辦人傳達的核心訊息始終如一：只要正確建立利害關係人地圖、清晰定義訊息傳遞策略，剩下的流程就會自然順利推進。反之，若忽略了這一點，即使投入再多資源，也無異於帶著船錨啟航，增加市場推廣的困難度。

HONG KONG AUGUST 2026

From HKUST Lab to the world stage:

How SmartCare is redefining the patient journey with AI Medtech World’s Duncan Barry speaks with SmartCare CEO JUSTIN CHENG about the company’s journey from a research initiative at the Hong Kong University of Science and Technology (HKUST) to a pioneering AI-driven platform transforming patient-centred care, reducing clinicians’ administrative burden, and wreshaping the healthcare experience.

Artificial intelligence is transforming industries worldwide, but few sectors stand to benefit more than healthcare. Born out of research at the Hong Kong University of Science and Technology (HKUST), SmartCare is emerging as a powerful example of how AI can address one of medicine’s most persistent challenges: giving clinicians more time to focus on patients.

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The company describes its philosophy as “co-pilot, not autopilot.” Transparency and human oversight remain central.

The inspiration behind SmartCare came from a simple yet widespread problem. Researchers at HKUST’s Smart Lab observed that clinicians were spending a significant portion of their working hours completing documentation rather than delivering care. Across both public and private healthcare settings, doctors often stayed late to finish clinical notes, contributing to burnout and reducing valuable patient interaction time.

從香港科技大學實驗室走向世界舞台： SmartCare 如何以人工智慧重塑病患就醫旅程

Medtech World 的 Duncan Barry 專訪 SmartCare 執行長 Justin Cheng，深入探討該公司如何從香港科技大學（HKUST）的一項研究計畫，發展成為業界領先的人工智慧醫療平台。透過 AI 技術，SmartCare 正致力於推動以病患為核心的醫療服務，減輕臨床人員的行政負擔，重新定義整體醫療體驗。人工智慧正在為全球各行各業帶來深刻變革，而醫療健康領域無疑是最具潛力的受益者之一。源自香港科技大學研究成果的 SmartCare，正逐漸成為 AI 賦能醫療創新的代表案例。SmartCare 平台聚焦於醫療產業長期面臨的核心挑戰之一：讓臨床醫師能夠從繁瑣的行政工作中解放出來，將更多的時間投入於病患照護與醫療決策上。

SmartCare 的誕生源於一個看似簡單卻普遍存在於醫療體系中的問題，香港科技大學智慧實驗室（Smart Lab）的研究人員發現，臨床醫師往往需要將大量時間花在病歷與文件紀錄等文書事務，而非直接提供病患照護。無論是在公共或私人醫

HONG KONG AUGUST 2026

MedTech World | SmartCare

At the same time, advances in large language models (LLMs) were opening new possibilities. Rather than treating AI as a technological novelty, the SmartCare team saw an opportunity to bridge the gap between what AI could achieve and what was actually being deployed in healthcare environments. Today, SmartCare supports the entire patient journey through an integrated AI-powered workflow. The process begins before a patient even meets a doctor. SmartTriage helps frontline staff assess symptoms and direct patients to the appropriate level of care, reducing waiting times and easing pressure on emergency departments. Once the consultation begins, SmartConsult listens in real time, extracting key clinical information from conversations involving multiple participants and languages. By the end of the appointment, SmartDoc automatically generates a structured clinical record with more than 97 per cent accuracy, ready for clinician review and approval. Supporting these tools is SmartChat, a conversational assistant that allows clinicians to quickly summarise medical histories, review treatment guidelines, and retrieve relevant patient records. Together, these technologies create a seamless workflow from patient admission through to medical record completion. At the heart of the platform is MedDr, one of SmartCare’s core medical large language models. Trained on extensive multimodel medical data, MedDr uses the company’s GSCo framework to combine its own reasoning with specialist diagnostic models and comparable historical cases. This enables the system to identify inconsistencies, surface relevant clinical guidelines, and suggest differential diagnoses with both breadth and precision. Importantly, SmartCare’s success has been driven by clinician trust. Feedback from healthcare professionals has been overwhelmingly positive, particularly regarding the accuracy of its documentation capabilities. Clinicians report significant reductions in time spent correcting consultation notes, while pathologists have noted that the platform achieves significant accuracy 20

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療機構，醫師經常得熬夜完成臨床記錄，不僅增加了職業倦怠的風險，也壓縮了與病患互動與診療的時間。

與此同時，大型語言模型（LLM）的快速發展為醫療創新開啟了新的可能性。SmartCare 團隊不把人工智慧視為一時的技術熱潮，而是看見將 AI 技術真正落實於醫療場景的機會。他們希望縮小人工智慧潛力與醫療應用的落差，讓先進的技術可以解決臨床現場面臨的問題。 SmartCare 透過整合式 AI 驅動工作流程，支援病患從就診前到就診後的完整醫療流程，整個流程甚至在病患見到醫師之前就已經開始。 SmartTriage 協助前線醫護人員評估症狀，將病患分流至合適的護理級別，從而縮短等候時間、減輕急診室的壓力。

當診療開始，SmartConsult 會即時分析對話內容，從涉及多位參與者或多種語言的對話中讀取關鍵的臨床資訊。診療結束後，SmartDoc 會自動生成結構化的病歷紀錄，準確度超過 97%，可供臨床醫師審核和確認。

支援這些工具運作的是 SmartChat，一款對話式 AI 助理，可協助臨床醫師快速整理病史、查閱治療指引、並調閱相關病歷資料。這些技術共同建構出一套從病患入院到病歷完成的無縫工作流程。

平台的核心是 MedDr，這是 SmartCare 的核心醫療大型語言模型之一。 MedDr以大量多模態醫療數據進行訓練，並透過該公司自主開發的 GSCo 框架，整合自身推理能力、專業診斷模型、以及相似歷史病歷進行分析。這使得系統能夠識別潛在異常或資訊不一致之處，提供相關的臨床指引，並提出兼具廣度與精準度的鑑別診斷建議。 SmartCare 的成功很大程度是建立在臨床醫師的信任上。醫療專業人員對平台的回饋普遍正面，尤其肯定其在醫療文件生成方面的準確度。許多臨床醫師表示他們修改診療記錄的時間大幅減少；病理學家則指出平台在辨識醫學術語方面達到高度準確性。這不僅提升了工作效率、也有效減輕行政負擔，讓醫療人員能夠投入更多的時間與病患互動。

除了臨床實務之外，SmartCare 也致力於推動醫學教育的創新。藉由採用 AI 技術打造的虛擬病人系統，該系統將會用於香港臨床醫生的培訓，讓醫事培訓人員能夠在安全的模擬環境中練習處理罕見且複雜的病例，補足日常訓練中較少接觸到的實戰經驗。

SmartCare | MedTech World

in recognising medical terminology. The result is improved efficiency, reduced administrative burden, and more meaningful patient engagement. Beyond clinical practice, SmartCare is also helping shape the future of medical education through its collaboration with the Hong Kong Academy of Medicine. Using virtual patients powered by the same AI technology, trainees can safely practise managing rare and complex cases that they may not encounter during routine clinical training. The platform also addresses challenges of cost and accessibility. Unlike traditional standardised patient programmes, virtual patient training can be conducted anytime and anywhere, making repeated practice more affordable and scalable. Reflecting Hong Kong’s multilingual healthcare environment, these virtual patients can communicate in Cantonese, Mandarin, and English, helping trainees develop both clinical and communication skills. Despite its advanced capabilities, SmartCare’s developers are clear about one principle: AI should enhance clinical judgment, not replace it. Every recommendation, whether a triage suggestion, drafted note, or diagnostic insight, is presented as a recommendation for review, modification, or rejection by a healthcare professional. The company describes its philosophy as “copilot, not autopilot.” Transparency and human oversight remain central to the platform’s design, ensuring clinicians understand the reasoning behind AI-generated suggestions and retain full responsibility for patient care. With its world-class research institutions, multilingual clinical environment, and strong healthcare infrastructure, Hong Kong has provided the ideal testing ground for innovation. For SmartCare, the journey from an HKUST research lab to international healthcare markets reflects a broader story about Hong Kong’s growing role in global health technology. As healthcare systems worldwide search for ways to improve efficiency without compromising quality, SmartCare demonstrates how AI can empower clinicians, enhance patient experiences, and help shape the future of medicine.

該平台同時也解決了成本與可及性方面的挑戰。相較於傳統的標準化病人（standardised patient）培訓計畫，虛擬的病患訓練可以隨時隨地進行，讓培訓人員能以更低的成本進行反覆練習，並具備更高的擴展性。因應香港多語言的醫療環境，這些虛擬病人能以粵語、普通話及英語進行互動，協助學員同時培養臨床技能與增進醫病溝通能力。

儘管具備先進的 AI 技術能力，SmartCare 團隊始終堅持一項核心原則：AI 的角色是輔助而非取代臨床判斷。無論是分診建議、診療紀錄草稿、還是診斷分析建議，所有 AI 生成的內容都僅作為參考建議，由醫療專業人員進行審核、修改或否決。

SmartCare 將這項理念形容為 “Co-pilot, not autopilot（副駕駛，而非自動駕駛）”。平台的設計始終以透明度與人工監督為核心，確保臨床醫師能夠理解 AI 建議背後的邏輯與依據，同時對病患照護保有最終決策權與責任。

憑藉世界一流的研究機構、多語言的臨床環境、以及完善的醫療基礎設施，香港為醫療創新提供了理想的試驗場域。對 SmartCare 而言，從香港科技大學的研究實驗室走向國際醫療市場的發展歷程，反映出香港在全球醫療科技領域日益重要的地位。當全球醫療系統都在尋找兼顧品質與效率的解決方案時，SmartCare 證明了 AI 技術不僅能提升效率，更能協助臨床醫師發揮更大價值、優化病患就醫體驗，對醫療發展開拓更多的可能性。

Rather than treating AI as a technological novelty, the team saw an opportunity to bridge the gap between what AI could achieve and what was actually being deployed in healthcare environments.

HONG KONG AUGUST 2026

From bank notes to lab notes:

Powering precision at the point of care

The VitaPCR™, Credo Diagnostic’s first breakthrough platform, delivers highly accurate results when time is critical. Duncan Barry interviews TAI LIM TAN, Head, Chairman’s Office and Vice President at Credo Diagnostics and MedTech Innovator, Asia Pacific Alumni, on his career journey and Credo Diagnostics’ strategic direction and global mission.

After a long career in private banking, Tai Lim Tan made an unconventional career move at 53, leaving finance behind to join the fast-evolving world of medical diagnostics. Seven years later, he serves as Head of the Chairman’s Office and Vice President at Credo Diagnostics, where he plays a central role in shaping the company’s strategic direction and global mission. Working closely with founder, Chairman and CEO Dr Wong Jr Winston, his portfolio spans corporate development, investor relations, operations, and internal communications, offering a comprehensive view of the inner workings of a rapidly growing healthcare technology company. Central to that mission is advancing awareness of point-of-care molecular testing and its transformative potential in modern medicine. Credo’s first breakthrough platform, the VitaPCR™, was developed to address urgent respiratory threats including Influenza, RSV, COVID-19 and Strep A. Designed as a 20-minute, multi-target PCR system using direct lysis technology, it delivers laboratory-grade accuracy in time-critical environments such as emergency departments and urgent care clinics. During the COVID-19 pandemic, the VitaPCR™ demonstrated its clinical value. Beyond speed, it provided clinicians with the confidence to make immediate,

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MedTech World | Credo Diagnostic

informed decisions at a time when every minute carried heightened risk. “As point-of-care molecular diagnostics gained wider acceptance, clinical demand expanded beyond respiratory infections to more complex, syndromic applications. That shift led to the development of the VitaSIRO solo™,” Tai Lim Tan explained. Engineered with built-in nucleic acid extraction integrated into a patented microfluidic cartridge, the VitaSIRO solo™ enables multiplex testing, detecting up to six pathogens in a single run in about 40 to 45 minutes. Its expanding test menu includes 16 high-risk HPV strains; sexually transmitted infections such as CT, NG, TV and MG; hospital-acquired infections including MRSA, SA and Candida auris; gastrointestinal infections; human genotyping applications; and respiratory panels covering COVID-19, Influenza and RSV. The platform is also advancing into protein detection through chemiluminescence technology, including Troponin I. Recognising that decentralised testing increases the risk of human error, Credo embedded a mandatory quality control system within the VitaSIRO solo™. The instrument will not operate unless quality control requirements are met, a safeguard developed in consultation with an experienced point-of-care testing manager in London to ensure both regulatory compliance and real-world practicality. Both the VitaPCR™ and VitaSIRO solo™ are calibration-free, supported by comprehensive warranties and replacement programmes, and designed for room-temperature reagent storage, simplifying logistics and reducing handling risks. At their core, the platforms are built around accountability, usability and uncompromising laboratory standards. Digital integration is another pillar of Credo’s strategy. The VitaDataLink™ platform connects diagnostic devices across locations, securely aggregating data to improve workflow efficiency and reduce manual error. In decentralised testing environments, seamless interoperability prevents the creation of data 24

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silos and enables proactive patient monitoring. The result is a more coordinated and predictive healthcare model. “Balancing speed with accuracy and regulatory compliance remains fundamental, particularly for rapid assays such as SARS-CoV-2/Flu/RSV tests. Robust assay design, rigorous validation, internal controls and adherence to international regulatory standards, including CE-IVD, MDSAP and ISO certifications, ensure that accelerated turnaround times do not compromise reliability or legal requirements,” he highlighted. Credo has also expanded into veterinary diagnostics, adapting its molecular platforms for companion animals. The move reflects both technological versatility and a broader “One Health” perspective, recognising the interconnectedness of human and animal health. Unlike traditional lab-centred diagnostics, Credo’s focus on point-of-care testing aims to decentralise healthcare delivery. By enabling same-visit clinical decisions, POCT reduces turnaround times, expands access in remote settings, and strengthens outbreak response capabilities. The approach is reshaping how and where diagnostics are delivered, from hospitals to clinics, pharmacies and potentially even homes. Affordability remains a core consideration, particularly for low-resource settings. Through efficient manufacturing, flexible pricing models and strategic distribution partnerships, Credo seeks to ensure high-quality diagnostics remain accessible. Simplified interfaces and remote training further support deployment in settings without specialised laboratory personnel. Looking ahead, point-of-care molecular diagnostics are poised to redefine clinical decision-making. By delivering rapid, laboratorygrade results at the patient’s side, clinicians can reduce empirical treatments, improve antimicrobial stewardship, enhance infection control, and respond more effectively to emerging outbreaks. In the coming decade, the convergence of molecular accuracy, digital connectivity and decentralised care may not only accelerate diagnosis but fundamentally reshape global healthcare delivery.

Credo Diagnostic | MedTech World

重新定義臨床決策：即時分子診斷創新之路

VitaPCR™ 是 Credo Diagnostics 推出的首個突破性診斷平台，能在分秒必爭的關鍵時刻提供高度精準的檢測結果。Duncan Barry 採訪了 Credo Diagnostics 董事辦公室負責人暨副總裁、 MedTech Innovator Asia Pacific 校友 Tai Lim Tan，聊聊他的職涯、以及 Credo Diagnostics 的策略方向和全球使命。

在私人銀行領域深耕多年後，Tai Lim Tan 在 53 歲時做出了一個大膽的職涯轉換：離開金融業，投入快速發展的醫療診斷產業。七年後，他擔任 Credo Diagnostics 董事長辦公室主管暨副總裁，在塑造公司策略方向與推動全球使命方面扮演關鍵角色。

與創辦人、董事長暨執行長 Dr Wong Jr Winston 密切合作的 Tai Lim Tan，職責涵蓋企業發展、投資人關係、營運、內部溝通等範疇，使得他能以全面視角參與這間快速發展的醫療技術公司的發展。他工作的重要目標之一，是推動市場對於即時分子檢測（point-of-care molecular testing）的認識，並彰顯該技術在現代醫學變革中的潛力。

Credo 推出的首款突破性平台 VitaPCR™，專為快速檢測流感、呼吸道融合病毒 (RSV)、COVID-19 和 A 群鏈球菌等呼吸道疾病所設計。它採用直接裂解技術，可在 20 分鐘完成多靶點 PCR 檢測，並在急診室與緊急照護中心等時間敏感場域中提供實驗室等級的檢測精準度。

在新冠肺炎疫情期間，VitaPCR™ 展現出其臨床價值。除了快速檢測之外，它協助醫生在分秒必爭情境中迅速做出臨床決策。

「隨著即時分子診斷（point-of-care molecular diagnostics）技術的廣泛應用，臨床需求已從呼吸道感染擴展到更複雜的綜合症診斷應用。這個轉變也催生了 VitaSIRO solo™ 的研發。」Tai Lim Tan 解釋道。

VitaSIRO solo™ 採用內建核酸萃取技術，並整合到專利微流體載卡（microfluidiccartridge）中，具備多重檢測能力，可在約 40 至 45 分鐘內單次檢測多達六種病原體。其持續擴展的檢測項目涵蓋 16 種高風險 HPV 株；性傳播感染，如 CT、NG、TV 和 MG；醫院獲得性感染，包括 MRSA、金黃色葡萄球菌（SA）和耳念珠菌（Candida auris）；胃腸道感染；人類基因分型分析；以及涵蓋 COVID-19、流感和 RSV 的呼吸道檢測組合。該平台亦透過化學發光技術拓展至蛋白質檢測領域，包括肌鈣蛋白（ I Troponin I）。

鑑於分散測試可能會增加人為錯誤的風險，Credo 在 VitaSIRO solo™ 中內建強制性品質控管機制。確保系統在未通過品質控制要求前無法啟動。該設計是由倫敦具豐富經驗的即時檢測專家共同參與開發，以確保兼顧法規合規性與實際臨床應用需求。 VitaPCR™ 和 VitaSIRO solo™ 皆為免校準系統，並提供完整的保固和更換計劃，同時支援室溫試劑儲存，有助於可簡化物流流程並降低操作與處理風險。兩大平台的核心理念，圍繞責任性、易用性、與不容妥協的實驗室級標準所構建。

數位整合是 Credo 策略的另一大支柱，VitaDataLink™ 平台可連接跨地點的診斷設備，並安全整合數據，以提高工作流程效率，同時減少人為操作錯誤。

在去中心化的檢測環境中，無縫的系統互通性有助於防止資料孤島的形成，並實現更具前瞻性的患者監測管理。其結果是建立一個更協同且可預測的醫療照護模式。

「在快速檢測的環境中，尤其是 SARS-CoV-2、流感、RSV 檢測，速度、準確性與監管合規性之間的平衡始終至關重要。透過穩健的檢測設計、嚴格的驗證流程、內部控制機制、以及對於國際監管（包括 CE-IVD、MDSAP 和 ISO 認證）的遵循，可以確保在縮短周轉時間的情況下，也不會影響檢測的可靠性或法律合規要求。」他強調。

Credo 亦已將業務延伸至獸醫診斷領域，並針對伴侶動物調整其分子診斷平台。這個舉動既展現了其技術的靈活性，也體現了 One Health 理念，強調人類與動物健康之間的密切連結。

有別於傳統以實驗室為中心的診斷模式，Credo 聚焦於即時檢測 (POCT)，推動醫療服務的去中心化。透過實現當次就診即時臨床決策， POCT 可縮短檢測週期、提升偏遠地區醫療服務覆蓋範圍，並強化疫情應對能力。這個模式正在重塑診斷服務的提供模式和場域，從醫院、診所、延伸至藥局，甚至未來可能進一步走向居家場景。

可負擔性仍然是核心考量因素，尤其是在資源有限的醫療環境中。Credo 透過高效率生產製造流程、彈性定價模式、以及策略性經銷夥伴合作，力求提升高品質診斷服務的可及性。同時，簡化的操作介面和遠端培訓機制，支援在缺乏專業實驗室人員的環境中進行部署。展望未來，即時分子診斷有望重新定義臨床決策模式。透過在患者端快速提供實驗室等級的檢測結果，讓臨床醫師得以減少經驗性治療、優化抗菌藥物管理、加強感染控制、並更有效應對新興傳染病或疫情爆發。

在未來十年，分子診斷的高度精準性、數位化連結能力和去中心化醫療模式的整合，不僅將加速診斷流程，更可能從根本上重塑全球醫療服務體系的提供模式。

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The scientific architecture behind Verge HealthTech Fund Medtech interviews DR JOSEPH MOCANU, Managing Partner, Verge HealthTech Fund, whose scientific background is, in many ways, a ‘key architecture point in how Verge operates’.

“When we launched Verge, the gap was pretty clear. The global healthcare system is fundamentally broken; over 4.5 billion people lack access to essential health services, there's a shortage of more than 10 million doctors globally, and healthcare spending continues to outpace GDP growth with no structural fix in sight,” Dr Mocanu told Medtech. “We saw that the real opportunity lay in technologies that could deliver scalable, affordable, and accessible solutions at a much faster pace (healthtech), and while there were entrepreneurs developing such solutions, there were no venture capital funds (that I could find) that were both trying to address this systemically and investing early where access to capital was the scarcest. “Most health-focused capital supported traditional biotech, biopharma, and capital-intensive medical devices, and emerging-market focused capital tended to be at growth/PE stage. “Healthtech funds that existed tended to be country-specific, without a global lens, and most importantly they were not in Southeast Asia, where I lived, and what capital existed tended to be generalists dabbling in health.” Dr Mocanu’s own background shaped this conviction profoundly. “I started as a scientist, having received my PhD in Medical Biophysics from the University of Toronto, with 19 scientific papers on subjects ranging from cancer therapies and stem cells to immunology and gene therapy, and three patents in brain imaging and analysis from a medical device startup I co-founded concurrently. 26

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When founders present complex diagnostic platforms or therapeutic technologies, we can engage deeply from the very first meeting rather than relying entirely on external experts.

Verge HealthTech Fund 的科學投資邏輯

Medtech 專訪 Verge HealthTech Fund 管理合夥人 Dr. Joseph Mocanu，從許多層面來看，他的科學背景深深影響了 Verge 的投資理念與運作模式。

“當我們創立 Verge 時，市場缺口其實非常明顯。全球的醫療體系存在著根本性的問題：有超過 45 億人無法獲得基本醫療服務、全球醫生短缺超過 1,000 萬人、醫療支出的增長持續高於 GDP 的成長，而市場仍看不到任何結構性的解決方案。”Dr. Mocanu 告訴 Medtech。

“我們認為，真正的機會在於醫療科技能夠以更快的速度提供規模化、可負擔、且易於取得的解決方案。雖然當時已經有一些創業者投入這個領域，但我找不到任何一家創投基金既致力於從系統層面解決這個問題、又願意在資金最匱乏的早期階段進行投資。”

Verge HealthTech Fund | MedTech World

This gave Dr Mocanu first-hand knowledge of how powerful emerging technologies can be, but also how frustratingly slow the traditional path from lab bench to patient bedside tends to be. “After transitioning through an MBA at Ivey and seven years at Oliver Wyman, where I executed or led healthcare and life sciences consulting projects across 20 countries (where I saw many of these healthcare challenges firsthand), I saw that the intersection of technology, innovative business models, and healthcare systems thinking was where the real leverage existed.” Dr Joseph Mocanu realised the major gap in the market: very few investors were backing early-stage companies using transformative technologies to make healthcare more accessible and affordable, particularly for underserved populations. That insight led him to Ed Deng, cofounder and CEO of Health2Sync, Asia’s largest diabetes management platform outside China. Deng brought the perspective of a founder who had experienced the challenges of building an early-stage healthtech company. Together, they launched Verge HealthTech Fund in 2018 with a shared goal: to support innovations capable of bridging global healthcare gaps. Dr Mocanu’s scientific background continues to shape Verge’s investment philosophy. Trained as a life sciences researcher, he says the discipline instils habits that translate naturally into venture investing, evidence-based thinking, intellectual rigour and a focus on first principles.

“大多數聚焦於醫療領域的資本都流向傳統的生物技術、生物製藥、和資本密集型醫療器械；而聚焦於新興市場的資本則往往集中於成長期或私募股權階段。” “當時的醫療科技基金大多侷限在單一國家市場、缺乏全球視野，更重要的是東南亞幾乎沒有專注於醫療科技的投資基金。而市場上現有的投資者，大多只是將醫療視為眾多廣泛的投資領域之一，而缺乏深厚的產業背景。” Dr. Mocanu 的個人經歷塑造了這個理念： “我職涯的起點是科學家。我在多倫多大學取得醫學生物物理學博士學位，發表過 19 篇科學論文，研究領域涵蓋了癌症療法、幹細胞、免疫學和基因治療。當時我曾經聯合創辦一家醫療器械新創公司，並取得三項腦成像和分析相關的專利。 “

這段經歷讓 Dr. Mocanu 親身感受到新興技術所蘊含的巨大潛力，同時讓他深刻體會到，從實驗室研究走向臨床應用這條傳統路徑是多麽漫長又充滿挑戰。

“之後，我在 Ivey Business School 完成 MBA 學位，於 Oliver Wyman 國際管理諮詢公司工作了七年，期間我曾在全球 20 個地區參與或主導醫療保健和生命科學相關的顧問專案，親眼目睹了許多醫療體系面臨的挑戰，我也逐漸發現真正能帶來改變的關鍵在於技術、商業模式創新、與醫療體系思維三者的結合。” 也正是這段經歷讓 Dr. Mocanu 意識到市場上的重要缺口：鮮少有投資人願意支持利用顛覆性技術以提升醫療可及性、可負擔性的早期新創企業，尤其是那些致力於服務醫療資源匱乏族群的企業。這項洞見讓他結識了 Health2Sync 的共同創辦人暨執行長 Ed Deng，Health2Sync 是亞洲（不含中國）最大的糖尿病管理平台之一，Deng 從創辦人的第一視角，深刻理解身為草創期健康科技企業面臨的挑戰。雙方於 2018 年共同創立 Verge HealthTech Fund，其核心目標在於支持能縮小全球醫療資源落差的創新技術。

Dr. Mocanu 的科學背景至今仍深刻影響 Verge 的投資理念。作為曾經受過生命科學研究訓練的學者，他表示這段訓練培養的思維方式能自然延伸到創投領域，包括以實證為基礎的決策思維、嚴謹的學術分析方法、以及專注在第一性原則的思考方式。

“科學訓練使我們能具備對技術的理解能力，” 他解釋道， “當企業創辦人提出複雜的診斷平台或是治療技術時，我們能夠從第一次會議就深入交流，而不必完全依賴外部專家。 “ 他也強調了數據的重要性： “假設固然重要，但最終還是要回到證據本身” Dr. Mocanu 說。他在癌症療法、幹細胞研究、與公共衛生領域的研究經驗也深刻影響了 Verge 評估投資標的的方式。例如 BrainCapture 為新興市場開發價格可負擔的腦電圖診斷設備、OLI Technologies 則

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MedTech World | Verge HealthTech Fund

“Scientific training gives us genuine technical fluency,” he explains. “When founders present complex diagnostic platforms or therapeutic technologies, we can engage deeply from the very first meeting rather than relying entirely on external experts.” It also reinforces a strong emphasis on data. “Hypotheses are important, but ultimately the evidence matters,” Dr Mocanu says. His experience researching cancer therapies, stem cells and population health also informs how Verge evaluates companies. Investments such as BrainCapture, which develops affordable EEG diagnostics for emerging markets, and OLI Technologies, which is redesigning home dialysis to significantly reduce dialysate usage, reflect the fund’s focus on innovations that combine scientific credibility with real-world impact. Verge’s multidisciplinary team plays an important role in its investment approach. The partners bring experience across scientific research, consulting, investment banking, SaaS and healthcare entrepreneurship, and have collectively invested in more than 70 healthtech companies across six continents. Scarlett Chen, Erki Mölder, Carl Nicholas Ng, Ed Deng, all bring their knowledge and vast expertise to the table. And when assessing founders, Dr Mocanu says two qualities stand out: coachability and

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intentionality. Founders who are open to feedback and committed to ensuring their solutions reach underserved populations tend to build more resilient and scalable companies. While Verge invests globally, its strategy is guided by a simple principle. “Humans share the same biology and suffer from the same diseases,” Dr Mocanu says, noting that innovations developed in one region can often be adapted elsewhere. Beyond financial returns, the fund measures success through impact. Using an investment framework based on IRIS+ principles, Verge tracks the number of people positively affected by its portfolio companies. To date, those companies have reached more than 31 million lives. He also believes early-stage healthtech investing can play a critical role in reshaping the system, supporting innovations ranging from accessible Alzheimer’s diagnostics and affordable home dialysis to digital infrastructure that enables fragmented healthcare systems to become more connected. “I hope Verge’s investments will help bring transformative healthcare technologies to more than one billion people within the next decade, while demonstrating that early-stage healthtech investing can deliver both strong financial returns and meaningful societal impact,” Dr Mocanu said.

重新設計居家透析流程，顯著減少了透析液的使用。這些投資體現了 Verge 對兼具科學可信度和實際影響力創新的重視。

Verge 的多學科團隊在投資方法中扮演了關鍵角色，合夥人背景涵蓋了科學研究、管理顧問、投資銀行、SaaS 和醫療創業領域，至今已經在全球六大洲共同投資了超過 70 家醫療科技企業。Scarlett Chen、Erki Mölder、Carl Nicholas Ng、Ed Deng 皆貢獻了他們豐厚的專業知識與實戰經驗。

Dr. Mocanu 表示，在評估創辦人時，有兩個特質至關重要：可指導性與目標導向。願意接受回饋、並有意識地確保解決方案能夠惠及醫療資源匱乏族群的創辦人，往往能夠建立更具韌性且規模化的企業。雖然 Verge 的投資佈局遍佈全球，但其策略始終遵循一個核心原則。Dr. Mocanu 說： “人類在生物學層面是相通的，也面對著同樣的疾病挑戰。” 他指出，在某一個地區誕生的創新，往往可以在其他地區進行調整與應用。

除了財務上的回報之外，該基金也以影響力來作為衡量成功的重要指標。 Verge 採用基於 IRIS+ 的投資框架，來追蹤受到其投資組合企業帶來正面影響的人數。至今這些公司已惠及超過 3,100 萬人。

他也認為，早期醫療科技投資能夠在重塑醫療體系方面發揮關鍵作用，支持的創新範疇涵蓋了更便捷的阿茲海默症診斷、價格可負擔的居家透析、到能夠連接碎片化醫療體系的數位基礎設施等多種領域。

“我希望 Verge 的投資，能夠在未來十年內幫助超過十億人受益於具變革性的醫療技術，同時證明早期醫療科技投資不僅能帶來可觀的財務回報，也能創造深遠的社會影響。” Mocanu 博士說。

Shaping the future of

Duncan Barry interviews DR RENZO DE GABRIELE, Permanent Secretary, Office of the Deputy Prime Minister and Ministry for Health in Malta on Malta's Digital Health and Health Data Strategy 2030.

healthcare

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MedTech World | Ministry for Health, Malta

Malta has unveiled an ambitious Digital Health & Health Data Strategy 2030. If you had to summarise its vision in a few words, what would it be? Our vision is simple: better health through digital transformation, innovation and data-driven care. The Strategy aims to create a more connected, proactive and patient-centred healthcare system, where citizens benefit from modern digital services and healthcare professionals have access to the tools and information needed to deliver safer, faster and more personalised care. The Strategy is centred around three pillars: Health Data, Digital Transformation and Artificial Intelligence. Can you explain further? The three pillars work together to modernise healthcare. Health Data focuses on secure, interoperable and high-quality information that supports better care, planning and research. Digital Transformation focuses on redesigning services around patients and healthcare professionals, reducing administrative burdens and improving access through technology. Artificial Intelligence explores how emerging technologies can support diagnostics, predictive analytics, personalised medicine and operational efficiency. AI adoption, however, must remain ethical, transparent, human-centred and supported by strong

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governance. Together, these pillars provide the foundations for a modern and sustainable healthcare system. There is a recurring emphasis in the launched digital health 2030 document on putting citizens at the centre of healthcare. What will digital healthcare actually mean for the average Maltese patient over the next five years? Digital health should simply make life easier for citizens. Over the coming years, people will increasingly be able to access health information online, communicate more easily with healthcare providers and benefit from more streamlined services. At the same time, healthcare professionals will have more complete information available, supporting safer and more coordinated care. The result will be a more accessible, personalised and convenient healthcare experience. The Strategy highlights the importance of empowering citizens to own and access their health information. How do you see this changing the traditional relationship between patients and healthcare providers? Secure access to personal health information allows citizens to become active participants in their care. Better-informed patients can engage more effectively in decisions, improving transparency, health literacy and shared decision-making.

Healthcare professionals remain central to clinical decision-making, but digital tools help strengthen the partnership between patients and providers. International evidence shows that engaged patients are more likely to manage their health effectively and achieve better outcomes. Malta has consistently ranked among Europe's leaders in digital public services. How does this existing digital maturity give Malta an advantage in implementing a comprehensive digital health ecosystem? Malta's long-standing investment in digital public services, digital identity and connectivity provides a strong foundation for digital healthcare. Our size is also an advantage, allowing innovation to be implemented quickly and coordinated effectively at a national level. Our ambition is not simply to digitise services, but to position Malta among Europe's leaders in digitally enabled, data-driven healthcare. The Strategy speaks about creating an innovationfriendly environment. What opportunities do you see for start-ups, SMEs, academia and international health technology companies to collaborate with Malta? Innovation depends on collaboration. The Strategy seeks to create an environment where government, healthcare providers, academia,

Ministry for Health, Malta | MedTech World

researchers, start-ups, SMEs and international companies can work together on digital health solutions. Opportunities exist in areas such as AIenabled healthcare, health data analytics, cybersecurity, telehealth and personalised medicine. Supported by strong digital infrastructure and a skilled workforce, Malta can continue attracting innovation and investment while ensuring citizens benefit from these advances. Healthcare professionals are at the heart of this transformation. How are doctors, nurses and allied health professionals being involved in shaping and adopting these new digital tools? Healthcare professionals are essential partners in this transformation. Their experience helps ensure that digital tools improve clinical workflows and patient care. The Strategy emphasises consultation, co-design, training and digital skills development so that professionals can confidently adopt new technologies and AI. Ultimately, technology should reduce administrative burdens and allow more time for patient care.

Our ambition is not simply to digitise services, but to position Malta among Europe’s leaders in digitally enabled, data-driven healthcare.

塑造醫療照護的未來

Duncan Barry 專訪馬爾他副總理辦公室暨衛生部常任秘書 Dr Renzo De Gabriele，深入探討馬爾他《2030 年數位健康與健康數據策略》的願景與未來發展。

馬爾他日前公布了雄心勃勃的《2030 年數位健康與健康數據策略》，如果要用幾句話概括這項策略的願景，您會怎麼形容？

我們的願景很簡單：透過數位轉型、創新與資料驅動的醫療照護，提升全民健康。這項策略的目標是建立一個更加互聯、主動且以病患為中心的醫療照護體系，讓民眾享有現代化的數位醫療服務，同時讓醫療專業人員取得提供更安全、更快速、更個人化醫療所需的工具與資訊。

這項策略以三大支柱為核心：健康數據、數位轉型、與 AI，您能否進一步說明？

這三大支柱相互配合推動醫療體系現代化。健康數據著重於打造安全、可互通且高品質的健康資料體系，以支援更完善的醫療照護、政策規劃及研究。數位轉型則聚焦於重新設計醫療服務，以病患與醫療專業人員為核心，減少行政負擔，並透過科技改善醫療服務的可近性。AI 則探討新興技術如何應用於診斷、預測分析、個人化醫療及提升營運效率。然而，AI 的應用必須建立在符合倫理、具透明度、以人為本及完善治理的基礎之上。這三者共同構成現代化且永續醫療體系的重要基礎。

《2030 年數位健康與健康數據策略》多次強調「以公民為醫療照護核心」。在未來五年，對一般馬爾他民眾而言，數位醫療將帶來哪些改變？

數位醫療最重要的目的就是讓民眾的生活變得更便利。在未來幾年，

民眾將能夠更方便地在線上取得自己的健康資訊、更容易與醫療服務提供者溝通、也能享有更流暢的醫療服務。同時，醫療專業人員也能取得更完整的病患資訊，進一步提升醫療照護的安全性與協調性，最終民眾將享有更便利、更個人化且更容易取得的醫療服務。

策略中特別強調賦予民眾掌握與存取自身健康資訊的能力。您認為，這將如何改變目前病患與醫療服務提供者之間的關係？

安全存取個人健康資訊，將使民眾成為自身醫療照護的積極參與者。當病患掌握更多資訊後，就能更有效參與醫療決策，提升醫療透明度、健康識能以及共同決策的品質。醫療專業人員仍然是臨床決策的核心，但數位工具能夠進一步強化病患與醫療服務提供者之間的合作關係。國際經驗也顯示，積極參與自身健康管理的病患，更有可能有效管理健康，並獲得更好的治療結果。

馬爾他長期位居歐洲數位公共服務領先國家。這樣的數位成熟度，如何幫助馬爾他建立完整的數位醫療生態系？

馬爾他多年來持續投資數位公共服務、數位身分識別及數位基礎建設，這些都為數位醫療奠定了堅實基礎。此外，馬爾他的國家規模較小，也是我們的一項優勢，使創新技術能夠更快速導入，並在全國層級有效協調推動。我們的目標不只是將醫療服務數位化，更希望讓馬爾他成為歐洲數位化、資料驅動醫療的領導者之一。

HONG KONG AUGUST 2026

Ministry for Health, Malta | MedTech World

Cybersecurity has become one of healthcare's biggest risks worldwide. How is the Ministry preparing healthcare infrastructure to withstand increasingly sophisticated cyber threats? Protecting sensitive health information and ensuring the resilience of critical services are core priorities. Our approach combines secure system design, strong governance, continuous risk assessment, digital literacy and close collaboration with national cybersecurity authorities. We are strengthening infrastructure, improving incident response and aligning with European requirements and international best practice. Citizens must be confident that their information is protected and healthcare services remain resilient against evolving threats. By 2030, what tangible milestones would demonstrate that the Strategy has been successfully implemented? What metrics will define success? Success will be measured by the difference citizens experience in their daily lives. By 2030, we aim to see healthcare professionals working within an integrated digital environment, citizens securely accessing their health information and health data being used responsibly to improve care, public health and research. Key indicators include service efficiency, patient satisfaction, digital service adoption, workforce capability, cybersecurity resilience and responsible AI implementation. Ultimately, the Strategy's success will be reflected in better health outcomes and a more sustainable, resilient healthcare system.

Healthcare professionals remain central to clinical decision-making, but digital tools help strengthen the partnership between patients and providers. 策略強調要打造有利於創新的環境，您認為新創公司、中小企業、學術界以及國際健康科技企業，可以與馬爾他展開哪些合作？

創新必須建立在合作之上，這項策略希望打造一個政府、醫療服務提供者、學術界、研究人員、新創公司、中小企業以及國際企業能共同合作開發數位醫療解決方案的環境。合作機會包括 AI 醫療應用、健康數據分析、網路安全、遠距醫療以及個人化醫療等領域。在完善的數位基礎建設與專業人才支持下，馬爾他將持續吸引創新與投資，同時確保民眾能真正受惠於這些發展。

醫療專業人員是這場轉型的核心，醫師、護理師及其他醫療專業人員如何參與新數位工具的設計與導入？

醫療專業人員是這場轉型不可或缺的重要夥伴，他們的專業經驗有助於確保數位工具真正改善臨床流程及病患照護品質。因此這項策略特別強調廣泛諮詢、共同設計、教育訓練及數位能力培養，讓醫療專業人員能有信心採用新的數位技術及 AI 工具。最終，我們希望科技能有效減少行政工作，讓醫療人員投入更多時間照顧病患。

網路安全已成為全球醫療體系最大的風險之一，馬爾他衛生部如何強化醫療基礎設施，以因應日益複雜的網路威脅？

保護敏感的健康資訊，以及確保關鍵醫療服務具備韌性，是我們的核心優先事項。我們的方法包括安全的系統設計、完善的治理機制、持續性的風險評估、提升數位素養，以及與國家網路安全主管機關密切合作。我們也持續強化基礎設施、改善資安事件應變能力，並與歐盟相關要求及國際最佳實務接軌。我們希望讓每位公民都能放心，相信自己的健康資料能獲得妥善保護，而醫療服務也能在面對新型態威脅時維持穩定運作。

到 2030 年時，哪些具體成果代表這項策略已成功落實？將以哪些指標衡量成果？

成功與否，最終仍取決於民眾是否真正感受到生活上的改變。到了 2030 年我們希望看到醫療專業人員在整合式數位醫療環境中工作，民眾能安全存取自己的健康資訊，而健康數據能以負責任的方式運用於改善醫療照護、公共衛生及醫學研究。衡量成果的重要指標包括醫療服務效率、病患滿意度、數位服務採用率、醫療人力數位能力、網路安全韌性，以及負責任的 AI 應用。最終，這項策略是否成功，將反映在更佳的健康成果，以及建立一套更加永續、更具韌性的醫療照護體系。

HONG KONG AUGUST 2026

Turning Science Fiction into Clinical Reality 將科幻變為臨床現實

HONG KONG AUGUST 2026

What if the most transformative tool in your gastroenterologist’s arsenal could be swallowed with a glass of water? ARMAN NADERSHAHI, CEO of Endiatx, has turned that question into an engineering roadmap, one that begins with a pill-sized robot and ends somewhere no physician’s hand has ever reached. He speaks with Wara Samar about autonomous medicine, the data flywheel powering it, and why disrupting endoscopy is just the opening move.

For decades, the idea of a miniature robot navigating the human body belonged firmly to science fiction, the territory of paperbacks and Hollywood blockbusters, not doctor’s offices. Today, that vision is steadily moving toward clinical reality. Leading that shift is Endiatx, a California-based medical robotics company developing miniature robotics designed to go into the body, starting with the stomach. Driving it is Arman Nadershahi, a CEO whose career has woven together law, engineering, life sciences, and entrepreneurship into an unusually broad vantage point on what healthcare technology can become. When Wara Samar sat down with Nadershahi to discuss Endiatx’s ambitions, it quickly became clear that this is a leader who thinks in decades, not product cycles. “We are pioneering autonomous 38

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robots that work inside the human body,” he says. “The technologies we are building today are the foundation of that future, and we are just getting started.”

A founder shaped by medicine and multidisciplinarity

Healthcare has always been close to home for Nadershahi. Growing up in a family of physicians, he developed an early and instinctive appreciation for medicine, both its power and its limitations. Rather than following a conventional clinical path, he gravitated toward the intersection of disciplines, accumulating experience across technology, business, legal, and operations, contributing to companies that achieved acquisitions and public offerings.

We are pioneering autonomous robots that work inside the human body.

PillBot is being designed to be the world's first low-cost, disposable, remote-controlled, high-quality endoscopy pill.

Cover Story | MedTech World

What drew him to MedTech was a rare combination of intellectual rigor and genuine human impact. “Medical technology has many high barriers to entry, which makes it intellectually stimulating and highly rewarding,” he says. “It is a multidisciplinary field that is never boring, and it is very rewarding to see patients benefit from new treatments and innovative technologies.” That mindset eventually led him to Endiatx, where a single week might require fluency across hardware, software, mechanical engineering, regulatory, manufacturing, AI, clinical operations, intellectual property, and commercial strategy.

Reimagining a procedure that hasn’t changed much in decades

Traditional endoscopy is one of gastroenterology’s most indispensable diagnostic tools. It is also, for many patients, a source of anxiety and inconvenience. The procedure typically requires sedation, specialist facilities, expensive capital equipment, and the physical insertion of a scope, factors that can delay or discourage timely care and that is challenging to scale to meet demand. Nadershahi sees this as both a clinical gap and a commercial opportunity that has gone largely unaddressed for too long. Endiatx is currently developing three investigational devices: PillVue™, PillBot™, and PillSurgeon™. PillVue™ is designed to provide visualization inside the stomach through an internal ballasted system. PillBot™ advances that concept further, enabling physicians to remotely navigate the capsule for targeted, real-time examination, with the goal of soon becoming fully autonomous inside the body. Together, they aim to deliver stomach imaging without sedation, scope insertion, or large capital infrastructure, extending care into settings and patient populations currently underserved by conventional approaches. At the same time, built on the core foundation, the team is developing PillSurgeon, a capsule that is being designed to navigate and take biopsies or deliver a therapeutic intervention. While each generation introduces new capabilities, they all share the same goal: bringing highly scalable and sophisticated medical care closer

如果胃腸病學家手中最具變革性的診斷工具，可以像喝水一樣地被吞下，會發生什麼事？Endiatx 執行長 Arman Nadershahi 將這個問題轉化為一張工程路線圖，從藥丸大小的機器人開始，逐步邁向醫師過去無法觸及的體內領域。他與 Wara Samar 分享了關於自主醫療的未來、驅動這個系統運作的資料飛輪，以及為何顛覆傳統內視鏡檢查只是他的第一步。幾十年來，微型機器人在人體內穿梭的概念，一直停留在科幻小說和電影場景中，與實際的臨床醫療保持著距離。然而，這個想像正在逐步邁向臨床現實。走在這場變革前端的是總部位於加州的醫療機器人公司 Endiatx，這間公司正在開發可進入人體的微型機器人裝置，首先應用於胃部檢查。Endiatx 的領導者為執行長 Arman Nadershahi，他融合了職涯中的法律、工程、生命科學經驗和創業精神，形塑出對於醫療科技發展的前瞻視野。

當 Wara Samar 與 Nadershahi 深入探討 Endiatx 的願景時，我們很快就看出，這位創辦人著眼於未來數十年，而非以產品週期來定義技術發展。 “ 我們正在開創在人體內自主運作的機器人，”他表示， “我們今天所開發的技術，是未來醫療體系發展的基礎，而我們才剛剛起步。”

位由醫學和跨領域背景塑造的創辦人

醫療一直與 Nadershahi 的人生密不可分，他成長於一個醫師家庭，從小就對醫學的力量與限制有深刻的理解。他並沒有選擇傳統的臨床道路，轉向跨領域發展，在科技、商業、法律和營運等領域累積經驗，並參與多家成功完成併購與上市的企業。

吸引他投入醫療科技的，是這個產業同時具備高度技術門檻與對人類健康的實際影響力的雙重特性 “醫療科技的門檻很高，既帶來智力上的挑戰，也帶來高度的成就感，” 他表示， “這是一個高度跨學科交會的領域，永遠不會讓人感到枯燥乏味。而最有成就感的，是看到患者從新技術與新療法中受益。” 這樣的理念促使他加入 Endiatx，在這裡，他可能在短短一週內需要處理硬體、軟體、機械工程、法規、製造、AI、臨床營運、智慧財產權和商業策略等多種領域問題。 HONG KONG AUGUST 2026

to the patient through increasingly intelligent, miniaturized robotic systems. Endiatx’s devices remain investigational and have not yet received regulatory approval, but they represent the first rungs of a considerably longer ladder.

Engineering the impossible: Robotics at millimeter scale

Building a robotic capsule small enough to swallow, yet capable of sophisticated real-time operation inside the body, is an extraordinary engineering challenge. Every component must fit within a form factor roughly the size of a vitamin. Inside that tiny package, engineers must integrate propulsion systems, cameras, lighting, power management, wireless communications, and navigation capabilities, each individually complex and collectively formidable. “Balancing size, performance, safety, and manufacturability has been one of the most significant technical challenges throughout development,” Nadershahi acknowledges. Image quality adds another layer: physicians need clear, detailed visual information to make sound clinical decisions, and delivering that from a battery-powered capsule operating within the dynamic environment of the stomach is far from straightforward. Success requires continuous optimization across hardware, software, and system design simultaneously, with little margin for error at a scale measured in millimeters. “We are confident we will deliver the smallest capsule with the best optics on the market,” Nadershahi added.

The data flywheel: Every procedure makes the system smarter

Beyond the hardware, Endiatx is quietly building what Nadershahi describes as a data flywheel. Each procedure the system performs will create a detailed record: anatomical environments, navigation pathways, imaging data, and procedural outcomes. Over time, those datasets become increasingly valuable for training navigation systems and AI models. More procedures generate more data; better data improves algorithms; improved algorithms drive adoption; greater adoption generates still more data.

重新定義數十年未變的醫療程序

傳統內視鏡檢查是胃腸科中最重要診斷工具之一，但對許多患者來說，它是帶來焦慮和不便的來源。這樣的檢查通常需要鎮靜、專業設備、昂貴儀器、以及內視鏡置入等流程，這些因素都可能延誤或阻礙患者及時受到治療，而且難以規模化。Nadershahi 看見這既是一個臨床缺口，也是個長期未被充分開發的商業機會。 Endiatx 目前正在開發三款處於研究階段的設備：PillVue™、 PillBot™ 和 PillSurgeon™。 PillVue™ 旨在透過內建配重系統，提供胃部影像視覺化；PillBot™ 在此基礎上更進一步，使醫生能夠遠端操控膠囊，在胃內進行即時且精準的定點檢查；PillSurgeon™ 則是個未來概念裝置，目標是在體內進行自主導航，並執行活檢或治療性介入。這三款設備共同的目標，是在無需鎮靜、內視鏡置入、或大型醫療設備的情況下，實現胃部影像診斷，從而將醫療服務擴展到目前傳統模式難以覆蓋的醫療場域。Endiatx 的相關裝置仍處於研究階段，尚未獲得監管核准，但已為長期技術的發展奠定初步基礎。

挑戰不可能：毫米級機器人技術

要打造一個既小到可以被吞嚥、又能在人體內執行複雜即時操作的機器人膠囊，是一項極具挑戰的工程性任務。每個元件都必須被壓縮進一顆顆大小接近維生素的微型膠囊之中。在這個極限空間內，工程師必須同時整合推進系統、攝影鏡頭、照明、電源管理、無線通訊和導航功能，每個元件本身就已經相當複雜，組合後更是難度倍增。

“在整個研發過程中，如何在尺寸、性能、安全性與可製造性之間取得平衡，一直是最大的技術挑戰之一，” Nadershahi 坦言。影像品質又進一

MedTech World | Cover Story

It is a dynamic that has created durable competitive advantages across other data-intensive industries, and Nadershahi sees no reason it cannot do the same in medical robotics. As healthcare becomes increasingly connected and AIdriven, the integration of realworld procedural data with autonomous robotic platforms has the potential to enable more personalized, proactive, and precise care, at a scale that would be impossible through purely manual means.

The stomach is only the beginning

For all its near-term focus on upper GI visualization, Endiatx’s longer horizon is considerably more expansive. Nadershahi speaks of autonomous microsurgical platforms capable of highly targeted procedures from within the body itself and multiple capsules working in coordination. Potentially, the robotic systems could operate within other systems. These concepts remain exploratory, but they are far from idle speculation. They are the logical extension of a platform strategy built on staged, compounding progress.

“The stomach is only the beginning,” Nadershahi puts it simply, and in those six words lies the full scope of what Endiatx is working toward. The company has invested heavily in digital twins, simulation environments, and advanced control systems to prepare

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for increasingly autonomous generations of its technology. As those capabilities develop, the distance between science fiction and clinical practice continues to narrow.

Leading through complexity

Operating at the cutting edge of medical robotics means navigating technical development, regulatory requirements, fundraising, commercialization, and strategic partnerships, often simultaneously and always under resource constraints. For Nadershahi, the foundation of managing that complexity begins with the team. “Focus starts with the team,” he says plainly. Recruiting highperforming talent, maintaining strong communication, and keeping priorities clear are, in his view, the preconditions for everything else. His advice to emerging MedTech founders is characteristically grounded: understand the standard of care before attempting to change it; build robust quality systems early; engage end users from the outset; develop a credible regulatory strategy; and ensure the market opportunity is large enough to justify the considerable risks involved. Above all, he cautions against confusing creativity with execution. “Innovation alone is not enough,” he says. “Execution determines whether transformative ideas ultimately reach patients.”

步提高了技術門檻：臨床醫師需要清晰、高解析度的視覺資訊，才能做出正確的臨床判斷；然而要讓一個電池驅動的膠囊在胃部這種高度動態環境中穩定提供這樣的影像，絕非易事。這一切都得仰賴硬體、軟體與系統設計的持續優化，而在毫米級尺度下運作，幾乎沒有容錯空間。 “我們有信心推出市面上體積最小、同時具備最佳光學性能的膠囊，” Nadershahi 補充道。

數據飛輪：每一次的操作都讓系統更加聰明

除了硬體層面的突破之外，Endiatx 正在悄然建造一套 Nadershahi 稱之為 “數據飛輪” 的系統。每一次系統執行檢查，都會生成一份高度細節的資料記錄，包括人體解剖環境、導航路徑、影像數據、以及整體操作結果。隨著時間的累積，這些數據將逐漸轉化為訓練導航系統與AI 模型的關鍵資產。更多的檢查產生更多數據，更豐富的數據優化演算法，更成熟的演算法提升臨床表現，而更好的臨床表現則進一步推動技術普及，進而再次增加數據來源。

這樣的動態機制，已經在其他數據密集型的產業中建立起長期且難以撼動的競爭優勢，而 Nadershahi 認為醫療機器人領域同樣具備複製這個機制的條件。隨著醫療領域的互聯互通和AI 驅動程度的不斷提高，將真實臨床操作數據與自主機器人平台整合，將有望實現更個人化、更前瞻、也更精準的醫療服務，而這樣的規模與效率是傳統人工方式難以企及的。

胃部只是起點

儘管 Endiatx 近期的重心仍聚焦在上消化道的影像視覺化，但長期來看其技術願景遠比當前的應用還更爲宏大。Nadershahi 提到，未來將研發出能夠從體內進行精準手術的自主微型手術平台，以及多個膠囊

Cover Story | MedTech World

A new era of medicine from within

As Endiatx prepares for future regulatory milestones and advances its nextgeneration technologies, Nadershahi sees the company positioned at the convergence of several defining trends: rapidly advancing artificial intelligence, increasingly capable miniaturized robotics, expanding connected health infrastructure, ageing global populations, and widening healthcare workforce shortages. Each of these forces, independently, is reshaping how care is delivered. Together, they are creating conditions in which what Endiatx is building becomes not merely compelling, but essential.

“Endiatx was founded on an idea that once belonged to science fiction,” Nadershahi reflects. “The enabling technologies have arrived, the clinical need has never been greater, and we believe we are helping usher in a new era of robots inside the body.”

The stomach is only the beginning. For an industry constantly searching for its next frontier, Endiatx is making a compelling case that the future of healthcare may not lie in larger systems or more complex facilities, but in miniature robots navigating some of the most challenging environments imaginable, one swallowable capsule at a time.

醫療科技的門檻很高，既帶來智力上的挑戰，也帶來高度的成就感。協同運作的系統架構。在更長遠的想像中，這些機器人甚至有可能在不同的生理系統中同時運行與協作。這些構想目前仍處於探索階段，但絕非空泛的技術想像，它們是 Endiatx 平台策略的必然延伸，建立在分階段、持續積累的進步之上。

“胃部只是起點，” Nadershahi 簡潔地說，而這短短的一句話，幾乎概括了 Endiatx 所追求的全部技術邊界。為了實現這項長期願景，該公司已經大量投入數位孿生、模擬環境、以及先進控制系統的開發，已準備迎接未來更高自主性的機器人世代。隨著這些能力逐步成熟，科幻與臨床實務之間的距離也正在持續縮短。

在複雜中領導創新

在醫療機器人技術的最前沿，意味著必須要同時面對技術研發、法規要求、募資、商業化、策略合作等多重挑戰，且往往需要在有限的資源下同步推進。對 Nadershahi 而言，駕馭這份複雜性的基礎來自於團隊。 “一切始於團隊，” 他直言。在他看來，招募優秀的人才、維持高效溝通、讓每個人都清楚優先事項，是推動一切的基礎。

談到對新創醫療科技創辦人的建議時，Nadershahi 的觀點一如既往務實， “ 在嘗試改變現有醫療模式之前，必須充分理解目前的標準照護；儘早建立健全的品質管理系統；從產品開發初期就與最終使用者保持密切互動；制定可信的監管策略；並確保市場規模足以支撐醫療科技開發時所蘊含的巨大風險。” 最重要的是，他提醒創業者不要將創新與執行力混為一談。 “光有創新還不夠，” 他說， “真正決定讓一項顛覆性技術是否能走出實驗室、最終惠及病患的，是執行力。”

從人體內開啟醫療新時代

隨著 Endiatx 持續朝下一個法規里程碑邁進，並推動新一代的技術研發，Nadershahi 認為，公司正站在多個關鍵趨勢的交會點，包括快速發展的 AI、日益成熟的微型機器人技術、不斷擴展的智慧醫療基礎設施、全球人口高齡化、以及持續擴大的醫療人力短缺。這些趨勢各自在改變醫療服務的提供方式，而當它們交互作用時，也讓 Endiatx 正在打造的技術不再只是令人期待的創新，而是未來醫療體系不可或缺的一部分。

“Endiatx 的創立源自一個曾經只存在於科幻作品中的想法，” Nadershahi 表示， “如今支撐這項願景的關鍵技術已經成熟，臨床需求也比以往任何時候都更加迫切，我們相信我們正在協助開啟體內機器人醫療的新時代。” 對一個不斷追尋下一個突破點的醫療產業而言，Endiatx 正在提出一個全新的可能性：醫療的未來，或許不在於建造更大、更複雜的醫療系統，而是在於讓一顆顆可被吞服的微型機器人穿梭在人體最具挑戰性的環境中，重新定義疾病的診斷與治療方式。

HONG KONG AUGUST 2026

Healthcare without hospital walls

JAYNA LEUNG, Project Assistant at the Hong Kong Centre for Cerebro-cardiovascular Health Engineering (COCHE), explains to Duncan Barry how wearable technologies, AI and community-based screening are helping support earlier health assessment, improve access to care and reshape preventive healthcare in Hong Kong.

AUGUST 2026 HONG KONG

The Hong Kong Centre for Cerebro-cardiovascular Health Engineering (COCHE) is taking a new approach to healthcare by focusing on prevention rather than treatment. As a Health@ InnoHK centre dedicated to cerebro-cardiovascular health engineering, it combines expertise in biomedical engineering, clinical science, data science and artificial intelligence to develop technologies that identify health risks earlier and improve access to care.

We want to shift the focus from treating illness to identifying risks earlier and supporting prevention. "Our distinctive focus gives us unique opportunities," says Jayna Leung, Project Assistant at COCHE. “We work with leading global institutions, including the University of Oxford and the Karolinska Institutet, bringing together multidisciplinary expertise to develop innovative solutions for cerebro-cardiovascular health.” The centre also collaborates with large public health programmes, such as the Hongqiao CerebroCardiovascular (C2) Health Guardian Programme, giving

打破醫院圍牆的健康管理

香港心腦血管健康工程研究中心（COCHE）專案助理 Jayna Leung 接受 Duncan Barry 專訪，分享穿戴式科技、人工智能（AI）與社群健康篩查如何協助更早發現健康風險、提升醫療服務可及性，並重新定義香港的預防醫療模式。香港心腦血管健康工程研究中心（COCHE）正將醫療重心從治療轉向預防，開創醫療服務的新模式。作為 Health@InnoHK 旗下專注於心腦血管健康工程的研究中心，COCHE 結合了生物醫學工程、臨床醫學、數據科學與 AI 等跨領域專業，開發能夠及早辨識健康風險、並提升醫療服務可及性的創新技術。

「我們的研究定位十分獨特，也因此擁有許多合作機會，」COCHE 專案助理 Jayna Leung 表示。「我們與 University of Oxford、Karolinska Institutet 等世界頂尖研究機構合作，整合跨領域專業，共同開發心腦血管健康的創新解決方案。」 COCHE 也與多項大型公共健康計劃合作，例如宏橋心腦健康守護計劃，讓研究人員得以取得寶貴的真實世界數據（RWD），用於開發與驗證新的醫療服務模式。

在香港特別行政區創新科技署（Innovation and Technology Commission）資助下，COCHE 的使命是將前沿科研成果轉化為實際可應用的醫療技術，造福更多社群。

COCHE 的重要目標之一，是將預防性健康篩查與健康評估帶入社群，提升市民接受預防醫療服務的便利性，同時幫助更多人了解自身潛在的心腦血管健康風險。這類社群篩查並非取代既有醫療服務，而是作為醫療體系的重要補充。「當市民更了解自己的健康狀況後，便更有可能主動尋求進一步的醫療評估，」Leung 表示。透過手提超聲波儀器及其他便攜式健康評估設備，COCHE 將健康篩查服務帶進香港的基層社群，包括簡約公屋及過渡性房屋居民。 COCHE 藉由將健康篩查帶入社群，協助及早辨識潛在健康風險，促進預防醫療發展

COCHE 致力於確保研究實驗室開發出的創新成果能真正應用於日常生活。

同樣重要的是，如何加強社區健康篩查、臨床醫療服務及健康數據系統之間的銜接。

「我們的願景是打造能夠更完善整合居家健康監測與社群醫療服務的技術，」Leung 解釋。

HONG KONG AUGUST 2026

MedTech World | Hong Kong Centre for Cerebro-cardiovascular Health Engineering

researchers access to valuable real-world data to develop and validate new healthcare models. Funded by the HKSAR Innovation and Technology Commission, COCHE's mission is to translate advanced research into practical healthcare solutions that benefit the wider community. A key part of that mission is bringing preventive screening or health assessments closer to local communities, as way of improving access to preventive health screening and provide individuals with greater awareness of their potential cardiovascular risks. The community screenings complement existing healthcare services. “Once participants receive a better understanding of their health status, they may be encouraged to seek further medical assessment.” Using handheld ultrasound devices and other portable health assessment technologies, COCHE delivers health screening to vulnerable communities, including residents of Hong Kong's Light Public Housing and Transitional Housing. By moving screening into the community, it serves as a means of preventive healthcare to help identify health risks. COCHE is committed to ensuring that innovations developed in research laboratories can be used in everyday life. Equally important is improving the connection between community screening, clinical services and health data systems. "Our vision is to create technologies that support better integration between home monitoring and community healthcare services," Leung explains. The impact of this approach is already becoming clear. Community outreach programmes have identified many participants with previously unrecognised cardiovascular risk factors. Screening programmes act as an early-engagement mechanism which may help identify asymptomatic individuals, who, in turn, may choose to seek appropriate follow-up care. The programmes have also revealed an important public health challenge. “Many people with elevated risk factors remain unaware because they have no obvious symptoms,” Leung says. Waiting for symptoms to appear is often ineffective, as many cerebrocardiovascular conditions yield better outcomes when risks are identified and managed early." Accessibility has also proved crucial in encouraging participation. Delivering services within local communities reduces barriers such as travel and long hospital waiting times, while providing rapid

AUGUST 2026 HONG KONG

這項模式的成效已逐漸顯現，社群外展計劃已辨識出許多原本未察覺自己具有心腦血管風險因子的參與者。健康篩查計劃是一項提早接觸市民的重要機制，有助於辨識沒有症狀的高風險族群，而這些市民也可能因此選擇尋求適當的後續醫療評估。

這些計劃同時也揭示了一項重要的公共衛生挑戰。

「許多具有高風險因子的人，由於沒有明顯症狀，因此一直不知道自己處於高風險狀態，」Leung 表示。

「等到症狀出現才就醫，往往不是有效的方法，因為許多心腦血管疾病若能及早辨識風險並加以管理，通常能改善整體結果。」醫療服務的可及性也是提升市民參與的重要因素，將健康服務帶進社群，可降低交通及醫院長時間候診等障礙；而快速提供健康評估回饋，也能幫助參與者更了解自己的健康狀況，以及評估是否需要採取下一步行動。

COCHE 並非依賴單一項健康檢查，而是透過多項健康評估來全面瞭解每位參與者的健康狀況。社群健康篩檢包括腎功能、動脈粥狀硬化、中風風險、血壓、血糖及膽固醇等相關評估。

「每一項檢測都提供不同的資訊，」 Leung 表示。「將這些資訊整合後，我們便能更全面了解個人的健康狀況，並判斷是否需要接受醫療評估或其他進一步的臨床檢查，例如進階影像檢查。」

展望未來，Leung 認為，預防醫療最大的進展將來自多項技術的整合。

「我們相信，真正帶來最大影響力的，不是依賴單一創新，而是結合穿戴式健康監測、AI 輔助風險評估及社群健康篩檢。」她說，「三者結合，

Hong Kong Centre for Cerebro-cardiovascular Health Engineering | MedTech World

feedback helps participants better understand their health and any necessary next steps. Rather than relying on a single health assessment, COCHE uses multiple assessments to build a comprehensive picture of each participant's health. Community screening includes assessments related to kidney function, atherosclerosis, stroke risk, blood pressure, blood glucose and cholesterol levels. “Each test provides different information,” says Leung. “Together they give us a much more complete understanding of an individual's health and help determine whether a medical evaluation or any additional clinical assessments may be needed, such as advanced imaging for instance. Looking ahead, Leung believes the greatest advances in preventive healthcare will come from integrating multiple technologies. "Rather than relying on a single innovation, we believe the greatest impact will come from combining wearable monitoring, AI-assisted risk assessment and communitybased screening," she says. "Together, they enable a more comprehensive understanding of health risks and support earlier intervention."

"We want to shift the focus from treating illness to identifying risks earlier and supporting prevention," Leung concludes. “By developing easy-to-use home technologies, we enable people to monitor their health more effectively, better understand their risks and ultimately reduce the financial and social burden on the healthcare system.”

將能更完整掌握健康風險，並支持更早期的醫療介入。」

COCHE 的長期願景，是透過協助人們更主動管理自己的健康，從而改變香港的預防醫療模式。

「我們希望將重心從治療疾病轉向更早辨識風險及支持疾病預防，」 Leung 總結。「透過開發容易使用的居家健康技術，我們希望讓市民更有效監測自己的健康、更了解自身風險，最終降低醫療系統所承受的經濟及社會負擔。」

Established in 2020 by City University of Hong Kong in collaboration with the University of Oxford and 我們相信，真正帶來最大影 the Karolinska Institutet, COCHE continues 響力的，不是依賴單一創 to bridge scientific 新，而是結合穿戴式健康監 research, clinical practice and community 測、AI 輔助風險評估及社群 healthcare. Through AI健康篩檢。 driven health solutions, wearable technologies COCHE 於 2020 年由香港城市大學 and community screening 成立，並與牛津大學及 Karolinska programmes, it is helping bring Institutet 合作。透過 AI 驅動的健 the latest medical innovations 康解決方案、穿戴式技術及社群健 directly to the people who 康篩檢計劃，COCHE 持續串聯科 need them most - making 學研究、臨床實務與社群醫療服務， preventive healthcare more 將最新醫療創新帶給最需要的人， accessible, more connected 使預防醫療變得更普及、連結更加 and more effective. 緊密，也更有效率。

COCHE's long-term vision is to transform preventive healthcare in Hong Kong by helping people take greater control of their own health.

HONG KONG AUGUST 2026

Engineering a new era in soft-tissue surgery Aliform is a US-Dutch medical device company developing technologies for the controlled release of fibrotic skin tethering in reconstructive and aesthetic surgery. Duncan Barry speaks to VICTOR SUTURIN, CEO and founder of Aliform.

Every successful startup has a defining moment. Can you take us back to that first conversation with the plastic surgeon that ultimately led to Aliform?

In 2019, Melbourne, Australia, I left my academic career at Monash university with a goal to begin a medical device startup journey. I wanted to make sure the idea is grounded in practical reality from the start. Here we talked about cellulite – a huge unaddressed need in aesthetics, with few technological innovations available due to less research funding compared to say, the cardiovascular field. We immediately saw the opportunity to leverage our existing expertise in medical devices and working with tissues in the lab to come up with a new solution for that niche.

AUGUST 2026 HONG KONG

What convinced you that fibrotic skin tethering wasn't just another clinical challenge, but an entirely overlooked field worthy of its own category?

When we conducted our first clinical cases in the US, it became apparent that the way our device works transcends cellulite alone and is best positioned as a tool to work with the connective tissue of the adipose layer of the skin in general. As surgeons kept discovering new uses, we kept the device classification open as a general use dissector. We saw it as a better way to maximise the creative freedom of surgeons. Consequently, we started to see that working with skin fibrous septae is its own pillar on par with volume or skin laxity. When the three pillars are balanced, amazing results can be achieved, and our tool makes it possible for a lot of cases for the first time.

Before founding Aliform, what experiences shaped your approach as both a physiologist and an inventor?

During my PhD time, I worked a lot with live, sensitive tissues like the blood vessels. When doing competitor analysis for Aliform, I was surprised to see how the existing technologies were quite aggressive and used cutting blades or lasers to destroy the fibro-septal

network of the skin to achieve the effect. This included damaging native blood vessels that exist in there to keep the tissue alive. These fallbacks limit how much of the patient's skin can be treated safely. I used blunt dissection in the lab for years when dissecting connective tissue in order to protect the blood vessels. This experience helped us to design Celluleaf in order to do what it does – release the fibroseptal tethering across large areas safely.

Aliform describes skin tethering as the "third pillar" of soft-tissue surgery. What does that concept mean, and why do you believe the industry has overlooked it for so long?

We all heard about facelifts and fillers – common techniques to address skin laxity and volume deficit. Few people realise that when working with the first two pillars, it is important to balance the pulling forces exerted on the skin by the underlying connective tissue strands. More often than not, you cannot inject a fat graft into an area held down by stiff fibrous tissue, nor can you tighten the skin and achieve complete smoothness if there are dozens of bands still pulling on the surface underneath. Hence, fibrous tethering, the third pillar and our niche - is a real thing.

開創軟組織手術的新時代

Duncan Barry 專訪 Aliform 執行長暨創辦人 Victor Suturin，深入探討這家美國與荷蘭醫療器材公司如何開發用於重建與美容手術的技術，以可控方式釋放纖維化皮膚沾黏，為軟組織手術帶來全新可能。

每一家成功的新創公司都有一個關鍵時刻。能否帶我們回到您與整形外科醫師第一次對話、最終促成 Aliform 誕生的那一刻？

2019 年，我在澳洲墨爾本離開了蒙納許大學的學術工作，決定踏上醫療器材創業之路。我希望我的創業構想從一開始就建立在真正的臨床需求上，當時我們討論的是橘皮組織——這是美容醫學中一項龐大卻長期未被滿足的需求。相較於心血管醫療等領域，美容醫學獲得的研究資源較少，因此技術創新也相對有限。我們很快便意識到，可以運用既有的醫療器材開發經驗，以及在實驗室處理組織的技術，為這個利基市場打造全新的解決方案。

是什麼讓您相信，纖維化皮膚沾黏並不只是另一項臨床挑戰，而是一個長期被忽略、值得獨立發展的領域？

當我們在美國完成第一批臨床案例後，很快就發現我們的裝置並不只是適用於橘皮組織、而是一種能廣泛應用於皮膚脂肪層結締組織的工具。隨著外科醫師持續發掘新的應用方式，我們也將裝

置定位為通用型組織分離器，因為我們希望最大程度保留外科醫師的發揮空間。後來我們逐漸意識到，皮膚纖維隔膜的處理，本身就是與「體積」及「皮膚鬆弛」並列的第三大支柱。當這三個面向取得平衡時，就能達到非常出色的治療效果，而我們的工具也首次讓許多原本難以處理的案例成為可能。

在創立 Aliform 之前，哪些經歷塑造了您作為生理學家與發明家的思維？

攻讀博士期間，我經常處理血管等活性高、非常脆弱的組織。而當我在為 Aliform 進行競品分析時，我很驚訝地發現市面上的技術大多相當激進，會透過刀片或雷射直接破壞皮膚中的纖維隔膜網絡，以達到治療效果。然而這樣的方式也會損傷原本負責維持組織存活的血管，因此限制了可安全治療的皮膚範圍。我在實驗室多年來都採用鈍性分離技術處理解剖中的結締組織，以保護血管不受損傷。也正是這段經驗幫助我們設計出 Celluleaf，讓它能夠安全地在大範圍內釋放纖維化皮膚沾黏。

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MedTech World | Aliform

Celluleaf began as a solution for cellulite but has evolved into a much broader surgical platform. Was that always the vision, or did it develop over time?

The real world uses showed us the greater potential pretty quickly. We listened and let the surgeons guide us.

Deep-tech startups face unique challenges. Looking back, what were the toughest moments during Aliform's early years?

We are not in DeepTech because we have no AI or even any software, but as a medical device startup this is not easy. Looking at the worst death-valley moment, we had to solve a supplier-related issue for one of the critical components for the first batch. The six-month delay would have killed Aliform. We internalised the process instead and got it done ourselves.

Which milestone made you feel that Aliform had truly transitioned from an ambitious idea into a real medical technology company?

First successful production run and first happy patients in the US.

The real world uses showed us the greater potential pretty quickly. We listened and let the surgeons guide us. 50

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Aliform | MedTech World

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Aliform | MedTech World

You built Aliform alongside your wife and co-founder, Alisa. How have your different strengths contributed to the company's success? We are both PhD-trained. I am the dreamer, Alisa is the structural force. When I want to buy a 3D-printer, she asks “Why?”. When the door is blocked, I kick it in with creativity. She makes sure the whole building doesn’t come down.

Some of the world's leading plastic surgeons joined your advisory board before the company had significant commercial traction. What do you think convinced them to believe in your vision so early?

Using the device for the first time did the trick. It sneaks up on you. Celluleaf looks simple from the outside, but when you use it, it all makes sense all of a sudden.

The SKINERGY initiative represents significant support from European innovation partners. What does that recognition mean for Aliform's future?

It puts us in a unique position to showcase what happens when a startup retains sovereignty over its own early R&D and production. Aliform has something truly special – control of the entire lifecycle, making it extremely resilient for the battles to come.

Aliform 將皮膚牽拉稱為軟組織手術的「第三大支柱」。這個概念代表什麼？為何您認爲它長久以來一直被業界忽視？

大家都知道拉皮手術與填充，它們分別用來改善皮膚鬆弛與組織容量不足。但很少有人意識到，在處理這兩個面向時，同時也必須平衡皮下結締組織纖維束對皮膚施加的牽引力量。很多情況下，如果某個區域仍被僵硬的纖維組織牢牢固定，就無法有效注射脂肪移植；同樣地，即使拉緊皮膚，只要下方仍有數十條纖維束持續向下牽拉，表面也無法真正變得平滑。因此，纖維性牽拉，也就是我們專注的第三大支柱，是真實存在且不可忽視的問題。

Celluleaf 最初是為治療橘皮組織而開發，如今卻逐漸發展成更廣泛的外科手術平台。這一直都是您的願景嗎？還是後來逐步演變而成？

真實世界的臨床應用很快就讓我們看到更大的潛力。我們持續傾聽外科醫師的意見，並讓他們引導我們產品的發展方向。

深度技術新創公司面臨許多不同於其他企業的挑戰，回顧 Aliform 創業初期，您感到最艱難的時刻是什麼？

嚴格來說，我們並不屬於一般所稱的 DeepTech 公司，因為我們沒有 AI，也沒有軟體。不過身為一家醫療器材新創，我們遇到的挑戰依然不少。最危急的一次是第一批產品中某個關鍵零組件的供應商出了問題，如果真的延誤六個月，Aliform 很可能就此結束。我們最後決定把這項製程收回公司內部自行完成，最終成功度過危機。

哪一個里程碑，讓您真正覺得 Aliform 已經從一個充滿理想的構想，成為真正的醫療科技公司？

第一批產品成功量產，以及第一批美國患者獲得滿意的治療成果。

您與共同創辦人、同時也是您的妻子 Alisa，一起打造了 Aliform。你們各自的優勢如何促成公司的成功？

我們兩人都擁有博士學位。我負責做夢，Alisa 則負責建立架構。當我想買一台 3D 印表機時，她會先問：「為什麼？」當門被堵住時，我會用創意把門踢開；而她則確保整棟房子不會因此倒下。

在公司尚未取得明顯商業成果之前，多位世界頂尖整形外科醫師就已加入您的顧問團隊。您認為，是什麼讓他們這麼早就相信您的願景？

只要親自使用一次這個裝置就足夠了。Celluleaf 的厲害之處不是第一眼就能看出來，而是在實際使用後才會真正理解。

SKINERGY 計畫獲得歐洲創新夥伴的大力支持。這項肯定對 Aliform 未來代表什麼？

這讓我們有機會向外界展示，一家新創公司如果能掌握自身早期研發與生產的主導權，究竟能做到什麼。Aliform 最大的優勢，就是掌握產品從研發、生產到後續發展的完整生命週期，這讓我們在未來面對各種挑戰時，都能具備更強的韌性。

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The future of stem cell therapy Duncan Barry interviews YAN MENG, Executive Director, CSU Xiangya Pharmaceutical Cell Medical Technology (Shenzhen) Co., Ltd, on its pioneering new approaches in regenerative medicine.

CSU Xiangya Pharmaceutical Cell Medical Technology is pioneering new approaches in regenerative medicine. Can you tell us about the company's mission and what sets it apart in the field of stem cell technology?

CSU Xiangya Pharmaceutical Cell Medical was jointly established by Xiangya Pharmaceutical and FANCELL Innovative Pharmaceutical. Our core innovation is a proprietary neural-targeted stem cell and extracellular vesicle (EV) platform, which we are applying to the treatment of neurological disorders such as autism spectrum disorder and Alzheimer's disease. Our mission is to harness advanced cell technologies to help restore cognitive function and improve patients' quality of life, with the hope of reducing the emotional and social burden these conditions place on families.

Your work focuses on innovative neural and targeted stem cell therapies. What are the biggest breakthroughs you've achieved so far? Our neural-targeted stem cell and extracellular vesicle technology has entered clinical research

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at several leading tertiary hospitals in China. To date, close to one hundred children with autism spectrum disorder and elderly patients with Alzheimer's disease have participated in these studies, with many showing improvements in their overall health status and daily functioning, enabling them to better reintegrate into family life.

The company is developing therapies for conditions ranging from autism spectrum disorder and Alzheimer's disease to stroke, Parkinson's disease and heart disease. What makes stem cell technology such a promising approach for these complex disorders? Stem cells possess unique biological properties, including tissue repair, cellular differentiation and immune modulation. They have the potential to differentiate into functional nerve cells that may replace damaged neurons, while also secreting a range of neurotrophic factors that help improve the brain's microenvironment. This multifaceted therapeutic approach offers possibilities beyond symptom management and may address underlying disease mechanisms that conventional therapies have struggled to target.

MedTech World | Sino-South Vanya Pharmaceutical Cell Medical Technology

Neurological diseases have traditionally been among the most difficult to treat. How is your research changing what's possible for patients?

We have developed genetically modified neural stem cells delivered via extracellular vesicles, using specific protein-mediated mechanisms to regulate the gut-brain axis. Combined with an innovative non-invasive delivery system using nebulisation and intranasal administration, our platform leverages the natural signalling capabilities of extracellular vesicles to cross the blood-brain barrier efficiently and deliver targeted therapeutic components directly to sites of neurological injury.

Your technologies have received international patents and are already being applied clinically. How important is it to bridge the gap between laboratory research and real-world patient care?

Bridging the gap between laboratory innovation and real patient needs is essential. It is the only meaningful pathway for translating patented technologies and promising preclinical research into clinically validated therapies. This translational approach has been a key driver of our work in autism spectrum disorder, Alzheimer's disease and other neurological conditions, where we aim to deliver measurable improvements in patient outcomes.

Collaboration appears to be central to your work. How have partnerships with institutions such as the VandyCell Research Institute, Sun Yat-sen University and other research organisations accelerated innovation?

These research partnerships provide the scientific foundation that underpins our technology platform. Together, we collaborate on technology development, process optimisation, clinical evaluation frameworks, and rigorous assessments of safety and efficacy. By combining expertise across multiple disciplines, we have been able to accelerate innovation and achieve significant advances in both research and clinical translation.

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The company is also developing extracellular vesicle technology and advanced drug delivery systems. Could you explain what these are and why they represent an exciting area of research?

Extracellular vesicles are naturally secreted nanoscale membrane-bound particles that serve as biological carriers for intercellular communication. In our platform, they can transport key functional components derived from genetically engineered neural stem cells while also helping regulate the gut-brain axis. Coupled with our innovative nebulised and intranasal, noninvasive delivery system, extracellular vesicles can facilitate the targeted transport of therapeutic payloads across the blood-brain barrier to affected neurological tissues - addressing one of the major challenges in treating diseases of the central nervous system.

Finally, what is your long-term vision for CSU Xiangya Pharmaceutical Cell Medical Technology, and what impact do you hope the company will have on the future of global healthcare?

Drawing on the integrated strengths of Xiangya's research, clinical and industrial resources, our long-term goal is to develop effective therapies for complex diseases that remain difficult to treat, including neurodegenerative disorders and chronic non-healing wounds. We are committed to advancing cell biotechnology from the laboratory into accessible clinical practice and to helping establish internationally recognised standards for cell-based therapies developed in China. Ultimately, we hope our innovations will contribute to improving healthcare outcomes for patients around the world.

Our long-term goal is to develop effective therapies for complex diseases that remain difficult to treat, including neurodegenerative disorders and chronic non-healing wounds.

Sino-South Vanya Pharmaceutical Cell Medical Technology | MedTech World

幹細胞治療的未來

Duncan Barry 專訪 CSU Xiangya Pharmaceutical Cell Medical Technology (Shenzhen) Co., Ltd 執行董事 Yan Meng，深入探討該公司如何透過再生醫學的創新技術，開拓幹細胞治療的新方向。 CSU Xiangya Pharmaceutical Cell Medical Technology 正積極推動再生醫學的新發展。請介紹公司的使命，以及在幹細胞技術領域有哪些獨特優勢？

CSU Xiangya Pharmaceutical Cell Medical 由 Xiangya Pharmaceutical 與 FANCELL Innovative Pharmaceutical 共同成立，我們的核心創新是自主研發的神經靶向幹細胞（Neural-targeted Stem Cells）與細胞外囊泡（Extracellular Vesicles，EV）技術平台，目前主要應用於自閉症類群障礙及阿茲海默症等神經系統疾病的治療。我們的使命是運用先進的細胞技術協助患者恢復認知功能、提升生活品質，從而減輕這些疾病為家庭帶來的情緒壓力與社會負擔。

貴公司的研究聚焦於神經靶向幹細胞療法。到目前為止，最大的技術突破是什麼？

我們開發的神經靶向幹細胞與細胞外囊泡技術，目前已於中國多家三級甲等醫院展開臨床研究。截至目前已有近百位自閉症類群障礙兒童及阿茲海默症患者參與相關研究，其中許多患者的整體健康狀況與日常生活能力都有明顯改善，也更容易重新融入家庭生活。

公司目前正開發涵蓋自閉症類群障礙、阿茲海默症、中風、帕金森氏症及心臟疾病等多項治療方案。為什麼幹細胞技術被視為治療這類複雜疾病的重要方向？幹細胞具備組織修復、細胞分化及免疫調節等獨特的生物學特性。它們有潛力分化為具功能性的神經細胞，取代受損神經元，同時也能分泌多種神經營養因子，幫助改善腦部微環境。這種多面向的治療方法不僅能夠緩解症狀，更有機會直接作用於傳統療法難以介入的疾病機制。

神經系統疾病一直被視為最難治療的疾病之一，貴公司的研究如何改變患者的治療可能性？

我們開發了以基因改造神經幹細胞為基礎、透過細胞外囊泡傳遞的治療平台，利用特定蛋白質介導的機制調控腸腦軸。結合霧化吸入與鼻腔給藥等創新的非侵入式遞送方式，我們充分利用細胞外囊泡天然的訊號傳遞能力，使治療成分能有效穿越血腦屏障，精準送達神經受損部位。

貴公司的技術已取得多項國際專利，也開始投入臨床應用。您認為，縮短實驗室研究與臨床治療之間的距離有多重要？

將實驗室的創新成果真正轉化為患者可以受惠的治療方案，是整個研發過程中不可或缺的一環，也是專利技術與前期研究成果產生實際價值的唯一途徑。這種轉譯醫學的理念，一直是我們推動自閉症類群障礙、阿茲海默症及其他神經疾病研究的重要驅動力，我們希望最終能為患者帶來真正可量化的臨床改善。

合作似乎是貴公司創新的重要關鍵，請問與 VandyCell Research Institute、中山大學等研究機構的合作，如何加速技術發展？

這些研究合作夥伴為我們的平台提供了堅實的科學基礎，我們共同致力於技術研發、製程優化、臨床評估機制建立，以及安全性與有效性的嚴謹評估。透過跨領域的專業整合，我們得以加快技術創新，同時在研究和臨床應用方面取得顯著進展。

公司同時正在投入細胞外囊泡技術與新一代藥物遞送系統的開發。您能否介紹這項技術，以及它為何受到高度關注？

細胞外囊泡是一種由細胞自然分泌、奈米等級的膜狀顆粒，也是細胞彼此傳遞訊息的重要媒介。在我們的平台中，它不僅能攜帶基因工程神經幹細胞產生的重要功能性成分，同時也能協助調節腸腦軸。結合我們自主開發的霧化吸入與鼻腔給藥等非侵入式遞送系統，細胞外囊泡能協助治療成分有效穿越血腦屏障，精準運送至神經病變組織，突破中樞神經系統疾病治療長期面臨的重要瓶頸。

最後，請分享 CSU Xiangya Pharmaceutical Cell Medical Technology 的長期發展願景，以及您希望公司對全球醫療帶來哪些影響？

我們將持續整合 Xiangya 在科研、臨床及產業化方面的優勢，長期目標是開發更多針對神經退化性疾病及慢性難癒合傷口等複雜疾病的有效治療方案。我們致力於推動細胞生物科技從實驗室真正走向臨床，並協助建立具國際認可的中國細胞治療標準。最終，我們希望透過持續創新，改善全球患者的治療成效，並為全球醫療健康的未來發展貢獻一份力量。

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Beyond approval:

Maintaining global compliance in the post-market era Alira Health is a patient-centric and technology-enabled advisory firm and a full-service CRO. Its approach helps clients improve access, adoption, and impact, bringing the patient perspective into healthcare decision-making. Duncan Barry speaks with AINOA FORTEZA, Vice President of Regulatory Affairs, Medtech, at Alira Health.

Regulatory strategy is often associated with obtaining market approval, but what does "success" look like once a device is already on the market?

Success shifts from a single milestone (regulatory approval) to a continuous state (post-market requirements). Approval demonstrates that a device is safe and effective at a specific point in time. Post-market success means continually demonstrating that this remains true throughout the product's lifecycle. That means adverse events are captured and reported within required timelines, periodic safety updates are delivered on schedule, label and design changes are filed in every relevant market, and technical documentation remains audit-ready. If a regulator asks a question, the organization should be ready to respond immediately, not begin assembling the response from scratch. 58

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Success also depends on understanding how the device performs in real-world clinical practice. Manufacturers need to monitor how intended users interact with the product, evaluate its implementation in healthcare settings, and determine whether technical updates or design improvements are needed over time.

Once a product has entered multiple markets, what are the biggest regulatory challenges manufacturers typically underestimate?

Companies plan meticulously for one submission but reporting obligations don't multiply evenly across markets. A single safety signal or label change in one market can trigger a cascade of separate filings elsewhere, each with its own timeline. In my experience, without a centralized regulatory intelligence function tracking all of this,

核准之後：

後市場時代如何維持全球法規合規

Alira Health 是一家以患者為中心、以科技驅動的醫療顧問公司，同時也是提供全方位服務的臨床研究機構（CRO）。該公司透過整合患者觀點，協助客戶提升醫療產品的可近性、臨床採納率及整體影響力，並將患者需求納入醫療決策過程。 Duncan Barry 專訪 Alira Health 醫療器材法規事務副總裁 Ainoa Forteza，探討醫療器材上市後如何在全球市場持續維持合規。法規策略通常與取得上市核准畫上等號，但當醫療器材正式上市後，您認為真正的「成功」代表什麼？

成功的定義，會從單一里程碑（取得法規核准），轉變為一種持續維持的狀態（符合後市場法規要求）。取得上市核准，只能證明某項醫療器材在特定時間點符合安全性與有效性的要求；而後市場的成功，則代表企業必須在產品整個生命週期內持續證明這一點。這意味著企業必須依規定時限蒐集並通報不良事件、按時提交定期安全性更新報告、在所有相關市場完成標示與產品設計變更的法規申報，並確保技術文件隨時維持可供稽核的狀態。如果主管機關提出問題，企業應能立即回應，而不是臨時開始蒐集資料。

此外，成功也取決於企業是否真正了解產品在真實臨床環境中的表現。製造商必須持續監測使用者如何操作產品、評估產品在醫療場域中的實際應用情況，並持續評估是否需要進行技術更新或產品設計改善。

當產品已進入多個市場後，製造商最容易低估哪些法規挑戰？

企業通常會針對首次上市申請投入大量規劃，但上市後，各市場的法規義務並不會只是等比例增加。例如，一項安全訊號或產品標示變更，可能在某個市場觸發後連帶引發其他市場一連串不同的法規申報，而

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MedTech World | Alira Health

companies either miss deadlines (which can mean suspension of market access) or end up building redundant local processes that don't talk to each other. Additionally, without that centralized visibility, it becomes very challenging to stay up to date with regulatory updates from each region and to understand how changes in one area may affect not only the current device submission but also submissions in other regions.

How has the regulatory landscape changed over the past five years regarding post-market obligations?

The direction has been towards a lifecycle-based regulation. MDR and IVDR tightened vigilance timelines significantly compared with the old Medical Device Directive (shortened serious incident reporting from a 30-day window to 15 days), while also raising the bar on post-market surveillance, clinical evidence updates, and traceability. In the US, the FDA's Total Product Life Cycle inspection approach reflects the same philosophy: regulators increasingly care as much about what happens after launch as what happens before it.

Much attention is often given to market entry into Asia-Pacific, but companies increasingly operate across Europe, N. America, Latin America, the Middle East, and emerging markets. What are the biggest challenges in maintaining compliance across these diverse regulatory systems after marketing authorisation?

The core challenge is that "compliant" means something different in every jurisdiction. A vigilance timeline that satisfies the FDA won't automatically satisfy other markets’ expectations. Companies that built their compliance infrastructure around their home market often assume it will simply extend outward, but in practice, each new region requires local regulatory expertise, separate documentation, and its own monitoring rhythm. In my view, companies that manage this well treat compliance as a single global operating model with local execution.

AUGUST 2026 HONG KONG

Real-world evidence is becoming increasingly important across healthcare. How is its role evolving within medtech regulatory affairs?

RWE is moving from a nice-to-have supplement to a core part of the evidence lifecycle, spanning pre-approval, approval, and post-market. The FDA's updated December 2025 guidance is a good example: it now accepts aggregate and de-identified real-world data rather than requiring participant-level detail, without lowering scientific standards. Perhaps the biggest shift is in mindset. Companies are starting to design their real-world data architecture at launch, so the same evidence base can support post-market safety monitoring and, where relevant, entry into additional markets, rather than being assembled reactively each time a regulator asks for more.

Which types of real-world data tend to provide the strongest regulatory value for medical devices?

Registry data (where patient outcomes are systematically tracked over time) tends to carry the most weight because it's structured, consistent, and built for exactly this purpose. Claims and electronic health record data can be powerful for safety signals at scale, but only when linked to reliable device-exposure information, ideally through unique device identifiers. Ultimately, regulators value transparency above perfection. They want companies to clearly explain where the data came from, how it was validated, and its limitations, rather than present it as flawless.

Companies are starting to design their real-world data architecture at launch, so the same evidence base can support post-market safety monitoring and, where relevant, entry into additional markets.

Alira Health | MedTech World

且每個市場都有各自的時程要求。依我的經驗，如果企業沒有建立集中式法規監測機制來統籌管理，很容易因錯過申報期限而影響產品上市資格，或是在不同地區建立彼此無法整合、重複且低效率的法規流程。此外，缺乏集中管理也會使企業難以及時掌握各地法規更新，並評估某一市場的法規變動是否會影響目前或其他地區的產品申請。

企業開始在產品上市初期就規劃完整的真實世界資料架構，使同一套證據基礎除了可支援後市場安全監測，也能在適用情況下協助產品進入其他市場。

過去五年間的後市場法規要求有哪些重要變化？

整體趨勢已逐漸朝向以產品生命週期為核心的監管模式。相較於過去的《醫療器材指令》（Medical Device Directive，MDD），《醫療器材法規》（MDR）及《體外診斷醫療器材法規》（IVDR）大幅縮短警戒通報時程，例如嚴重事件通報期限由 30 天縮短為 15 天，同時也提高了後市場監測、臨床證據更新及產品可追溯性的要求。在美國，FDA 推動的「產品全生命週期（Total Product Life Cycle, TPLC）」監管模式，也反映出相同理念。主管機關現在同樣重視產品上市後的管理，而不僅僅是上市前的審查。

許多企業關注如何進入亞太市場，但如今不少公司同時布局歐洲、北美、拉丁美洲、中東及新興市場。產品上市後，要在不同法規制度下持續維持合規，最大的挑戰是什麼？

套證據基礎除了可支援後市場安全監測，也能在適用情況下協助產品進入其他市場，而不必等到主管機關提出要求後才臨時蒐集資料。

哪些類型的真實世界資料對醫療器材法規最具價值？

其中最具法規價值的通常是登錄資料，也就是長期、有系統地追蹤患者治療結果的資料。這類資料具有結構完整、品質一致，且原本就是為此目的而建立，因此最受主管機關重視。保險理賠資料（Claims Data）及電子病歷（Electronic Health Records，EHR）則可用於大規模安全性訊號分析，但前提是必須能與可靠的醫療器材使用資訊建立連結，最佳方式是透過醫療器材唯一識別碼進行串接。對主管機關而言，相較於資料是否完美，更重視的是資料的透明度。企業應清楚說明資料來源、驗證方式及其限制，而不是將資料包裝成毫無缺陷的證據。

最大的挑戰在於「合規」在不同法規管轄區有不同的定義。符合 FDA 要求的警戒通報時程，未必符合其他國家或地區主管機關的規定。許多企業都是依照本國法規建立合規架構，因此往往認為只要將既有流程延伸到其他市場即可。然而實際上每拓展至一個新市場都需要當地法規專業知識、獨立的技術文件，以及符合當地要求的持續監測機制。在我看來，真正能做好全球合規管理的企業，會將合規視為一套全球一致的營運模式，再依各地法規要求執行在地化管理。

真實世界證據在醫療領域的重要性持續提升。您認為它在醫療器材法規事務中的角色正如何改變？

真實世界證據已從過去的輔助性證據，逐漸成為產品證據生命週期的重要核心，涵蓋上市前、上市審查及上市後管理各階段。美國 FDA 於 2025 年 12 月更新的指引就是一個很好的例子。新版指引已接受彙整式（aggregate）及去識別化（de-identified）的真實世界資料，而不再要求提供每位受試者的個別資料，同時仍維持相同的科學標準。我認為最大的改變其實來自思維模式。企業開始在產品上市初期就規劃完整的真實世界資料架構，使同一 HONG KONG AUGUST 2026

Listening

before it’s too late Sparrow BioAcoustics co-founder and Chief Product Officer NADIA IVANOVA on a too-late diagnosis, an unlikely path from law to medtech, and why the future of cardiac care will be defined by timing, not treatment.

What problem was Stethophone created to solve?

“I learned I had a serious cardiovascular condition in intensive care. That is far too late – and it is the problem we set out to solve. We already know how to treat most heart diseases remarkably well. The difficulty is timing: too many people are found only after the window for effective intervention has narrowed. Stethophone exists to move detection earlier, to the moment when a clinician can still change the course of the disease rather than manage its consequences.”

You trained as a lawyer. How did you end up building a cardiac screening tool?

“Law taught me to think critically. Fifteen years in software product development taught me how to turn a hard problem into something people actually adopt. My own experience as a patient gave me the problem worth spending years on. Looking back, those three threads were always going to meet here.”

Why is early detection, not treatment, the real bottleneck in cardiac care?

“In most heart conditions, symptoms appear only once structural changes are already advanced. By then, care shifts to complex drug regimens or surgery that cannot always reverse the damage. The limiting factor is not a lack of treatments – it is the window in which the disease can still be influenced. Detect earlier, and you widen that window.” Stethophone is the world’s only FDA-cleared software-only stethoscope. What made you turn to something as ordinary as a smartphone? For some reason, no one had done it before. “We first built our technology on specialised hardware. Then that device left the market, and we asked whether the value really depended on any particular equipment. If the goal was earlier detection, ubiquity had to become a design requirement – and the most widely distributed medical-relevant sensor in the world was already in everyone’s pocket. That is what makes screening scalable – one phone can reach whole populations, not just the few who make it to a clinic.”

The published research said smartphones could not capture clinical-grade heart sounds. How did you prove otherwise?

“That earlier research was right about one thing: a phone’s raw audio is nowhere near medical quality. Closing that gap was neither quick nor easy – it took years of work on the proprietary algorithms that make an ordinary recording clinically useful. The proof came in a later clinical study, where our recordings were graded against the best devices on the market and judged equally good or better.”

What role does AI play, and what evidence supports it?

“Stethophone uses purpose-built machine-learning models trained on physiological sound – not language models. They are fixed after deployment, changing only through controlled software releases. Their accuracy comes from the scale of the data behind them, dozens of rigorous tests, and further clinical and field validations.”

提前聽見心臟的警訊

Sparrow BioAcoustics 共同創辦人暨產品長 NADIA IVANOVA 分享她如何因一次為時已晚診斷，而從法律背景跨入醫療科技領域；並闡述了為何心臟護理的未來將取決於時機，而非治療方法。 Stethophone 最初是為了解決什麼問題而誕生？

「我是在加護病房裡才得知自己罹患了嚴重的心血管疾病，那時已經太遲了——而這正是我們希望解決的問題。我們早就知道如何有效治療大多數心臟疾病，真正的瓶頸在於『時機』：太多患者是在錯過最佳介入時機之後才被診斷出來。Stethophone 的存在，就是希望把疾病發現的時間提前到醫師仍有機會改變病程的時候，而不是只能處理疾病後果的那一刻。」

您原本接受的是法律訓練，為何最後投入心臟篩檢工具的開發？

「法律訓練讓我學會批判性思考；十五年的軟體產品開發經驗，則讓我懂得如何把一個困難的問題，轉化為真正會被使用者採用的產品；而我作為患者的親身經歷，讓我找到一個值得投入多年去解決的問題。回頭來看，這三段經歷其實早就注定好會在此交會。」

為什麼心血管醫療照護真正的瓶頸是早期發現，而不是治療技術？

「大多數的心臟疾病，往往在心臟結構已經出現明顯變化時，患者才開始出現症狀。到了那個階段的治療往往只能依賴複雜的藥物或手術，而且未必總是能逆轉既有損傷。真正的限制因素並不是缺乏治療方式，而是疾病仍可被有效介入的時間窗口。一旦能夠更早發現，就可以大幅延長這個黃金治療期。」

Stethophone 是全球首款獲得 FDA 核准、純軟體形式的數位聽診器。為什麼會選擇智慧型手機這樣看似普通的裝置？之前似乎從未有人這樣做過。

「我們最初是建立在專用硬體平台上開發技術，後來那款裝置退出了市場，讓我們開始思考：真正的

HONG KONG AUGUST 2026

MedTech World | Sparrow BioAcoustics

Is Stethophone a regulated medical device?

“Yes – deliberately so. It is FDAcleared in the United States and licensed by Health Canada. Delivering Stethophone only as a regulated medical device – never as a wellness app – is a core part of our strategy: it holds us to standards of quality and reliability that ordinary wellness products are never required to meet.”

Who is your primary audience – patients, clinicians, or health systems?

“Health systems, because they decide how care is structured and scaled. Get it right at that level and the benefit flows to clinicians and patients through better triage, clearer referral pathways, and earlier access to assessment. Hospital adoption is where we start – but the software is designed for anyone to use, and putting cardiac screening within everyone’s reach is the ultimate goal.”

How do you see this transforming cardiovascular care over the next decade?

“Our next generation moves from detecting murmurs to interpreting them – classifying them as structural or non-structural, systolic or diastolic, and flagging conditions such as aortic stenosis and atrial fibrillation. And this is only the beginning: heart sound holds far more

AUGUST 2026 HONG KONG

The information has always been in the heart sound – what was missing was a way to capture and interpret it. clinical information than medicine uses today, across many conditions and symptoms. But the real shift isn’t only about detecting more or building better devices – it’s about making them an integrated

part of the healthcare system, feeding into the pathways that decide what happens next. Together, these bring us closer to a future where earlier timing, not just better treatment, changes outcomes.”

Sparrow BioAcoustics | MedTech World

價值，是否真的必須依賴某一種特定設備？如果我們的目標是讓更多人能夠及早發現疾病，那麼『普及性』就必須成為產品設計的一部分。而全球最普及、同時具備醫療相關感測能力的裝置，其實早就在每個人的口袋裡：智慧型手機。正因如此，心臟篩檢才能真正擴展到整個族群，而不只是那些有機會走進醫院的人。」

過去已有研究指出，智慧型手機無法錄製達到臨床等級的心音。你們如何證明事實並非如此？「那項研究有一點是正確的，手機原始錄製的聲音品質，確實遠遠達不到醫療用途的標準。要彌補這個差距並不容易，我們花了數年時間開發專有演算法，才讓一般手機錄製的心音具有臨床應用價值。後來的臨床研究證明了這一點：我們錄製的心音品質與市面上最好的聽診設備進行比較，結果顯示表現同樣出色、甚至更好。」

靠性標準，而這些要求並非一般健康產品所必須達到的。」

目前 Stethophone 的主要服務對象是患者、醫師，還是整體醫療體系？

「醫療體系，因為醫療體系決定了醫療服務如何被組織與擴展。只要在這個層級上做好，醫師與患者自然都能受益，包括更有效率的分流、更清楚的轉診流程，以及更早接受評估的機會。醫院是我們目前導入的起點，但這套軟體本身是為任何人都能使用而設計，讓每個人都能輕鬆取得心臟篩檢服務才是我們的最終目標。」

您認為，這項技術將如何改變未來十年的心血管醫療照護？

「我們的下一代產品將不只是『偵測心雜音』，更能進一步判讀它們，例如區分是否屬於結構性病變、收縮期或舒張期雜音，並辨識主動脈瓣狹窄、心房顫動等疾病。但這只是個開始，心音蘊含的臨床資訊遠比當今醫學所使用的要豐富得多，可應用於更多疾病與症狀的評估。真正的改變不只是偵測更多疾病、也不是打造更好的設備，而是讓這些技術真正融入醫療體系，成為臨床決策流程的一部分，協助決定患者下一步該接受什麼樣的照護。當這一切實現時，我們將更接近一個新的醫療未來，真正改變醫療結果的，不只是更好的治療，而是更早的時機。」

The most widely distributed medical-relevant sensor in the world was already in everyone’s pocket.

AI 在 Stethophone 中扮演什麼角色？有哪些證據支持其可靠性？

「Stethophone 採用的是專門針對生理聲音訓練的機器學習模型，而不是大型語言模型（LLM）。模型部署後即固定不變，只有透過受控的軟體更新才會調整。它的準確性建立在龐大的資料庫、數十項嚴格測試，以及後續多項臨床與實地驗證之上。」

Stethophone 是否屬於受監管的醫療器材？

「是的，我們刻意將它定位為醫療器材。Stethophone 已取得美國 FDA 核准，也獲得加拿大 Health Canada 的許可。我們始終堅持將它作為受監管的醫療器材，而不是一般健康管理 app。因為這代表我們必須致力於符合更高的品質與可

HONG KONG AUGUST 2026

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MedTech World

Who’s Who Directory

alirahealth.com

ascendcro.com

Alira Health is a global healthcare consultancy redefining evidence generation through patient partnership. By uniting strategic consulting, CRO services, and technology, the company supports life sciences organizations in accelerating development, improving access, and delivering measurable outcomes across the product lifecycle.

Ascend CRO is a next-generation clinical research organization that helps medtech innovators move faster from idea to evidence. Blending regulatory expertise, agile trial design, and handson execution, Ascend turns complex clinical studies into clear, efficient pathways–accelerating development while maintaining uncompromising scientific and operational quality.

Ainoa Forteza Vice President, Regulatory Affairs, Alira Health

cslifesciences.com CS Lifesciences is a USA, UK, and Ireland-based consultancy providing end-to-end Quality, Clinical, and Regulatory support for Medical Devices, IVD, and Clinical Diagnostics. We help you build QMS, run clinical studies, manage FDA and CE submissions, and deliver post-market support with practical, hands-on expertise. Edwin Lindsay Managing Director, CS Lifesciences

Jules Bligh Operations Director, Ascend Clinical Research Organisation

bluegoatcyber.com Blue Goat Cyber supports medical device teams in meeting FDA cybersecurity requirements. Its services include threat modelling, SBOM support, penetration testing and documentation, helping companies streamline submissions, reduce review friction and launch connected products securely and efficiently. Christian Espinosa Founder and CEO, Blue Goat Cyber

endiatx.com

lindo.group

At Endiatx, we’re building the first robots that live and work inside the human body — starting with the stomach. Our pill-sized robotic investigational capsules are being designed to expand patient access to GI diagnostics and make clinical practice more efficient. Every mission inside a body will make the platform smarter. The stomach is where we start. Not where we stop.

Lindo develops advanced lightingdisinfection systems using antimicrobial blue light technologies to reduce pathogens in air, water, and surfaces. Its solutions support healthcare, aged care, facilities, and transport environments, providing automated, chemical-reducing disinfection through installed, monitored, and maintained lighting systems.

Arman Nadershahi CEO, Endiatx

Robert Gangi CEO/Founder, Lindo Technology Group HONG KONG AUGUST 2026

nexinfinitymeta.ai

oculoo.com

chooseoxygen.com

NexInfinityMeta is an end-to-end IT studio building AI-accelerated digital products for healthcare and beyond. We engineer custom SaaS, mobile apps, medical publishing platforms, and patient-education portals. Serving clients across India, the US, and the Middle East. Explore our custom solutions at nexinfinitymeta.ai/services.

Oculoo is a Dutch MedTech company transforming eye drop use for millions of people. Our mission is simple: make applying eye drops easy, safe and independent for everyone. By removing everyday barriers, Oculoo helps users regain confidence, reduces dependence on care and aims to improve eye drop use worldwide.

S VEERA KUMAR Founder, NEXINFINITY META

Simon Terhürne CEO, Oculoo B.V.

Oxygen Strategic Partners helps healthcare and MedTech leaders fix fragmented systems and disconnected data. We build CRM, RevOps and digital transformation that connect marketing, sales and operations into one workflow, giving teams clear reporting and reliable pipeline visibility to support commercial growth. Based in Hong Kong, Shenzhen and the UAE.

cxwbioexpo.cn

stethophone.com

zhongchuangmedical.com

The China Smart City Construction Investment Alliance is a collaborative platform supporting smart city infrastructure, digital government, and urban transformation. It connects policy, capital, and technology resources to develop standards, deliver pilot projects, enhance urban governance, and accelerate the digital economy.

Sparrow BioAcoustics is a Canadian digital health company eliminating barriers in cardiac care. Its FDA-cleared platform, Stethophone, turns ordinary smartphones into clinical-grade tools that surface heart disease earlier in the care pathway. By enriching patient mix upstream, Stethophone makes existing cardiovascular infrastructure more productive — connecting detection to action.

Zhongchuang Medical is dedicated to the life sciences and healthcare sector. Backed by the Zhongguancun Beijing–Hong Kong–Macao Life Sciences Innovation Center, it delivers integrated solutions covering medical services, medical device distribution, technology transfer and commercialization, and international trade for enterprises and high-net-worth clients.

Cai Ming GM, SCSS Smart Healthcare & Digital Health Committee

Nadia Ivanova Chief Product Officer, Sparrow BioAcoustics

Gareth Jones Managing Partner, Oxygen Strategic Partners

Zhang Xuefei-Eric Founder, Zhongchuang Medical

HONG KONG AUGUST 2026

MedTech World

Speakers See the speakers for MedTech World, Hong Kong, Asia 26-28 August 2026

bluebox-adv.com

insilico.com

Ajeesh Ashraf is the Managing Partner of Blue Box Advancements, advising MedTech start-ups & SMEs to scale & go to market. He is the MedTech Instructor for Singapore’s GRIP program at NUS & NTU, and a key commercialization expert for MedTech Innovator and Medtech Actuator.

Alex Aliper, PhD, is Co-Founder and President of Insilico Medicine. He pioneered the use of AI in multiomics data for drug discovery, drug repurposing, generative chemistry, and generative biology, and helped advance an AI-designed drug into human clinical trials. He has been recognized as a leading biotechnology executive.

Ajeesh Ashraf Managing Partner, Blue Box

valueaddition.com.sg Alok Mishra is CEO of Value Addition Singapore, a healthcare strategy consultancy advancing MedTech commercialization across Asia Pacific, and Adjunct Associate Professor at Duke-NUS Medical School. With 25+ years of regional leadership, including two decades at Johnson & Johnson, he is the author of the recently published book Medtech Focus. Alok Mishra CEO, Value Addition

AUGUST 2026 HONG KONG

Alex Aliper Co-Founder and President, Insilico Medicine

quadriacapital.com

govincapital.com

A critical care physician turned investor, Amit is Co-founder and Managing Partner of Quadria Capital, Asia’s pre-eminent healthcare private equity firm, and Co-founder of HealthQuad, India’s largest healthtech venture firm. Over three decades across the US and Asia, he has worked at the intersection of strategy, investing, and care delivery.

Anand is Founder, Director and CEO of Govin Capital, a Singapore-based venture capital firm investing in digital health, medtech and biotech. With 23 years’ investment experience, he has led 20 successful exits, including two biotech and pharmaceutical unicorns, while championing innovation, entrepreneurship and impact investing.

Dr. Amit Varma Cofounder and Managing Partner, Quadria Capital Investment Management Pte Ltd,

Anand Govindaluri Founder & CEO, Govin Capital, Singapore

google.com With over a decade of leadership at Google and previous experience at Microsoft, Angel Lam is the Startup Territory Lead at Google Cloud, driving innovation across the Greater Bay Area. She specializes in AI-driven enterprise transformation, bridging startups with the resources to scale, while empowering the next generation of tech talent. Angel Lam Senior Representative, Startup Territory Lead, Google Cloud Hong Kong

gobi.vc Fred Li brings over 15 years of experience across private markets, management operations, and business turnaround. Fred holds a Bachelor of Business Administration in Accounting and Finance from the University of Hong Kong and a Master of Science in Biotechnology from the Hong Kong University of Science and Technology. He is a certified HKICPA CPA and Certified ESG Analyst (CESGA). Fred Li Managing Director and Head of University Ventures, Gobi Partners

every-baby.com Dr Bernard Ng is Director of Innovation, Enterprise and Commercialisation at Singapore General Hospital. He leads its transformation into a phygital hospital, advancing research, digital health, AI and medtech to deliver accessible, personalised, sustainable care at one of the world’s leading healthcare institutions.

Dabriel Choi is Founder & CEO of EveryBaby, a University of Sheffield and Sheffield Teaching Hospitals NHS spin-out. Its cervical electrical impedance device assesses preterm birth risk from 14 weeks with 92% accuracy detecting up to six weeks earlier than ultrasound, with no blood, no lab, and results in seconds.

Dr. Bernard Ng Kee Huat Director, Singapore General Hospital (SGH)

Dabriel Choi CEO, EveryBaby

medsightcapital.com Mr. Hou Jian is a former soldier and police officer turned entrepreneur, leading three industries across Asia. With his business rooted in Malaysia for nearly a decade, he focuses on crossborder resource integration, philanthropy, and international cooperation, bringing Chinese enterprise values to the global stage. Mr Hou Jian Founder, Lung Yam Capital

Ivanny Gorski Franklin is Managing Partner at MedSight Capital and a molecular biologist by training. Combining clinical, regulatory and venture capital expertise, she guides MedTech startups globally through evidence generation, regulatory strategy and reimbursement pathways, accelerating innovation and investment success. Ivanny Gorski Franklin Managing Partner, MedSight Capital

HONG KONG AUGUST 2026

honourmedical.com

svp.gov.mt

Jo Choi is Founder of Honour Medical with 20+ years of MedTech leadership across Asia Pacific. Former APAC Head of Marketing at Guerbet and Strategic Marketing Director at Merit Medical, she has launched 30+ products, driven double-digit growth, and led regional transformations. She brings deep expertise in commercial strategy, regulatory navigation, and scaling innovations.

St Vincent de Paul is Malta’s leading public provider of holistic geriatric care, delivering specialised, person-centred services under the Office of the Deputy Prime Minister and Minister for Health. Through multidisciplinary expertise, rehabilitation, innovation, and active ageing initiatives, we promote dignity, independence, wellbeing, and excellence across residential, rehabilitative, and specialised geriatric care services.

Jo Choi Founder, Honour Medical Company Limited

Jorgen Souness Chief Executive Officer, St Vincent De Paul

smartcaredev.xyz

hklss.org

Dr. Justin is a healthcare innovator championing AI and robotics to advance Hong Kong and East Asia’s medical competitiveness. A passionate advocate for local self-reliance, he bridges technology and care delivery, driving entrepreneurship in the new AI era while transforming healthcare financing and innovation across the region.

Ken Wong is Executive Director of the Hong Kong Life Sciences Society (HKLSS), founded by Nan Fung Group. Since joining its CEO Office in 2018, he has led biotech ecosystem development and established HKLSS to nurture talent and foster publicprivate and investor-academic collaborations. He was educated in Hong Kong and the UK.

Justin Cheng CEO, SmartCare Technology Co Limited

Ken Wong Executive Director, Hong Kong Life Sciences Society

lumatsers.com Dr. Shen is co-founder of LUMATSERS Limited and Associate Research Scientist at COCHE, specializes in materials science and SERS based detection technology. He leads the commercialization of needlebased sensors for ultra-sensitive, rapid cardiovascular disease (CVD) diagnostics, while extending platform applications into environmental monitoring and food safety. Junda Shen Co-founder, CEO of LUMAT-SERS Limited, Associate Research Scientist of COCHE

Tao Li, CTO of MicroPort MedBot, has over 14 years of surgical robot R&D experience. He has developed multiple landmark surgical robot systems, led national key research projects, formulated industry standards, and holds more than 230 patents including over 60 international PCT patents. Li Tao CTO, Shanghai MicroPort MedBot (Group) Co., Ltd.

HONG KONG AUGUST 2026

verge.fund

cimple.com.hk

beluntech.com

Lincoln Heng is an investor at Verge HealthTech Fund, a global early-stage VC fund backing impactful healthcare technologies worldwide. A biomedical engineer by training with First-Class Honours from King’s College London, he sources, evaluates, executes, and manages investments in breakthrough startups across AI, diagnostics, and digital health worldwide.

Liu Wengang (PhD, CityU HK, 2024), a former biotech sales engineer, cofounded Cimple as CEO during his doctoral studies. The firm develops self-driven microfluidic home tests that offer quantitative results, overcoming the qualitative-only limitation, for chronic disease, cancer screening, and reproductive health, enabling convenient personal health management.

Dr. Lydia Leung is CEO & Co-founder of Belun Technology, pioneering wearable medical devices and AI-powered sleep diagnostics for preventive healthcare. Previously Founding Director of MedTech at ASTRI, she led medical device innovation and telehealth R&D. She holds four degrees, has published 50+ papers, and owns 20+ US and China patents.

Lincoln Heng Investor, Verge HealthTech Fund

Liu Wengang CEO, Cimple Biotechnology Limited

Dr. Lydia Leung CEO & Co-founder, Belun Technology

apollohospitals.com

a-star.edu.sg/imcb

Dr Madhu Sasidhar is President and CEO of Apollo Hospitals. A US board-certified physician in internal, pulmonary and critical care medicine, he combines clinical, leadership and technology expertise, driving healthcare innovation through digital transformation, research, commercialisation and patient-centred care.

Maxine Lam is a cancer researcher turned medtech innovator, Singapore Biodesign Innovation Fellow, and champion for women’s health and active aging. She leads development of a novel treatment for stress urinary incontinence - an overlooked, stigmatised condition disproportionately affecting women.

Dr. Madhu Sasidhar Apollo Hospitals, President & CEO, Hospitals Division

AUGUST 2026 HONG KONG

Maxine Lam Senior Scientist, A*STAR

Medical Management PhD and Professor, and biomedical expert for government review in Mainland China. With 15 years’ experience, he is a pioneer in CAR-T and neural stem cell research, and a co-founder of early industry teams. He has founded and led multiple biotech enterprises and public platforms, including Carti.cn, Jingchen Biotech, and the VandyCell Research Institute. Meng (Evan) Yan Deputy General Manager, Hunan Xiangya Pharmaceutical Co., Ltd.

Philippe Gerwill is a global digital healthcare humanist, futurist, keynote speaker, and innovation advisor. A recognized key opinion leader and influencer on LinkedIn and Instagram, he champions human-centered innovation across AI, healthcare, longevity, and emerging technologies. Philippe Gerwill Founder & Managing Director, PGEA Ltd

info.mergermarket.com Rashmi Kumar is a writer, editor and moderator with 15 years of experience covering Asia’s financial markets. Since 2023, she has been an M&A Editor for Asia Pacific at Mergermarket, a leader in providing actionable intelligence into M&A opportunities and deals. Rashmi’s expertise spans capital markets, investment banking, private banking and wealth management, private equity and M&A. Rashmi Kumar M&A Editor, Mergermarket

Dr Renzo De Gabriele is the Permanent Secretary within the Office of the Deputy Prime Minister and Ministry for Health, Malta. A family physician with over 30 years of public service experience, he previously led Primary HealthCare and Active Ageing and Community Care, and contributed to Malta’s Digital Health and Health Data Strategy. Dr. Renzo De Gabriele Permanent Secretary ODPM and Ministry for Health

speedoc.com

cbridgecap.com

ciphergene.com

Dr. Shravan Verma is Co-founder and CEO of Speedoc, an AI-enabled Virtual Hospital platform delivering hospitallevel care at home across Asia. A medical doctor by training, he is leading the transformation of acute, post-acute and chronic care beyond hospital walls through technology, clinical innovation, and scalable home-based care models.

Vijay Karwal is Managing Director at CBC Group, Singapore, with over 25 years of global healthcare investment, advisory and operating experience. A CFA charter holder, he specialises in strategy, M&A, capital raising and portfolio management across healthcare, biotech and life sciences globally.

Dr. Xiao Qian is Partner and Director of Marketing at Cipher Gene, a leading Chinese genomics company. He specializes in precision medicine commercialization, strategic partnerships, and healthcare ecosystem development, helping translate genomic innovation into clinical and commercial impact.

Dr. Shravan Verma Co-founder & CEO, Speedoc

Vijay P. Karwal Managing Director, CBC Group

Xiao (Chris) Qian (PHD.) Partner & Director of Marketing, Cipher Gene

HONG KONG AUGUST 2026

Agenda 活動議程 More than a conference, MedTech World Asia brings the region’s healthcare ecosystem together. anrim.cn Dr. Xuan Luo, PhD in Biomedical Engineering from CityUHK, is an Associate Research Fellow at COCHE and CEO of ANRim Biotech. Her research focuses on neuropharmacology models, and spatial omics, actively driving the translation of advanced nanotechnology into clinical applications. Dr. Xuan Luo, PhD CEO, ANRim

MedTech World Asia 不只是一場展會，更是串聯亞洲醫療健康生態系的重要交流平台。

Floor Plan 展館平面圖

Scan the QR code to view the interactive exhibition floor plan and locate exhibitor booths, the conference stage, and key event facilities.

掃描 QR Code，查看展館平面圖，快速找到參展商攤位、會議舞台及各項活動設施。

eqtgroup.com Zoe Zhu is a Director at EQT Group based in Hong Kong, where she focuses on early-stage healthcare investments across Asia. As an active medtech investor, she has backed many medtech innovators and plays an active role in shaping portfolio companies’ growth strategies, with a particular emphasis on global expansion and strategic partnerships. Zoe Zhu Director, EQT Group

Startup pitch list

Startup Pitch 入圍名單 Meet the 10 startups selected to pitch live at the MedTech World Startup Competition.

認識入選 MedTech World Startup Pitch Competition 的 10 家新創團隊，現場見證他們展示創新技術與商業構想。

HONG KONG AUGUST 2026

MedTech World

Media Partners European Hospital and Healthcare Management, a prominent B2B global print publication, serves as the authoritative guide for healthcare professionals. Committed to delivering in-depth insights, our platform provides a comprehensive view of healthcare trends, management strategies, and innovative solutions, empowering healthcare leaders to navigate complexities and drive positive change.

BioPartner UK is an independent trade organisation promoting international partnerships, trade, and investment with UK life science companies. Collaborating with public and private sectors, it organises events, projects, and missions, leveraging technology partners to connect global stakeholders and efficiently support the UK life science sector with innovative solutions.

ochre-media.com

biopartner.co.uk

The Distretto Biomedicale Mirandolese in northern Modena, Italy, is Europe’s leading biomedical cluster and third largest globally. Hosting over 300 companies, it specializes in medical devices and disposables. Renowned for innovation, export strength, and advanced manufacturing, the district plays a pivotal role in healthcare production and supports the global medical technology industry.

Founded in 2002, the European Association of Authorised Representatives (EAAR) represents ARs operating under EU medical device law. EAAR works to strengthen professional conduct, competence, and understanding of AR responsibilities under MDR and IVDR. The MDR/IVDR Summit 2026 is the flagship expression of this mission.

distrettobiomedicale.it

eaarmed.org

Health Wildcatters, founded in 2013, is a Dallas-Fort Worthbased health innovation hub. Its portfolio includes 130 startups that have raised over $350 million. The accelerator selects 8–12 startups annually for a ten-week program, offering seed investment, in-kind perks, and access to a robust network of 200+ healthcare and industry mentors.

The French Tech Mission, which is part of the Directorate General for Enterprise within the Ministry of the Economy, Finance and Industrial and Digital Sovereignty, implements its activities through a team of more than 25 people based in the Paris region and a network of more than 1,400 volunteers in 52 countries.

healthwildcatters.com

lafrenchtech.gouv.fr

AUGUST 2026 HONG KONG

Masters of Longevity is a leading platform connecting the global longevity ecosystem through market intelligence, industry insights, strategic advisory, events, and partnerships. We help founders, investors, clinicians, researchers, and companies navigate the rapidly evolving longevity landscape, build meaningful connections, and accelerate innovation in preventive health and healthy aging worldwide. masters-of-longevity.com

Medicaspace is a dedicated medical networking and marketing platform connecting professionals, companies, and organizations across the healthcare sector. Targeting doctors, biomedical engineers, consultants, manufacturers, and educational centers, it enables efficient C2C networking and B2B/B2C marketing, delivering accurate, affordable, and specialized solutions to reach the medical market quickly and effectively. medicaspace.com

MedTech Spectrum is an online media platform dedicated to medical technology and healthcare innovation. It publishes news, analysis, interviews, events and job listings covering medical devices, diagnostics, digital health and industry trends, keeping professionals and enthusiasts informed about breakthroughs, regulatory updates and the evolving MedTech landscape. medtechspectrum.com

Medgate Today is a leading international MedTech and healthcare magazine headquartered in India. It connects innovators with the medical community, offering in-depth reporting through its monthly print and digital editions. The publication also hosts the prestigious MT India Healthcare Awards to recognise excellence in the sector. medgatetoday.com

MedTech Europe promotes innovative medical technology across Europe, supporting sustainable healthcare and valuebased solutions. Formed in 2012 from EDMA and Eucomed, it engages policymakers, drives research, and organizes events to highlight medical technology’s impact. By fostering collaboration and innovation, MedTech Europe ensures healthcare systems meet Europe’s evolving needs effectively. medtecheurope.org

NXT Horizon is the market intelligence, campaign and AI partner for healthcare and life sciences organisations. Our nine-box model gives medtech, pharma and digital health teams the strategic clarity, compliant execution and governed AI adoption they need to compete more precisely in complex, regulated markets. nxthorizon.ai

HONG KONG AUGUST 2026

One HealthTech is a global community promoting diversity and inclusion in health innovation. Supporting women and underrepresented groups, OHT provides mentorship, education, and networking across digital health. With hubs in the UK, Europe, and Australia, it champions leadership, collaboration, and participation in healthtech events and initiatives. onehealthtech.com

SEHTA (Science and Engineering Health Technologies Alliance) is a UK‑based, not‑for‑profit health technology network founded in 2005 that supports innovators, SMEs, clinicians, care providers and academics. It accelerates health tech innovation from concept to commercialisation with business support, training, events and networking, including the International MedTech Expo & Conference. SEHTA’s mission is to improve healthcare outcomes and grow economic impact through collaboration and expert guidance.

SEE UP is Southeastern Europe’s first private accelerator for startups in FinTech, Pet, FMCG, BioTech, and Health. Its six-month program offers mentorship, workshops, strategic partnerships, and a strong distributor network to accelerate growth and prepare startups for global markets. seeup.net

Startups Magazine, launched in April 2018, is a bi-monthly platform championing tech startups. It offers expert content, digital issues, event access, and startup features, while connecting a passionate community of founders, investors, and innovators. It also curates industry events, podcasts, and practical guidance for entrepreneurial success. startupsmagazine.co.uk

sehta.co.uk

StartupNews.fyi is India’s leading news and technology media company, focusing on startups in India and global stories. With over 2 million enthusiasts, it offers curated news, funding updates, and event coverage. The platform also facilitates international startup delegations and partnerships, connecting startups and investors worldwide.

THE HORIZONS Life is Asia’s premier luxury longevity intelligence platform exploring the future of performance and regenerative living. Connecting science, lifestyle, hospitality, residential living, and capital, we feature global thought leadership to decode high-performance systems and provide an Asia–global perspective on the evolving longevity economy.

startupnews.fyi

thehorizons.life

HONG KONG AUGUST 2026

103

Times of AI is a comprehensive platform dedicated to the latest advancements in AI. It delivers breaking news, expert insights, and in-depth analysis on AI and emerging technologies. With a commitment to accuracy and accessibility, it bridges the gap between complex innovations and everyday understanding. timesofai.com

World Business Outlook is a Singapore-based business magazine delivering global financial news, market insights, and industry views across sectors. Its pages feature innovative companies and showcase opinions from top business leaders, providing readers with in-depth coverage of trends, market developments, and the latest business strategies worldwide. worldbusinessoutlook.com

ZEX PR WIRE® is an automated press release distribution platform, syndicating content to over 500 global media outlets. Designed for PR teams and agencies, it allows users to conduct and manage campaigns with zero mail trails and mediators. The platform delivers press releases within 72 hours, ensuring fast, efficient service.

Share your #MTWAsia2026 moments 分享你的 #MTWAsia2026 精彩時刻

Your feedback is important to us 分享您的活動體驗

Contact the team 聯絡我們

zexprwire.com

HONG KONG AUGUST 2026

105

MedTech World Team

Meet the squad

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Dr. Dylan Attard CEO MedTech World

Yulia Yurevich Head of Client Relations & Partnerships

Shara Layton Head of Marketing

Dr. Miguel Fenech Business Development Manager

Dylan strongly believes in collaborative efforts to enhance the healthcare system. He is dedicated to making MedTech World the epicenter of investment and progress. He aims to create a platform for meaningful discussions, fostering innovation and connections for entrepreneurs to scale their solutions.

As an entrepreneurial enthusiast in the MedTech industry, Yulia specialises in connecting global innovators, investors, and healthcare professionals to accelerate healthcare transformation also creating strategic opportunities for emerging ventures in the MedTech ecosystem.

Shara believes working in the MedTech industry is not just a profession but a purpose. She finds it incredibly fulfilling to contribute to groundbreaking innovations that are transforming global healthcare and improving lives around the world.

Miguel is a medical doctor with extensive clinical experience across London and the UK. He has a keen interest in the safety, regulation, and ethical integration of AI-driven healthcare solutions in patient care and is a certified Clinical Safety Officer with NHS England.

AUGUST 2026 HONG KONG

Anastasia Coleiro Global Account Manager

Emma Giannatiempo Junior Events Manager

Amisha Patidar Junior Media Operations

Wara Samar Senior Content Writer

A business graduate, Anastasia finds purpose in contributing to the MedTech industry, connecting people, building meaningful relationships, and delivering seamless, high-quality experiences through authenticity, organisation, and a people-first approach.

With a background in tourism and hospitality, Emma’s passionate about bringing people together, connecting industry leaders, and creating meaningful conversations across the MedTech industry.

An economics and business graduate with hands-on experience in marketing, media relations and digital strategy, Amisha helps build impactful partnerships in the healthcare technology sector. Ready to connect with driven individuals who share a passion for innovation and growth.

A postgraduate in biotechnology, Wara has extensive experience in scientific editing and content writing. She covers impactful medical technology stories with a keen editorial eye for clarity and detail.

HONG KONG AUGUST 2026

107

MedTech World Team

Meet the squad

108

Rusudan Khotivari Media Partnerships Coordinator

Nivi Xinying Tan Lead for Asia

Dayana Rodriguez Monaco Videographer & Photographer

Katarina Milojevic Graphic Designer

A communications professional with 7+ years of experience in UN agencies, NGOs, and the private sector, Rusudan is specialised in strategic communications, media relations and stakeholder coordination. Rusudan is passionate about MedTech and Public Health.

As Lead For Asia at MedTech World,Nivi’s focus is on expanding the organisation’s presence across Asia by fostering cross-border collaboration, building strong industry networks, and enabling meaningful partnerships that advance healthcare innovation globally.

A photographer & videographer, with 10+ years of experience and Barcelona-trained, Dayana is driven by design and creativity in all forms. From compelling imagery to the art of cooking, creation is where she finds purpose.

As a freelance graphic designer, Katarina has developed a strong foundation in advertising, storytelling, and presentation skills. Working independently and with clients in Malta, she has honed her creative process, balancing multiple projects and deadlines. Her commitment to impactful storytelling drives her work, helping to craft designs that connect.

AUGUST 2026 HONG KONG