Puchuang Medical's Differentiated Strategy for Global Expansion in Cardiovascular Devices

Against the backdrop of a持续攀升的全球心血管疾病防治需求, China's cardiovascular device industry is emerging at an impressive pace, becoming a significant player in the international market. With deep technological积累 in材料科学, 生物工程, and数字医疗, core products such as domestically produced心血管支架, 起搏器, and介入导管 have gradually transformed from早期的技术跟随者 to创新引领者.

Empowered by both technological breakthroughs and cost advantages, China's innovative cardiovascular medical device companies are actively embracing the global market, with "going overseas" becoming a crucial step in expanding their territory. The international market shows strong demand for innovative medical devices but also comes with stringent regulatory standards and fierce competitive challenges. How can these companies navigate the global stage and establish a firm foothold?

On May 9, at the 2025 Future Healthcare and Pharmaceutical Top 100 Exhibition · Cardiovascular Disease Industry R&D Innovation Forum hosted by VCBeat,Spectrumedics Founder and CEO Dr. Huiqun Peng Delivered a Keynote Speech on "The Overseas Journey of Cardiovascular Innovation Medical Device Companies", combining Spectrumedics' overseas practice and experience accumulation, in-depth analysis of how cardiovascular device companies should avoid risks and better address various challenges in the process of going overseas.

Dr. Huiqun Peng, Founder and CEO of Spectrumedics

Dr. Peng Huiqun pointed out that, against the backdrop of the "14th Five-Year Plan" and the "2035 Long-Range Objectives Outline" explicitly proposing the establishment of a new development pattern of "domestic circulation as the main body, with domestic and international dual circulations reinforcing each other," actively expanding overseas markets has become an inevitable choice for enterprises to integrate into the global industrial system and achieve high-quality development. Going global is of great significance for companies to broaden their marketing regions, increase revenue, and enhance the international recognition of Chinese innovative products.

Currently, the formation of the overseas expansion trend among medical device companies is driven by both internal and external factors.From the perspective of internal development logicThe domestic niche market has entered a white-hot stage, compounded by the continuous advancement of medical insurance cost-control policies, leading to increasing pressure on profit margins for enterprises. Objectively, this necessitates breaking through growth bottlenecks by expanding into international markets. At the same time, favorable policies such as the "Belt and Road" initiative are driving companies to explore overseas markets. On the technical side, the performance parameters of domestically produced medical device products have aligned with international standards, with some high-end interventional devices and medical imaging equipment reaching internationally advanced technical levels, facilitating smooth expansion into overseas markets.

Analysis of the External Market EnvironmentMany emerging economies have relatively weak medical technology foundations, low self-sufficiency rates, and have long relied on imported products from Europe and the United States. However, constrained by healthcare budget limitations, these markets are highly sensitive to product prices, creating a strong demand for high-quality, cost-effective products, which provides a good opportunity for Chinese products to enter.

Dr. Peng Huiqun emphasized that when planning overseas market entry strategies, the following key factors need to be considered: whether the target market size has growth potential, whether the market access regulatory standards align with the company’s product technical specifications, and whether there is room for differentiated entry in the local competitive landscape.Only by conducting research and planning on key factors in advance can effective market competition strategies be built.

At the same time, the political ecology of the target market cannot be ignored, including tendencies toward trade protectionism, geopolitical risks, and even religious and cultural constraints in specific regions. For example, companies engaged in the production of heart valves need to complete cultural adaptability compliance preparations such as halal certification in advance when entering markets like Indonesia and the Middle East. Such details must be incorporated into the early planning system.

Observing the global medical device market landscape, the United States is recognized as the largest market worldwide, with China following closely in second place. Among emerging markets, India, Brazil, and the Middle East have formed considerable market sizes, while primary emerging markets along the "Belt and Road" such as Latin America and Southeast Asia, have also become important directions for Chinese enterprises' global expansion due to policy benefits and market potential.The implementation of the "Belt and Road" initiative provides systematic support for enterprises to break through geographical and institutional barriers and accelerate their integration into regional medical markets.

Dr. Peng Huiqun took Spectrumedics' shockwave balloon product as an example to introduce the company’s overseas practices. She noted that there is a U.S.-based对标company in the international market, which is performing well in its本土market, accounting for 79% of the overall market share in 2023. Since this field is not dominated by traditional giants like other cardiovascular markets and has only one competitor, overseas markets, especially emerging ones, remain空白, providing Spectrumedics with a great opportunity to enter these markets. The company quickly seized this opportunity to tap into the空白market.

Before elaborating on the overall overseas expansion strategy, Dr. Peng Huiqun emphasized that the Chinese market needs to be separately categorized. The vast majority of Chinese companies rarely focus solely on exports and overseas markets; instead, they prioritize deeply cultivating the Chinese market. Especially in the field of active medical devices, there are significant differences in regulatory standards across regions, and companies need to pre-evaluate whether their products can meet all testing requirements in the target market.

Spectrumedics Synchronously Expands into Southeast Asia and Latin America Markets. The Southeast Asia region has a population of nearly 700 million, with an annual GDP exceeding 4 trillion US dollars, and relatively lower market entry barriers. Companies that obtain domestic registration certificates in the early stage and conduct solid preliminary clinical validation can achieve relatively rapid market access in this region.

In the Latin American market layout, Brazil and Mexico are relatively larger markets within the region, but they have higher entry barriers. In particular, Brazil has established an independent certification system with a longer approval cycle, requiring companies to formulate targeted market entry plans in advance.

Central Asia, the Middle East, and Eastern Europe are also overseas markets laid out by Spectrumedics, with market expansion efforts in Southeast Asia, Latin America, and Central Asia being carried out simultaneously.

The process of going overseas presents both opportunities and challenges. In terms of advantages, the overall level of China’s medical device industry continues to improve and has reached internationally recognized standards. Dr. Peng Huiqun stated that in recent months, she has received feedback from clinical experts in Singapore, Malaysia, and Europe regarding the demand for domestically produced brand products. However, the regulatory systems of most countries tend to refer to or follow European and American standards, requiring more time and effort to overcome entry barriers when accessing these markets. Particularly,Innovative medical devices, some of which require clinical trials to be conducted overseas, must pass rigorous quality system certifications. During the market cultivation process, they also face the challenge of building brand awareness and need to enhance brand visibility and gain market recognition through effective strategies.

Overall, in terms of opportunities, the demand from overseas markets for domestically produced innovative and cost-effective products continues to rise; the main potential risks stem from the volatility of the international political and economic environment, which requires real-time attention and dynamic responses.

Dr. Peng Huiqun emphasized,In the process of going global, apart from the product's high cost-performance ratio and market potential, intellectual property rights are key elements that require focused attention.The key reason why Spectrumedics has been able to enter multiple international markets lies in its high compliance with patent regulations. According to the company, many similar products produced in China face difficulties entering the European and American markets due to patent issues.

Spectrumedics is headquartered in Shanghai and has a branch office in Singapore, which serves as the main R&D center and a key window for engaging with overseas markets. The crucial factor enabling the company to quickly enter target markets lies in its overseas localization strategy—by establishing overseas branches and building professional teams to provide direct support for market expansion.

Dr. Peng Huiqun stated that China's innovative medical device industry is undergoing a profound transformation from "Made in China" to "Created in China." The product characteristics have gradually upgraded from low-price and low-quality in the early days to high quality and cost-effectiveness, achieving a leap from OEM dominance to independent innovation. This shift has gained widespread recognition in the international market. She suggested,Enterprises can carry out collaborative cooperation and jointly explore international markets by integrating resources and complementing each other's strengths, to jointly address the complex international market environment and enhance the overall competitiveness of China's medical devices in the global market.