There’s a saying in the medical device industry: “Getting a prototype to work is just the beginning of the challenge; the journey from the prototype to the patient is the most grueling part.”

For an innovative medical device, the journey from a laboratory prototype to actual use in the operating room or ICU involves crossing a long “Valley of Death.”

R&D cycles often span five to eight years, and the approval process for a Class III medical device registration certificate can take two to three years. Every step—from animal testing and clinical validation to pilot-scale production—burns through funds.

The true barrier to innovation in medical devices lies not merely in a single technical breakthrough, but in transforming what is “optimal in the lab” into something “clinically effective,” and then consistently manufacturing a clinically validated product and successfully bringing it to market.

In recent years, an increasing number of high-end medical device companies have established their R&D headquarters and industrialization bases in Changping, Beijing.

A 1.2 million-square-meter park—the Beijing Changping International Medical Device City—is building a comprehensive support system covering R&D, pilot production, registration, manufacturing, and market expansion, focusing on the critical stages of medical device commercialization.

01 Great Products Grow from Clinical Needs

There is a consensus in the medical device industry: whether a product succeeds often depends not on how impressive it is in the lab, but on whether it is truly practical in clinical settings.

The problem lies in the disconnect between R&D and clinical practice. Engineers may optimize parameters to the extreme based on their own understanding, yet these may not align with the actual operational scenarios faced by clinicians. Only when the product is tested in a clinical setting does it become apparent that it is either awkward to use or falls short of real-world needs—forcing a return to the drawing board.This back-and-forth wastes both time and money, and the success rate of commercializing these innovations remains low.

Changping’s approach is to reverse this sequence, taking a path where clinical needs drive R&D.First, clinicians identify the problems; then, research teams solve them; and finally, enterprises handle the engineering and product development. This is precisely the “user-driven innovation” emphasized by Professor Wang Jici of Peking University in his research on medical device industry clusters—precisely directing R&D toward validated clinical needs is the most efficient path to innovation.

The International Medical Device City is located adjacent to top-tier hospitals such as Beijing Jishuitan Hospital, Peking University Third Hospital, and Beijing Tsinghua Changgeng Hospital, and collaborates with medical and engineering departments at universities including Tsinghua University, Peking University, and Beihang University.The park routinely facilitates “industry-medical” collaboration, enabling clinicians to provide precise lists of needs, participate fully in product testing, and provide real-world clinical data—bringing “engineers who understand medicine” and “doctors who understand engineering” together around the same table.

The Changping area is home to 41 universities, including 14 “Double First-Class” institutions. The park’s goal is not merely to list these academic resources but to organize research teams, clinical needs, and corporate engineering capabilities into a single translation chain through platforms such as joint laboratories and innovation centers.The International Center for Intelligent Medical Engineering Innovation, established in 2025, serves as a key platform for this medical-engineering collaboration.

This is how Tupai Medical came into being. Its core technology originates from Tsinghua University and focuses on ophthalmic swept-source OCT and intraoperative navigation microscopes. Ophthalmic surgery is an “art performed on the tip of a needle”; traditional microscopes offer only a two-dimensional view, making it impossible to clearly see the three-dimensional structure of the fundus.Tupai integrated real-time intraoperative 3D OCT into a surgical microscope—the resulting “Tupai Puyun” is a smart surgical microscope equipped with real-time intraoperative 3D OCT navigation capabilities, and its swept-source OCT product has held a higher market share than imported brands for three consecutive years.This startup, which began as a tiny micro-enterprise, has grown over the course of about seven years into a large-scale enterprise with annual revenue of 200 million yuan.

Qinghan Medical, building on research achievements from Tsinghua University’s Institute of Precision Medicine, focuses on core technologies such as in vitro blood oxygenation and mechanical perfusion. The company has developed domestically produced ECMO (artificial lung) systems and a complete set of extracorporeal circulation equipment, breaking foreign monopolies in core mechanisms, basic materials, and anticoagulation technologies.ECMO represents a region’s level of critical care and emergency response and has long been subject to foreign technological constraints—yet the source of its technology lies right within the same industrial park.

When the source of technology, clinical applications, and engineering teams can collaborate continuously, the distance for enterprises to bridge the gap from technological achievements to marketable products is significantly shortened.

02 Pilot-scale testing serves as a bridge, reducing the burden of heavy investment on companies

Even with the right direction, the product still needs to be manufactured.

The path from a laboratory prototype to a product ready for regulatory testing and clinical trials involves process scale-up, sterilization, and the establishment of a quality management system—all of which require significant investment, and many companies get bogged down at this stage.

The approach taken by the Changping International Medical Device Park is to transform these costly and resource-intensive stages into shared public platforms within the park. These include a one-stop CMO/CDMO commercialization platform, an animal testing facility, sterilization services, and quality system development—allowing companies to avoid building these capabilities from scratch on their own.

When Wei Gong Medical was a startup with limited funding, this public platform perfectly met its pilot production needs. Equipment such as cleanroom laboratories, flow cytometers, and sequencers can all be used on an as-needed basis.Founder Li Weigong ran the numbers: Building a pilot production line in-house would cost a company approximately 8 million yuan, whereas renting space and equipment at the Changping International Medical Device Park costs no more than 800,000 yuan per year.

More importantly, upstream and downstream companies collaborate closely within the park. While advancing product validation, Weigong Medical can also connect with partners and potential customers nearby. For startups, the public platform not only saves on equipment investment but also frees up more funds and time for R&D iteration and market expansion.

Capital services have also been effectively addressed. Changping has established a multi-layered matrix comprising a cluster of science and technology innovation industry mother funds and specialized direct investment funds, covering the entire lifecycle of enterprises—from “R&D incubation to technology commercialization, acceleration, and IPO”—specifically designed to alleviate the financing anxieties of technology-based enterprises regarding “high initial investment and long return cycles.”To date, Changping District has nurtured nine listed medical device companies.

03 Bringing Approval Services Forward to Accelerate Product Launch

Once a product is manufactured, it still needs to obtain certification to enter the market. The review process for a Class III registration certificate often takes one to two years—a period that companies with tight cash flow simply cannot afford to wait.

In March 2025, the Medical Device Innovation Service Station of the National Medical Products Administration’s Center for Medical Device Evaluation was officially established in Changping.This means companies no longer need to mail application materials and passively wait for results; instead, they can establish a proactive communication mechanism with regulatory authorities right on their doorstep—featuring a forward-deployed review focus, dedicated follow-up personnel, a “one company, one strategy” approach, and coordinated research and review efforts.

The results are tangible: this proactive, front-loaded service mechanism has provided customized guidance to a cumulative total of 219 companies.Within the park, the average approval time for medical device companies has been reduced by more than 50% compared to before the reform, and the average time-to-market for innovative medical devices has been shortened by approximately 30%. For a company, obtaining a license half a year earlier means entering the market half a year sooner and generating cash flow half a year earlier.

This certainty is propelling a new generation of high-end domestically produced medical devices. NewCloud Medical, specializing in chronic pain, has established three product pipelines: brain-computer interfaces, neuromodulation, and minimally invasive interventions.Its flagship product, the C-7 implantable pain brain-computer interface, can directly capture electroencephalographic signals from the brain’s pain center, converting patients’ subjective pain sensations into quantifiable objective data—targeting precisely the intractable pain that traditional therapies have been unable to address.DaYi Group’s TaiChiRT radiation therapy system has received Breakthrough Device designation from the U.S. FDA and has now been installed and deployed in the North American market.

The clearer the path from R&D to market, the more confident companies are in continuing to invest in long-term R&D.

04 Policies Addressing Critical Stages Give Companies Confidence

If the first three layers represent “capability,” then policy represents “confidence.”

Changping District has specifically issued the “Several Measures to Promote the Development of High-End Medical Device Industry Clusters,” which, in conjunction with the “Big Nail” 2.0 Action Plan (the “Changping District Medical Device Industry Upgrading Action Plan (2026–2028)”), directs resources precisely toward key stages of corporate development:

Certification Phase: Companies that obtain a Class III medical device registration certificate will receive support of up to 30% of the R&D investment for the certified product; those that successfully complete the National Special Review Procedure for Innovative Medical Devices will receive up to 8 million yuan per registration certificate.

International Benchmarking: Enterprises that qualify for the U.S. FDA’s Breakthrough Device Program will receive support equivalent to 30% of their R&D investment, up to a one-time maximum of 8 million yuan.

Scale Expansion: Companies whose annual output value for a single product first exceeds 50 million, 100 million, 500 million, and so on—up to 2 billion yuan—will receive tiered rewards of up to 10 million yuan.

Early-Stage Hard Tech: Up to 20 million yuan in proof-of-concept funding is allocated annually to specifically help “0-to-1” clinical achievements overcome their earliest hurdles.

Whether it’s obtaining certifications, scaling up production, or expanding overseas, the policy provides support whenever companies reach critical junctures requiring significant investment.

The road ahead remains long, but with a sense of certainty, those on the journey dare to take bolder strides.

05 Conclusion: Bringing More Certainty to the Toughest Journey

Looking back, the Changping International Medical Device City is paving the way, step by step, along the even more arduous path of commercialization that medical device companies must navigate beyond their core technologies.

Clinical demand drives R&D, addressing the question of “who will use it”; pilot production platforms and fund-of-funds resolve the issue of “sufficient funding”; pre-approval processes tackle the question of “how long it will take to bring a product to market”; and tangible policy support provides an extra push at every critical juncture. These four layers combine to form a comprehensive innovation-to-commercialization system.

The data serves as a vivid testament to this system: the park has secured approval for a cumulative total of 30 innovative medical devices, accounting for 9.1% of the national total; by the end of 2025, it was designated as a “2025 Medical Device Innovation Ecosystem Demonstration Park”—one of only five such parks nationwide.Companies gathered here—including Aimeike, BaiRen Medical, Tupai Medical, Weigao Smart, Chunfeng Huayu, Weigong Medical, Qinghan Medical, Zhongke Weizhi, and Xinyun Medical—represent a group of leading enterprises within this ecosystem.

The core competitiveness of the medical device industry has never lain in the sheer number of companies, but rather in the ability to provide full-cycle support for innovation—from the “laboratory” to “clinical application.”As more and more innovative domestic medical devices make their way from here to operating rooms and global markets, the “Valley of Death”—which once caused countless companies to fail—is being transformed into a well-trodden path right here in Changping.

This path has never been an easy one. But here, an increasing number of companies are successfully bringing their products to patients.