HopkinsMedTech Compliance (HMC): A Specialized CRO Powering Chinese IVD Companies' Global Expansion

The COVID-19 pandemic has significantly accelerated the global expansion of IVD companies.

During the pandemic, many IVD companies experienced significant revenue growth, driving them to actively seek new growth opportunities in the post-pandemic era. Andover Healthcare’s impressive export performance has drawn the attention of numerous enterprises to overseas markets in Europe and America, sparking a vigorous wave of global expansion.

Dr. Wu Xiaohui has over 20 years of consulting experience with U.S. companies and is a firsthand witness to the current surge of Chinese IVD companies expanding overseas. “After the COVID-19 pandemic, numerous IVD companies consulted me on how to conduct clinical trials in the United States and how to apply for Emergency Use Authorization (EUA) for COVID-19 antigen self-test kits.”

Hopkins CRO was established against the backdrop of numerous IVD companies seeking to expand into overseas markets. Currently, Hopkins CRO specializes in clinical trials for IVD products and innovative medical devices in Europe and the United States, providing enterprises with end-to-end services spanning clinical trial execution, regulatory approval, and commercialization. These services include EUA applications, 510(k) submissions, clinical trials in Europe and the U.S., registration of medical devices and over-the-counter drugs, FDA establishment registration, and U.S. Agent services. The company has served more than 30 domestic IVD enterprises in China, covering projects such as COVID-19 antigen self-tests and early cancer screening.

Dr. Wu Xiaohui recalled that he had not initially intended to independently establish a CRO company specializing in the global expansion of IVD enterprises. “Upon receiving requests from companies seeking to expand overseas, I immediately contacted several overseas CRO firms. However, most of these CROs primarily focused on clinical trials for pharmaceuticals, with medical devices handled only as a secondary service. They were unfamiliar with the application process for COVID-19 antigen self-test kits, and their fees were prohibitively expensive, making them unaffordable for domestic IVD companies. With no other option, we directly approached a clinical institution and discovered that the costs at clinical sites were actually manageable. This presented us with an opportunity to establish a CRO company in the United States dedicated specifically to the IVD industry.”

In summary,No U.S. CRO firm possesses the capacity to meet the robust demand for overseas expansion from Chinese IVD companies.This revealed a vast untapped market to Dr. Wu Xiaohui.

Thus, in October 2020, Dr. Wu Xiaohui founded Hopkins MedTech Compliance (HMC, Hopkins CRO), initially focusing on the clinical development and FDA applications for COVID-19 antigen self-test kits, integrating U.S. clinical institutions to conduct clinical trials and regulatory certification for Chinese IVD companies.

Undoubtedly, Chinese IVD companies have achieved tremendous success in exporting COVID-19 antigen self-test kits. ACON Biotech’s Flowflex became the first COVID-19 antigen self-test kit from China to receive FDA approval, while Andon Health created a wealth phenomenon with its COVID-19 antigen self-test kits.

Hopkins CRO has helped Hotgen and two other IVD companies obtain FDA EUA approval for antigen tests in the past year.

It is worth noting that,IVD Global Expansion Is Not a Fleeting Trend. To date, the wave of IVD global expansion has long extended beyond COVID-19 antigen self-test kits.

In the past, import monopolization was quite prominent in China’s IVD industry. In recent years, domestic enterprises have focused on import substitution. Recently, against the backdrop of the COVID-19 pandemic, policy incentives, and enhanced hard power in technological products,China’s IVD and medical device companies are gradually transitioning from domestic substitution to global expansion.Furthermore, the excessive hypercompetition within China’s IVD industry has also accelerated the global expansion of Chinese IVD companies.

“For a long time, companies such as Abbott, Roche, and Beckman have dominated the U.S. laboratory testing market, with relatively limited presence in scenarios such as point-of-care testing (POCT).”COVID-19 antigen self-testing has proven to be a successful case, effectively opening a breach in the market. Building on this success, Chinese companies can leverage their experience to enter the U.S. market through segments such as home-based testing, early cancer screening, and point-of-care testing (POCT).”

Furthermore, the growing acceptance, welcome, and recognition of Chinese IVD companies in the United States, as evidenced by the adoption of COVID-19 antigen self-tests, highlight the promising prospects for the global expansion of China’s IVD sector. It is certain that the internationalization of IVD products represents a long-term and broad-ranging trend.

Generally speaking, the United States, Europe, and Southeast Asia are popular destinations for overseas expansion.

The FDA imposes stringent regulations, making clinical registration for products highly challenging. Furthermore, the U.S. market is dominated by many leading international IVD companies, resulting in intense competitive pressure. Consequently, many enterprises have not considered entering the U.S. market. However, Dr. Wu Xiaohui emphasizes that FDA approval enjoys high global recognition and can significantly enhance brand value. Moreover, despite fierce competition, the United States offers substantial market potential, with its medical device market accounting for 40% of the global share.

Meanwhile, pricing flexibility is greater in Europe and the United States, granting companies stronger pricing power. Taking COVID-19 antigen self-test kits as an example, current retail prices in Europe range from €1 to €2, while in China they are RMB 2–3. A Google search shows that Andon Health’s iHealth tests are priced at $16 for two, Abbott’s tests at $23.99 for two, and ACON Laboratories’ Flowflex test at $7.99 each.

Therefore, the United States is arguably the preferred destination for IVD companies expanding overseas; even if a company does not enter the U.S. market, obtaining FDA certification remains a competitive advantage.

For example, the Suzhou Municipal Government recently issued a policy document providing a subsidy of RMB 1 million per product for drugs and medical devices that have newly obtained approval for overseas marketing from regulatory agencies such as the FDA, EMA, and PMDA, with a maximum cap of RMB 5 million per enterprise.

However, IVD companies lack sufficient capabilities for international expansion. Their insufficient understanding of target markets makes it difficult to assess market size and entry barriers. A shortage of relevant talent, lack of experience in dealing with the FDA, and challenges in smoothly conducting overseas clinical trials and sales all pose significant obstacles.

In other words,The U.S. FDA imposes stringent regulatory requirements, yet the vast majority of in vitro diagnostics (IVD) companies lack experience in international expansion. Challenges include how to comply with the FDA’s rigorous oversight, select appropriate products for market entry, accurately grasp market dynamics in Europe and the United States, and formulate sound market strategies. Under these circumstances, choosing a reliable contract research organization (CRO) is critical.

Hopkins CRO provides FDA consulting services, including EUA applications, medical device 510(k) submissions, U.S. clinical trials, OTC drug registration, FDA establishment registration, FDA U.S. Agent services, FDA quality system compliance, U.S. market strategy, and the establishment and operation of U.S. sales entities.

Talent is the foundation upon which the CRO industry survives. Dr. Wu Xiaohui, a partner at the company, has over 20 years of consulting experience with U.S. enterprises and previously served as a Senior Manager at PwC’s New York headquarters, where he advised numerous Fortune 500 companies. Dr. Wu has integrated multiple specialized U.S.-based CROs and FDA consulting teams.Boasting a team of over 1,500 professional consultants, many of whom are retired FDA officials.

“The company has both Chinese and American colleagues, enabling it to adapt to the work habits and schedules of Chinese clients, thereby overcoming language barriers and cultural differences,” stated Dr. Wu Xiaohui. Meanwhile, the company boasts extensive accumulated clinical resources, having established partnerships with numerous specialized U.S. clinical institutions and over one hundred clinical sites, which helps enterprises identify the most suitable clinical sites in the shortest possible time.

Currently, Hopkins CRO serves more than 30 IVD companies in China.It covers multiple leading IVD companies, with projects including COVID-19 antigen self-test kits and early cancer screening. Notably, for the COVID-19 antigen self-test kit project, Hopkins CRO operated 13 clinical sites in the United States and enrolled over 15,000 cases. The company has also established multiple clinical sites for mpox virus detection reagents.

Hopkins CRO has also established a club focused on European and American markets and clinical consulting. It provides Chinese IVD and medical device companies planning to enter these markets with domestic and international industry consulting, policy interpretation, customs data analysis, updates on global epidemics and emerging infectious diseases, information on new products and technologies, FDA regulatory guidance and the latest clinical trial data, as well as capital market trends. Additionally, it shares the company’s extensive experience in quality control, regulatory affairs, certification, and clinical operations for helping Chinese enterprises expand overseas, and offers pre-clinical trial assessment services for Europe and the US, thereby comprehensively supporting the global expansion of domestic companies.

Additionally, Hopkins CRO is building an overseas e-commerce platform called “Best Test At Home” to promote high-quality Chinese home diagnostic products to 120 million American households and more than 300,000 U.S. clinics. In the future, amid the growing trend of Chinese IVD companies expanding globally, Hopkins CRO will be a reliable partner for enterprises seeking to go global.