Baiming Tech Files IPO Prospectus: Enabling Global Market Access for High-Risk Medical Devices with Near 100% Regulatory Approval Rate

In recent years, expanding overseas has increasingly become a critical strategic choice for companies seeking to broaden their commercial footprint. Driven by the pressure of China’s centralized procurement policies, enterprises are turning to global markets in search of incremental growth, yet they commonly face regulatory barriers in their target markets.

Unlike the domestic "baseline compliance" model, the international regulatory framework’s open structure requires companies to develop technical documentation entirely in foreign languages that align with the logic of target markets, and to dynamically communicate technical proposals with regulatory authorities. Differences in language and thinking often hinder the review process. Furthermore, over the past few decades, Chinese medical device products entering the international market have been predominantly low-value consumables, with high-risk Class III devices remaining extremely limited in global presence.

The path to global expansion is fraught with challenges, and enterprises increasingly require the support of third-party professional regulatory consulting teams. BiomenGroup was established in response to this industry demand.The company aims to become an “enabler of globalization in the medical device industry,” specializing in providing global regulatory consulting services for various high-risk products and committed to helping more high-value medical devices achieve global market access.

Guo Changliang, CEO of BiomenGroup and Global Regulatory ExpertHolding a Ph.D. in Biomaterials, he possesses 18 years of experience in the medical device industry, with expertise in the research and development of interventional, orthopedic, and neurosurgical products. From 2014 to 2022, Guo Changliang served as a Technical Review Expert at BSI, a leading Notified Body, where he was responsible for the technical assessment of high-risk cardiovascular and interventional medical devices worldwide. He has reviewed hundreds of products from top-20 global companies, including Abbott, Medtronic, and Stryker, specializing as a technical review expert for passive medical devices.

In 2022, Guo Changliang embarked on his entrepreneurial journey. He candidly admitted that he initially had no intention of engaging in regulatory consulting; instead, he founded an assisted reproductive technology company. His later entry into the global compliance services for medical devices and the establishment of BiomenGroup were primarily driven by the urgent needs of the industry. “The barriers to CE MDR compliance are extremely high. Many companies seeking to expand overseas have repeatedly hit walls, investing substantial funds and effort with little to show for it. As a result, numerous enterprises have turned to us for assistance.”

In 2023, under the leadership of Guo Changliang, BiomenGroup was established and assembled an international team of experts with extensive experience in product R&D, clinical affairs, and global regulatory compliance. Core team members hail from China, the United States, the Netherlands, Australia, and other countries, bringing rich overseas work experience and proficiency in bilingual communication.

Ronald Rakos, Global Regulatory ExpertHolding a Ph.D. in Biomedical Engineering, with over 30 years of experience in the medical device industry and 15 years of technical review experience at BSI, a top-tier Notified Body. As the Global Head of the Vascular Team at BSI, managed and developed an international team of 30 vascular medical device experts, conducting technical file reviews for CE certification of Class III, IIb, and IIa medical devices, and performed over one hundred design reviews for numerous coronary, neurovascular, and peripheral vascular devices.

Chen Xi, Global Regulatory ExpertWith 16 years of experience in domestic and international regulatory affairs for medical devices, having secured market access in over 50 countries and regions worldwide, specializing in the international registration of Class III high-risk cardiovascular implantable and interventional medical devices.

Clinical Expert and International Sales Specialist, Kim GiliamHolding an M.D. degree, Giliam has over 25 years of experience in the medical device industry, with expertise spanning product R&D, sales, and lifecycle management. He specializes in clinical evaluation and clinical data statistics. As a seasoned strategic consultant, Giliam possesses deep commercialization knowledge and frequently collaborates with private enterprises, government agencies, and universities to provide innovative solutions to technical challenges. He is particularly adept at offering commercialization consulting services for start-up technology companies.

Such a team lineup is undeniably impressive among consulting firms—currently, teams with professional backgrounds from former regulatory review agencies and dedicated to providing related regulatory compliance consulting services are rare in the market.As former technical review experts at top-tier notified bodies, the expert team at BiomenGroup possesses in-depth knowledge of international regulatory standards and assessment logic, enabling efficient handling of various complex projects.Since officially launching its operations last year, the team has successfully helped numerous domestic projects—once considered extremely challenging to expand overseas—break through barriers and achieve market access in international markets.

Furthermore, the assisted reproductive technology products of BiomenGroup, operated by Guo Changliang, CEO of Biomen Technology, are currently in the phase of expanding into overseas markets.Accumulated extensive hands-on experience in frontline practiceAccording to Guo Changliang, the company secured FDA approvals for dozens of products last year. Notably, one high-risk product gained approval in just over 50 days from application submission to approval without any requests for additional information. “We aim to share these experiences with more companies, helping them obtain CE, FDA, and other certifications faster and at lower costs, thereby facilitating their successful expansion into overseas markets,” said Guo Changliang.

“We aim to help more high-end Class III medical devices made in China enter the global market, which is our unique business focus. We generally do not engage with Class II products, concentrating solely on global regulatory consulting for high-risk Class III products,” introduced Guo Changliang.In the field of regulatory consulting for Class III high-risk medical devices in China, BiomenGroup’s professional expertise has reached a top-tier level within the industry.

This is inseparable from the core team’s multidimensional and profound expertise in regulatory affairs, clinical development, and product R&D.Unlike most domestic consulting firms that primarily focus on regulatory backgrounds, the core team of BiomenGroup possesses profound expertise in technology research and development.Guo Changliang, CEO of BiomenGroup, has been deeply engaged in the R&D of orthopedic implant materials and medical dressings since his graduate and doctoral studies. He previously led neurosurgical product development at a publicly listed company, accumulating comprehensive technical expertise spanning material selection, biological evaluation, and clinical application requirement analysis.

Leveraging extensive product development expertise, the BiomenGroup team can accurately identify issues related to design verification, biology, materials science, and clinical aspects, providing precise solutions. According to Guo Changliang, with the team’s assistance, 80% of clients’ issues were resolved prior to submission, significantly reducing certification time. Throughout the service process, the team has consistently upheld the principle of “"Because We Understand the Product, We Can Provide Effective Product Guidance"” philosophy, by providing technology-driven regulatory consulting.

BiomenGroup has established a highly rare cross-dimensional capability matrix in China encompassing “technology–clinical–compliance,” enabling precise identification of the intrinsic correlation between product technical requirements and international regulatory standards., it not only enables the preparation of compliance documentation using regulatory language, but also provides insights from perspectives such as materials science, biological evaluation, and clinical needs analysis,Integrate the design validation logic from the R&D side and the risk assessment experience from the clinical side into the regulatory guidance chain at an early stage, achieving deep integration of technical solutions with regulatory requirements and filling the capability gap of traditional regulatory consulting in technical implementation.

BiomenGroup integrates compliance planning into the design and testing phases of research and development. Taking shelf-life testing as an example, this process determines the period during which a medical device can maintain its performance and safety under specified storage conditions. Although accelerated aging tests are commonly used, they still require several months to complete. If shelf-life testing is not completed during the R&D phase, or if the sample size is insufficient, additional samples must be submitted for retesting. This single step alone can result in a delay of at least six months. BiomenGroup’s technical compliance team can identify and resolve such issues prior to regulatory submission, thereby helping companies avoid rectification costs that could be two to three times higher.

Currently, most domestic peers generally follow the path of "obtaining domestic certification first, then pursuing international registration," which often leads to the need to redo R&D testing and clinical data collection because they fail to meet international regulatory requirements. In contrast, BiomenGroup is able to largely avoid such situations in its client services. Taking a real service case as an example, during the domestic clinical study of a client's product, the BiomenGroup team predicted, based on their technical expertise, that the existing data already met international regulatory requirements when the clinical trial was halfway through. They simultaneously extracted usable data to initiate the international registration process. Before the client even submitted its domestic registration application, the product had already obtained global medical device registration certificates, thereby avoiding redundant investment by the enterprise.

According to Guo Changliang,BiomenGroup maintains a near-100% approval rate for all undertaken projects, with the vast majority bypassing the third-round review., with core issues largely resolved during the initial review, and only a few remaining cases requiring the settlement of outstanding details in the second round to secure approval. It is worth emphasizing that BiomenGroup rejects “template-based” service models,Provide customized end-to-end solutions for each project., tailor rectification pathways to the technical characteristics and compliance requirements of each product category, precisely identifying key areas for optimization.

From a business perspective, BiomenGroup focuses on global compliance services for medical devices, building a full-chain closed-loop model that covers certification, quality management systems, technical breakthroughs, and capability training.

The company closely addresses industry pain points, specializing in scarce, high-barrier sectors to fill domestic compliance gaps. It helps enterprises reduce trial-and-error costs and rapidly enter the international market. Its core services encompass four key areas: global product certification, quality management system consulting, specialized technical support, and premium training, covering a wide range of active devices, passive devices, and IVD products.

BiomenGroup’s Specialty Services

BiomenGroup possesses extensive experience in the research, development, and regulatory review of Class III high-risk medical devices. It has conducted reviews for hundreds of high-risk products from top 20 global companies, including Abbott, Medtronic, and Johnson & Johnson. The company specializes in regulatory consulting for ultra-high-risk products, such as drug-device combinations, animal-derived materials, biodegradable materials, implantable and interventional devices, and medical aesthetics products.

BiomenGroup has assisted clients in accelerating the CE certification process for their cutting balloon products, completing the entire workflow from application submission to certificate issuance in just five months. It also helped a domestic enterprise secure China’s first CE certificate for its IVUS product within only seven months. Furthermore, BiomenGroup has facilitated CE certification and international market entry for a range of products, including drug-coated balloons, drug-eluting stents, dural patches, medical-grade hyaluronic acid for aesthetic medicine, central venous catheters, and left atrial appendage occluders.

Another core advantage of BiomenGroup lies in its deep expertise in specialized compliance. Taking the establishment of an ISO 22442 system for medical bovine tissues as an example, no domestic enterprise has yet obtained global compliance certification using locally sourced bovine materials. This is primarily because domestic cattle farms, slaughterhouses, and tissue extraction processes fail to meet international regulatory requirements. The BiomenGroup team possesses auditing experience with internationally compliant cattle farms in countries such as Australia and has a profound understanding of the key elements involved in source control for medical bovine tissues. Currently, the company is assisting a Chinese medical aesthetics enterprise in establishing a medical-grade cattle farm that meets international standards, accelerating the compliance process through end-to-end support ranging from feed management at the breeding stage and slaughter specifications to tissue extraction technologies. Furthermore, the company has extensive experience in EDQM certification for animal-derived materials and customized global registration strategies.

Meanwhile,BiomenGroup excels in integrating global regulatory frameworks to achieve “a single registration dossier for worldwide submissions.”The company adopts the highest standards to chart a compliant pathway for corporate products, enabling simultaneous compliance with global market registration requirements through a single round of high-standard testing and documentation preparation. This approach eliminates the double costs associated with the traditional model of “first complying with domestic standards, then redoing the work according to international standards for export.”

Given the high cost sensitivity of domestic enterprises, BiomenGroup benchmarks its service quality against top international standards while aligning its pricing structure more closely with domestic market conditions. Guo Changliang explained that leading international consulting firms are constrained by fixed pricing mechanisms, often quoting fees for individual projects at levels prohibitive for Chinese companies, thereby limiting their expansion in the domestic market.By optimizing service processes and resource allocation, BiomenGroup has established a unique competitive advantage of “international standards at local prices,” while ensuring service quality. This enables the company to provide cost-effective and professional global expansion solutions for Chinese medical device manufacturers.。

BiomenGroup has consistently minimized certification costs from a corporate perspective by prioritizing less resource-intensive validation methods: leveraging linguistic argumentation over testing, physical testing over animal studies, animal studies over clinical trials, and post-market clinical follow-up over pre-market clinical trials. This approach effectively balances the baseline requirements of regulatory compliance with the optimization of corporate costs.

It is worth noting that, leveraging its international team background, BiomenGroup not only serves Chinese enterprises but also possesses the capability to serve foreign companies, having assisted several overseas firms in obtaining certifications and expanding into global markets.

Furthermore, market access barriers often present a greater challenge than regulatory registration. Obtaining medical device registration certification is merely the first step toward globalization; the key determinant of whether a product can achieve commercialization in the target market lies in overcoming its implicit market thresholds. Substantive obstacles such as clinical acceptance, physician preferences, and integration with reimbursement systems constitute the “last mile” that determines whether a product can truly enter the local market.

BiomenGroup’s differentiated competitiveness lies in its ability to not only help enterprises overcome international regulatory registration barriers but also provide international sales expertise and resources by leveraging its in-depth understanding of the business environment in target markets.Kim Giliam, the company’s clinical expert and international sales specialist, possesses a robust background in international business. Having previously served as Global Business Director at Cook Medical, she assists enterprises with global business planning. Furthermore, the core team has accumulated extensive industry resources in nearly every country worldwide, establishing commercial channels in key markets across Southeast Asia, the Middle East (such as Iran and Israel), and Europe (including France, Spain, and the United Kingdom), thereby providing market support for the company’s product exports.

“We do not engage in ‘one-off transactions.’ In undertaking each project, we simultaneously provide training to our clients’ teams and share industry know-how, thereby helping to cultivate more international regulatory talent in the Chinese market and serving as an enabler for enterprises on their path to globalization,” said Guo Changliang at the conclusion of the interview. Looking ahead, BiomenGroup will continue to focus on facilitating the successful global expansion of domestically produced high-value medical consumables, helping companies overcome regulatory and market barriers and enabling more outstanding Chinese-made medical devices to reach the global market.