JoyMed Technology Strengthens Medical Translation Services Under China's Medical Device Marketing Authorization Holder System, Files IPO Prospectus

During the pandemic, drug regulatory authorities across various regions implemented emergency approval procedures for medical devices urgently needed for epidemic prevention and control. Meanwhile, medical device CRO+CDMO companies leveraged their strengths and made rational use of emergency registration policies for anti-epidemic medical devices, helping to accelerate the market launch of “anti-epidemic” products.

For example, Joymed actively assisted enterprises in applying for emergency approvals for critical epidemic prevention products such as masks and protective suits, while also accelerating the research, development, and market launch of disinfection products. Cao Changqing, General Manager of Joymed, stated, “In the face of the pandemic, we have done our utmost to contribute to the efforts in combating and preventing the disease.”

Joymed, established in 2014 and headquartered in Shanghai, is a technology platform enterprise integrating CRO (Contract Research Organization) and CDMO (Contract Development and Manufacturing Organization) services for medical device development. A CRO is a professional organization that primarily provides product development and research services to pharmaceutical and medical device companies through contractual agreements. CDMO is an emerging outsourced service model that deeply integrates with a company’s entire supply chain system—including R&D, procurement, and production—across stages ranging from preclinical research and clinical trials to process development and commercial-scale manufacturing, thereby providing innovative process development and large-scale production services.

Cao Changqing stated, “Joymed aims to provide services in the research and development, clinical trials, regulatory registration, and manufacturing of innovative medical devices for global medical device companies, universities, and healthcare institutions. We strive to offer end-to-end solutions for medical device enterprises both domestically and internationally, covering product feasibility studies, technical research, product development, supply chain management, mass production, clinical trials, and regulatory submissions.”

In 2015, Joymed officially commenced operations, focusing on product research and development services as its core business. From foreign enterprises to domestic ones, Joymed has continuously expanded its client base. In 2016, after securing its first round of financing, Joymed established a production base in the Jiangsu Medical Device Technology Industrial Park to launch its CDMO business.

Cao Changqing engaged in extensive deliberation before launching CDMO services. There are significant differences between medical device CROs and pharmaceutical CROs. The pharmaceutical CRO sector is characterized by large scale, lengthy processes, and substantial capital requirements, which can meet the development needs of pharmaceutical CRO enterprises. In contrast, if a medical device CRO focuses solely on registration or R&D services, it will struggle to achieve significant growth. Therefore, enterprises must extend their value chain upstream into R&D and downstream into CMO, expanding service boundaries to deliver greater value to clients, thereby enabling sustainable business development.

The decision to first establish operations at the Jiangsu Medical Device Technology Industrial Park was driven by Suzhou’s mature talent pool in medical device manufacturing and its robust supply chain. Additionally, Suzhou’s proximity to Shanghai helps reduce the cost and complexity of design transfer during the later stages of research and development.

Cao Changqing introduced: “Currently, Joymed operates an R&D and service center for medical devices spanning over 800 square meters across multiple regions in China, along with several hundred square meters of product R&D laboratories, safety compliance and reliability verification testing laboratories, and a Class 10,000 clean aseptic testing laboratory. The company also boasts an assembly and testing workshop for active medical devices exceeding 4,000 square meters, as well as an 800-square-meter GMP-compliant Class 100,000 cleanroom.”

Over the past five years, joymed has provided R&D and manufacturing services to numerous leading domestic and international medical device companies, innovative device enterprises, and clinical institutions. Multiple projects involving high-end drug infusion systems, surgical instruments, rehabilitation devices, and IVD products have gained customer recognition, demonstrating joymed’s strong R&D capabilities and comprehensive service system.

According to reports, joymed begins each project with conceptual research and market analysis to ensure that the product aligns with market demands, regulatory requirements, clinical considerations, and technological leadership. These factors are continuously validated throughout the product development process. Only when all criteria are met does the company consider the project to have the potential to become a successful innovative product.

The second phase involves the development and validation of engineering prototypes and design prototypes. In this phase, product functions and performance must be refined in alignment with project objectives, early-stage DFx (Design for Excellence) analyses must be conducted, and manufacturability, quality, and cost-effectiveness must be ensured. The third phase encompasses design transfer, process validation, regulatory registration, and mass production. “Our goal is to help clients achieve mass production and large-scale market launch of their products, as the ultimate objective for our clients is to bring products to market at scale as early as possible, thereby serving more patients and healthcare professionals and delivering greater value,” explained Cao Changqing.

Regarding product registration, joymed has a professional team well-versed in international regulations and product registration. Due to their frequent involvement in international projects, this team has developed a global perspective on the healthcare market.

Joymed’s R&D and management team comprises approximately 80 experienced professionals, with its principal engineers boasting over 15 years of expertise in R&D and production management. The R&D team encompasses specialists across multiple disciplines, including electronics, software, mechanical engineering, testing, supply chain management, and regulatory affairs.

Driven by multiple factors including its team, R&D capabilities, service system, and industry reputation, Joymed has achieved steady growth, with its 2019 business volume approximately 2.5 times that of 2018.

Customer recognition of joymed stems not only from its ability to help enterprises reduce costs and accelerate product time-to-market, but also from its comprehensive service system that safeguards customer interests.

Cao Changqing stated, “Joymed’s core competitiveness lies in its productization capability—that is, the systematic ability to support products from the concept stage through R&D to registration and production. Therefore, we remain committed to R&D as our core, aligning with international standards to deliver high-standard, high-quality manufacturing services. Our service system, which has been validated over time and by our clients, constitutes our core competency, enabling us to serve customers efficiently while ensuring both quality and quantity.”

Currently, Joymed has developed or is developing nearly 20 Class II and Class III medical device products for its clients, with several Class II and Class III devices having entered clinical trials, regulatory registration, or imminent mass production stages. “Through Joymed, multiple clients have successfully transformed their concepts into market-ready products. Meanwhile, compliance has been ensured while reducing costs and accelerating time-to-market.”

Cao Changqing introduced that the customer base targeted by joymed mainly includes four categories:

First, foreign medical device companies that need to localize. Today, the Chinese market is large and growing rapidly, with more and more foreign enterprises hoping to compete for the domestic market. Geopolitical factors will drive foreign companies to carry out localization activities. This has brought many opportunities to joymed. Cao Changqing stated: "We hope to support the acceleration of the localization of foreign devices and technologies, helping to improve the level of healthcare in China and reduce medical prices."

Second, leading enterprises within each sub-sector and domestically listed companies. Under the current medical insurance policies and market competition environment, these enterprises need to continue expanding their product lines and achieve import substitution for domestic medical devices in more areas. Joymed can help these companies achieve their strategic goals through efficient R&D services.

Third, innovative enterprises in the biomedical sector or established companies undergoing transformation. Joymed can provide them with one-stop services spanning new product R&D, regulatory registration, and manufacturing, facilitating their successful transition.

Fourth, research institutions such as medical institutions, research centers, and universities. Since the National Medical Products Administration issued the Notice on Expanding the Pilot Program of the Medical Device Registrant System in 2019, announcing the expansion of the medical device registrant system to 21 provinces and municipalities, Joymed infers that the translation of innovative technologies from research institutions will be the main channel for future medical device innovation in China. Therefore, Joymed has joined hands with well-known domestic universities and clinical institutions to build a medical device innovation platform focused on research and production transformation.

Joymed offers flexible collaboration models tailored to medical device companies with diverse needs and across different sectors. Given the wide variety of medical devices, Joymed modularizes its technology platforms and matches them to specific products based on the most suitable platform, thereby delivering efficient, high-quality services.

Regarding intellectual property, Cao Changqing stated, “Intellectual property is at the core of our business. To safeguard our clients’ IP rights, we have established a comprehensive intellectual property protection system. Furthermore, since our inception, we have committed not only to protecting our clients’ intellectual property but also to helping them develop their own proprietary IP, actively assisting them in filing relevant patents throughout project implementation.”

In fact, Joymed was among the first companies to anticipate the widespread adoption of the Medical Device Registrant system. Against this backdrop, Joymed has established outsourced R&D and contract manufacturing service bases across multiple provinces and cities in China, as well as overseas business development centers. These include a product R&D service center in Shanghai; a product R&D service, sterile device, and active device contract manufacturing base in Suzhou; an R&D and vertical PCBA plus active device contract manufacturing base in Shenzhen; a CDMO base under construction in Changsha; and an international customer service center in the United States.

Regarding future planning, joymed intends to proceed from two aspects. First, for enterprise-level clients, it will continuously improve and provide high-quality R&D CRO and CDMO services, thereby expanding its business scale and service capabilities. Second, it will establish long-term collaborations with clinical institutions and universities to promote the translation of industry-academia-research outcomes.

Cao Changqing concluded, “We hope that joymed’s technology and service platform will evolve into one of the foundational infrastructures in the medical device industry, empowering more enterprises and clinical institutions, and contributing to the development and upgrading of China’s medical device sector.”