From CRO to CRO+CDMO

From 2011 until now, MedicalStrong has been concentrating on the medical device business to provide the manufacturers one-stop services before their products released in Chinese market, which including NMPA registration application, testing outsourcing, clinical investigation, clinical equivalence evaluation report, production system establishment tutorship, design and implementation of zoopery plan, R&D of medical device, the regulation training, medical translation etc. Our characteristic service is NMPA registration application and clinical investigation for the implant products(Class Ⅲ).

Based on the profitable items from new state policy, in 2018 we start up upgrading strategy to establish multi-service platform, which expands our business extent from steady CRO to CRO+CDMO.

2011-2015

• In 2011, MedicalStrong (Beijing) Technology Development Co., Ltd is founded.
• Our primary Business is NMPA registration application of medical device and IVD. The sales amount was been increasing exponentially year by year and archived nearly RMB 8,000,000 in 2015.

2015-2017

• The company grew faster and faster and expanded main business from NMPA registration application to a full range of registration solutions for medical device, including NMPA registration application, testing outsourcing, clinical trial, production system tutorship etc.
• We established some branch offices in 8 provinces/municipalities directly under the central government, and a CRA/CRC service network covering 20 cities.
• Until 2017, annual sales were almost 40 million. At present, we have entered the top3 of the consulting industry.
• Infused tens of millions RMB by A round financing capital for the hospital partner development and strategic talent pool.

2018

• Development strategy

1. Improvement of organization structure：According to our service mode and business contents, we are always working on improvement of organization structure. It means we usually recruit some personnel whom specialized in medical regulations and technology to form our consulting team and provide strategic planning, resource exploration and share, support to academic activities etc. At the same time, the personnel specialized in biochemistry and industrial design are also recruited in the development department and system guidance department to guide the clients how to establish qualified QC system at every stage from design to final controls.
2. New business mode：Our CDMO business includes service to R&D outsourcing and pre-registration production. Deferent from traditional CDMO, we divide the “D” (Development) into 3 patterns such as cooperative, contract, independent to satisfy deferent requirement from R&D clients. Until now, we are working on construction of GMP purification workshop (covers 1,000m²) in Shanghai Putong new district. The 1^st phase project is mainly used for IVD area. The 2^nd and 3^rd phase will be added with functions for the active, passive and other high-risk implant device(Class Ⅱ and Class Ⅲ). At last the production shall be commercialized.
3. Type of product and client：The many years of experience gave us on extra edge in Orthopedics and IVDs area. The businesses about Orthopedics and IVDs account for 1/3 of our total business. and most of them is about Class Ⅲ medical device. But our advantage is changed recently because we keep growth of the business about innovative fields (such as AI, surgical robot etc.) due to the strategy arrangement. Besides, the number of foreign clients is close to 40% of our total clients. Most of them are from the United States, Europe, Japan, Korea. In consideration of high-level requirement and appraisal system of those foreign clients, our management and operation system are optimized and upgraded to provide better service.
4. Brand promotion：The CRO is our basic and core business from the establishment of MedicalStrong. Based on our branding philosophy “concentration, profession, expert”, we have completed many registration application and clinical trial projects which are initiated in China or Asia at first time. Now we have occupied a position of prominence in consultation service market of medical device. But we still need to optimize and improve our service to become an international brand and update our orientation and direction. So, we use the slogan “Your Persistent NMPA assistant” and expect to become the first partner and regulation assistant for more global medical device manufacturers when they get access to Chinese market.
5. Optimization of visual identification：New simpler visual identification represents our industry attribute more distinctly and shows brand meaning of concentration, steady, flexibility, connection, continuity. It also indicates long-term experience of our concentration on medical industry, assurance of Industry pulse, initialization of strategic upgrading.