How Can Medical Device Startups Overcome Slow Registration, Long Timelines, and High Barriers to Industrialization?

A series of industrialization challenges, such as slow registration, long cycles, and high entry barriers, have plagued countless medical device companies. Contract Development and Manufacturing Organizations (CDMOs), which provide process R&D, design, and manufacturing services directly to medical device developers, offer effective solutions to these problems.

2021In recent years, with the formal inclusion of the Medical Device Registrant System in the "Regulations on the Supervision and Administration of Medical Devices (2021 Revision)," the medical device CDMO sector has developed accordingly. Currently, CDMOs specializing in various niche fields are continually emerging; however, before entering into partnerships, companies still seek a more comprehensive understanding of potential CDMO partners.

To address the aforementioned issues, VCBeat Select Open Course will launch“Medical Device CDMO Special Topic” Lecture Series。March 2, 2023 (Thursday) 20:00-21:30，VBSelectJoin HandsDongmai Medical, launching the second session of the special series on CDMO for medical devices. This session will“Medical Device Startups: How to Overcome Industrialization Challenges Such as Slow Registration, Long Cycles, and High Barriers?”Focusing on this theme and incorporating practical case studies, we will share insights on how to overcome the challenges of industrializing early-stage medical device startups.

This course also invitesLu Peihua, Academician of the European Academy of Natural Sciences and Deputy Director of the Research Department at Wuxi People’s Hospital; Jiang Haihong, Director of the Medical Product Management Program (Department) at Shanghai University of Medicine & Health SciencesandLi Yong, Chairman of the Management Representative Coordination Committee of the Shanghai Medical Device Industry Association, jointly participating in "The Significance and Value of Medical Device CDMO Platforms in Advancing Industry DevelopmentThematic Roundtable Discussion: Helping Enterprises Understand How Medical Device CDMOs Drive Industry Development.

For viewers participating in the live interactive consultation, Dongmai Medical also provides enterprises with “Full Lifecycle CDMO Listing Pathway Review Service“Free consultation services, plus a 6% discount for corporate partnerships. During the live stream, you’ll also have the chance to receive cash red envelopes!”Scan the QR code in the poster below to register for the live stream:

1New Solutions Brought by the Registrant System to Start-up Medical Device Projects

2How Can CDMO Platforms Overcome the Challenges of Slow Regulatory Approval, Long Development Cycles, and High Entry Barriers?

3What factors should be considered when selecting a CDMO platform for innovative projects?

4Case Study: Upgrading Dongmai’s CDMO Model from 1.0 to 2.0 for Startups

Medical Device CompanyFounder, General Manager

[Recommendation: ★★★★★]

Heads of R&D, Quality Systems, and Production at Medical Device Companies

[Recommendation: ★★★★★]

Clinicians, Import Agents of Medical Devices

[Recommendation: ★★★★★]

If you belong to the above-mentioned groups or have products in urgent need of commercialization, be sure not to miss this information-packed open lecture.

Chairman of Dongmai Medical Group, Senior Engineer with Researcher-level Title. He serves as a member of international and domestic standardization technical committees, including IEC/TC29, and concurrently holds the position of Chairman of the Medical-Engineering Translation Professional Committee under the Jiangsu Society for Biomedical Engineering. From 2003 to 2017, he served as Director of the Active Device Room (Electrical Safety Room) at the Jiangsu Provincial Medical Device Testing Institute. He has over 20 years of experience in providing full-lifecycle industrialization services for medical devices, encompassing CDMO and CRO solutions.

Academician of the European Academy of Natural Sciences, Deputy Director of the Research Department at Wuxi People's Hospital, Director of the Patent Translation and Training Center at Jiangsu Institute of Translational Medicine, and Director of the Medical Technology Translation Center at China Technology Exchange (Hubei).

Director of the Medical Product Management Department, Shanghai University of Medicine & Health Sciences; Associate Professor; Master’s Supervisor; Executive Director of the Dongmai Medical Group Academy. He also serves as a specially appointed expert or committee member for multiple organizations, including the Senior Training Institute of the National Medical Products Administration (NMPA). He has been deeply involved in the revision of national regulations and rules such as the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Measures for the Supervision and Administration of Medical Device Operation.

Chairman of the Management Representative Coordination Committee of the Shanghai Medical Device Industry Association, with 19 years of experience in the medical device sector. He has participated in the drafting of more than 20 national and industry standards and currently serves as a member of the National Technical Committee on Quality Management and General Requirements for Medical Devices (SAC/TC221).

Dongmai Medical Group is a leading domestic integrated service provider of CDMO (Contract Development and Manufacturing Organization) and CRO (Contract Research Organization) for medical devices. Leveraging the Medical Device Registrant System, the company employs mature innovation translation and contracted production management models to deliver a comprehensive business chain centered on three sub-platforms. It offers one-stop, full-process professional services, including quality system guidance, compliant development, engineering translation, contracted manufacturing, inspection and testing, clinical evaluation, and registration consulting. Dongmai has established China’s first new-type rapid industrialization service cluster for medical devices. In 2021, it became the first CDMO platform in Jiangsu Province to obtain a Production License. To date, it has undertaken contracted production for over sixty Class II and Class III medical device projects, ranking among the top nationwide in terms of project scale and experience. Currently, Dongmai is the only CDMO platform in China qualified with a production license for high-end Class III medical devices. Furthermore, Dongmai pioneered in China the approval of medical device registration based on inspection reports issued through self-inspection by the contracted party, further solidifying its leading position in the industry.

“VCBeat Select Open Course” is one of the brand columns under VCBeat’s “VCBeat Select.” Focusing on pain points in healthcare development and systematic solutions, it leverages an online live-streaming platform for knowledge sharing and exchange. By continuously inviting seasoned industry practitioners and experts to collaboratively develop a series of thematic courses, it aims to provide healthcare enterprises with in-depth, high-value, practical content. VCBeat Select Open Course: Making the selection of knowledge simpler.

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