Johnson & Johnson and Stryker Announce Layoffs, FDA Issues Class I Recall for Philips Respiratory Devices, and Zhongtian Medical Secures Series C Funding

Oct 05, 2024 16:47 CST Updated 16:47

Johnson & Johnson

Medical Device R&D and Manufacturer

Stryker

Medical Device R&D, Production, and Sales Company

Zenith Vascular

Cerebrovascular Device R&D and Manufacturer

Recently, global medical device giants Johnson & Johnson and Stryker announced layoff plans.

According to the WARN notice files in New Jersey, Johnson & Johnson plans to lay off hundreds of employees in the state. Specifically, the company will cut 231 jobs in New Brunswick, where its headquarters is located. In addition, since the middle of 2022, Johnson & Johnson’s global layoff actions have involved at least 1,000 employees.

A spokesperson for Johnson & Johnson explained the reason for the layoffs in a statement: "Johnson & Johnson is addressing some of the world's most pressing health challenges through science and technology-driven innovation. To meet the needs of patients worldwide, we must adapt and evolve our business in a complex and rapidly changing external environment."

Stryker's layoff plan at its Lakeland, Florida plant is also underway. The company plans to further cut hundreds of jobs and expects this project to eventually result in the permanent layoff of approximately 500 employees. Stryker plans to close the facility by December 31, 2026.

Stryker stated in the letter that it hopes to implement the layoff plan in a way that "causes the minimum possible disruption to employees and the community." The company began implementing layoffs on December 31, 2021, and so far, approximately 220 positions have been eliminated.

Although the layoffs and plant closures by Johnson & Johnson and Stryker may raise concerns about the medical industry's prospects in the short term, these actions primarily reflect corporate strategies to adapt and optimize in a constantly evolving market environment.

What "Instrument" News is Worth Paying Attention to in the Medical Device Circle This Week? Insights into New Industry Policies, Observations of Corporate Movements, and a Review of Market Investments and Financing, tracked and reported by the Pharmaceutical Economy News!

Insights into New Industry Policies

Guiding Principles for the Registration Review of Six Medical Devices, Including Metal Cable and Wire Systems, Released

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration has organized the revision of six medical device registration review guidelines, including the "Guiding Principles for the Registration Review of Metal Cable and Wire Systems," which are now released. The aim is to further standardize the management of medical devices such as metal cable and wire systems. Including:

1. Guidance Principles for the Registration Review of Metal Cable and Cable System

2. Registration Review Guidelines for Lamina Fixation Plate Systems

3. Guidance Principles for the Registration Review of Posterior Spinal Internal Fixation Systems (2024 Revised Edition)

4. Guidance Principles for the Registration Review of Interbody Fusion Devices (2024 Revised Edition)

5. Guidance Principles for the Registration Review of Gutta-Percha Points

6. Guidance Principles for the Registration Review of Dental Implant Systems (2024 Revised Edition)

(Scan the QR code below to view and download the full text of the attachment)

EU New Release: Application of Transitional Provisions for Class D IVD Device Certification under IVDR

Recently, the EU MDCG released the "Revised Guidelines for the Application of Transition Provisions for the Certification of Class D In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746." The clarifications provided in the guideline include:

1. Revise the question of when the notified body must submit the manufacturer's performance evaluation report to the expert panel;

2. Whether there is a Notified Body that can accept the manufacturer's Class D IVDR certification application and issue the corresponding certificate without designating a European Union Reference Laboratory (EURL) for the IVD device.

3. Revise the answer regarding what will happen to IVDR-certified IVD devices in the absence of a designated EURL within the corresponding scope.

Observation of New Trends in Enterprises

FDA Issues Class I Recall for Philips Ventilators

Recently, the U.S. Food and Drug Administration (FDA) announced that several models of ventilators under Philips have been classified as Class I recalls, the highest level of recall. The models involved are Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal, with a total of approximately 90,000 devices worldwide, including about 67,000 in the United States.

Philips recently announced a recall due to a software error that could have serious implications for patients. Issues caused by the software error include inaccurate oxygen readings, false power failure or battery depletion alerts, and incorrect volume measurements. Additionally, there were previous reports of debris accumulation on the internal flow sensors of the machines, which could partially obstruct pressure, volume, or airflow. According to the FDA, these issues have resulted in nine injuries and one death.

The FDA noted that Philips Respironics had sent an "Urgent Medical Device Correction Update" to all affected customers on July 16, urging them to immediately update the device software to the latest version and follow the instructions in the appendix of the user manual, using Philips-approved particulate filters to prevent environmental contamination.

Intuitive Medical Establishes Global Capability Center in India

Recently, Intuitive Surgical opened a Global Capability Center (GCC) in Bengaluru, India, aiming to drive innovation, enhance operational efficiency, and attract top talent. The center will provide employment opportunities for 250 full-time professionals across various fields, supporting Intuitive Surgical's continued growth in the global market.

Intuitive Medical, as a leader in the field of minimally invasive care and robot-assisted surgery, has widely applied its technology in leading hospitals in India, trained over 850 surgeons, and performed more than 100,000 surgeries.

Hoya's First Intraocular Lens Production Base in China Settles in Suzhou

Recently, the China production base of HOYA Medical's intraocular lens project, a Japanese medical device giant, has officially completed in Suzhou High-Tech Zone, becoming its first intraocular lens production base in China.

Since its establishment in 1941, Japan's HOYA Corporation has demonstrated its globally leading technological strength in the two major fields of "life care" and "information communication." As its subsidiary, HOYA Surgical Optics holds a significant position in the global intraocular lens market.

The park where the project is located is an important platform for the medical device industry in Suzhou, the Jiangsu Medical Device Technology Park Medpark. Through its unique operating model, the park is committed to building a high-end medical device industry hub that integrates ecological, clustered, and professional elements, contributing to the development of the medical device industry in the region and throughout China.

Market Investment and Financing Review

New Source Brain Science Secures Tens of Millions in Pre-A Funding

Recently, Sichuan Xinyuan Bioelectronics Technology Co., Ltd. (Xinyuan Brain Science) announced the completion of a multi-million yuan Pre-A round of financing, led by Pine Capital. The funds will be used for the research and development and market promotion of perioperative brain function monitoring products and a new generation of neuromodulation products.

Xinyuan Brain Science, established in 2014, is a high-tech enterprise integrating the research, development, and production of medical devices. It focuses on research in the fields of brain science, clinical medicine, and artificial intelligence. The company aims to provide advanced research equipment to biomedicine research institutions and reliable monitoring and auxiliary diagnostic tools to clinical and health management organizations.

Ai Health Highway Completes $1.5 Million Pre-A Round Financing

Recently, Turbostart, a globally renowned venture capital platform, announced its lead investment in Ai Health Highway's $1 million Pre-A funding round. The total amount raised in this round reached $1.5 million, with other investors including Rainmatter by Zerodha, The Chennai Angels, BITS BioCyTiH Foundation, and multiple angel investors.

Ai Health Highway is a technology-driven medical company, and its core product is India's first AI-powered stethoscope — AiSteth. This innovative device assists medical professionals and non-professionals in diagnosing heart diseases by analyzing heart sounds, providing clinical insights. With AI technology and advanced signal processing capabilities, AiSteth transforms the traditional stethoscope into a cutting-edge screening tool capable of early detection of life-threatening heart conditions, helping healthcare workers make timely clinical decisions.

Zenith Vascular Secures Series C Financing

Recently, Suzhou Zenith Vascular Co., Ltd. ("Zenith Vascular"), a pan-vascular interventional enterprise, announced the completion of its Series C financing round. The amount of financing has not been disclosed yet and was jointly invested by Hengdian Capital and Juming Venture Capital. This round of financing will help Zenith Vascular accelerate the development progress of new products, improve product quality, further consolidate the company's competitive position in the market, and also actively expand domestic and international markets to benefit more patients.

According to IQVIA data, in the first half of 2024, China's medical device market size decreased by 3.2% year-on-year based on ex-factory prices, but the market size of vascular interventional devices increased by 10.1% year-on-year. The growth in the number of surgeries across all segments under vascular intervention has been relatively stable, generally higher than in other fields.

Editor: Wanwan