Happy New Year – Onward 2025!
Fire and Ice dominated global headlines as we step into a brand-new year, recognizing the dynamic, polarizing nature of the Healthcare industry. In this edition of our newsletter, we are pleased to share various acquisitions in the device industry, healthcare policy changes, and regulatory framework developments.
Enjoy reading, and here’s to a successful and fulfilling year ahead!
This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).
Learn More ⟶In order to further strengthen the supervision and management of medical devices, continuously standardize the production behavior of medical devices, and improve the quality management compliance capabilities and levels of enterprises, in accordance with the "Medical Device Supervision and Management Regulations" and "Medical Device Production Supervision and Management Measures", the State Drug Administration organized the drafting of the "Medical Device Production Quality Management Standards (Revised Draft for Comments)", and now solicits public opinions.
The public comment period is from January 16 to February 14, 2025. Relevant units and individuals can provide feedback to mdgmp@cfdi.org.cn . Please indicate "Medical Device Production Quality Management Standards-Opinions and Suggestions Feedback" in the subject of the email.
Attachment:
1. Medical Device Production Quality Management Standards (Revised Draft for Comments).
Attachment 1.docx
2. Opinion and Suggestion Feedback Form Template
Attachment 2.docx
Regulation (EU) 2017/745 on medical devices (MDR):
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):
UK approved bodies:
The 2024 Clinical Trial Enabling Infrastructure grant opportunity will provide $35.7 million for medical research and innovation projects that:
• address areas of unmet medical need through adaptive platform trials or registry-based randomised controlled trials
• strengthen the research sector’s capability and collaboration through new or expanded clinical trial practice networks.
Private equity acquisitions of hospitals have increased over the past decade in the US.1, The growing presence of private equity in health care has been controversial, attracting widespread scrutiny from US congressional committees, health care leaders, and the public. This has been driven by concerns that private equity firms’ incentive to generate financial gains rapidly could have adverse implications for patient care.2-4
Learn More ⟶On Sunday, 12 January, the Regulation on Health Technology Assessment (HTA) will become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU.
Learn More ⟶Stryker (NYSE: SYK), a global leader in medical technologies, announced today a definitive agreement to acquire all of the issued and outstanding shares of common stock of Inari Medical, Inc. (NASDAQ: NARI) for $80 per share in cash, representing a total fully diluted equity value of approximately $4.9 billion. Inari, which was founded in 2011, will bring a leading peripheral vascular position in the fast-growing segment of venous thromboembolism (VTE) to Stryker. Inari’s innovative product portfolio is highly complementary to Stryker’s Neurovascular business and includes mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein thrombosis and pulmonary embolism.
Learn More ⟶Vensana Capital today announced the closing of Vensana Capital III with $425 million in committed capital. The fund was oversubscribed at its hard cap with the support of the firm’s existing limited partners alongside select new institutional investors, and it brings Vensana’s total capital under management to approximately $1 billion.
Learn More ⟶Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) acquired 96.8% of shares of EndoStream Medical Ltd. (Headquarters: Or Akiva, Israel; CEO: Danel Mayer; hereinafter referred to as ESM), an Israeli medical equipment company, on December 23,2024. By combining Kaneka's manufacturing and ESM's technology, we will jointly develop new medical devices, mainly for cerebrovascular treatment, in addition to the Nautilus™ device for aneurysm treatment currently under development. We aim to achieve sales of over 20 billion yen by 2030.
Learn More ⟶QUALITY MANAGEMENT SYSTEM
Using GenAI for QMS?
Templates aplenty. eQMS getting more affordable
What is left to do? Customisation
However, the very nature of customization means that resources would need to be deployed to look into the procedures and determine which parts needs to be written specific for your organisation.
Is there some way that GenAI can help with this writing?
GenAI would need to have an information repository to form the context of this customization. This information repository would involve organisation, and product information. But what if these foundational information is not there? Then GenAI may try to interpolate according to what can be found publicly, and attempt to still have something ‘fairly customized’.
How about implementation? Developing the necessary competency? Using day to day, and to withstand a quality inspection? GenAI may or may not be able to answer these questions correctly, and if you implement a checkpoint, the review time may already be sufficiently substantial – might as well write it out directly!
GenAI can, however, be useful to populate templates. For example, validation protocols, where information is predictable. However, some clever documentation practices and nifty cut n paste, could just be as quick.
Perhaps GenAI can save a bit of time here and there, or allow a second look at something you feel you may have a jaded view. But nothing would be able to replace the human engagement to be competent in your organisation’s quality management system, to ensure good quality product is consistently produced, and improved.
Still clear as mud?
Contact Us Now! ⟶ |
India International Healthcare And Medical Diagnostics Expo Chandigarh, India 22- 24 Jan 2025 Click Here ⟶ |
13th Annual Outsourcing in Clinical Trials : Medical Devices Europe 2025 Munich, Germany 28 - 29 January 2025 Click Here ⟶ |
MEDIZIN Stuttgart Stuttgart, Germany 31 Jan - 02 Feb 2025 Click Here ⟶ |
Health Expo Athens Megaron Athens International Conference Centre, Greece 15 - 16 Feb 2025 Click Here ⟶ |
Medicall Kolkata Biswa Bangla Mela Prangan Convention Centre, Kolkata 15 - 17 Feb 2025 Click Here ⟶ |
Medtrade East Dallas Dallas, US 18 - 20 Feb 2025 Click Here ⟶ |
Saudi Hospital Design & Build Expo Riyadh Riyadh, Saudi Arabia 24 - 27 Feb 2025 Click Here ⟶ |
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