|
|
Dear Readers, February was skipped as there were too many public holidays, and our Group Executive Director was in Japan in for an entire month! Here’s to share the various stages of the long trip and catch our Special Feature below. You’ll not be short of the various out and about news in the healthcare industry. Enjoy!
|
|
|
|
|
|
SINGAPORE Public Consultation on Best Practices Guide for Medical Device Cybersecurity |
|
The Medical Devices Cluster (MDC) has released a draft of the Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. Feedback is invited from 10 March to 12 May 2025 via the online form: https://go.gov.sg/md-best-practices-for-consult. Submit feedback using the provided template by 13 May 2025. |
|
|
|
|
|
EUROPE Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
|
|
Vigilance reporting is essential for post-market surveillance, safeguarding medical devices under EU MDR & IVDR. Notified Bodies play a key role by auditing procedures and collaborating with authorities, though some face challenges with duplicate reviews. MedTech Europe calls on the European Commission and the Medical Device Coordination Group (MDCG) to streamline vigilance data evaluation processes and eliminate duplicate reviews of vigilance cases.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNITED KINGDOM AI and software cyber security market analysis |
|
DSIT commissioned Perspective Economics to analyze the market for software and AI cybersecurity services, supporting efforts like the AI Cyber Code of Practice. Using data collection, machine learning, and classification frameworks, the study maps three key segments: AI cybersecurity, specialist software security providers, and broader software security services. |
|
|
|
UNITED STATES FDA admonishes Chinese device testing lab for falsified studies, copied data
|
|
On 11 March 2025, the FDA barred all data from Chinese lab Mid-Link Technology Testing due to falsified and copied results. Despite prior warnings, the lab submitted unreliable test data, including duplicated results and implausible study outcomes. Mid-Link’s response was deemed inadequate, and its data will remain inadmissible until issues are fully addressed.
|
|
|
|
TAIWAN Taiwan unveils standardized medical data platform
|
|
Taiwan’s Ministry of Health and Welfare is launching a standardized medical data platform to enhance smart medicine and interhospital cooperation. Using Fast Healthcare Interoperability Resources, the platform will unify data, improve treatment accuracy, and boost efficiency. It will also implement Clinical Quality Language for consistent clinical evaluation and streamline National Health Insurance processes. |
|
|
|
CHINA Updated Guidelines for Imported Medical Device Production in China
|
|
The National Medical Products Administration (NMPA) has issued "The Announcement on Further Clarifying Matters Relevant to the Production of Imported Medical Device Products by Enterprises in China" (No. 104 of 2020) to align with the "Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry", optimizing regulations and supporting innovation in the medical device sector.
|
|
|
|
|
|
|
|
EUROPE
Femasys Announces FemBloc Delivery System Approval in Europe; A Significant Step Towards FemBloc Permanent Birth Control Availability as the First-Ever Non-Surgical Approach
|
|
Femasys Inc. (Nasdaq: FEMY) has received the world’s first CE mark approval for its FemBloc® delivery system, a non-surgical permanent birth control option. The FemBloc blended polymer is undergoing final EMA review, with potential approval by mid-2025. Market launch in select European countries is planned, alongside ongoing U.S. clinical trials. |
|
|
|
UNITED STATES
Hinge Health Files Registration Statement for Proposed Initial Public Offering |
|
Hinge Health has filed for an IPO on the NYSE under the ticker “HNGE,” with Morgan Stanley, Barclays, and BofA Securities as lead bookrunners. The offering size and price range are yet to be determined. Hinge Health provides AI-driven MSK care solutions to improve outcomes and reduce costs.
|
|
|
|
US FDA says shortage of dialysis device component to extend through early fall
|
|
The U.S. FDA warned that supply shortages of hemodialysis bloodlines, essential for dialysis treatments, are expected to persist until early 2025 due to production disruptions. The FDA urged healthcare providers to conserve supplies and is collaborating with manufacturers to minimise patient impact.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Design and Development How to prevent overspending in development
Most of the time we discuss about the details of technical documentation, this time we discuss about the economics of design & development. There were (and will be) many instances where the startup flames out (i.e. shuts down) because they have run out of money at the clinical trial stage or could not sustain beyond market launch. The typical reasons cited will be the costly and long processes in the clinical study, and the high costs of development. There were situations where the research had spun out too early to form a company because the research funds have run dry and the only way to keep going is to have institutional funds. Sounds familiar? It actually starts from the design/ development processes, or even earlier, the proof-of-concept stages
When too much is spent on the early phases of the proof of concept, that leave less for the next steps of design & development, which then impacts the clinical studies / usability studies. Therefore, the shortfall escalates.
There are several ways around this, potentially. - Being clear about your beachhead markets, and design accordingly. - Not to allocate too much funds to research or even development staff and leave almost nothing for external help (mostly service providers, material providers) - Not to spin out too quickly, and ensure at least the animal study, first in human (if applicable), and usability study are completed first. This may consume more funds early, but it will prove useful as the chances of running dry of funds is reduced - Not waiting for patients to turn up, quickly turn to multi site if possible. This is because with each passing month, there are overheads and development costs.
With prudent spending, clear design objectives according to beachhead markets, and ensuring the patient recruitment is complete as soon as possible with whatever methods possible, goes a long way to ensure the survival of the startup.
Still clear as mud?
|
|
|
|
|
|
|
|
The month of March was certainly eventful (pardon the pun) for quality and regulatory.
Taking place in Tokyo, Japan, the ISO TC210 meetings and plenary, as well as the 27th IMDRF Management Committee meetings were held back-to-back from the 3rd to the 14th of March, 2025. This gathered some of the globally recognized quality and regulatory experts, regulatory bodies, industry associations, and academia in one location, to determine the framework of the medical device industry for the next 5 to 10 years. Our Group Executive Director was actively involved in both. Find out more in our blog post! |
|
|
|
|
|
|
|
Healthcare Asia Summit 2025
Grand Ballroom 2, 1st Floor, Renaissance Kuala Lumpur Hotel & Convention Centre
8:30 AM - 5:00 PM, 9th April 2025
Click here ⟶ |
18th Annual Device Research & Regulatory Conference
Hyatt Regency Newport Beach, 1107 Jamboree Road
Newport Beach, CA 92660
24th & 25th April 2025
Click here ⟶ |
|
4th Annual Medical Device and Diagnostic Regulatory Affairs Conference Brussels, Belgium
8th, 9th & 10th April 2025
Click here ⟶ |
EU MedTech Compliance Summit: Navigating New Timelines, Regulations & Clinical Evidence Sitem-Insel, Freiburgstrasse, Bern, Switzerland, 3010
9:00 AM - 4:30 PM, 2nd Apr 2025
Click here ⟶ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.jpg)
.png)
.png)
.jpg)
.png)
.png)
.png)
