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Movements in politics, movement in data, our MedTech Insights noted this month’s news as very data-focused around the world. Data is no longer the new currency – it IS the “currency” for barter. A few more IVDR Notified Bodies certainly helps more diagnostics companies to launch, together with Access-2-Healthcare
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JAPAN Japan set to fully cover childbirth costs possibly from April 2026 |
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In light of Japan’s falling birth rates, a government panel announced an elimination of out-of-pocket payments associated with child delivery, possibly from April 2026. Normal childbirth is not currently covered by Japan's public medical insurance, as it is not considered a medical condition, though cesarean sections are an exception; epidurals are also expected to remain uncovered. While the government provides a lump-sum payment of 500,000 yen per birth, the average cost of a normal childbirth nationwide in early fiscal 2024 was around 518,000 yen, meaning expenses often exceed the subsidy.
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CHINA Guangzhou Unveils First Achievements of Trusted Health Data Space |
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On May 8, the Guangzhou Health Commission launched the city's trusted health data space, featuring 5 data products and 28 high-quality datasets to enable secure, compliant sharing of de-identified medical data across institutions, promoting innovation in clinical care, pharmaceutical R&D, and health services. This initiative aims to break data silos, improve healthcare delivery, and support the biomedical industry’s full-chain development, with plans to scale across all local medical institutions and integrate with the Greater Bay Area.
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VIETNAM Deputy Minister of Health: The Health Insurance Law Will Be Amended to Move Toward Free Medical Care for All Citizens |
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The Vietnamese Ministry of Health is gathering feedback to amend the Health Insurance Law, aiming to provide free healthcare for citizens as directed by General Secretary Tô Lâm. Deputy Minister Trần Văn Thuấn announced plans to expand health insurance coverage, including regular check-ups and early disease detection, while addressing current challenges like overcrowding and out-of-pocket costs. The goal is to achieve universal free healthcare by 2035, with reforms focusing on preventive care and equitable access.
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SOUTH KOREA South Korea-based Vuno's AI-powered cardiac arrest risk management system earns CE MDR and UKCA certifications |
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Vuno's AI-powered cardiac arrest risk management system, DeepCARS, has received CE MDR certification in the EU and UKCA marking in the UK, accelerating its global expansion more than a year ahead of schedule. With plans to enter European and Middle Eastern markets, Vuno builds on its success in South Korea, where DeepCARS is deployed across over 48,000 hospital beds. |
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UNITED STATES
Sonova forecasts double-digit earnings growth, says CEO to step down |
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Swiss hearing aid maker Sonova forecasts double-digit earnings growth for fiscal 2025/26, with sales and EBITA to rise amidst CEO Arnd Kaldowski’s September departure. The company expects most of their products to be exempt from US tariffs under the Nairobi Protocol and plans a new product launch this summer to boost sales. Shares rose 2.6% as outlook exceeded market expectations with strong performance from their AI-powered hearing aid, released last year.
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UNITED STATES FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline |
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FDA Commissioner Dr. Martin A. Makary announced a groundbreaking plan to fully integrate generative AI across all FDA centers by June 30, 2025, following a successful pilot that significantly reduced scientific review time. The agency will deploy a secure, unified AI system to streamline workflows, enhance efficiency, and support its public health mission, with continued improvements and updates planned post-integration. |
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EUROPE Euro Convergence: Experts discuss AI Act’s future and impact on medtech |
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Medtech companies and notified bodies are actively hiring AI and software specialists to comply with the European AI Act alongside MDR and IVDR, though challenges remain due to a lack of clear guidance, scarce technical talent, and insufficient standardisation, with the European Commission working on FAQs and new standards to provide clarity. Industry experts emphasize the need for regulatory alignment, with only 20 of 44 Team-NB members seeking AI Act designation, raising concerns about consolidation and the readiness of notified bodies, while ongoing efforts focus on training, accreditation pathways, and leveraging emerging standards for trustworthy AI implementation.
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INDONESIA ASEAN-Japan Medical Devices Regulatory Symposium and Seminar |
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The ASEAN-Japan Medical Devices Regulatory Symposium and Seminar, supported by Japan and Indonesia, aims to enhance regulatory harmonization and capacity-building among ASEAN member states by sharing knowledge on emerging medical device technologies and regulatory practices to ensure timely, safe, and equitable access to innovative healthcare solutions.
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GOING TO MARKET
Relationship with Politics No, this is not a rant about the current state of politics globally, but to connect on-the-ground knowledge about local politics with your go-to-market strategy.
Gone are the days of paid market data – perhaps some are still doing it but why spend money on outdated data?
What does politics tell you about the market sentiment? Other than healthcare policies, it is about the economic pulse - is the middle class spending, what are the new subsidies? How’s the crowd like in certain public places? Are the people happy? Why? Back to healthcare, are there population studies, or grant calls for innovation to be deployed and adopted?
This links to sectors that are elective in nature (elective surgery, aesthetics etc) or on diagnostics, or on anything that can improve health. Combine this with the current healthcare reimbursement in the country, you would be able to put together a sense of the acceptability of your medical device in the market.
Another important factor is to actually visit or talk to your prospective clients – what if they had this, or used that, would they care to pay for it? These questions will gain valuable insights to market prioritisation (which markets first, second, and the relative efforts on them).
To quote James Bond and Q in “Skyfall” when they met at the museum... James Bond: Oh, so why do you need me? Q: Every now and then a trigger has to be pulled. James Bond: Or not pulled. It's hard to know which in your pajamas.
Let’s craft your go-to-market or market expansion strategies together
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European Medical Device Summit Maritim Hotel Düsseldorf - Düsseldorf, Germany 3-4 June 2025 More info ⟶ |
MedTech Summit 2025 Mercure Hotel MOA Berlin, Germany or 100% Digitally 16 - 20 June 2025 More info ⟶ |
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The Health Industry Series ASEAN 2025 Kuala Lumpur Convention Center, Malaysia 9 - 11 June 2025 More info ⟶ |
PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025 JW Marriott Indianapolis, United States 24 - 26 June 2025 More info ⟶ |
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