Asia

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

India’s medical technology industry is raising the alarm over steep new US tariffs on imported medical devices. It argues for structural change to address “unequal regulatory access” and non-tariff barriers.

The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.

Zydus Lifesciences plans to expand global markets for patented products of French orthopedic tech company Amplitude Surgicals which it is acquiring from PE firm PAI Partners and others. Could the European business also serve as a buffer to upheaval in the US amid talks of tariffs?

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.

China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.

The revival in funding of healthtech and pharma startups was significantly influenced by PharmEasy's $216m funding round, led by the Manipal Education and Medical Group (MEMG), albeit at a reduced valuation of $710m—a sharp decline from its previous $5.6bn valuation in 2021.

The Union Budget 2025 has overlooked several critical aspects that the medical devices and in-vitro diagnostics (IVD) sector had been expecting, industry leaders have pointed out.

With increased government focus on self-reliance and digital healthcare, 2025 will be a pivotal year for the sector. From startups to established players, all eyes are on the breakthroughs that will define the future of medtech in India.

Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.

Indian startups hold significant potential to address the gap created by the ban on import of refurbished medical products, but they face challenges on several fronts and call for more government support.

Healthcare experts believe that India’s ban on imports of refurbished medical devices has left a vacuum and if an implementable policy is not introduced soon, it could prove disastrous for healthcare providers and patients.