Agentic AI in medicine supports multitasking across clinical tools, data and workflows to improve decision-making and efficiency. Credit: Volodymyr Horbovyy / Shutterstock

Since 2024, the EU’s Ecodesign for Sustainable Products Regulation (ESPR) has set new benchmarks for medical devices, emphasising repairability and recycled content under its 2025–2030 plan. With more than half of healthcare emissions linked to materials and manufacturing, ESG compliance has become central to product lifecycles. “ESG standards are no longer voluntary, they are an integral part of products from conception to disposal,” notes an expert from the EU Commission.

Tariffs are reshaping supply flows, while the Quality Management System Regulation (QMSR), finalised in January 2024 and set to take effect from 2 February 2026, aligns US rules with ISO 13485. This mandates tighter supplier controls and digital sourcing records. Hospitals, under pressure to secure resilience, now view digital platforms as compliance-critical rather than optional.

Despite industry efforts, procurement teams continue to face volatility in the availability of critical supplies. “Failure to ensure that the US government and healthcare providers have the same information as our European counterparts poses a risk to providers, patients, caregivers, and consumers,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, in a press release issued earlier this year.

In the US, ESG obligations surged in 2025. The EPA’s PFAS rule requires detailed chemical reporting for medical polymers, while California’s Climate Corporate Data Accountability Act (SB 253) introduces phased reporting of Scope 1, 2, and 3 emissions for companies exceeding $1 billion in sales. Pankaj Bhatia, director of the Greenhouse Gas Protocol, emphasises that these rules will ripple beyond California, influencing compliance, supply-chain and sustainability practices nationwide. 

Globally, 260 ESG-related regulatory updates were recorded by June 2025. In Europe, ESPR and UDI rules establish harmonised requirements for device sustainability and traceability, reinforcing ESG as a key driver of innovation and industrial partnerships. 

In 2025, medical devices account for an estimated 25% of healthcare-related carbon emissions, with single-use products responsible for up to 94% of device-related emissions during production, according to MedTech Europe. Manufacturing, sterilisation, raw material extraction and logistics remain the most carbon-intensive stages. ISO-compliant lifecycle assessments now help identify emissions-reduction opportunities and guide sustainable procurement. 

Driven by ESG pressures, demand for sustainable device procurement is rising. Maionic’s 2025 MedTech Industry Stats show that 70% of customers now include ESG criteria in procurement. In the US, ESG compliance has already impacted major contracts, including a $3.8 billion hospital network deal cancelled in May 2023 over sustainability requirements. 

Leading manufacturers such as Medtronic, Boston Scientific, B. Braun and Johnson & Johnson MedTech are forging long-term partnerships with certified suppliers integrating ESG criteria. Commercial relationships combine ISO 13485 standards, energy-efficient cleanrooms and comprehensive waste management to enhance product quality and environmental performance. 

Key ESG-driven initiatives include: 

• Stricter ESG criteria in contracts with regular sustainability audits. 
• Circular economy programmes incorporating refurbishment and recycling. 
• Geographically diversified manufacturing to mitigate supply-chain risks. 
• Digital platforms for real-time ESG traceability and AI-driven resource optimisation. 
• Co-investment in sustainable R&D for greener devices. 

​​​​​​​These partnerships are shaping a more resilient, responsible, and innovation-focused industrial landscape. 

The adoption of biodegradable polymers such as polylactic acid (PLA) and polyhydroxyalkanoates (PHA) is accelerating, particularly for packaging, surgical instruments and single-use devices. Innovative products use PLGA, PLA and PHAs in absorbable screws, sutures, bone scaffolds, drug-eluting stents and regenerative tissue matrices. Corbion’s PURASORB® PL38 PLA polymer, FDA-approved, already supports orthopaedic applications. Advances in extrusion and additive manufacturing enable customisable, 3D-printed implants which optimise healing and keep material waste to a minimum. 

Bioplastics are increasingly used in wound-care dressings, syringes and implantable devices, with regulatory reforms in the EU and US accelerating market access. PLA now represents 32.8% of the global biodegradable medical plastics market, while PHAs and PLGA are the fastest-growing segments, with compound annual growth rates up to 11.7%. The global market is projected to reach $485.81 million in 2025. 

Between 2023 and 2025, leading OEMs introduced modular device structures supporting component refurbishment, reducing material costs by up to 30% while complying with ESPR modularity requirements. Closed-loop injection moulding systems increase material utilisation by 25–40%, cutting waste. 

Cleanroom operations are also evolving. Advanced HVAC and air filtration systems reduce energy consumption by 20–35%, paying for themselves within three to five years. Renewable energy adoption averages 33% through long-term power purchase agreements and on-site solar, yielding 12–15% ROI and regulatory benefits. 

AI and data analytics streamline operations, improve sustainability and deliver measurable results. The global AI-driven predictive maintenance market reached $837 million in 2024 and is projected to hit $2.5 billion by 2034, growing 12% annually according to Fortune Business Insights. North America leads the way, supported by IoT, data centres, and machine learning investments. 

AI anticipates failures, reducing downtime and maintenance costs. InsightAce Analytics notes maintenance teams now rely on real-time validated metrics rather than fixed schedules. Medtronic US reports predictive monitoring can cut maintenance costs by up to 25% while maximising equipment availability according toVamstar’ State of the MedTech Industry 2024–2025. 

AI also supports waste reduction. Medtronic and BD’s US facilities operate “zero-waste” programmes, achieving up to 30% operational reductions in under a year. Brightmark and Lewis Salvage use AI to track and recycle medical plastics, creating unprecedented industrial circularity. US healthcare generates 1.7 million tons of plastic waste annually (5.1 kg per person), with plastics accounting for nearly 49% of medical waste. 

Supply chain traceability is another frontier. BD’s RFID-enabled iDFill syringes track units from sterilisation to delivery, while Pfizer, Bayer, and Johnson & Johnson use MediLedger blockchain for tamper-proof audits. McKinsey reports AI-optimised supply chains can save up to 10% in procurement costs. Adoption surged from 41% to 65% in 2025, a 24% increase in one year (AllAboutAI.com). 

Sustainability-driven capital flows

In 2025, leading European medical device manufacturers are committing multi-billion-euro investments to advance sustainability. Industry portfolios now range between €2 billion and €4 billion in the European Union, targeting research, development, and the industrialisation of eco-friendly materials, waste-reduction strategies and low-carbon manufacturing solutions. 

Public-private financing

These initiatives are backed by a mix of private capital, European public co-financing under flagship programmes such as Important Projects of Common European Interest (IPCEI) and Horizon Europe, and significant in-kind contributions. Financial commitments vary widely, from a few million euros to more than €100 million, covering infrastructure, specialist expertise and technology platforms. 

Strategic alliances 
​​​​​​​
Innovation is accelerating through cross-sector alliances which bring together start-ups, industry leaders and centres of research. These alliances typically channel 3  to 10 million euros annually into the development of biodegradable medical devices and circular-economy technologies, reinforcing the EU’s transition toward a more sustainable healthcare ecosystem.

Multi-billion-euro investments to drive sustainability

Leading medical device manufacturers in 2025 are making multi-billion-euro investments to drive sustainability. Industry portfolios now exceed 2 to 4 billion euros in the EU for research, development and industrialisation of eco-friendly materials, waste reduction and low-carbon solutions  

Public-private investments

Financial commitments from partners range widely, from a few million  to over 100 million euros, combining private investments, European public co-financing under programmes such as PIIEC and Horizon Europe, and in-kind contributions including infrastructure and specialist expertise. 

Strategic alliances

​​​​​​​Innovation is accelerating through  strategic alliances which unite start-ups, industry leaders and centres of research . These groups typically channel 3 to 10 million euros annually into developing biodegradable medical devices and circular economy technologies.

Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.

The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.