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Analysis Medtech’s cautious A


fter several turbulent years, medtech is sounding more hopeful again. The pandemic’s aftershocks, supply chain disruption and staffing shortages forced hospitals and manufacturers alike into survival mode. Now the mood is shifting. In a GlobalData survey of medical device professionals, 89% say they are somewhat or very optimistic about the sector’s prospects over the next 12 months. Sentiment alone does not transform an industry. But confidence tends to change behaviour. When executives believe conditions are improving, budgets loosen, pilot programmes move towards procurement and deal- makers become more willing to act. Investment patterns already reflect that shift.


Venture capital and private equity remain active in digital health, AI-enabled devices and minimally invasive technologies. Yet the conversation around innovation has grown more pragmatic. Investors no longer pay simply for ‘AI inside’. They want proof – workflow improvements, measurable outcomes and a credible path to reimbursement. Strategic buyers are behaving similarly. Large medtech groups continue selective acquisitions, but novelty alone rarely closes a deal. Interoperability with hospital systems, regulatory maturity and a strong evidence base increasingly determine whether a technology can scale.


$11.9bn GlobalData 10


The estimated amount that the AI-in-medical- devices market could reach by 2029.


AI – experiment to infrastructure AI has spent much of the past decade in the healthcare pilot phase. Now it is starting to become infrastructure. GlobalData notes that AI-driven diagnostics, image analysis and workflow tools are moving from experimental projects into routine clinical deployment. That transition is less glamorous than early prototypes, but far more consequential. Running algorithms on curated datasets is straightforward. Deploying them across multiple hospitals, imaging systems and patient populations is not. Bias emerges, data drifts and clinicians ask sensible questions about reliability and liability. Regulators are responding. In January 2025 the FDA published draft guidance on life-cycle management and marketing submission recommendations for AI-enabled device software functions. The direction is clear: The FDA expects AI-enabled device software


optimism


A new GlobalData survey suggests confi dence is returning to medical devices. But the coming year will favour companies that can turn digital promise into reimbursable outcomes, treat cybersecurity as a patient-safety discipline and stabilise supply chains in a less predictable trading environment, as Thom Atkinson reports.


functions to be managed across their total product life cycle, with appropriate oversight of updates and post-market performance.


For manufacturers, this shifts attention from development to maintenance. Monitoring algorithm performance, managing updates and ensuring regulatory compliance over time become central tasks. Imaging remains the most visible application. AI systems that flag pulmonary nodules or misplaced devices are increasingly common in radiology departments. Yet the real value rarely lies in the algorithm alone. It lies in how that algorithm fits into clinical workflows – triage rules, reporting systems and escalation pathways. When those pieces align, AI begins to deliver measurable operational benefits.


Minimally invasive care – a safe bet If AI promises the future, minimally invasive technologies continue to deliver the present. Survey respondents ranked minimally invasive devices among the trends most likely to shape the industry in 2026. The reason is straightforward. Few innovations align patient preferences, clinical outcomes and hospital economics quite as neatly. Smaller incisions mean shorter recovery times and fewer complications. Procedures that once required open surgery increasingly move to outpatient settings. For hospitals struggling with surgical backlogs and staffing shortages, that efficiency matters. The technology behind the shift continues to evolve – better imaging systems, smaller electronics, advanced materials and robotic assistance. Each expands the number of procedures that can be performed using minimally invasive techniques. The next stage may connect those devices more closely with monitoring systems. Sensors embedded in implants or surgical tools could track patient outcomes long after the procedure ends. But that connectivity also raises new expectations. Once devices remain permanently connected to patients, cybersecurity becomes part of the product itself.


The technology works, trust must follow Remote patient monitoring sits at the centre of


www.medicaldevice-developments.com


malerapaso/gettyimages.co.uk


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