Visiongain has published a new report entitled Automation in Medical Devices Manufacturing Market Report 2025-2035(Including Impact of U.S. Trade Tariffs): Forecasts by Process (Assembly & Packaging, Material Handling, Inspection & Quality Assurance (QA), Others), by Automation Type (Fixed, Flexible/Programmable, Robotics & AI, IIoT Systems), by Device Type (Surgical Instruments, Diagnostic Devices, Others), by End-users ((Medical Device OEMs, Contract Manufacturing Organisations (CMOs), R&D and Prototyping Facilities)) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.

The global automation in medical devices manufacturing market is estimated at US$9.63 billion in 2025 and is projected to grow at a CAGR of 12.8% during the forecast period 2025-2035.

Impact of US Trade Tariffs on the Global Automation in Medical Devices Manufacturing Market   

The effects of U.S. trade tariffs are no longer confined to policy circles—they are playing out on factory floors and in boardrooms across the global medical device manufacturing sector. For an industry reliant on precision-engineered components—often sourced from China and the EU—these tariffs have introduced both cost volatility and supply chain friction. Sensors, actuators, microelectronics, and motion systems that underpin automation are now harder to procure, more expensive, and slower to deliver.

This disruption, while challenging, is proving to be a catalyst. Rather than dampening innovation, it has prompted CXOs to reassess their operational dependencies. Automation is no longer viewed purely through the lens of efficiency—it’s being repositioned as a strategic hedge against geopolitical uncertainty. Progressive manufacturers are investing in modular automation platforms, building dual-sourcing models, and enhancing their digital capabilities to increase agility and local responsiveness.

In this sense, the tariffs have accelerated a pivot towards more self-reliant, digitally fluent manufacturing ecosystems. It’s not just about weathering the current storm—it’s about futureproofing operations for a world where disruption is the norm, not the exception.

Automation Unlocks Agility and Competitive Advantage for Medtech Manufacturers

Automation has become more than a production upgrade—it now underpins the strategic direction of forward-thinking MedTech organisations. As product lifecycles shorten and regulatory demands increase, automation is enabling firms to scale with precision, adapt at speed, and maintain compliance across global markets.

C-suite leaders are recognising automation as a lever for long-term value creation. It supports not only operational stability but also digital transformation, innovation pipelines, and faster time-to-market for complex medical technologies. With configurable systems and smart validation tools, manufacturers can manage product variations and regulatory workflows without compromising throughput or quality.

This transformation is also reshaping workforce strategy. Automation is reducing dependence on repetitive, labour-intensive tasks, allowing teams to focus on high-value roles—such as data oversight, machine orchestration, and quality analytics. Upskilling is becoming a central theme as manufacturers shift towards a hybrid model where humans and machines co-create value.

Finally, post-pandemic realities have reframed how resilience is defined. Automation is now integral to risk management—whether it’s through autonomous operations in sterile zones or cloud-enabled diagnostics for remote oversight. The future of MedTech manufacturing lies not just in productivity, but in building agile, intelligent systems that can adapt, absorb shocks, and lead with confidence.

How will this Report Benefit you?

Visiongain’s 264-page report provides 111 tables and 167 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the automation in medical devices manufacturing market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Automation in Medical Devices Manufacturing. Get financial analysis of the overall market and different segments including type, process, upstream, downstream, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing automation in medical devices manufacturing market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Growing Complexity of Next-Generation Medical Devices

Medical devices are becoming markedly more sophisticated. Whether it’s wearable diagnostics, minimally invasive surgical tools, or smart drug-delivery systems, today’s products combine intricate mechanics, sensors, and electronics in compact, high-precision formats. These aren’t easily assembled by hand. The industry is now grappling with micro-assembly challenges, stringent process validation, and an increasingly complex regulatory landscape.

Automation has become essential in addressing this step-change in complexity. High-precision robotics, AI-enabled vision systems, and closed-loop control technologies are enabling manufacturers to deliver the accuracy and repeatability these devices demand. Automated processes also provide scalability, making it possible to ramp up production without compromising on quality. Cleanroom automation, in particular, is proving vital for maintaining sterile conditions in the manufacture of Class III and implantable devices.

Equally important is automation’s role in enabling real-time data capture, monitoring, and traceability—crucial for meeting regulatory demands from bodies like the FDA, EMA, and PMDA. In today’s environment, maintaining a digital audit trail isn’t a luxury; it’s a requirement.

Firms that delay automation risk falling behind on efficiency, regulatory agility, and time-to-market. Those that act decisively will gain a competitive edge—not just through cost and quality improvements, but by creating agile platforms that support rapid innovation and adaptation to clinical needs.

Executive Push for Digital Manufacturing Integration

Across the MedTech sector, automation is now seen as a cornerstone of enterprise-wide digital transformation. It has moved well beyond the factory floor and into board-level strategy discussions. Forward-thinking executives understand that automation isn’t merely a productivity tool—it sits at the intersection of innovation, compliance, and operational risk management.

By integrating automation into enterprise systems like ERP, MES, and PLM, manufacturers are building intelligent, interconnected production environments. This enables faster product launches, tighter coordination across departments, and more responsive decision-making. Increasingly, cloud-based architectures, digital twins, and AI-driven analytics are also being used to improve visibility and resilience across global operations.

For CXOs, this integration matters. It shortens product development timelines, supports real-time compliance, and reduces vulnerabilities—from cyber risks to supply chain disruptions. As more organisations shift from isolated pilot projects to enterprise-wide automation strategies, capital is being channelled into scalable platforms that align with long-term business goals. Automation, in this context, is no longer optional. It’s the infrastructure underpinning the future of MedTech manufacturing.

Where are the Market Opportunities?

Strategic Expansion into Mid-Tier and Emerging Medtech Firms

Until recently, advanced automation was largely the domain of large multinational device makers. High upfront costs and system complexity created barriers for mid-tier and emerging MedTech firms. That’s now changing.

As automation technologies become more modular, cost-effective, and user-friendly, they are increasingly accessible to smaller manufacturers. These firms—many of which operate in specialised or regional niches—stand to benefit immensely from automation’s ability to reduce lead times, enable customisation, and support compliance without heavy capital expenditure.

Smaller manufacturers expanding into global markets also need to meet international regulatory benchmarks. Automated systems make it easier to comply with standards such as ISO 13485, the EU MDR, and US FDA QSR. By embracing cloud-based monitoring, plug-and-play robotics, and smart inspection tools, these companies can deliver consistent product quality at scale.

Automation vendors that offer adaptable, affordable solutions tailored to this segment will be well-positioned for growth. In an industry that’s diversifying fast, the mid-tier market is no longer a ‘nice to have’—it’s a central pillar of future expansion.

Development of Workforce-Centric Automation Solutions

The conversation around automation is evolving—from job displacement to job enhancement. In the medical device industry, where compliance and precision are paramount, there’s a growing shift toward workforce-centric automation that augments human roles rather than replacing them.

Collaborative robots (cobots), intuitive human-machine interfaces (HMIs), and AI-guided decision tools are empowering operators to work smarter and more safely. These technologies remove repetitive or physically demanding tasks, freeing up human expertise for higher-value functions like oversight, root cause analysis, and product customisation.

This shift couldn’t be timelier. The sector faces talent shortages and an ageing technical workforce. Workforce-centric automation not only improves operational continuity—it also boosts employee engagement and supports retention by creating more dynamic, tech-enabled roles.

Companies that pair automation investment with structured upskilling will extract the greatest long-term value. These systems also align with regulatory expectations, helping ensure operators are properly trained and that every step of a process is documented and auditable.

For automation suppliers and system integrators, the opportunity lies in delivering human-friendly solutions—ones that are not only technologically advanced, but ergonomically sound, intuitive to use, and aligned with the evolving culture of medical device manufacturing.

Competitive Landscape

The major players operating in the automation in medical devices manufacturing market are Emerson Electric Co., JR Automation, Mikron Group, Sanmina Corporation, Celestica HealthTech, Flex Ltd., Beckhoff Automation, Festo AG & Co. KG, The Dürr Group, Rockwell Automation, Genesis Automation, Honeywell International Inc., ATS Life Sciences plc, Omron Corporation, PAR Systems, and GE HealthCare. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Notes for Editors

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