Surgical robotics has moved from moonshot to mainstay. In 2025, the field is defined by rapid platform upgrades, broader indications, and a regulatory climate that’s finally catching up with software-defined devices. Following is a take on where surgical robotics sit inside the wider medical device industry, with implications for where it’s headed next.

The Market Picture: Bigger, Broader, More Competitive

Robotic surgery remains one of medtech’s fastest-growing segments. Independent forecasts peg the global surgical robotics market in the low-double-digit billions today, with a mid-teens CAGR expected through the decade, outpacing almost all other device categories.¹

Intuitive still anchors the category. The company ended 2024 with 9,902 systems across da Vinci multiport, da Vinci SP, and Ion. As of June 30, 2025, the installed base for da Vinci systems reached 10,488, reflecting continued procedure growth and placements (Table 1).^2,3 Intuitive also secured FDA clearance in 2024 for the next-generation da Vinci 5 system and added a CE mark in 2025, underscoring a fresh product cycle.⁴

Competition is real in the U.S. soft-tissue market. CMR Surgical won FDA De Novo authorization for Versius in October 2024, initially for cholecystectomy, and is now weighing strategic options as it scales commercially.⁵ Medtronic’s Hugo remains a factor outside of the U.S. and is adding capabilities in Europe while it works toward U.S. clearance.⁶ In a long-awaited milestone, Johnson & Johnson advanced OTTAVA into U.S. clinical use in April 2025.⁷ Together, these moves signal a multi-platform, multi-indication race from medtech giants and startups alike. 

Orthopedics remains robotics’ other powerhouse. Stryker’s Mako leads the field in knee/hip arthroplasty, with incremental platform updates and flourishing procedural breadth; Zimmer Biomet’s ROSA is doing the same in shoulder. While exact installed-base figures vary by source, the direction is clear: robotics is now integral to joint replacement strategies.⁸

Three Product Trends to Watch

1. Lightweight, modular, and ASC-friendly systems—Smaller footprints, modular arms, and faster room turnover are no longer “nice to have.” The shift of suitable cases to ambulatory surgery centers (ASCs) is structural, with industry analyses projecting double-digit growth in ASC case volume this decade.⁹ Vendors are responding with platforms designed for outpatient economics and staffing constraints (e.g., Versius’ cart-based approach; emerging “assistant robotics” like Moon Surgical’s Maestro).

2. From mechanics to mechatronics + software—The competitive frontier is increasingly software and data—advanced vision, haptics, energy integration, and AI-assisted workflows. Intuitive’s da Vinci 5 emphasizes revamped architecture and data capture; Medtronic’s Hugo is pairing with vessel sealing portfolios; and newer players are pushing AI-enhanced intraoperative features and cloud connectivity. 

3. Indication expansion and “good enough” economics—Expect continued expansion beyond urology and gynecology into general surgery, thoracic, bariatrics, hernia, and more complex orthopedics. The business case is tightening as systems spread to community hospitals and ASCs, pushing vendors to offer creative financing, service models, and efficiency-driven feature sets (faster OR turnover, automated setup, analytics for utilization).

The Demand-Side Backdrop: Capital, Sites of Care, and Hospital Finances

Hospital finances have improved since pandemic lows but remain mixed. National margin indices in 2025 show modest stability with variability by market and size, and capital budgets are still scrutinized, especially for high-ticket platforms like robots. This reality favors vendors that can demonstrate procedure capture, staffing efficiency, and ASC suitability.¹⁰

At the same time, case migration continues; multiple sources project rising outpatient and ASC volumes through the decade, with ASCs accelerating in complexity and consolidation. This is key to robotics adoption in settings with tight per-case economics.^8,9

Reimbursement tailwind: In the U.S., CMS’s Transitional Coverage for Emerging Technologies (TCET)—finalized in August 2024—offers a (limited-capacity) on-ramp to coverage for certain FDA Breakthrough devices while evidence is generated. While not robot-specific, TCET can accelerate adoption for adjacent enabling tech (navigation, imaging, AI modules) that integrate into surgical ecosystems.¹¹

Strategic Implications for Medtech Companies

Design for the ASC—Power-to-weight ratio, setup time, instrument economics, and reprocessing workflows are now competitive levers. Systems that can be efficiently turned over in <15 minutes and fit into smaller ORs will win in outpatient settings. Pair platform sales with utilization analytics that help administrators validate ROI under ASC payment models.

Own the software stack, comply by design—Treat cybersecurity and AI change control as product features, not compliance chores. Bake SBOM management, vulnerability response service level agreements (SLAs), and secure update mechanisms into your quality system; architect AI features around predetermined change control plans (PCCPs) to enable continuous improvement without serial 510(k)s. Map EU AI Act timelines into your MDR plans to avoid dual-regulatory surprises. 

Compete on procedure coverage and team ergonomics—Surgeons and hospitals increasingly evaluate robots on procedure breadth, ergonomics, energy integration, and workflow rather than raw kinematics. Intuitive’s breadth remains a moat; challengers are picking targeted entry points (e.g., cholecystectomy) and secondary differentiators (modularity, footprint, capital model). Expect more vendor partnerships with endoscopy and imaging firms. 

Bet on connectivity—Post-market evidence, predictive maintenance, and OR efficiency all depend on connected systems. Regulators are signaling acceptable pathways. Recent clearances plainly addressed cloud connectivity and AI update plans. Make secure telemetry and analytics part of your commercial “value story,” with clear answers on protected health information handling and uptime. 

M&A and capital markets: Selective, strategic—Cash-intensive platforms are pushing firms toward strategic partnerships, selective acquisitions, or even sales processes. CMR’s exploration of strategic options in 2025 illustrates the capital intensity of U.S. scaling, even with FDA authorization. Expect acquirers to prize clinical data, installed-base momentum, and software differentiation. 

The Look of Success in 2026–2028

Platform refresh cycle pays off—Vendors that launched next-gen consoles (or software overhauls) in 2024-2025 should show procedure share gains. Intuitive’s da Vinci 5/CE mark and procedure growth guide the benchmark. 

ASC penetration accelerates—Expect more robotic general surgery and hernia cases in ASCs, driven by time-to-room metrics and staffing models compatible with outpatient settings. 

AI becomes visible in-room—Early AI features such as camera control, instrument tracking, and safety checks move to standard options, governed by cybersecurity frameworks. Moon Surgical’s sequence of AI-related clearances is an early template.¹²

Regulatory clarity reduces friction—With the EU AI Act phasing in and FDA AI/cyber guidance maturing, cross-border launch sequencing becomes more predictable—albeit with heavier documentation.

Takeaways for Executives

Treat robotics as a software-defined service—Growth will hinge on iterative software releases, analytics, and training—not just carts and arms. Build roadmaps that monetize capabilities over time.

Prove the ASC business case—Provide credible, site-of-care-specific ROI models tied to turnover time, staffing, and instrument mix.

Institutionalize regulatory by design—Embed PCCPs and cybersecurity controls into development and marketing claims to speed updates and reassure risk committees. 

Pick your first battles wisely—Focus indications where you can deliver a clear cost-to-benefit delta against laparoscopy and where OR workflow gains matter most (e.g., hernia, cholecystectomy, bariatrics, knees). 

The Medi-Vantage Perspective

Robotic surgery is in a new phase: platform diversity, software-led differentiation, ASC-ready design, and regulatory-enabled iteration. The winners will be those who convert mechatronics into measurable operational gains and who treat AI, cybersecurity, and reimbursement strategy as core product features—not back-office tasks. ASCs have different needs than hospital ORs—be sure you design for the difference. The same goes for software-led differentiation—ensure your offering meets true unmet needs while thoroughly tested and ranked. This is a rapidly growing and highly competitive market. Ensure your company maintains and grows its place in it.

References

1. tinyurl.com/mpo251001
2. tinyurl.com/mpo251002
3. tinyurl.com/mpo251003
4. tinyurl.com/mpo251004
5. tinyurl.com/mpo251005
6. tinyurl.com/mpo251006
7. tinyurl.com/mpo251007
8. tinyurl.com/mpo251008
9. tinyurl.com/mpo251009
10. tinyurl.com/mpo251010
11. tinyurl.com/mpo251011
12. tinyurl.com/mpo251012

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Maria Shepherd has more than 20 years of experience in marketing in small startups and top-tier companies. She founded Medi-Vantage, which provides marketing and business strategy for the medtech industry. She can be reached at mshepherd@medi-vantage.com. Visit her website at www.medi-vantage.com.