Forging a path for MedTech Innovation.
Somi Ekwealor’s path into surgical robotics didn’t begin with robots—it began with curiosity. Trained in pharmaceutical sciences, Somi entered the medical device industry through combination products, working at the intersection of drugs, devices, and patient safety. But it was the rapid evolution of technology—and its potential to directly transform patient outcomes—that pulled him deeper into the world of complex medical devices.
While working in Silicon Valley, Somi became increasingly drawn to systems where software, electromechanics, and clinical impact converge. Surgical robotics—one of the most sophisticated expressions of modern MedTech—emerged as a natural specialization. Now, Somi joins IQVIA MedTech as the Director of Robotics & EMC Regulatory Affairs, where he partners with companies developing next-generation robotic platforms, helping them navigate regulatory complexity and bring transformative technologies to patients safely and efficiently.
Q: What initially drew you to the medical device industry, and how did that interest evolve into a specialization in robotics and complex medical devices?
I was initially drawn to the medical device industry by the opportunity to work at the intersection of pharmaceuticals and medical devices through a Class III combination product. It allowed me to apply my pharmaceutical sciences background while expanding into device development.
Over time, particularly while working in Silicon Valley, I became increasingly fascinated by the technology itself and its direct impact on patients. My focus naturally evolved toward more innovative systems that required deeper integration of software and electromechanics.
Surgical robotics, representing one of the most sophisticated segments of MedTech, became a particularly compelling specialization, especially given the regulatory complexity associated with these platforms.
Q: When we talk about “robotics” in medical devices, what technologies and systems are we really referring to?
Robotics in medical devices spans a broad spectrum of technologies, integrating advanced hardware with increasingly intelligent software into cohesive systems. These platforms can enable entirely new medical capabilities or enhance existing procedures by improving precision, control, and consistency, ultimately improving patient outcomes.
From a regulatory standpoint, robotically assisted surgical systems differ significantly from conventional devices. Regulatory authorities evaluate far more than mechanical performance alone, placing increased emphasis on functional safety, clinical performance, and the training paradigms required for safe and effective use.
For robotics, the question shifts from “does the device work?” to “does the entire ecosystem perform predictably and safely?”
Q: What excites you most about partnering with companies developing next-generation robotic technologies?
What excites me most is the opportunity to help make technologies that can redefine standards of patient care available to healthcare professionals as quickly as possible, while ensuring they are safe and effective. Reimagining how procedures are performed and building next-generation robotic systems involves pushing boundaries, which inevitably introduces regulatory uncertainty.
I find it especially rewarding to translate complex regulations and uncertainty into actionable regulatory strategies. Supporting teams from feasibility through commercialization is critical, because regulatory strategy should never be reactive.
The most successful medical device companies engage regulatory early and often, using it as a strategic enabler rather than a hurdle.
Q: What trends are you seeing in how regulators globally are approaching surgical robotics and digital health convergence?
Regulators around the world are becoming more sophisticated and increasingly recognize that robotics and digital health are converging into integrated ecosystems. At the same time, the regulatory landscape continues to evolve rapidly.
With exponential advances in software and healthcare technologies, there is heightened scrutiny around software validation, cybersecurity, AI/ML integration, electrical safety, electromagnetic compatibility, and usability.
Regulatory expectations are expanding to keep pace with increasingly interconnected, software-driven systems.
Q: Why is this moment such an important — and challenging — time for innovation in surgical robotics and digital platforms?
This is a pivotal moment because innovation is accelerating faster than many traditional regulatory frameworks were originally designed to accommodate. Companies are integrating automation, AI, advanced imaging, and increased connectivity into surgical care at an unprecedented pace.
These technologies don’t fit neatly into historical categories. I anticipate regulatory expectations will evolve toward comprehensive, ecosystem-level oversight, with greater emphasis on lifecycle evidence.
Clearance or approval is no longer a static milestone—it’s part of a continuous process of monitoring, learning, and data generation.
Q: What advice would you give companies developing first-of-their-kind robotic or combination products?
Start your regulatory strategy early. First-of-their-kind technologies often struggle not because the innovation lacks promise, but because regulatory considerations were not aligned early enough with device design and evidence generation.
Regulatory should be treated as a core design function—not a downstream submission exercise.
Somi Ekwealor’s career mirrors the evolution of MedTech itself—from early work on complex combination products to advising on today’s highly integrated, software-driven surgical robotic platforms. Throughout this conversation, he reinforces a clear message: successful innovation depends on proactive, lifecycle-oriented regulatory strategy.
IQVIA MedTech brings deep expertise in robotically assisted systems, software-enabled medical devices, and global regulatory strategy to help innovators navigate this complexity. By aligning development, evidence generation, and regulatory planning from the earliest stages, IQVIA MedTech helps companies accelerate innovation without compromising safety, performance, or compliance.
Developing a robotic, software-enabled, or first-of-the-kind medical device?
Partner with IQVIA MedTech to embed regulatory expertise into your innovation strategy from day one—and turn regulatory complexity into a competitive advantage.
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