Bringing a new surgical device to life is rarely a straight line. The journey begins long before it reaches an operating theatre and long before a surgeon ever holds it in their hands. For companies developing next generation technology, particularly those working at the forefront of ultrasonic innovation, the path from early concepts to clinical readiness is shaped by rigorous testing, collaboration, and a deep sense of responsibility.

For Nami Surgical, each stage is driven by one principle: every step must move us closer to safer, more precise, and more efficient surgery. Building a device that consistently performs in the clinical environment demands careful engineering, biological assessment, regulatory alignment, and continuous refinement.

Building the foundations in the lab

The earliest stages of development focus on proving what is technically possible. Our engineers begin by assessing the behaviour of ultrasonic energy at a miniature scale, mapping how it interacts with soft tissue, bone, and other materials relevant to surgery. These insights shape the mechanical and electronic design and ensure the device delivers controlled, reliable performance.

This phase is highly iterative. Prototypes are designed, tested, adjusted, and rebuilt, with teams evaluating power delivery, thermal behaviour, ergonomics, vibration patterns, and component durability. Early design rigour is also vital for reducing risk later in development, particularly as regulatory reviews show rising numbers of device recalls linked to issues that could have been prevented through stronger early testing. Our cross functional approach helps identify these risks early and refine solutions quickly.

Moving into biological testing

Once core engineering principles are validated, prototypes progress into biological assessment. This stage is strengthened by our ability to manage the full design cycle in house. With rapid prototyping capabilities, the team can produce precision components, refine the ultrasonic engine, and adjust casing geometry without delay.

Biological testing focuses on key questions: does the device cut or dissect in the way the surgeon needs, how consistent is energy delivery, and what impact does it have on surrounding structures. Engineers and biologists work side by side to assess performance on real tissue models, with each study informing the next refinement.

Much of this work is supported by simulated operating room assessments, where detailed metrics such as burst pressure and sealing time help the team understand how the device behaves under realistic conditions. These datasets allow electrical engineers to fine tune energy regulation with millisecond level accuracy and ensure the device remains predictable across tissue types and surgical scenarios.

This evidence-based approach is essential, particularly given that 82% of HealthTech companies report being affected by regulatory uncertainty. Building robust data early strengthens confidence in the device’s trajectory and supports a clearer path toward clinical use.

Simulated procedures and operating room environments

As prototypes mature, they must demonstrate performance beyond laboratory and tissue testing. Simulated operating room environments expose the device to the practical pressures of surgery, including instrument handling, visibility constraints, fluid behaviour, and robotic system movement. These sessions allow the team to observe how the device integrates into real workflow conditions and to refine aspects that support surgeon control and procedural efficiency.

For technology designed to interface with robotic systems, such as our ultrasonic platform, these simulations are particularly important. They allow engineers to evaluate performance across different workloads and confirm that integration is seamless. This work comes at a time when the robotic assisted surgery market is expected to grow significantly, with forecasts projecting annual growth of up to 16% in the coming years.

Simulated procedures also help test usability. Even advanced technology must feel natural and intuitive for the surgeon. Refining balance, grip, motion, and interface behaviour ensures the device supports surgical flow rather than interrupting it.

Verification, validation, and regulatory readiness

Clinical readiness depends not only on performance but on meeting detailed regulatory expectations. Verification and validation confirm that the device meets essential standards in safety, reliability, and biocompatibility. For a company expanding internationally, this means preparing for multiple regulatory systems, each with its own requirements. We discuss this in our latest blog here. By embedding compliance considerations early, we support a smoother transition through later stages of review.

Clinical engagement from the outset

Strong clinical engagement is central to shaping a device that genuinely supports surgical practice. Surgeons who provide feedback on early prototypes influence everything from tip geometry to energy behaviour. Their insights ensure that when the device reaches its first clinical cases, it has already been shaped by real surgical experience.

This collaboration continues throughout development. Engineers, biologists, clinicians, and quality specialists work together, building a shared understanding of how the device should perform and what surgeons need from it. This partnership helps create technology that is both innovative and practical in the operating theatre.

From prototype to patient care

The journey from lab to operating theatre is long, deliberate, and grounded in evidence at every stage. Each round of testing and simulation builds confidence in the device’s behaviour and brings it closer to clinical readiness. While the process is complex, the goal remains clear: to support safer procedures, quicker recovery, and better outcomes for patients.

By combining scientific rigour with close clinician partnership, we can ensure ultrasonic technology reaches the operating theatre with confidence. The transition from prototype to patient care is shaped by responsibility, precision, and a commitment to improving surgery for people everywhere.