When one of the world’s largest medical technology companies sought to advance its surgical device portfolio, it partnered with Cardinal Peak for their next-generation surgical device development.
In a partnership spanning more than a decade, this collaboration has resulted in multiple successful product launches, including advanced electrosurgical generators (ESGs) and an innovative handheld ultrasonic device — indispensable technologies in operating rooms world wide. Leveraging deep product engineering expertise, our team has helped develop innovative healthcare products that address complex technical challenges while adhering to rigorous industry standards.
Addressing the Challenges of Modern Surgery and Medical Device Development
Current surgical techniques involve smaller and fewer incisions that offer significant benefits including reduced risk of complications and faster recovery times. Yet, these minimally invasive procedures demand increasingly sophisticated surgical tools. Surgeons performing these procedures rely on high-definition monitors and specialized instrumentation, requiring sophisticated algorithms in energy delivery systems.
Through dozens of projects, we’ve established a framework for continued innovation, and our experience working within client QMS, using their SOPs and regulatory frameworks has proven invaluable in developing complex medical devices.
The development of advanced surgical devices faces numerous technical and practical challenges, including controlling energy output while maintaining absolute patient safety. In addition, regulatory requirements for medical devices continue to evolve and become more stringent, particularly in areas of usability and cybersecurity. Surgical innovations must meet these requirements while also being intuitively usable in high-stress operating room environments, where surgical teams need to focus on the patient rather than complex equipment interfaces.
Furthermore, the digital OR demands integrated solutions that share data and connect with hospital systems, adding additional layers of complexity to medical device development. In operating rooms worldwide, these solutions must seamlessly integrate with existing hospital infrastructure and workflows.
In our case, our client aimed to meet evolving industry demands for usability, reliability and connectivity. Two key projects emerged:
Electrosurgical Generator (ESG)
A device that delivers radio frequency (RF) energy used to dissect and coagulate tissue, as well as seal blood vessels in surgical procedures.
Handheld Ultrasonic Dissection Device
A compact surgical tool that uses ultrasonics to dissect tissue.
Seamlessly integrating software components, both surgical devices required compliance with medical device regulations such as IEC 62304 and IEC 62366 and long-term support to maintain performance and safety in the field. Our challenge was clear: Support development of easy-to-use surgical devices that meet the required quality and reliability standards while also supporting aggressive project timelines to launch products to market.
Comprehensive Engineering for Advanced Surgical Device Development
Cardinal Peak’s engineers helped overcome these challenges by providing end-to-end engineering services that combined technical expertise with agile development processes. Here’s how we supported each devices’ development.
Electrosurgical Generator (ESG) Development
Our team delivered healthcare product development services for multiple generations of electrosurgical generators, sophisticated systems that help surgeons perform open and minimally invasive procedures, with applications ranging from basic surgical dissection to complex laparoscopic procedures.
Our team’s participation in the development process extended across multiple product generations and encompassed creating a sophisticated impedance matching algorithm to ensure patient safety and prevent tissue damage, alongside implementing intuitive touchscreen interfaces compliant with IEC 62366 usability standards, developed in C++, adhering to our customers standard operating procedures. We supported the development of robust software systems to control ESG functionality and integrated robust cybersecurity measures to protect sensitive medical solutions from bad actors. Our engineers worked as part of a team that developed cloud connectivity solutions for system-level support and data sharing in the operating room. Throughout the development cycle, we provided comprehensive embedded software development and testing protocols.
Handheld Ultrasonic Dissection Device Development
In parallel with the ESG development, our team contributed to creating a cordless handheld ultrasonic surgical device that untethers the surgeon from the generator, by including the electronics in the handpiece. This handheld device allows the surgeon the freedom to move around the patient delivering ultrasonic energy for tissue dissection and vessel sealing.
The Cardinal Peak team focused on enhancing functionality and usability through embedded software engineering:
- Embedded software development and testing: Designed and tested software to control the ultrasonics, ensuring safe, reliable performance.
- Agile development methodology: Embedded agile practices into the development process to accelerate timelines and adapt to changing requirements.
In addition to technical solutions, Cardinal Peak provided collaborative engineering support over the 10-year partnership, including requirements definition and stakeholder alignment, verification testing and documentation to comply with quality management systems, and sustaining engineering services to support product iterations and resolve field issues.
Delivering Long-Term Value Through Collaboration
The decade-long collaboration has yielded remarkable results through multiple successful product launches and continuous innovation in surgical device technology. Ensuring consistent innovation and quality, we’ve helped our client build devices that empower surgeons with accurate, and safe tools to improve patient outcomes.
Our partnership’s success stems from our deep understanding of medical device development requirements and engineering capabilities that complemented the client’s internal team. Through dozens of projects, we’ve established a framework for continued innovation, and our experience working within client QMS, using their SOPs and regulatory frameworks has proven invaluable in developing complex medical devices.
Struggling with the complex requirements of medical device development? Cardinal Peak’s proven surgical device development expertise can help get your project across the finish line. Let’s chat about accelerating your medical device development journey.
