Advancing Medical Diagnoses with Enhanced Endoscopy Machine Video Capabilities

Early detection of esophageal and colon cancer can mean the difference between life and death. In medical diagnostics, advanced endoscopy video systems empower gastroenterologists and healthcare providers to examine the esophagus for early signs of cancer, celiac disease, GERD and more when treatment is most effective.

In 2016, Cardinal Peak’s parent company, FPT, began what would become a transformative multiyear collaboration with a Japanese medical imaging technology manufacturer to enhance and modernize its essential endoscopy video system.

The Challenge with Existing Endoscopy Equipment

As medical imaging technology progressed and component procurement created increasing challenges, our client sought a partner capable of both maintaining and upgrading its existing endoscopy video system. The existing platform faced mounting technical constraints that limited its diagnostic capabilities, particularly in providing precise measurements of esophageal dimensions and a comprehensive field of view necessary for thorough examinations.

The system’s reliance on mechanical interface components posed maintenance challenges such as difficulty sourcing replacement parts and some components reaching end-of-life. These challenges limited the potential for future enhancements to improve both the video quality and user experience.

Beyond these immediate technical hurdles, the project demanded a partner with deep expertise in navigating the complex regulatory landscape of Class II medical devices. Any improvements needed to maintain strict compliance with ISO/IEC regulatory requirements while meeting HIPAA — a delicate balance of innovation and regulatory adherence that few healthcare product engineering firms could confidently manage.

Our Phased Development Approach

The engagement started small, with an offshore engineering team of four aiding our partner with technology repairs and service desk support, before eventually growing to a robust team featuring seven people on-site in Japan and over 40 remote engineers in Vietnam.

Endoscopy Machine Phased Development Timeline

Improving the Endoscopy Machine’s Video Capabilities, Interface and More

Our comprehensive approach to medical product development transformed the endoscopy equipment’s diagnostic capabilities. Our efforts began with development of a video circuit board, which was followed by adding a web app and strengthening the system’s video processing capabilities.

By expanding the video system’s operational range, optimizing the field of view and implementing advanced measurement capabilities, the engineering team delivered precise tools for assessing esophageal diameter and length — critical parameters for accurate diagnosis and treatment planning. Our team also developed sophisticated algorithms that significantly enhanced video quality, enabling physicians to observe subtle tissue changes with unprecedented clarity.

With upgrades to the endoscopy device system, how information comes in and is processed, care providers receive detailed video information, ultimately improving diagnoses and positively affecting patient care outcomes.

The system architecture masterfully integrates multiple technologies. The development team created a sophisticated cloud application infrastructure that enables seamless device access and software updates across peripherals and endoscope parts and functions, utilizing Python for back-end development and C/C++ for embedded systems. The peripheral device controller orchestrates complex interactions between the endoscopy device and external components, creating a unified and responsive medical imaging platform. These external components include the video scope controller and light source, the touch peripheral controller, the display controller and additional system peripherals.

The user interface also underwent a complete modernization, transitioning from mechanical button controls to an intuitive touchscreen system. This alteration required extensive human factors engineering and careful consideration of clinical workflows. Fortunately, a thorough understanding of IEC 62366 usability requirements helped the team ensure that every aspect of the user interface met regulatory standards while improving operational efficiency in clinical settings.

Throughout the development process, we maintained unwavering attention to compliance requirements. Expertise in ISO 13485 including IEC 62304 and IEC 60601 helped us in working under our customers Standard Operating Procedures (SOPs). Every modification met stringent usability and quality management requirements. This comprehensive approach to regulatory compliance, combined with thorough documentation practices, facilitated a smooth FDA 510(k) submission and approvals process which demonstrated our capability to deliver medical device solutions at the highest level of quality and safety.

The Results: A Better Endoscopy Machine

The long-term collaboration yielded significant improvements to the endoscopy video system:

• Successful product launch with high customer satisfaction.
• Enhanced video quality, leading to improved diagnostic capabilities.
• Modernized user interface, improving usability and operational efficiency across clinics and other care facilities.
• Strengthened system flexibility through peripheral device integration.
• Maintained continuous compliance with medical device standards.

Most importantly, the improved imaging capabilities and enhanced visualization tools directly contributed to better patient care outcomes by enabling more accurate and earlier detection of potential health issues.

The project’s success can be attributed to several factors, most of which boil down to a long-term collaborative relationship that grew organically from basic support to comprehensive product development. Other success factors include:

• Multidisciplinary expertise spanning hardware, software and regulatory requirements.
• Seamless integration of offshore and on-site engineering teams.
• Commitment to maintaining medical device quality standards while driving innovation.
• Focus on enhancing usability without compromising system reliability.

This endoscopy video system project exemplifies how a strategic engineering partnership can evolve from essential support services into a comprehensive product development collaboration that advances medical technology and improves patient outcomes. The success of this collaboration stems from our team’s unique combination of technical depth, regulatory expertise and scalable engineering resources. Growing the team from four offshore engineers to nearly 50 professionals across multiple locations demonstrates our joint ability to adapt and scale to meet increasingly complex healthcare product development challenges.

The ongoing engagement emphasizes the value of building lasting technological partnerships in the medical device industry, where extensive domain knowledge and consistent quality underpin success. As a leading medical device product development company, we are advancing the medical products that healthcare professionals rely on every day.

Are you ready to turn your medical innovation into a life-saving reality? Cardinal Peak stands ready to partner with medical device manufacturers and develop the medical devices of tomorrow. Let’s talk!