Handheld Device for Clinical Study Protocol Compliance
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Solution Overview
Problem
The certification of BCVA examiners and the configuration of exam lanes across multiple sites globally is non-standardized, leading to increased costs and time delays due to variability in certification approaches and the need for on-site validation by certification officers.
Innovation Solution
A system and method utilizing handheld devices with smartphone or tablet features, such as object recognition, ambient light measurement, and lidar for distance measurement, to assess lane requirements and examiner expertise in a standardized manner, including geotagging, training materials, and scheduling meetings with certification officers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If certification officers travel to sites to ensure standardization, then measurement precision and reliability are improved, but loss of time and device complexity increase
Solution Approach 1:
The patent replaces the mechanical system of physical travel and on-site validation by certification officers with an automated digital system. The mobile application uses computer vision, object recognition, and data processing to remotely assess exam lane compliance and examiner certification, eliminating the need for physical travel while maintaining standardization requirements.
Solution Approach 2:
The patent introduces a mobile application as an intermediary between certification requirements and site execution. This application collects, validates, and transmits certification data remotely, serving as a mediator that enables standardization without direct human presence at each site.
2Measurement precision
If certification officers travel to sites to ensure standardization, then measurement precision are improved, but device complexity and cost increase
Solution Approach 1:
The patent employs a universal mobile application that performs multiple certification functions on a single device: capturing images, measuring distances, detecting ambient light, validating equipment, and assessing examiner knowledge. This consolidates what would traditionally require multiple separate systems and personnel into one integrated tool.
Solution Approach 2:
The patent replaces complex manual certification processes with automated digital systems embedded in the mobile application, including computer vision for equipment validation and algorithms for compliance assessment, thereby reducing operational complexity while maintaining precision.
3Adaptability or versatility
If different certification approaches are used, then adaptability to local conditions is improved, but homogeneity and standardization deteriorate
Solution Approach 1:
The patent applies local quality by allowing the system to adapt to specific local conditions (different equipment models, room configurations, language preferences) while maintaining core standardization requirements. The mobile application can be configured for local needs without compromising the standardized assessment protocol.
Solution Approach 2:
The patent segments the certification process into standardized modules: equipment validation, environmental assessment, examiner knowledge evaluation, and practical demonstration. Each module can be independently configured for local conditions while maintaining overall protocol consistency, enabling flexibility without sacrificing standardization.
4Reliability
If manual certification processes are used, then reliability of assessment is improved, but productivity and time efficiency deteriorate
Solution Approach 1:
The patent implements self-service by enabling site personnel to autonomously complete certification assessments using the mobile application. The system automatically validates equipment, measures distances, detects ambient light, and generates compliance reports without requiring manual intervention from certification officers, thereby maintaining reliability while dramatically improving productivity.
Solution Approach 2:
The patent replaces manual assessment processes with automated digital systems that objectively evaluate compliance criteria. The mobile application uses computer vision, sensors, and algorithms to consistently apply certification standards, eliminating human variability while accelerating the certification timeline.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This solution enables objective and standardized assessment of exam lane compliance and examiner expertise, reducing costs and time delays by automating the certification process and minimizing human resource requirements, while ensuring consistency and reducing potential biases.
Implementation Method 1
object and/or character recognition using pictures captured using a camera
Implementation Method 2
ambient light intensity measurement using the light sensor of the handheld device
Implementation Method 3
length/distance measurements using lidar
Data Source
AI summary
A handheld system for the objective measurement of compliance with a clinical study protocol, such as an ETDRS BCVA study protocol. The system and methods use a handheld device application and associated sensors of the device to measure ambient light, and the distances between objects in an examination lane to determine compliance. The system may also identify objects in the room and provide an interface for users to understand compliance and receive training.