Portable Biomarker Collection Device Structured Protocol
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Solution Overview
Problem
Current devices for managing chronic diseases like diabetes lack structured guidance for biomarker collection, leading to uninterpretable data and patient burden, which discourages further therapy optimization.
Innovation Solution
A portable hand-held device with a processor that implements a structured collection protocol, classifying samples as primary or secondary based on adherence criteria, ensuring contextualized data collection and analysis for therapy optimization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If unstructured biomarker collection is performed, then patient burden is reduced, but data interpretability is lost
Solution Approach 1:
The system pre-defines structured collection protocols with specific timing, conditions, and parameters before the actual biomarker collection occurs. These protocols are loaded into the portable device in advance, guiding the patient through structured collection without requiring real-time clinical decision-making, thus maintaining ease of operation while ensuring data interpretability.
Solution Approach 2:
The portable collection device acts as an intermediary between the patient and the clinical system. It automatically captures contextual information (time, date, conditions) and structures the biomarker data according to pre-defined protocols, eliminating the need for manual documentation while preserving data interpretability for clinicians.
2Reliability
If multiple collection requests are provided by different clinicians, then comprehensive diagnosis is improved, but patient burden increases
Solution Approach 1:
The system merges multiple collection requests from different clinicians into a unified structured protocol. The portable device consolidates overlapping or conflicting requests into a single coherent collection schedule, maintaining comprehensive diagnostic coverage while reducing redundant measurements and patient burden.
Solution Approach 2:
The collection protocol is dynamically adjusted based on the specific patient needs and clinician requirements. The system allows flexible modification of collection parameters while maintaining the structured framework, enabling comprehensive diagnosis without fixed rigid schedules that increase patient burden.
3Loss of information
If structured collection protocol is implemented, then data interpretability is improved, but device complexity increases
Solution Approach 1:
The structured collection protocol is segmented into discrete, manageable components that can be independently loaded and executed on the portable device. Each protocol element (timing, parameters, conditions) is separated into distinct data structures, simplifying implementation while maintaining overall protocol structure and data interpretability.
Solution Approach 2:
Standardized protocol templates are created and copied across different usage scenarios. Rather than programming complex logic into the device, pre-defined protocol copies are loaded onto the portable device, reducing implementation complexity while ensuring consistent data interpretability across different patients and clinicians.
Data Source
AI summary
Methods for performing a structured collection procedure by utilizing a collection device are disclosed herein, in which a collection procedure is initiated for performing one or more data collections for one or more data event instances occurring according to a schedule of events. Each data event instance is determined to be successful or unsuccessful on the basis of actual performance of the data collection and meeting certain conditions of the predetermined adherence criteria for the data event instance. Contextual information for successful data collections is generated and a data file generated for storing records relating to successful data collections. For unsuccessful data event instances, substitute data relating to data collections performed separately from the collection procedure are included in the data file records for the collection procedure if the substitute data is determined to meet conditions of the predetermined adherence criterion for the corresponding data event instance.