CygnusMed, Inc. Advancing Endovascular Procedure Safety

Background Context

Endovascular surgeries, crucial for treating various vascular conditions, often require multiple arterial accesses, increasing the risk of complications like significant blood loss. To address this issue, CygnusMed, Inc. developed an innovative medical device designed to perform arterial blood pressure measurements from a single arterial access point. This advancement aims to reduce the need for multiple accesses, thereby decreasing potential blood loss and enhancing overall patient safety. 

The Problem

Despite the theoretical benefits of the new device, practical acceptance and integration into existing medical practices necessitated thorough validation. The challenges associated with this type of work include the need for specific expertise in research design, considerable time investment, and substantial resource allocation. 

Methodology

CygnusMed, Inc. partnered with Qualz.ai to conduct a methodologically dynamic survey among 30 doctors specializing in relevant medical fields. The survey was designed to seamlessly collect both quantitative and qualitative data. 

Seamless Data Collection and Integration

Qualz.ai’s AI-driven platform facilitated seamless data collection, integrating responses in real-time and ensuring accurate data capture. The initial part of the survey included structured quantitative questions to assess initial reactions to the device’s concept and perceived utility. Based on these responses, follow-up qualitative questions were automatically generated to delve deeper into specific concerns or endorsements, providing richer contextual insights. 

Intelligence Layers in Survey Design

Qualz.ai’s intelligence layers played a crucial role in designing the survey. By analyzing preliminary data and identifying key areas of interest, the platform tailored the qualitative follow-up questions to extract maximum insight, ensuring that all relevant aspects were thoroughly explored. 

 Data Analysis

The analysis employed a mixed-methodology approach, streamlined by Qualz.ai’s robust analytical tools: 

• Descriptive Statistics: Summarized basic data from the survey, offering an overview of general trends and initial reception of the device. 
• Basic Statistical Analysis: Quantified the strength and significance of observed trends, providing concrete numerical backing to the findings.  
• Thematic Analysis: Qualz.ai’s advanced AI algorithms conducted an in-depth thematic analysis of qualitative responses, identifying common themes, concerns, and suggestions. This analysis provided deeper insights into practical considerations and potential improvements. 

Results

Quantitative Results

Initial Reception of the Device: 

• 80% of doctors rated the device as potentially beneficial for reducing patient blood loss. 
• 70% indicated that the device could integrate well into current surgical practices.

Qualitative Results

Themes Identified-Based on the provided thematic analysis, here are three broad themes: 

User Interface Satisfaction

User Interface Design Rating: 

• 60% of respondents rated the user interface as “good” or “very good”. 
• 30% identified specific areas for improvement in the user interface. 

A. Usability and Integration of Medical Devices 

• Ease of Use: Users are likely to adopt the device if it is straightforward and user-friendly. 
• Device Integration with Existing Practices: The device must integrate seamlessly into current medical procedures and practices. 
• Setup and Flexibility: Challenges related to the calibration, setup, and size availability of the device need to be addressed. 

B.  Economic Accessibility and Cost Considerations 

• Cost as a Barrier: The high cost of the device is a significant deterrent to its adoption. 
• Return on Investment (ROI): Users will consider the device if it offers a reasonable ROI, such as reducing procedure time or room time. 
• Cost-Benefit Analysis: The decision to adopt the device will depend on whether it provides a tangible cost advantage over existing tools. 

C.  Safety and Risk Management 

• Complications and Safety Concerns: Users are wary of potential complications such as arterial damage or dissection. 
• Single vs. Multiple Access: There is a preference for devices that reduce the need for multiple access points, thereby minimizing risk. 
• Effectiveness in Reducing Complications: The device must demonstrate its ability to reduce patient discomfort and procedural complications. 

Example Quotes

• Ease of use and cost are essential elements. 
• The major issue will be cost if it is to replace some existing equipment. 
• It can be very good if the device turns out to be quite easy to use and safe without other limitations. 

From qualitative analysis, it is evident that while there is interest in the new medical device, the success of its adoption hinges on addressing usability, cost, safety, and institutional barriers. 

Outcomes 

The survey provided CygnusMed, Inc. with critical insights essential for further product development. Feedback highlighted the potential for significant improvements in patient safety and procedural efficiency. The thematic analysis, powered by Qualz.ai, uncovered specific areas for enhancement, such as user interface design and device integration into existing workflows, which CygnusMed plans to address in the next development phase. 

Time and Resource Savings 

By leveraging Qualz.ai, CygnusMed, Inc. saved substantial time and resources. The platform’s ability to automate data collection, integrate real-time responses, and conduct thorough analyses reduced the workload on researchers and accelerated the feedback loop. 

Conclusion 

This case study illustrates the pivotal role of Qualz.ai in making the study possible very efficiently, with minimal expertise, resources, and time. By integrating dynamic methodological approaches and leveraging AI for seamless data collection and in-depth analysis, Qualz.ai enabled CygnusMed, Inc. to gather comprehensive insights that will significantly shape the final product. The detailed thematic analysis provided valuable and actionable insights, crucial for decision-making. This collaboration ensured that the innovative medical device is closely aligned with the needs of end-users, enhancing its practical acceptance and integration into medical practice.