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The Business Applications Layer | Part 2 of The Data Strategy Framework Series

Written by Piotr Sokolowski | March 27, 2025

This extract is part two of a five-part series that breaks down the layers of the Data Strategy Framework for Connected Medical Devices, which we introduced in our recent whitepaper. Featuring insights from industry leaders at Cochlear, Dexcom, Medtronic, Omron, Vocxi Health, and S3 Connected Health, the paper offers a practical framework for leveraging data to stay competitive and succeed in a data-driven healthcare landscape. 

The business applications layer is essential for organizations to transform data-driven insights into evidence-based decisions that facilitate regulatory approval, enhance market access, boost medical device adoption, and improve other critical aspects of the medtech industry. This layer integrates tools and applications with internal business functions and external systems, converging data analytics to support informed, strategic decisions that lead to tangible business outcomes and patient-centered innovations. 

 

Aligning business goals with data strategy

Defining business goals  

A successful data strategy begins with clearly defined business goals. Establishing these goals is critical; otherwise, organizations risk becoming overwhelmed by data collection without a clear direction. Achieving core elements such as regulatory approval, market access, and device adoption relies on a well-structured data strategy aligned with these business goals. Without clear objectives, data applications can become unfocused, leading to inefficient decision-making and a lack of alignment across teams. 

 

Collaborative decision-making  

Ensure that business leaders, product managers, regulatory experts, and other functions work closely with data science teams toward shared objectives. Hiring data experts is insufficient; their efforts must align with the broader business strategy. This is achieved through an integrated approach, where every department utilizes the same data, fostering a consistent understanding across the organization. As companies grow, they may struggle to manage data effectively, often neglecting the importance of strategic planning in their data initiatives. 

 

Single source of truth 

A critical element of this layer is maintaining a single source of truth. This ensures that all teams are working from consistent and accessible data, eliminating discrepancies and ensuring that everyone refers to the same insights and performance metrics. This unity is essential for making informed decisions and driving the organization toward its goals. 

“One noticeable gap is that data science teams often receive attention too late, especially as companies scale. Small companies can manage data better because the process is more straightforward, but as they expand, they tend to throw more people at the data problem without a strategic plan, which doesn’t always work.”  

Harsimran Singh, Director of Behavioral & Translational Data Science, Dexcom 

How internal and external functions use business applications 

 

Support for product development 

This function leverages historical and real-time data to accelerate R&D and innovation. Medical device vendors can use product data to identify trends and performance insights that inform future product iterations. 

Example: Device usage data from implanted devices can be analyzed to detect patterns, such as battery life issues or signal reliability, which can inform the design of next-generation devices. In the case of continuous glucose monitors (CGMs) combined with insulin pumps, data can help optimize closed-loop 

 

Support for operational excellence 

Enable operational functions to optimize their processes using real-time decision support systems. These systems provide predictive analytics to guide decisions, such as when to recalibrate or replace devices. 

Example: Real-time monitoring of implanted devices, such as pacemakers, allows the system to detect anomalies and issue alerts for preventive maintenance, helping to avoid device malfunctions and potential market recalls. 

 

Therapy management solutions 

Personalized therapy is a growing trend, and business applications help tailor treatments to individual patients based on device data. These applications can ensure that medical devices are optimally configured for each patient and monitor adherence to prescribed usage. 

Example: A wearable heart monitor can provide personalized health insights to patients, increasing adherence to prescribed treatments. Additionally, therapy management solutions can monitor patient outcomes and alert healthcare providers if adjustments to the treatment plan are needed. 

 

Integration of insights into sales and marketing  

Beyond product development and operations, business applications provide valuable insights into commercial strategies. These tools help identify unmet clinical needs, customer behavior patterns, and new market opportunities. 

Example: Aggregated data from thousands of wearable devices can provide population health insights, allowing medical device companies to identify national trends in disease management and tailor their sales and marketing strategies accordingly. 

 

Challenges in the business applications layer 

While the business applications layer offers immense value, it also presents several challenges organizations must navigate to ensure successful implementation and scalability. 

  • Usability: One major challenge is ensuring that business applications are user-friendly and accessible to non-technical stakeholders. These applications must translate complex data into clear insights that clinicians, business executives, and other users can act upon. 
  • Integration with existing workflows: Another challenge is ensuring these applications integrate seamlessly with existing business functions, such as CRM systems, IT solutions (like digital identity management systems), and clinical workflows, including EHRs and hospital IT systems. These applications may disrupt operations or fail to deliver their full value without proper integration. 
  • Scalability: As the proliferation of IoT-enabled devices grows, business applications must be scalable to handle increasing data volumes and ensure continuous performance. This requires robust data architecture that can grow with the business. 

 

The business applications layer is critical in turning data into actionable insights within medical device companies. While challenges such as usability, integration, and scalability must be addressed, the true value of this layer lies in its ability to drive meaningful business outcomes through data-driven insights, enhance product performance, optimize operational processes, and improve patient outcomes. 

Check out our recent whitepaper for more information on building an effective data strategy framework for connected medical devices. Featuring insights from industry leaders at Cochlear, Dexcom, Medtronic, Omron, Vocxi Health, and S3 Connected Health, the paper offers a practical framework for leveraging data to stay competitive and succeed in a data-driven healthcare landscape. You can read other extracts in this series to understand each layer better: