Recently, Bill Betten shared a thoughtful five-part series on the Medical Design & Outsourcing blog that explores how medtech companies can rethink their approach to data. This series covers the critical areas your data strategy will need to address, with each installment focusing on a key stage of the medtech data journey.
Betten’s central message is clear: data should not be viewed as an afterthought or a byproduct of connected devices — it is a strategic asset. When leveraged correctly, data can fuel innovation, enhance patient outcomes, and unlock new revenue streams.
There are no easy answers to the complex questions this topic raises. Instead, the goal of the series is to lay out a structured approach — one that guides medtech leaders and engineers through the critical conversations they should be having about data at each stage of the development process.
Below is a brief synopsis of each installment, with a link at the end of every section so you can dive deeper into the full content on the MDO website.
Article 1: Understanding the importance of data strategies
In today’s medtech landscape, data is more than just numbers collected by devices — it is a strategic asset. This first article sets the stage by outlining why a well-structured data strategy is essential. Betten explains how the role of data is shifting in connected health and introduces frameworks for integrating data-driven decision-making into business strategies. This article covers:
- Why data strategies matter
- The data value chain: Transforming business opportunities
- Build a data strategy early and enhance it as you move through the development process
Article 2: The role of data in concept design and definition
The second article focuses on the concept stage, where the foundation for a successful product is laid. Here, teams move from unstructured information about the project to a clear vision and business direction. Betten breaks this down into three stages:
- Discover: Define the product’s intended use.
- Identify: Map out data-driven use cases.
- Ideate: Build the business strategy around those use cases.
This stage is about shaping the future product through strategic thinking, ensuring data plays a role from the very beginning.
Article 3: The role of data in development and validation
Moving into development and validation, Betten highlights the shift from why the product exists to what the solution will be and how to bring it to life. This phase involves solution creation, system architecture, validation, and regulatory compliance.
One of the biggest challenges here is bridging the gap between business vision and technical feasibility. Data strategy is essential in closing this gap, ensuring the solution is designed to collect, manage, and process data effectively.
Highlights from this installment include:
- Solution creation: Designing the data ecosystem
- Architecture: Building scalable and secure infrastructure
Article 4: Understanding how regulatory compliance impacts your data strategy
No data strategy can succeed without a deep understanding of regulatory requirements. In this article, Betten explains how compliance influences every aspect of how medtech companies collect, store, share, and validate data.
Failing to address these issues early can lead to costly delays and limited market access. By proactively integrating compliance into the strategy, companies can avoid pitfalls and ensure long-term success. This article explores:
- Regulatory classifications: Medical vs. non-medical devices
- Real-world data (RWD) and outcomes: Leveraging data for compliance
- Validation and compliance: Ensuring performance and regulatory approval
Article 5: The role of data in operations and lifecycle management
The series concludes by examining the final stage: operations and lifecycle management. Once a product is on the market, data becomes critical for reliability, efficiency, and continuous improvement.
Betten emphasizes that lifecycle management is not static — devices must be maintained, updated, and integrated into healthcare workflows. Data informs these processes, helping companies roll out updates, ensure security, and enhance the product over time.
Key areas include:
- Operating the solution: Deployment and integration
- Managed service operation: Ensuring performance and optimization
- Updates and enhancements: Future-proofing the device
Closing thoughts
Bill Betten’s five-part series provides a comprehensive roadmap for medtech companies looking to elevate their data strategy. From concept definition to regulatory compliance and long-term lifecycle management, the series makes one thing clear: data is not just a supporting factor—it is central to innovation, patient outcomes, and business success. You can explore each article in depth by following the links above on the Medical Design & Outsourcing blog
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.
