Unlocking the power of data for connected medical devices

This series will cover the critical areas your data strategy will need to address, with each installment exploring a key stage of the medtech data journey.

By Bill Betten, S3 Connected Health

There’s hardly a day that goes by without me fielding a question about medical device data. Our industry has long understood the value data can bring, having used it to track and improve device performance for years. Yet few companies truly integrate data into their broader strategies in a meaningful way.

I see incredible innovation and remarkable devices being developed. I also see countless missed opportunities, where data is treated merely as a byproduct of a connected device rather than as a core asset. This mindset needs to change.

That’s why I’m launching this series: to explore how medtech companies can transform their approach by recognizing data as a strategic asset, one that can fuel innovation, enhance patient outcomes, and unlock new revenue streams.

There are no simple answers to the complex questions this topic raises. My goal is to lay out a strategic approach that covers the critical conversations teams should be having about data for connected medical devices at each stage of the development process.

In this first article, we’ll set the stage by discussing why shifting our collective perspective on data is essential to truly embed data-driven decision-making into our business strategies.

Why data strategies matter

Big tech is everywhere you look, and medtech companies would be remiss not to pay attention to where these non-medical players are making inroads. There are unprecedented opportunities for new entrants to reshape the market, and many of these new players are finding success by focusing on data within a single disease area to revolutionize treatment.

These problem-specific startups don’t yet pose an existential threat to the established giants of the medtech industry, but they do highlight the urgent need for robust data strategies and infrastructure if current medical device companies are to remain competitive. Over the past 30 years, medical device spending has remained stable at about 6% of total U.S. healthcare expenditure. Yet, across industry reports, one thing becomes clear: truly impactful growth opportunities require companies to look beyond the device itself. Data simply cannot be ignored. Those who are learning to harness data can improve at a rate that others, acting without it, simply won’t be able to match. The simplest approach is to use data to improve your product or track how it is working. A more complex yet more rewarding method is to begin to utilize that data for improving the delivery of healthcare.

To tap into this potential, companies must explore all the ways data can create value. Beyond improving the core product, medtech firms should look to move up the value chain by considering how data can drive value. For instance, rather than immediately expanding into new devices or markets, a neurostimulator company could first deepen its impact in the current market, using data to drive product innovation, generate clinical insights, and improve patient outcomes. This approach can transform devices into diagnostic tools or integrate them into broader service offerings, increasing their share of value in a specific disease area. The key is to create new value by utilizing the data already being generated by medical devices. Once this foundation is in place, companies can consider scaling into new markets and therapy areas, backed by clear, data-driven insight into what truly works.

We don’t have to look far to find examples of medtech companies that have launched impressive data-driven strategies, creating both value and new revenue models. Many are familiar with the success in diabetes care, starting with basic glucometers and insulin injections, then evolving through continuous glucose monitors, and now to life-changing closed-loop insulin pumps. In this space, data is used at the patient level to deliver treatment tailored to the exact needs of the individual.

It will also be interesting to watch the developments underway in dialysis and kidney care, where non-hospital care is being provided and data is being generated, offering unprecedented insights into patient care and treatment. Another sign of how critical data will become is the growing interest in smart implants that monitor physiological parameters as they perform their core function. These are just a few examples of how data is already a tool to transform medical care. But this is only the beginning. We’ve yet to see the full potential of data in medtech.

The data value chain: Transforming business opportunities

Suppose there was a surefire way to improve patient care, ensure regulatory compliance, and create new monetization models. Wouldn’t most medtech companies do everything they can to invest in it? Yet despite data offering exactly these opportunities, many companies remain hesitant to commit fully. They pilot smaller experiments at the device level but often fail to see or tap into the bigger picture.

Whether they like it or not, medical device manufacturers no longer operate in isolation. There is now a larger digital health ecosystem to consider when developing devices, and companies must understand how data moves between device vendors, healthcare providers, payers, and digital health platforms.

One of the most significant barriers to progress is the existence of silos. These silos go far beyond a lack of communication between departments and include disease areas, the separation of device and service data from therapeutic information, and even fragmented patient data.

Tackling this issue is challenging, as medtech companies and healthcare providers are typically structured around therapy areas like cardiovascular, endocrinology, and so on. Historically, medtech firms have focused on gathering data about product performance and usage within these silos. While this has clear value in refining devices, it often leaves patient-relevant data fragmented and underused.

To create greater impact, medtech companies must shift their focus from purely improving devices to exploring how patient-centered data can drive new forms of value. This means asking what can be done with data beyond product enhancement — using it to support clinical decisions at the individual level and, eventually, to unlock broader insights through big data analysis.

By identifying trends in larger, aggregated data sets, companies can uncover patterns that might otherwise remain hidden, such as symptoms clustered in specific demographics or regions, or risk factors unique to certain populations. While data collected in isolation helps optimize device performance and treatment, anonymized big data offers the potential for a deeper understanding of disease prevalence and patient behavior. Building this broader context can fuel meaningful advances in treatment, prevention, and overall patient care.

Another question on many people’s minds is whether patients should benefit financially from monetization of their data. The case of Henrietta Lacks (who died in 1951) is a landmark example. Her cervical cancer cells — known as HeLa cells — were taken without her consent and have since been cultured indefinitely, playing a crucial role in cancer research and vaccine development. In 2023, her descendants reached a settlement with Thermo Fisher Scientific over the use of these cells.

As companies increasingly profit from the data they collect from patient populations, the ethical questions this raises around consent and monetization will only become more pressing.

Build a data strategy early and enhance it as you move through the development process

There is no one-size-fits-all approach. Companies must tailor their data strategy for their specific business goals. The aim of this series will be to cover the critical areas your strategy will need to address. Each installment will explore a key stage of the medtech data journey:

• Part 2: The Role of Data in Concept Design and Definition – Establishing the product’s purpose and use cases
• Part 3: The Role of Data in Development and Validation – Bridging the gap between strategy and engineering feasibility
• Part 4: Understanding How Regulatory Compliance Impacts Your Data Strategy – Navigating compliance challenges
• Part 5: The Role of Data in Operations and Lifecycle Management – Ensuring long-term optimization and innovation

By the end of this series, you’ll have a clear roadmap for developing a strong, compliant, and forward-thinking data strategy that drives business success in the medtech industry.

Bill Betten [Photo courtesy of S3 Connected Health]

Bill Betten is director of solutions — medtech at S3 Connected Health, where he utilizes his decades of experience in the medical and life science industry to advance medical device and product development, with an emphasis on connected devices and digital health. Betten previously served in development and executive management roles at several medical device and Fortune 500 companies.

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.