Leveraging Bluetooth in Medical Combination Products

The way we design and run clinical trials is changing. Studies are becoming more decentralised, more personalised and more complex. As investigators, sponsors, and product teams adapt to these shifts, one thing is becoming increasingly clear for combination products: collecting high-quality data directly from a participant’s device at the right time, in the real world, is critical. And Bluetooth is quickly emerging as the most practical way to do it.

But while Bluetooth is everywhere, on our phones, in our wearables, powering billions of devices, it hasn’t always been an easy fit for regulated medical environments. That’s starting to change.

In this post, we explore how Bluetooth Low Energy (LE) can be used effectively in connected medical devices, particularly combination products like autoinjectors or inhalers, and how Blecon’s pairing-free, cloud-connected Bluetooth architecture is helping overcome the technical and regulatory barriers to adoption.

Why Bluetooth? Why Now?

Bluetooth has quietly become the most widely deployed short-range wireless technology in the world, with over 5 billion devices shipped annually. For medical device makers, that matters. The scale of the ecosystem means low-cost radios, well-tested silicon, and out-of-the-box support on every smartphone, tablet, and laptop.

Beyond ubiquity, Bluetooth LE also hits key product design requirements:

Tiny footprint: Bluetooth LE chips are small enough for space-constrained wearables and drug-delivery devices.

• Low power draw: Bluetooth LE radios can operate for months or even years on a coin cell battery.
  
• No custom infrastructure: Data can sync via a participant’s own phone, a clinical tablet, or a Bluetooth-enabled gateway - no Wi-Fi setup or app provisioning required.
• Global operability: Bluetooth uses globally unlicensed spectrum, so devices can be deployed worldwide without needing hardware changes.

Together, these advantages make Bluetooth LE a compelling foundation for capturing dosing events, monitoring usage, and gathering real-world evidence across diverse clinical settings, from investigational sites to patients’ homes.

Bluetooth Is a Great Start — But Clinical Trials Demand More

Despite these benefits, Bluetooth in medical devices hasn’t always lived up to expectations in clinical environments. That’s largely because traditional implementations were built for consumer convenience - not regulated, traceable, life-critical applications.

The most common pain points we see:

• Pairing is a barrier: Device-to-phone pairing sounds simple but becomes a nightmare at scale. It adds cognitive load for participants and staff, increases setup errors, and doesn’t adapt well to shared devices or transient settings.
• Data isn’t always delivered: Bluetooth LE by itself doesn’t guarantee delivery. Devices may think they’ve sent data via a phone that’s offline or has background app restrictions leading to silent data loss.
• No built-in time synchronisation: Bluetooth LE has no native concept of global time. If you're trying to track events to the minute, or second, accuracy breaks down fast without additional synchronisation.
• Cybersecurity and compliance: Most Bluetooth stacks are SOUP (Software of Unknown Provenance) and complex pieces of software. That’s a problem when building medical devices subject to FDA, EMA, or MHRA requirements. You need traceability and robust risk controls to mitigate safety and cybersecurity risks

Put simply, Bluetooth is a great foundation but not enough on its own.

A Better Approach: Secure, Pairing-Free Bluetooth LE Connectivity

At Blecon, we’ve built a Bluetooth-based architecture which can support the needs of combination products and clinical trials.

Here’s what makes it different:

🔗 No pairing required

Any Blecon-enabled device can securely transmit data through any phone, tablet, or gateway running Blecon software, without setup, provisioning, or user intervention. This means data flows from the participant’s home to the cloud seamlessly, reducing errors and support overhead.

🔐 End-to-end security

Data is encrypted and authenticated from device to cloud, independent of the underlying Bluetooth protocol. Each record is acknowledged, so you know exactly what’s been received and what hasn’t - enabling lossless transfer, even with intermittent connectivity.

🕐 Built-in identity and time

Every device includes a cryptographically secure identity that can be derived into a UDI or barcode, supporting traceability requirements and seamless association of a device with a participant. Global time synchronisation ensures timestamps are accurate and aligned with clinical events.

👩‍⚕️ Human factors first

Our architecture avoids asking participants or clinicians to configure, pair, or manage connectivity. This reduces training time, improves adoption, and lowers the risk of protocol deviations.

🔄 Over-the-air updates

Bluetooth LE devices using Blecon can receive encrypted, validated firmware updates remotely. Supporting rapid iteration, vulnerability patches, and compliance with FDA cybersecurity mandates like Section 524B.

Real-World Spotlight: A Bluetooth-Enabled Inhaler by i4 Product Design

At Med-Tech Innovation Expo, we spoke to Tristan from i4 Product Design, a hardware development company that supports medical device innovation from concept to manufacture. He showcased the Aflo™ Smart Inhaler Add-on (Aflo Analytics), developed during the COVID-19 period to improve adherence for metered-dose inhalers. 

“Over 70% of people don’t use their inhalers correctly,” Tristan explained. “We worked with a founder to build electronics that could monitor key usage parameters — from the shake, to the timing, to inhalation pressure — and transmit this data via Bluetooth to the user’s phone and onward to clinicians.”

The choice of Bluetooth was deliberate:

“Battery size was a key constraint,” said Tristan. “We needed a technology that was low power, lightweight, and didn’t add bulk to the device. Bluetooth fit the bill — and opens up possibilities beyond just compliance, like proximity sensing and clinical trial integration.”

This kind of retrofit approach aligns with what we have explored in our whitepaper: using Bluetooth to bring intelligence, compliance, and connectivity to combination products in a way that’s cost-effective and minimally invasive to the core therapy.

Real-World Impact: Faster Deployment, Better Data, Lower Risk

By using Blecon, medical device teams and study sponsors can:

• Launch faster: without building custom apps or IT infrastructure
• Ensure data quality: with secure, timestamped, acknowledged transmission
• Simplify compliance: with features aligned to 21 CFR Part 11, GCP, and EU MDR Annex I
• Reduce support load: thanks to pairing-free setup and standardised connectivity
• Iterate confidently: through OTA updates and modular software design

Whether you’re running a feasibility study with 10 participants or preparing a pivotal trial with 10,000, Blecon helps you spend less time wrestling with connectivity and more time focusing on the outcomes that matter.

Want to Learn More?

We’ve published a full whitepaper on Bluetooth in medical combination products, covering everything from FDA and EMA regulatory alignment to device traceability, software segregation, and cybersecurity.

👉 Download the whitepaper here

Or Schedule a chat with us to discuss your specific implementation needs.

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