Case Study: Successful development of a BLE app for a medical technology startup

This article is part of our series about [Bluetooth](/performance/system integration) Low Energy. You can find the comprehensive guide here: The ultimate guide to [BLE](/services/system integration) App Development in Germany (2026)

Case Study: Successful development of a BLE app for a medical technology startup

Theory is important, but nothing convinces more than an example from practice. In this case study, we (anonymized) describe the path of a German medical technology startup that has developed an innovative wearable for monitoring vital data. The project exemplarily demonstrates the typical challenges and success factors in the development of a BLE application in the demanding healthcare sector.

The starting situation

The startup had a vision: a small, inconspicuous wearable that continuously measures vital data such as heart rate and oxygen saturation and transmits it safely to a mobile app. The app should visualize the data and automatically trigger an alarm at critical values – both in the patient and in the attending physician. The product should be certified as a medical product of Class IIa, which required compliance with the strict Medical Device Regulation (MDR).

The challenges

The project presented the team with several complex challenges:

• Reliable BLE connection: The connection between the wearable and the smartphone had to be extremely stable. A connection termination during a critical measurement was unacceptable.

• ** Energy efficiency:** The wearable should pay at least one week with a battery charge, despite continuous data transmission.

• Data security: Health data is highly sensitive. The entire communication had to be encrypted at the end and correspond to the requirements of the GDPR.

• MDR certification: The software (both firmware and app) had to be developed and documented according to IEC 62304 to obtain approval as a medical product.

The solution

The startup decided to collaborate with an experienced BLE App developer who had already successfully launched several medical devices. The development process was divided into several phases:

Proof of Concept (PoC): In a first phase, a PoC was created with a standard development board to validate the basic feasibility and to define the requirements for the GATT profile.

• Parallele development: firmware and app development ran parallel, with regular integration tests to ensure that both sides play together perfectly.

• Safety from the outset: Security mechanisms (LE Secure Connections, Encryption, Safe Authentication) have been integrated into architecture from the outset, not subsequently added.

• Document as part of the process: The documentation required for the MDR was not as