Accelerating Time-to-Market: Secure Boot Implementation for MedTech Success

Client is an innovative healthcare technology startup dedicated to improving the lives of patients suffering from chronic Overactive Bladder (OAB) conditions.​

Challenges

  • To comply with FDA medical device regulations, a Class 2 device required secure boot functionality to prevent malicious code execution during bootup.​
  • The selected ST microcontroller had limited capabilities to support secure boot, posing challenges to the engineering team.​
  • A change of microcontroller was suggested, but this option would increase expenses and cause delays in product launch.​

Solution

  • Zimetrics effectively tackled the limitations by leveraging our in-depth knowledge of the secure boot process and subject matter expertise with ST microcontrollers.​
  • Through skillful implementation of the required boot script, code, and processes, secure boot was successfully established within a short timeframe.​
  • As a result, the medical device became market-ready, meeting the necessary security standards for production.​
  • Zimetrics also developed a secure Firmware Update Over The Air (FOTA) solution, enabling field devices’ firmware to be updated remotely.​

Impact Generated

  • Implementing secure boot on the existing microcontroller proved to be a game-changer, saving significant engineering costs and accelerating the time-to-market.​
  • The decision to avoid changing the microcontroller not only minimized expenses but also ensured the timely availability of the product to address the pressing medical needs of patients.

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Accelerating Time-to-Market: Secure Boot Implementation for MedTech Success

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