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Embedded Sensor Systems in Medical Devices: Requisites and Challenges Ahead.

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This study introduces a methodology for developing embedded medical devices, reducing costs and incorporating user feedback. This approach helps startups navigate regulatory hurdles and achieve successful product launches.

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embedded systemsmedical devicesnew product developmentwearable devices

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Area of Science:

  • Biomedical Engineering
  • Medical Device Development
  • Embedded Systems

Background:

  • Embedded systems are crucial for modern medical device advancement.
  • Stringent regulatory requirements pose significant challenges to medical device design and development.
  • High failure rates are common among startups in the medical device sector.

Purpose of the Study:

  • To present a methodology for designing and developing embedded medical devices.
  • To minimize economic investment during technical risk phases.
  • To integrate customer feedback throughout the development lifecycle.

Main Methods:

  • The methodology comprises three stages: Development Feasibility, Incremental and Iterative Prototyping, and Medical Product Consolidation.
  • The process emphasizes compliance with all applicable regulations.
  • Practical use cases, including a wearable vital signs monitor, were employed for validation.

Main Results:

  • The proposed methodology was validated through successful practical applications.
  • Devices developed using this methodology achieved CE marking.
  • Adherence to the procedures facilitated ISO 13485 certification.

Conclusions:

  • The presented methodology effectively supports the design and development of embedded medical devices.
  • It aids in navigating regulatory compliance and achieving market approval.
  • The approach is proven to reduce economic risks and enhance product viability.