COMS® One – a portable medical device for treating chronic wounds

Project description

Piomic Medical AG has developed COMS® technology, which promotes wound healing through combined optical and magnetic stimulation.

Piomic appointed Helbling at an early stage in the process to come up with a product vision and then design and develop a portable, easy-to-use and hand-operated medical device (Class IIa).

 

Key data and technical details

  • High output therapy LEDs and dedicated wound coil
  • Waterproof (IP44-tested) USB-C interface for charging and as a service interface
  • Elastomeric gripping surfaces for better haptics
  • Treatment progress indicator
  • User-friendly interface for sterile disposable
  • For use in outpatient settings or at home with trained personnel
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Services

  • Develop and implement product visions
  • Jointly work on and refine design input, including usability specifications (requirements/usability engineering)
  • Electromagnetic emission simulations, energy calculations and empirical determination of thermal behaviour
  • System and software risk assessments, including implementing, tracking and reviewing the resulting risk mitigation
  • Production-focused construction and configuration of all components in accordance with IEC 60601-1 and other applicable standards
  • Implement, integrate and verify embedded software in accordance with IEC 62304
  • Plan and implement verification and control of respective design changes

Result / success

The product visions created helped the customer flesh out their business plan and hold a successful seed financing round.

Helbling implemented a highly integrated, compact, and waterproof device design with minimal installation effort. It achieved this by closely cooperating with the customer and manufacturer.

The technical documentation for EU registration and proof of conformity has been prepared and is assisting the customer in the certification process.

Piomic is one of the winners of the W.A. De Vigier Startup Award 2019 with its COMS® One product. Piomic was also selected for the European Commission’s “SME Instrument” and funded under grant agreement no. 886276 from the European Union’s “Horizon 2020” research and innovation program.

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Helbling Technik Wil AG, Wil SG
Hubstrasse 24
CH-9500 Wil
Telephone:+41 71 913 82 11
info-htkw@helbling.ch