Prototyping a Multiparametric Point-of-Care IVD Device

Project:

An Indian start-up partnered with D2R Global Consulting to design and develop a multiparametric point-of-care device capable of conducting over 40 diagnostic tests. This innovative solution aimed to provide accessible diagnostics in rural, remote, and semi-urban areas, addressing the need for rapid, versatile healthcare tools.

Solution:

• Design and Development:
  D2R’s team, including hardware, firmware, software, and design engineers, created a modular, user-friendly device suitable for a wide range of diagnostic needs. The engineering approach allowed for easy adaptation for future tests, ensuring the device’s long-term utility.
• Material Selection and Sourcing:
  The team sourced high-quality, biocompatible materials that ensured durability while keeping costs manageable. Reliable electronics and sensors were selected to support precise, frequent testing in various healthcare environments.
• Prototyping, Testing, and Validation:
  The device was developed from concept to prototype within six months, meeting IEC 60601 standards for safety and performance. With only minimal adjustments, the prototype passed compliance in its second iteration, streamlining the process and maintaining project timelines.

Outcome:

The project enabled the start-up to be fully prepared for clinical trials, paving the way for regulatory approvals and a streamlined path to market. The device, capable of performing 40+ tests, is positioned for rapid adoption in underserved areas, combining accessibility with adherence to rigorous regulatory standards.