Delivering and sustaining innovation

Technology

Qualification Process for Newborn Care Devices

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    Step 1: Identify medical devices needed for Level 2+ newborn care

    Consult WHO/national guidelines for recommended product categories

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    Step 5: Conduct technical testing under laboratory conditions

    Test technical performance of candidate technologies under laboratory conditions

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    Step 2: Define Target Product Profiles (TPPs)

    Expert consensus to define minimal and optimal device performance characteristics

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    Step 6: Conduct technical testing after environmental exposure

    Test technical performance of candidate technologies after exposure to extreme heat, humidity, dust, and voltage surges

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    Step 3: Identify candidate technologies

    Identify technologies that may meet TPP requirements

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    Step 7: Evaluate usability

    Perform heuristic evaluations to identify major usability concerns. Perform comparative usability evaluation of candidate technologies with end users from high- and low-resource settings

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    Step 4: Evaluate candidate technologies against TPP

    Desk research to identify promising candidate technologies likely to meet the TPP

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    Step 8: Qualify technologies

    Qualify all candidate technologies within a product category that meet TPP and pass technical, environmental and usability evaluations

NEST360 Qualified Technologies

NEST360 uses a eight-step process to evaluate technology for newborn care in low-resource settings. Rigorous performance and usability testing is conducted on devices that are available for purchase and have regulatory approval.

NEST360 Qualified Technologies are robust, durable and suitable for low-resource settings and meet pre-defined performance metrics based on the Target Product Profiles (developed in collaboration with UNICEF). The technologies submitted align with our Pathways of Care.

Using the Technology Landscaping Survey, device manufacturers apply for inclusion in the next edition of the NEST360 Newborn Technology Landscape, a compendium of newborn healthcare technologies, both commercially available and in development, suited for use in resource-limited settings.

Syringe Pump

  • Mindray BeneFusion SP3

Bilirubinometer

  • Calmark AB Neo-Bilirubin
  • BiliDx Bilirubinometer 

Phototherapy Light

  • MTTS Colibri Phototherapy
  • MTTS Firefly
  • Phoenix Brilliance Pro

Glucometer

  • Nova StatStrip Glucose Hospital Meter System
  • Nova StatStrip Xpress2

Hemoglobinometer

  • EKF Diaspect™
  • HemoCue 201+

CPAP

  • Diamedica UK Baby CPAP 10
  • Pumani bubbleCPAP

Flow Splitter

  • Caire Chart SureFlow Oxygen Flow Station
  • Canta Flow Splitter
  • Longfian 5-way Flow Spitter

Oxygen Concentrator

  • Canta V8-WN-NS
  • CAIRE Airsep NewLife Intensity 10
  • Longfian Jay-10 Dual Flow

Pulse Oximeter

  • Acare Lifebox
  • Bistos BT-710
  • MindrayPM-60

Suction Pump

  • 3A Aspeed Professional

Radiant Warmer

  • MTTS Wallaby
  • Phoenix NWS-101