From Bench to Bedside – Developing New Technologies for Newborn Health Kara Palamountain Research Associate Professor, Northwestern University Kellogg School of Management k-palamountain@Kellogg.northwestern.edu KPA Annual Scientific Conference 2019 Mombasa, Kenya April 10, 2019

Commercially available Separate Neonatal Ward NEST Maintenance Tools Back Up Power Future technology Prevent & Treat Infections Syringe Pump Sepsis Diagnostic Temperature Stability Radiant Warmer Continuous Temp Monitor Warming Crib Hydration & Nutrition Future Technology Manage Jaundice Photo-therapy Lights Bilirubin Monitor Point of Care Diagnostics Glucose Monitor Hemoglobin Monitor pH Monitor Breathing Support Oxygen Source CPAP Suction Machine Pulse Oximeter O2 Concentrator Protector Apnea Monitor Commercially available 8 NEST facilities already equipped for Essential Newborn Care including resuscitation Clinical evaluation 6 Prototype 3

EFFECTIVE AFFORDABLE SUSTAINABLE

Draft TPPs for NEST Product Categories Introduction to the Product Category Methods and Inputs (literature reviewed, package inserts, standards, stringent regulatory authorities) Characteristic Categories Scope of Device (intended use, target population) Performance Characteristics (effective) Operational Characteristics (configuration, ease of use, rugged) Pricing (affordability) Characteristic Ranges Optimal Minimal

Draft TPPs for NEST Product Categories Phototherapy Example Draft TPPs for NEST Product Categories Introduction to the Product Category Introduction to the Product Category

Draft TPPs for NEST Product Categories Phototherapy Example Methods and Inputs (literature reviewed, package inserts, standards, stringent regulatory authorities)

Draft TPPs for NEST Product Categories Phototherapy Example Characteristic Categories Scope of Device (intended use, target population)

Draft TPPs for NEST Product Categories Phototherapy Example Characteristic Categories Performance Characteristics (effective)

Draft TPPs for NEST Product Categories Phototherapy Example Characteristic Categories Operational Characteristics (configuration, ease of use, rugged)

Draft TPPs for NEST Product Categories Phototherapy Example Characteristic Categories Pricing (affordability)

Proposed TPP Process Draft Development Feedback Round 1 Review of stakeholder needs Review of current and emerging products Initial draft developed and sent to suppliers as part of sourcing exercise Revise initial draft based upon sourcing exercises Feedback Round 1 Develop and test survey Survey of stakeholders Agreement will be scored on a Likert scale ranging from 1 to 5 (1=disagree, 2=mostly disagree, 3=do not agree or disagree, 4=mostly agree, 5=fully agree). Consensus will be pre-specified at greater than 50% of respondents providing a score of at least 4 on the Likert scale. Refinement of TPP to address feedback Feedback Round 2 Survey of stakeholders Consensus will be pre-specified at greater than 50% of respondents providing a score of at least 4 on the Likert scale. Refinement of TPP to address feedback Agreement will be scored on a Likert scale ranging from 1 to 5 (1=disagree, 2=mostly disagree, 3=do not agree or disagree, 4=mostly agree, 5=fully agree). Consensus will be pre-specified at greater than 50% of respondents providing a score of at least 4 on the Likert scale. Consensus Potential meeting with a subset of stakeholders to resolve final issues Characteristics on which fewer than 75% of the respondents agreed, or on which a distinct subgroup disagrees, will be discussed during the consensus meeting. The final draft of the TPPs will be shared with the NEST STAG for final review and approval. Refine and publish finalized TPP

When the 100&Change initiative came out, we knew it was our chance together with Queen to make sure that clinicians in Africa have the tools they need to help save babies lives. Instead of waiting 110 years for newborns in Africa to have the same chance of survival as those in the US, $100M means the chance to solve this problem is within our grasp.

THANK YOU Kara Palamountain Research Associate Professor, Northwestern University, Kellogg School of Management k-palamountain@kellogg.northwestern.edu #NEST360