Groundbreaking Devices to Save Lives at Birth · importance of investing in innovation at the Grand ... targeting preeclampsia Four new iron supplementation methods The Odon Device

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Groundbreaking Devices to Save Lives at Birth USAID/GH/CII | May 12th, 2017

WHO Global Medical Devices Forum 1

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Agenda

Background and CII Overview Grand Challenges Model Overview Case Studies on Saving Lives at Birth: A Grand Challenge For Development Resources


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Innovation is high on global agendas and USAID/GH is uniquely positioned to play a leading role

Bill Gates, Priti Patel, and Richard Branson discuss the importance of investing in innovation at the Grand Challenges annual meeting last year.

It is high on global agendas… Our partners believe in its importance and are invested…

USAID/GH is well positioned to support innovation…

Cutting-edge technical expertise across high-priority global health challenges More than 60 country and regional missions with connections to political leaders

Partnerships with leading global universities and corporations to facilitate collaboration Our patient, catalytic funding can de-risk investment and attract private capital


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CII plays a complementary role to support innovation and scale for GH Bureau priorities

Role

Approach

What we do

Accelerate the development, introduction and scale up of priority global health interventions

Catalyze Innovation

Scale for Impact

Identify Cutting-Edge Practices

Promote and reinforce innovative, business-minded approaches to address key bottlenecks in development, introduction and scale up


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Innovation is an important part of reaching our shared GH goals

We use a variety of novel approaches—from Grand Challenges to hackathons to prizes—to source groundbreaking solutions for tough and seemingly intractable health challenges.

USAID/GH is well positioned to support innovation: Cutting-edge technical expertise across high-priority global health challenges More than 60 country and regional missions with connections to political leaders Partnerships with leading global universities and corporations to facilitate collaboration


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Agenda



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Supporting 107 innovations aimed at saving the lives of

mothers & newborns

Rapidly sourced 14 innovations in the midst of

the Ebola crisis

Supporting 26 innovations aimed at curbing the

spread of Zika and stopping future global health threats

Seeks to overcoming key roadblocks to more

effective health supply chains

• Theory: Grand Challenges for Development focus global attention and resources on specific international development problems, and promote innovative approaches, processes, and solutions to solving them.

• They engage non-traditional solvers such as businesses, researchers, and scientists to identify innovations with global game-changing potential.

• Current grant programming is highly prescriptive. Grand Challenges invert this model, and pose a broad problem. In essence, we are crowd-sourcing innovation.

• Breadth: Across the Agency, USAID is host to 9 different Grand Challenges

• The Global Health Grand Challenges (4) are led by the CII team, in partnership with other offices around the GH Bureau. These include:

Grand Challenges Program Model


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Agenda


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USAID’s Flagship Grand Challenge: Saving Lives at Birth USAID Partners: Maternal Child Health & Nutrition Office (MCHN)

Diverse Portfolio of Innovations

• 7 rounds of global calls for solutions

• Highly competitive: funded 3% of >3,600 apps (102 countries)

• Diverse portfolio of 107 innovations

Global Partnership: Saving Lives at Birth is a partnership of USAID, The Government of Norway, The Bill & Melinda Gates Foundation, Grand Challenges Canada (Funded by the Gov. of Canada), The UK Department for International Development, and the Korea International Cooperation Agency

Global Impact

• Already reached 1.5M mothers and newborns

• Potential for 150K lives saved by 2030

• Formed 9 new partnerships for scale 81 SEED

27 VALIDATION

14 TTS

2 SCALING

107 innovations

Staged Funding

Saving Lives at Birth DevelopmentXchange, Washington DC


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Other1 19%

Tetanus 2%

Pneumonia 5%

Sepsis 15%

Intrapartum complications

24% Prematurity 35%

Other2 33%

Intrapartum comps

8%

Anemia 8%

Eclampsia 8%

Infection 11%

Post-Partum Hemorrhage

24%

Other dir.

causes3 8%

Five grantees, including CHX,

targeting sepsis

The Odon Device aims to reduce neonatal deaths from obstructed

or prolonged labor, a primary intrapartum complication

Funding an intervention to extend tetanus vaccination into low-resource settings

Four innovations at different stages of

development targeting PPH

Three low-cost tests and one

treatment targeting

preeclampsia

Four new iron supplementation methods

The Odon Device also has potential to save maternal lives

Seven innovations in the SL@B portfolio facilitating the treatment of neonatal respiratory distress and

hypothermia

SL@B supporting innovation

SL@B not supporting directly

A point of care diagnostic and an oxygen delivery device target neonatal

pneumonia

Causes of neonatal death 2.6 million in 2015

Causes of maternal death 303,000 in 2015

SL@B supports innovations targeting >60% of maternal deaths and >80% of neonatal deaths


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Innovations to help manage intrapartum complications and expand access to safe c-sections

Diagnostics and treatments for neonatal infections like sepsis, tetanus, and pneumonia

Low-cost, rugged devices and treatments for managing pre-term birth and its complications

New, accessible interventions for managing post-partum hemorrhage

New community-based methods aimed at broadening access to high-quality prenatal care

Supporting innovations for neonates... ~2.6 million neonatal deaths worldwide in 2015

...and mothers ~300,000 maternal deaths worldwide in 2015

• Our Xcelerator partnership with Venturewell provides all of our innovators with a structured training program in business model development, market understanding, product design, and launch planning

• We develop portfolio-level support and insight including landscape assessments of key market and public health opportunities that benefit multiple innovators

Providing cross-cutting

innovator support

Innovative approaches to vitamin & mineral supplementation, supporting maternal & neonatal health

New tests and treatments for critical conditions like preeclampsia

SL@B supports innovations focused on ending deaths of children and mothers at birth


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Four examples (of 100+) of SL@B innovations sourced via the Grand Challenge

SimPrints Technology, LTD.

SimPrints Biometric System is a rugged, low-cost, portable scanner for real-time id and

access to patient records

WHO / Becton Dickinson, and Co.

The Odon Device: A low-cost, easy to use innovation for assisted vaginal delivery

Next generation uterine balloon tamponade (UBT)

device to treat postpartum hemorrhage

Massachusetts General Hospital

Rice University

Low-cost bubble continuous positive airway pressure

(bCPAP) to reduce deaths from respiratory distress

Validation TTS SCALING Seed > TTS > Seed > SEED


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Lessons Learned

- On the ground assessments. Gaining real-world perspective, engaging with end users

- Understanding the local and global context. Acknowledging limitations of the environment and the user

- HCD supports innovation design, product training + use cases

- Innovator-specific support. Guidance in introduction planning, defining business model and sustainability strategies.

- Portfolio-level support. Landscape assessments of markets in which multiple innovators are operating (e.g., bCPAP, vector control); capacity building in planning for scale

- Line up testing sites/facilities - Develop strong relationships with key

partners and SMEs including: WHO, MSF, BD, DuPont, Gates Foundation, and others.

- Develop TPPs and safety standards. - Play a role in the conversation.

Facilitate and support ongoing conversations around the innovation ecosystem.

Connections to Partners, Technical Experts, and Key

Influencers

Expertise in Product Introduction and Scale Up,

Business Model Design

Human Centered Design to Keep the End-user in Mind

Sl@B Scale Up Support_Presentation on Findings_3 13 17_vFinal Sent.pptx 5

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Our effort focused on three key questions to prepare for scale-up of ESM-UBT

What are the

'business

fundamentals'?

How should

global scale-up be

organized, delivered

and funded?

How should

global scale-up be

sequenced?

Product

Core success factors

Customers

Market assessment

Operating model

Supply chain

Funding options

Country vetting criteria

'Short-list' of countries

Launch sequencing

Potential impact

Implications for implementation

Scaling approach

• Our team has a collective three decades of experience managing Grand Challenge Programs.

• From our experience with innovators, we have learned how to best support innovators to reach scale and eventual impact. Most importantly, we have realized that this requires targeted support – far more than just funding.


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Our IDEA to IMPACT Series: Featuring critical scaling insights and user-friendly tools

The IDEA to IMPACT series shares guidance for scaling global health innovations to help practitioners accelerate impact through better coordination and earlier planning.

IDEA to IMPACT • Priority delivery-related

activities through the product development process

• Project management oversight

READY, SET, LAUNCH • Geographic prioritization • Strategy development • Implementation

planning and costing

PATHWAYS to SCALE • Business-model design • Partnership evaluation


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IDEA TO IMPACT illustrates priority activities with a focus on deliverability

CASE STUDIES:

• Eighteen case studies highlight specific priority activities in action by stage

• Illustrate practical lessons and important considerations

• Offer “tips from the experts” − Global health practitioners − Industry (med tech, pharma, CPG) − Academia

FRAMEWORK AND PRIORITY ACTIVITIES:

• Identifies and defines a set of priority activities by area of focus: − Market/User Understanding − Manufacturing/Distribution − Policy and Advocacy − Clinical and Regulatory − Project Management


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Thank you! www.usaid.gov/cii

Documents

Groundbreaking Devices to Save Lives at Birth · importance of investing in innovation at the Grand ... targeting preeclampsia Four new iron supplementation methods The Odon Device