Moving Global Health Technologies to Impact: Examples from MNH, HIV, and Ebola

USAID Mini-University

Brinnon Garrett Mandel, MPH, MBA

Tigistu Adamu, MD, MPH

Deepti Tanuku, MA, MBA

March 2, 2015

2

JHPIEGO- AFFILIATE OF JOHNS HOPKINS UNIVERSITY

Founded in 1973Working in over 35 countries,

2000 people globallyJhpiego Innovations:

Programmatic and service delivery innovations

Small portfolio of technologies we are developing

Collaborating and partnering to advance technologies developed by others

To understand the pathway to impact for global health technology innovations- emerging or existing

To learn the value of critical success factors through select case studies

LEARNING OBJECTIVES

Brinnon Mandel, MPH, MBA Director of Innovations Program, Jhpiego

Tigistu Adamu, MD, MPH, Associate Medical Director, Jhpiego

Deepti Tanuku, MA, MPH Program Director, Accelovate Program

(USAID)

PANEL INTRODUCTIONS

DevicesDrugsDiagnosticsVaccinesConsumer ProductsmHealth or eHealth SolutionsTraining Solutions

WHAT ARE GLOBAL HEALTH TECHNOLOGIES?

Ten Years Ago

Past Five Years

Some Barriers to Entry Have

Lowered

Open Innovation

platforms and funding

opportunities that draw wider

and more diverse

participation

Developments in science and

technology

Broader interest in global health with new actors

Others Have Not

Messiness of Sustainability and Scale-Up

Sustained financing

through the pathway

Complexity of regulatory and

research requirements

Market dynamics:

viable commercial

product aligned with global health need

From: USAID CII “Idea to Impact: A Guide to Introduction and Scale of Global Health Innovations

From: USAID CII “Idea to Impact: A Guide to Introduction and Scale of Global Health Innovations

Development

Understand the market, develop solutions, test and evaluate,

plan for “launch”

WHAT IS THE PATHWAY FROM AN IDEA TO IMPACT

Assessment

Define and characterize the

problem and identify solution

requirements

Introduction

Program integration,

supply chain, manufacturing

and distribution, approvals

Scale

Institutionalize, sustained investment,

maintenance

Common Challenges and Success FactorsClear definition of the right solution for that problemUnderstanding the market factors that influence development, adoption, and scaleHaving the right research and stakeholders to introduce productIdentifying regulatory and registration requirements at global and national levelsFinding right partners along and throughout the pathway

Development

CASE STUDIES

Assessment

Introduction

Scale

Why Problem Definition Matters: Developing an

Improved PPE Suit

Why Program Implementation and Introduction Matters:

PrePex Device

Why Markets Matter: Scaled use of life-saving MNH

Commodities

Why Partnerships Matter: MamaU, ePartogram

Brinnon Mandel

WHY PROBLEM DEFINITION AND

SOLUTION REQUIREMENTS DO

MATTER: DEVELOPING AN IMPROVED

PPE FOR EBOLACase Study #1

Assessment Development

THE “PROBLEM”

Challenges to current personal protective equipment (PPE) used by healthcare workers treating Ebola: 1. Most of the exposures occurred at the time of PPE removal2. Many HCWs were not following the appropriate guidelines for

using PPE3. The high temperatures and humidity in Liberia, Guinea and

Sierra Leone are such that it is difficult for any HCW to be in the PPE for more than 60-90 minutes.

DIVERSITY OF PERSPECTIVES IN DEFINING PROBLEM AND SOLUTION

REQUIREMENTS

JHU-CBID, Jhpiego, and Clinvue hosted 3 day event with JHU Schools, the Applied Physics Laboratory, the Maryland Institute College of Art, private sector partners, as well as a seamstress, midwife, architect, and robotics expert

65 participants produced extremely promising and innovative concepts (100) that were refi ned and December 2014 USAID Announced that JHU-CBID and Jhpiego were one of several recipients

Responding to USAID Fighting Ebola Grand Challenge, October 2014

THE SOLUTION (IN DEVELOPMENT)

Tigistu Adamu

WHY RESEARCH AND PROGRAM

INTEGRATION MATTER: PREPEX FOR VMMC

Case Study #2

Development Introduction

SEEK TO IDENTIFY DEVICES THAT:

• Make adult male circumcision procedure safer, easier and quicker than current methods;

• Facilitate more rapid healing and/or entail less risk of HIV transmission in the immediate post-operative period;

• May be used safely by health-care providers with a shorter period of training (mid-level providers);

• Are more cost-effective for male circumcision scale-up than standard surgical methods.Courtesy: WHO

Scale-up of voluntary medical male circumcision program and coverage in 14 priority countries:

growth scenarios, 2008−2016.

Sgaier SK, Reed JB, Thomas A, Njeuhmeli E (2014) Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs. PLoS Med 11(5): e1001641. doi:10.1371/journal.pmed.1001641http://127.0.0.1:8081/ploscollections/article?id=info:doi/10.1371/journal.pmed.1001641

BACKGROUND

Initial devices consultation, 2009 Technical Advisory Group formed Dec

2010met July 2011 and January 2012

Formal prequalification programme established, September 2011

STUDY TYPES AND REQUIREMENTS

Initial safety and effi cacy clinical studies involving skilled surgeons in the country of origin or manufacture and the country of intended use

Comparative clinical studies involving skilled surgeons in the country of intended use

Acceptability studies in the country of intended final use

Field studies involving trained clinical personnel in a low-resource setting, reflecting anticipated conditions of intended use

Minimum for WHO global consideration: at least 2

comparative and 2 field studies in 2 diff erent settings

/countries

PREPEX STUDIES REVIEWED

Study (type) Location Clients Type of providers

Safety Study Rwanda 50 healthy HIV-negative men

Physicians and nurses

Randomized Comparison with Surgery

Rwanda 144 PrePex, 73 surgery Physicians and nurses

Pilot Study Rwanda 49 healthy HIV-negative men age 21–54 years

Nurses

Field Study Rwanda 666 generally healthy men [5 HIV-positive]

Lower cadre nurses

Safety Study Zimbabwe 53 HIV-negative men Physicians and nurse assistants

RandomizedComparison with Surgery

Zimbabwe 240 HIV-negative men As above

Field Study Zimbabwe 641 HIV-negative men Nurses with physician back-up support

Field Study Uganda (IHK) 634 healthy men Surgeons, medical officers, clinical officers and nurses

Field Study Uganda (Rakai)

187 HIV-negative men Not stated

THE WHO PQ PROGRAMME : PROCESS

Manufacturer submits application

Accepted

Rejected Application is screened

Manufacturer signs Letter of Agreement and submits

product dossier

Manufacturing Site Inspection

Meets WHO requirements

Product is prequalified

Post-market surveillance

Figure 1: Overview of the prequalification of Male Circumcision Devices process

Does not meet WHO

requirements

Does not meet WHO

requirements

Meets WHO requirements

Dossier Review Including Clinical Evidence

Two Years Application: 2011PreQual: 2013 Integration to Routine Service : 2014

INTEGRATING PREPEX IN ROUTINE SERVICES : RWANDA

24

2015

Deepti Tanuku

WHY MARKETS REALLY DO MATTER :

SCALED USE OF MNHH COMMODITIES

Case Study #3

Introduction Scale

27

IF YOU WANT TO GO FROM INTRODUCTION TO SCALED USE, MARKETS MATTER

Assessment

Development Introduction Scaled Use

Problem Identification and

Priority Setting

Applied research to fill implementation knowledge gaps

Catalytic activity to facilitate adoption of

product

Country-level program/ policy rollout/ diffusion

into sustained use

Fig 1: Accelerating the Path to Introduction and Use

1

From identifying a problem to

developing an appropriate

solution

2 3

From developing a solution to

planning for its introduction into the “real world”

From planned product introduction to its full integration

into policies and programs

Source: USAID-Accelovate Program, 2014

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IF YOU WANT TO GO FROM INTRODUCTION TO SCALED USE, MARKETS MATTER

Assessment

Development Introduction Scaled Use

Problem Identification and

Priority Setting

Applied research to fill implementation knowledge gaps

Catalytic activity to facilitate adoption of

product

Country-level program/ policy rollout/ diffusion

into sustained use

Fig 1: Accelerating the Path to Introduction and Use

1

From identifying a problem to

developing an appropriate

solution

2 3

From developing a solution to

planning for its introduction into the “real world”

From planned product introduction to its full integration

into policies and programs

Source: USAID-Accelovate Program, 2014

FAILURE TO ADDRESS MARKET REALITIES DERAILS INNOVATIONS

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FAILURE TO ADDRESS MARKET REALITIES DERAILS INNOVATIONS

MARKET BARRIERS ARE COMPLICATING SCALED USE OF MgSO4

31http://reprolineplus.org/misoprostol-case

FAILURE TO ADDRESS MARKET REALITIES DERAILS INNOVATIONS

* Top 3 MgSO4 Presentations Considered

Most Practical

5g in 10 mL (52%)4g in 20 mL (28%)

10g in 25 mL (16%)

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FURTHER INVESTMENT IN MH MARKETS WILL HELP SCALED USE OF MgSO4

http://reprolineplus.org/RH-assessments

34

FURTHER INVESTMENT IN MH MARKETS WILL HELP SCALED USE OF MgSO4

http://reprolineplus.org/RH-assessments

Brinnon Mandel

WHY PARTNERSHIPS MATTER :

MAMA U AND EPARTOGRAMCase Study #4

Introduction

ScaleDevelopme

ntAssessme

nt

Jhpiego partnered with Laerdal Global Health to develop Mama-U, an anatomical model for PPIUD insertion training

We knew of challenges with the current model, but didn’t have the capacity to improve it

Working closely and with numerous iterations of the design

Product was ready and being evaluated within 1-year

MAMA-U: A PPIUCD TRAINING SOLUTION

MamaU: a Postpartum ICUD Insertion Training Solution

MAMA-U, ON HER WAY TO SCALE!

EPARTOGRAM

Jhpiego’s ePartogram is a tool that will be used by health care providers in LMIC to manage labor and guide decision-making by helping to detect complications during labor and delivery, which will reduce neonatal and maternal mortality and morbidity.

Developed early concepts with

Sought design and user interface with

Working with ICT4D and Platform Partner

Developing path to scale strategy with support from

PARTNERS ON EPARTOGRAM

Product Development Partnerships (PDPs) International AIDS Vaccine Initiative Aeras Global TB Vaccine Foundation Drugs for Neglected Diseases Initiative Foundation for Innovative Diagnostics Global Alliance for TB Drug Development International Partnership for Microbicides Medicines for Malaria Venture MISSING: for maternal and newborn health

Chlorhexadine Working Group, led by PATH as an international collaboration of organizations to advance

use of 7.1% chlorhexadine digluconate for umbilical cord care Diversity of partners addressed all critical elements in

pathway: product, programs, research, advocacy, manufacturing, regulatory, etc

OTHER PARTNERSHIP EXAMPLES: ALL SIZES AND SHAPES

LessonsSO WHAT?

Implementing Community

Clinical Experts

Regulatory Bodies

Users

Commercial Partners

“Choosers” (payors)

LESSON #2: IT IS REALLY NOT LINEAR!

Clinical and Technical

Performance

Programmatic

Effectiveness

Market viability

Strong Need

Definition to Inform

Solution

All along the pathway these four major areas have to be considered, re-evaluated, and show proof of concept

Saving Lives at Birth: A Grand Challenge for Development

Round 5 Announced a few weeks ago

Community of Innovators from past 4 years

Great resources and lessons- focus on scalability and addressing bottlenecks

www.savinglivesatbirth.net

Center for Accelerating Innovation and Impact- Warm off the Press

SOME EXCITING RESOURCES AND OPPORTUNITIES

“It takes a system to save a life”

- Tore Laerdal, Laerdal Global Health