Developing a Country-level Launch Plan for Global Health Innovations

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1 Developing a Country-level Launch Plan for Global Health Innovations Mini-U September 14,2017

2 USAID/CII: what we do IDEA to IMPACT Series Overview of workshop 1

3 Role Accelerate the development, introduction and scale up of priority global health interventions Approach Promote and reinforce innovative, business-minded approaches to address key bottlenecks in development, introduction and scale up What we do Catalyze Innovation Scale for Impact Identify Cutting-Edge Practices 2

4 USAID/CII: what we do IDEA to IMPACT Series Overview of workshop 3

5 Critical global health interventions historically seen late introduction, slow uptake, and low coverage FIGURE 1: YEARS TO SCALE-UP FIGURE 2: BENEFITS OF ACCELERATED UPTAKE Gaps in coverage fall disproportionately on the poor and amplify inequity Accelerating scale-up by one year can result in an increased reach of 1 of the target population Source: Bill & Melinda Gates Foundation, Dalberg Global Development Advisors, Boston Consulting Group

6 CII s IDEA to IMPACT Series looks to accelerate impact by helping practitioners plan for launch 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 The IDEA to IMPACT series shares guidance for scaling global health innovations to help practitioners accelerate impact through better coordination and earlier planning.

7 USAID/CII: what we do IDEA to IMPACT Series Pathways to Scale Ready, Set, Launch Overview of workshop 6

8 Pathways to Scale supports business-model design and partnership evaluation Pathways to Scale: Guide Introduces most commonly found models for scaling up global health innovations Features case studies that highlight pathways innovators have taken to scale up Toolkit Contains exercises, structured questions, and key considerations to identify suitable scaling model(s) Download at

9 Pathways to Scale: Scope and definitions Innovations in scope Medical device Medical diagnostic Delivery mechanism for vaccines, drugs, and nutrition Information and communication technology (ICT) for health Scale Maximizing level of usage among targeted end-user segments in target countries in order to significantly improve health outcomes Pathways to scale A series of choices regarding business model and partnership approach to access the appropriate resources and capabilities needed to achieve scale Scaling models Broad categories of pathways to scale, including: 1. Organic growth with selective out-sourcing 2. Multi-stakeholder partnership 3. Licensing out 4. Open licensing 5. Getting acquired

10 USAID/CII: what we do IDEA to IMPACT Series Pathways to Scale Ready, Set, Launch Overview of workshop 9

11 Ready, Set, Launch is designed to support targeted country selection and launch planning Ready, Set, Launch: Guide Ready, Set, Launch Framework Key Questions and Outputs Illustrative Exercises Real-World Vignettes and Case Studies Supplemental Toolkit Editable Tools and Templates (Illustrative and Blank) Country Launch Canvas Download at

12 Ready, Set, Launch is organized across a threestep framework 1 Ready? Select a Geography Prioritizes an appropriate country (or set of countries) for scale-up, based on the vision for the product and market realities at hand 2 Set Build a Strategy Assess the chosen market in depth in an effort to identify barriers to scale and address those barriers with thoughtfully designed interventions 3 Launch! Plan for Scale-Up Develop a detailed operational launch plan to guide day-to-day activities, set realistic uptake targets, and create a plan to monitor progress

13 The Supplemental Toolkit contains tools to structure, inspire, and guide the process SUPPLEMENTAL TOOLKIT: Spans all steps and provides editable versions of the tools and templates highlighted in the Guide Growing set of tools, including 1. Country Prioritization Matrix Tool 2. Country Prioritization Table Tool 3. Go/No-Go Checklist Tool 4. Stakeholder Mapping Tool 5. Market Assessment Tool 6. Barrier Assessment Tool 7. Market Segmentation Analysis Tool 8. Comparable Product Analysis Tool 9. Intervention Design Tool 10. Operational Launch Plan Tool 11. Cost Estimate Tool 12. Monitoring and Evaluation Tool 13. Goals and Targets Tool 14. Country Dashboard Tool 15. M&E Framework Dictionary Tool (Other additions welcome!) COUNTRY LAUNCH CANVAS: Provides a composite of all key elements of a scaling strategy in one place Living document to collect notes and learnings Can be continually revisited and updated to ensure all pieces of the plan align Not intended to replace more detailed launch planning documents or tools

14 USAID/CII: what we do IDEA to IMPACT Series Overview of workshop 13

15 Your turn! Apply the tools to your innovation (or one you re familiar with) 1 Pair up find another team member or two 2 Fill out the tools analyze how you would complete for your innovation (20 minutes total) Country prioritization tool Market assessment tool 3 Discuss in pairs: what introduction planning aspects are highlighted by each tool, what questions does it raise, what might be next steps to consider? (20 minutes total) 4 Share a few reflections with the largest group (10 minutes total)

16 Ready? Select a Geography Ready, Set, Launch STEP STEP 1.1 EXERCISE 1 Country Prioritization Matrix Tool Illustrative Evaluation of country need based on neonatal mortality rate (NMR) and home births across USAID s 24 priority countries Analysis is limited to a select number of countries based on priorities 10 Ethiopia 9 % of births that happen at home Yemen Bangladesh Madagascar Nigeria Haiti Kenya Nepal Tanzania Zambia India 2 Mozambique Liberia Ghana Mali Uganda Senegal Indonesia Rwanda Pakistan Short List of Countries Short list of countries is split according to qualitative preferences Larger market size countries: Pakistan Ethiopia Yemen Nigeria India Demonstration effect countries: Haiti Nepal Kenya Zambia 2 1 DRC Malawi NMR Analysis examines two quantifiable data points that are most relevant to the product 1

17 Ready? Select a Geography Ready, Set, Launch STEP STEP 1.1 EXERCISE 1 Country Prioritization Matrix Tool 1 Evaluation of country need based on _ and _ across _ priority countries Short List of Countries Data on y-axis Larger market size countries: Demonstration effect countries: x x x x x x x x x x Data on x-axis 2

18 Ready? Select a Geography Ready, Set, Launch STEP STEP 1.2 EXERCISE 1 Country Prioritization Table Tool Market size will apply a limiting factor to the total population impacted by the disease/health issue to estimate the addressable market Measures of feasibility blend qualitative and quantitative information Illustrative Track feasibility vs. market size in a scorecard to populate underlying data for bubble chart Market Size Feasibility 1 (Measures of feasibility blend qualitative and quantitative information) Country Burden Addressable market size Uptake of similar products Existing substitutes Product registered Product on EML or related list Align with national priorities In-country relationships Overall feasibility 2,3 Uganda 10m 2m 7 Bangladesh 3m 1m 4 Note: (1) Use Harvey Balls to track feasibility variables with the exception of overall feasibility. Other variables can be used as identified; (2) Roll up individual countries feasibility variables to score overall on a scale of 1 (lowest feasibility) to 10 (highest feasibility); (3) Create bubble chart based on these two metrics. Harvey Balls are visually easier to absorb but each rating can map back to a specific number Overall feasibility = (distribution mechanism) + (2 * payers) (other products) + (.5 * substitutes) Overall feasibility formula will use simple math and favorably weight inputs that are more credible or that are better indicators of success 3

19 Ready? Select a Geography Ready, Set, Launch STEP STEP 1.2 EXERCISE 1 Country Prioritization Table Tool 1 Market Size Feasibility 1 (Measures of feasibility blend qualitative and quantitative information) Country Burden Addressable market size Uptake of similar products Existing substitutes Product registered Product on EML or related list Align with national priorities In-country relationships Overall feasibility 2,3 Note: (1) Use Harvey Balls to track feasibility variables with the exception of overall feasibility. Other variables can be used as identified; (2) Roll up individual countries feasibility variables to score overall on a scale of 1 (lowest feasibility) to 10 (highest feasibility); (3) Create bubble chart based on these two metrics. Overall feasibility = (distribution mechanism) + (2 * payers) (other products) + (.5 * substitutes) 4

20 Set Build a Strategy Ready, Set, Launch STEP STEP 2.1 EXERCISE 2 Market Assessment Tool 2 Core Component MARKET AND USER MANUFACTURING AND DISTRIBUTION Key questions to ask a part of a market assessment Who is the target user? Who influences the target user? What is the point of care/point of access that is most relevant? What competing products exist? Will the product be supplied via local and/or global manufacturing? What are the target delivery channels to reach target users (e.g., public, private)? Are production economics in line with ability and willingness to pay? CLINICAL EVIDENCE AND REGULATORY What additional clinical evidence is needed? What does the regulatory approval process require? How long does the process take? POLICY, ADVOCACY, AND FINANCING COORDINATION Who is the target payer? What is their ability to pay? Willingness to pay? What organizations have been involved in or provided resources for scale-up activities for similar activities in the past? How much have scale-up interventions in the past cost? What is the process for including the product in appropriate protocols/lists (e.g., essential medicines list, national (protocol)? Who are ideal candidates to lead the launch and scale-up and/or serve the uptake coordinator role? What entities have owned/managed interventions in the past? How long did these efforts take to carry out? 5

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