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<h2 class="hd hd-2 unit-title">Introduction</h2>
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<h4>Sustainability and Viability</h4>
<p>Even in the second decade of the twenty-first century, the unmet health needs of emerging markets remain tremendous. Complementary to efforts to improve health worker competencies and health systems capacities, medical technology can result in an improved standard of care for poorer populations across a host of developing world diseases.</p>
<p>Unfortunately, the typical means of introducing medical technology to the developing world is to take developed world technology, strip the “bells and whistles, ” and provide a cheaper, less feature-rich solution for the emerging market. We argue this approach is mistaken. Patient needs and cultural paradigms of medical care are different in emerging markets—from location and accessibility of health services, to health worker–patient interactions, expectations of patients, and price points that patients and their families can afford. Technology designed for the hospital or clinic may be of little use on rural roads and distant homesteads.</p>
<p>We suggest a more effective approach is to conduct localized development, where a medical service or device is designed from scratch in situ with the express purpose of addressing the needs of the local population, who may indeed contribute to the financing and delivery of the technology. Vital to success are effective organization and financing of the enterprise (particularly the social enterprise model, though these recommendations apply to for-profit ventures too), as well as successful commercialization of the medical technology. These topics are covered in detail below.</p>
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<h4 style="font-size: 16px;">Defining an Organizational Approach</h4>
<p style="font-size: 16px;">Successful technologic launches are driven by effective organizations—though an organization will grow and evolve over time to adapt to changing conditions or internal stakeholders, a clear mission and vision for success at the outset will give the new venture a platform from which to base all its future efforts. Social business models vary greatly, and careful consideration should be given to which model to pursue. One should choose the social enterprise route (which will be the focus of this section) only after conducting an analysis of the available options and determining a best fit alignment with one’s motivation, commitment, and definition of a satisfactory outcome. Simply put, founding a social enterprise may or may not be the most expeditious way to achieve the desired goal. Alternative models include:</p>
<ul>
<li>Starting a profitable business entity, selling either a health care product or service, which serve both a social and financial purpose</li>
<li>Innovating a new open-source digital tool or hardware product, making the technology free to the global public to use and build from</li>
<li>Conducting research to validate a new concept and sharing the learning among health practitioners and researchers</li>
<li>Developing a methodology or product, and then merging this new innovation into the operations of an existing entity</li>
<li>Starting a grant-receiving nonprofit organization.</li>
</ul>
<p style="font-size: 16px;">Each model carries a different balance of founder commitment; need for external validation and buy-in; funding requirements; administrative burdens; timelines for creation, and for return on investment (however defined); and control over outcomes. Successful products and projects have been launched out of all these models. Taking the time to establish the right fit will preserve motivation and conserve resources down the road for all involved.</p>
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<input type="radio" name="input_3599d665f9824d7b8df593b50c48d4ff_2_1" id="input_3599d665f9824d7b8df593b50c48d4ff_2_1_choice_1" class="field-input input-radio" value="choice_1"/><label id="3599d665f9824d7b8df593b50c48d4ff_2_1-choice_1-label" for="input_3599d665f9824d7b8df593b50c48d4ff_2_1_choice_1" class="response-label field-label label-inline" aria-describedby="status_3599d665f9824d7b8df593b50c48d4ff_2_1"> Innovate solutions customized for the environment and needs by working with local partners
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<h2 class="hd hd-2 unit-title">Determining Viability</h2>
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<h4>Commitment</h4>
<p>Committing to an open-ended, complex health care product requires reflection. The great majority of developing-world health product companies require years of commitment prior to reaching financial sustainability. At early stages, grant funding often provides financial backbone for the organization, even for the social business. Obtaining such funding and further investments can be frustrating, and requires both determination and perseverance.</p>
<p>This reality requires a more flexible definition of success than just the balance sheet, particularly in the early years of the enterprise. It requires a clear sense of motivations, as the stresses of creating a social enterprise are commensurate to founding a traditional for-profit firm, but without promise of large payouts. Evaluate regularly: is the potential for saving lives and health system resources sufficient to take this project on? Both vision and measured outcomes must sustain the motivation to continue the longer journey.</p>
<p>Time commitment is crucial. The timeline to achieve reasonable success in a developing world–focused health care start-up often stretches to many years. International health initiatives generally require relocation or frequent overseas travel for the life of one’s involvement in the project. Finally, a very competitive capital-raising environment and low returns in this sector lead to a slower scaling rate, and hence require longer commitments from both founders and investors before seeing return on investment.</p>
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<h4>Viability</h4>
<p>Once the team is committed for the foreseeable future, evaluate whether this product is viable as a sustainable business. A complete analysis should include the following.</p>
<h4>Product</h4>
<p>Is this product capable of being built within the specifications needed for deployment locally? If the product involves hardware, what is the supply chain? If it is a digital product, is it appropriate given the communications and technology infrastructures as well as human capacity available at intended deployment sites?</p>
<h4>Market</h4>
<p>Field research up front increases the odds of successfully entering a new market with a new product. It is crucial to have a good grasp of customer purchasing and use behaviors, as well as the requirements to make a service or product market-ready.</p>
<p>In the medical sector, there are significant hurdles: business and medical industry regulations; customs importation; and entrenched health care systems that vary regionally. How does this new product enhance or threaten established stakeholders? Who are the natural allies of the product? Seek strong evidence for the marketability of your good or service, including similar examples of successful enterprises in the same field and market.</p>
<p>When possible, it is best to hone concepts over multiple pilots before building a company around promising ideas. That learning will yield significant insights regarding viability of the product, potential for impact, routes to market, and team composition and commitment.</p>
<h4>Business Plan</h4>
<p>Raising any form of capital is highly competitive and requires a strong business plan. Often, founding teams are unfamiliar at the outset with the challenges of doing business in emerging and developing-world market environments.</p>
<p>Building a business plan based on remote assumptions and developed-country business templates may secure initial funding. However, doing the field research up front to assess the true viability of the business provides a more accurate picture. Research on the ground at targeted pilot sites, as well as reviewing relevant case studies, better justifies the financial projections and capital-raising decisions, and aligns all partners’ expectations for impact, scaling, and return on investment.</p>
<h4>Team</h4>
<p>Developing a product is but one of the many business challenges involved in starting a new enterprise. The same enthusiasm for research and development (R&D) problem solving must carry over to all facets of running the company. Does the team have the executive, administrative, legal, financial, operations, marketing, sales, and related skills and passions required to create a complete business? Success will depend on team strength all around.</p>
<p>Teams also grow and change over a company’s life cycle. It is healthy to discuss with cofounders from the outset long-term goals for management transition. Transitions are often triggered by financial needs—both personal and organizational, as well as by investor requirements for a more professional management team. If the company sells a physical product, how will it transition from small-batch manufacture to a larger scale or outsourced suppliers?</p>
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<h2 class="hd hd-2 unit-title">Financing</h2>
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<h4>Do I Need Capital?</h4>
<p>This answer to this question depends on the stage of development a business is in. We drew upon a framework that was first published in the report, 'From Blueprint to Scale - the case for philanthropy in impact investing', to classify the evolution of a business into four stages - Blueprint, Validate, Prepare, and Scale.</p>
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<p style="text-rendering: optimizeLegibility; margin-top: 20px; margin-right: 0px; margin-left: 0px; padding: 0px; border: 0px; outline: 0px; font-variant-numeric: inherit; font-stretch: inherit; font-size: 16px; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; vertical-align: baseline;">Jocelyn Ling<br />Principal, Incandescent</p>
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<h3 class="hd hd-2">Do I Need Capital?</h3>
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<h3>Steps</h3>
<h4>Blueprint:</h4>
<p>Start from the beginning and understand what is the capital and correlating milestones you need to hit before you move on to the next phases.</p>
<h4>Validate:</h4>
<p>Bring your idea to market. Stress test your assumptions. Do you really understand your market? You need to figure out the right and wrong questions to ask.</p>
<h4>Prepare and Scale:</h4>
<p>This is when you need a large amount of capital. Do I really want to scale? If I do, what are the systems or chains or individuals I need to reach out to?You by now have an organizational chart, human resources, distribution network to target; and you need to solidify it.</p>
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<h4>How Do I Get Capital?</h4>
<p>This questions will be broken down into 2 components: type of capital and pitching.</p>
<h4>Type of Capital</h4>
<p>There are many options along the spectrum of financing, they all have advantages and disadvantages. Typical example is you find an investor who loans you money at an interest rate, you pay it back. Another example is equity funding, your company is valued and then the equity you are willing to give is correlated with that value to decide how much money you will get.</p>
<h4>Pitching:</h4>
<ul>
<li>Understand your audience and the financing climate.</li>
<li>Create a tension between the problem and the solution.</li>
<li>Open with your investment thesis</li>
<li>Stir into your investors objectives</li>
<li>Show your milestones and successes - Pitch by analogy</li>
<li>Anchor your idea on top of an already successful business</li>
<li>Concept driven vs data driven</li>
<li>Showing maneuverability: clear vision, how do you maneuver around obstacles to get from A to B</li>
<li>If it doesn't make any sense, put yourself in the investors shoes!</li>
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<h3 class="hd hd-2">Types of Capital</h3>
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<h3 class="hd hd-2">Pitching</h3>
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<h3 class="hd hd-2">Where do I find capital?</h3>
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Unit Exercise
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<div class="wrapper-problem-response" tabindex="-1" aria-label="Question 1" role="group"><p>You have a new innovation you want to bring, but need funding to build and deploy.</p>
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<legend id="29d76a6a3fa64f26a295c82f9ad34800_2_1-legend" class="response-fieldset-legend field-group-hd">What are some of your possible funding sources? Choose all that apply.</legend>
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<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_1" class="field-input input-checkbox" value="choice_1"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_1-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_1" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Apply for a grant from a government
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<div class="field">
<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_2" class="field-input input-checkbox" value="choice_2"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_2-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_2" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Apply for a grant from a foundation
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<div class="field">
<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_3" class="field-input input-checkbox" value="choice_3"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_3-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_3" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Raise capital investment from an investor
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<div class="field">
<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_4" class="field-input input-checkbox" value="choice_4"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_4-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_4" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Raise debt from a loan
</label>
</div>
<div class="field">
<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_5" class="field-input input-checkbox" value="choice_5"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_5-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_5" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Seek charitable donations
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</div>
<div class="field">
<input type="checkbox" name="input_29d76a6a3fa64f26a295c82f9ad34800_2_1[]" id="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_6" class="field-input input-checkbox" value="choice_6"/><label id="29d76a6a3fa64f26a295c82f9ad34800_2_1-choice_6-label" for="input_29d76a6a3fa64f26a295c82f9ad34800_2_1_choice_6" class="response-label field-label label-inline" aria-describedby="status_29d76a6a3fa64f26a295c82f9ad34800_2_1"> Steal from a bank
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<h2 class="hd hd-2 unit-title">Commercialization</h2>
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<h4>Commercialization</h4>
<p>The R&D process is extremely important when creating a device to treat an unmet medical need. Equally important is distribution—getting the medical technology in the hands of as many of the right people as possible. Although there are nonprofit ventures that do an effective job creating and distributing medical innovations, in this chapter we assume a for-profit social enterprise. A for-profit social enterprise provides the potential benefits of organic scalability, sustainability, and operational efficiencies, while still maintaining a focus on social impact instead of maximizing profits. We break down commercialization in a for-profit institution into three key components—sales, marketing, and service.</p>
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<h4>Sales</h4>
<p>The art of sales is a unique craft whether one is a sales executive for a Fortune 500 company or a street peddler in a developing country. The fundamentals of sales—trust, credibility, dependability, and asking for business—are true across all verticals. However, there are some key strategic and tactical items that have unique caveats when trying to sell a medical technology in the developing world.</p>
<p>First, and similar to a developed-world business, the early stage venture needs to evaluate different sales channels for its new technology. The key high-level question to ask is: do you use direct channels with your own sales team, or do you leverage indirect channels, such as corporate partnerships or local distributors? Both direct and indirect channels have their own benefits and disadvantages, and may be utilized variably depending on the developmental stage of your enterprise. Within indirect channels, for the urban distribution of medical devices, partnering with a large multinational to leverage their sale and marketing infrastructure may be worth considering. For indirect rural channels, a venture may explore working with local distributors. Managing local distributors and making sure they can maintain their sales volumes can be a challenge, and is an area a venture would need local expertise to manage. Indirect channels can provide the reach, scale, and financial sustainability to cover broad geographical areas, such as India, Africa, or Latin America. Embarking on creating direct-distribution channels needing an internal sales force can be a costly proposition for an early stage venture. The strong benefit of this approach, however, is the ability to control every aspect of the sales process in the critical early days and generate internal knowledge of how to best market and service your product in the context of a developing nation. Many ventures find the right blend of direct distribution channels in the early periods and then transition to indirect channels later.</p>
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<h4>Sales Channels</h4>
<p><img src="/assets/courseware/v1/6f97ad0447370b4a0bd75963d57d080a/asset-v1:MITx+HST.936x+1T2019+type@asset+block/figure_23_02.png" alt="" type="saveimage" target="[object Object]" preventdefault="function (){r.isDefaultPrevented=n}" stoppropagation="function (){r.isPropagationStopped=n}" stopimmediatepropagation="function (){r.isImmediatePropagationStopped=n}" isdefaultprevented="function t(){return!1}" ispropagationstopped="function t(){return!1}" isimmediatepropagationstopped="function t(){return!1}" width="660" height="402" /></p>
<p>Assuming one begins with a direct sales channel, the next important step is creating the right sales team—thus targeting the correct sales representative profile for your product and your environment. This involves matching sales rep capabilities to the clinical and mechanical complexity of your medical device, teaching them the intricacies of the local sales cycles and purchasing process if not already known, and offering them appropriate compensation for the local environment (salary and commission). For example, for a simple-to-use medical device that could be sold directly to patients, working with local village entrepreneurs might be the right sales team profile. For a more complex device that has a more complicated sales cycle via a physician or hospital system, internally recruited and trained sales representatives may be needed.</p>
<p></p>
<p>Finally, one must define the customer interaction. Customer interactions for medical technologies in emerging markets can be very different than in the developed world. The value proposition must be clearly articulated to the potential customer (who likely has significant resource constraints on his or her ability to make new purchases of novel devices or services); crisp messaging for the sales rep to use with the potential customer must be provided and practiced. The organization should create best-in-class sales tools for the sales team, including product and clinical collateral, and provide comprehensive training on how to best use them with customers. Also, the venture should provide training on how to give product demonstrations. Overall, the organization’s leadership needs to understand their customer through the lens of a specific emerging market, determine what they would like the interaction to entail, and then provide training to allow the sales team to provide a consistent message to customers.</p>
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<legend id="14984b80637b4d9e89f5b2b5a13d0ffa_2_1-legend" class="response-fieldset-legend field-group-hd">Which of the following is a significant reason you would choose an indirect sales channel over a direct sales model?</legend>
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<h2 class="hd hd-2 unit-title">Marketing & Service</h2>
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<h4>Marketing</h4>
<p>There are many aspects of marketing that also need special focus when trying to commercialize a medical device or service in the developing world. Three key areas that need particular attention are market assessment, developing local physician opinion leaders, and creating lean start-up experiments to find effective marketing programs.</p>
<p>Market assessment can be complicated in the developing world. It is important to understand the local market, segment the market into different types of customers, and then target customer segments that make strategic sense for financial and social mission purposes. Unlike developed countries, where health market information can be found in expensive research reports, these reports either do not exist for emerging markets or are (often) grossly inaccurate. Often the venture needs to create its own market mapping. For example, a venture can have its sales reps profile the different types of local hospitals by revenue, volume, or acuity tiers, as well as the specific names of target physicians within key medical specialties as they enter new towns. The marketing team can use this data to strategically direct the sales team on market leaders or other vital opinion leaders.</p>
<p>Developing relationships with physician key opinion leaders (KOL) in the specialty areas of their medical device is important. For example, if the medical device is for the field of pediatrics, it is important to build relationships with local, regional, and national pediatric thought leaders. Building these relationships may have many benefits, including those following.</p>
<ol>
<li>Drive adoption with mass physician populations. Physicians are inclined to follow thought leaders whose clinical opinion they respect, which has a strong trickle-down effect in terms of product adoption.</li>
<li>Product development. KOLs can provide expert insights into ongoing R&D, from current product iterations to next-generation product development.</li>
<li>Governmental influence. As health care regulations for every country are constantly evolving, national KOLs can provide a strong voice to provide a better regulatory landscape for your device. For example, if a venture is trying to get their medical device implemented at every community health post, KOLs who support your medical device can provide their clinical opinions to the right medical governmental bodies to support widespread adoption.</li>
</ol>
<p>Finally, marketing organizations can leverage lean start-up methodologies to determine which marketing programs have the most effective return. Running a series of lean start-up experiments can help find the best programs to encourage technological adoption. For example, assume a venture wanted to run a “text message” marketing campaign, whereby target physicians would be sent informational texts about the product before the sales rep would call on them. The venture could run an experiment to see if the region with the “text message” campaign yielded higher product adoption rates than areas that did not employ the campaign. Through a series of experiments, one can find out which marketing campaigns are most effective for a particular device in a particular distribution or with a specific population.</p>
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<h4>Service</h4>
<p>Providing best-in-class service for your medical product is critical in creating product loyalists and champions. Many ventures will cease interaction with the physician or patient once the medical device is sold. In many of these cases, physicians, staff, and patients will not use the device properly or even stop using the device as issues crop up. Ongoing service and support is required for customers, especially soon after the sale. After the product is delivered, sales reps or other field personal from the company should do regular check-ins to ensure proper device usage by the physician, staff, and patients. Often times, ventures only focus on physician education and overlook the importance of the rest of the health care staff. This is not a wise practice, since it is often the surrounding health care staff who actually use the product and end-up having a strong voice in product adoption.</p>
<p>Furthermore, physicians and allied health care professionals all over the world are usually inundated with different clinical, administrative, and social responsibilities, and ongoing support of a product soon after the sale keeps your product top of mind with the customer.</p>
<p><img src="/assets/courseware/v1/278a196eccbf35d0f62de3ea9bb212fd/asset-v1:MITx+HST.936x+1T2019+type@asset+block/figure_23_03.png" alt="" type="saveimage" target="[object Object]" preventdefault="function (){r.isDefaultPrevented=n}" stoppropagation="function (){r.isPropagationStopped=n}" stopimmediatepropagation="function (){r.isImmediatePropagationStopped=n}" isdefaultprevented="function t(){return!1}" ispropagationstopped="function t(){return!1}" isimmediatepropagationstopped="function t(){return!1}" width="391" height="399" /></p>
<p>By providing best-in-class service, a venture greatly increases the opportunity to create product loyalists, which eventually leads to product champions. This becomes invaluable, as it is the basis for referral business. Product champions are likely to tell their other physician or patient counterparts about the value of the medical device, which is the strongest product-adoption mechanism possible.</p>
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<h4>Take Home Messages</h4>
<p>While any global health innovation should be linked to clinical outcomes- or clinical quality- improvement, its implementation should also be sustainable to have a widespread impact. To achieve success in launching a new device or service, innovators need to carefully consider the organizational structure and financing of their venture. Subsequent commercialization should be done prudently, in a stepwise manner, with continuing feedback between the enterprise and its customers and other stakeholders. These tasks can be challenging in the global health setting, but are feasible with clear planning, wise investment, and personal fortitude.</p>
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<p style="text-rendering: optimizeLegibility; margin-top: 20px; margin-right: 0px; margin-left: 0px; padding: 0px; border: 0px; outline: 0px; font-variant-numeric: inherit; font-stretch: inherit; font-size: 16px; font-family: 'Open Sans', 'Helvetica Neue', Helvetica, Arial, sans-serif; vertical-align: baseline;">Jocelyn Ling<br />Principal, Incandescent </p>
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<h3 class="hd hd-2">Take-Home Messages</h3>
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