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The chapter provides an overview of the various methods used today for identifying unmet needs and developing products. The healthcare domain is chosen as the medium for the description. The Biodesign process as developed at Stanford University is described, along with multiple off-shoots and adaptations of the process; specific to the adoption of the process in various countries is described. Success stories and shortcomings of the process with case studies are highlighted. The chapter analyzes other processes—examining the critical factors that lead to the success of these programs. It also analyzes through examples of medical device and medical technology developments, where lack of a structured process has led to ‘failures’ and the key learning from these case studies.


The key to MedTech entrepreneurship is to develop a product that addresses a clear unmet clinical need. Identifying and understanding an unmet need requires diligence; comprehensive clinical, technical, and market understanding. To address this need an appropriate solution concept must be formulated. The concept must take into account different parameters like regulatory considerations, intellectual property, business models and technical feasibility. The conceptualization process will culminate with the selection of the “strongest” solution concept. Transforming the chosen concept into a functional prototype and finally a usable product is the endpoint. Medical Device development has become increasingly complex with the constant influx of newer technologies and stricter regulatory and safety requirements. The final step in the developmental process is ensuring that the product meets all the necessary clinical, safety and user needs.

There is a difference between a “problem” and an “unmet need.” For example, the WHO states that 4 million newborn babies die each year. This is a problem. The unmet need here would be for a way to prevent or reduce the number of newborn deaths each year. However, being able to say that a mother’s lack of knowledge of newborn warming care is the primary cause of certain number of neonatal deaths due to hypothermia is a more specific and addressable issue. A method (program or tool) to teach pregnant women how to maintain the warm chain for newborns in order to reduce the incidence of mortality from environmentally induced hypothermia could be one of the solutions. Thus it is evident that there is a significant difference between a “problem” and an “unmet need” and a “solution.” By addressing real needs many problems can be solved or indeed prevented.

Perspective on Global Medical Technology Innovation—Globally, small private companies that have been funded through venture capital and research grants have led medical technology innovation. It is estimated that of the 10,000 unique product categories in MedTech, small private companies have developed two-thirds. Larger public companies have a very active licensing and company acquisition strategy to get access to these innovations and leverage their sales and marketing expertise to bring them to market.

This trend is particularly evident in the United States. The five years from 2007-2012 saw over 1,000 acquisitions of small private companies by global MedTech players. The industry is supported by a vibrant venture capital industry, which invests billions of dollars in startups that have identified an unmet need and are developing innovative products to meet the identified need. Technology incubators at universities, or private medical technology accelerators support many such startups. It is estimated that over a 1,000 such medical technology incubators and accelerators support companies each year. Israel has also developed a thriving medical technology industry over the last 20 years. This was achieved by a comprehensive government program to drive innovation and research by setting up 24 technology incubators to support startups in this space. These incubators were placed under private management and substantial early stage funding was made available for startups at these incubators through liberal grant funding, and technology venture capital funds. Today, Israel has a thriving MedTech sector, with over a 1,000 companies developing innovative products for the US and Western markets.

Now, Singapore is replicating the Israeli model through it’s A*STAR program to create a research-led MedTech industry. Technology incubation, supported by research grants, and ample high-risk venture capital for early stage, research-led companies, has been the model that has successfully created these global hubs of MedTech innovation. This model can be effectively deployed in India to create the world’s first ecosystem for affordable MedTech innovation in 5-7 years, and tap the emerging global opportunity in affordable medical technology. As described, the need to follow a process to identify unmet needs in medical technology innovation is self evident. But does everyone in the innovation ecosystem, at least for medical technology, follow a process? That yet remains to be seen.

Broadly, the different stages of an innovation process—either formal or informal, contains several common features looked at by entrepreneurs. More often than not, the innovation and entrepreneurial journey begins with an idea. This idea could be a result of the individual or group of individual’s experience of working in a particular industry or field; it could be the result of an observation made by an individual; or it could even be the result of an ‘aha’ moment where the individual discovers some hitherto undiscovered information.

What is the significance of getting an idea? Why is the idea given so much importance in the innovation process? The idea becomes important as it is addresses or seeks to address an underlying need. This underlying need might be based in reality and factually evident, it might be a perception of the innovator, or it might be something evident to only a few who understand the need’s intricacies and complexities. Nevertheless, the idea more often than not seeks to solve a problem that was faced by someone or a group of people.

By just having an idea is never enough is it? The innovator, to be called an innovator, would need to act on the idea—rather, build a solution that would solve this underlying problem. The solution would obviously depend on a whole host of factors—from what is the best technology to use in the solution, to the skills and ability of the innovator, to the resources available to develop this solution, to what is perceived to be required or demanded by the users of this solution—the list goes on. The next stage after identifying an idea, flushing out its details, and building a concept that could work, is to validate it. Often described in different ways—concept validation, proof of concept, etc. The goal is to get evidence of the working of the concept (now more than just an idea). This evidence could be external or internal. Innovators could get feedback from external users, buyers, technical experts, etc.—essentially stakeholders who might provide some feedback on the efficacy of such an idea. The concept could even be validated internally by the innovator, and by that, we mean through a set of laboratory tests designed to show the efficacy of the principle used to support the idea. Often called establishing the proof of concept in engineering terms, this could be done via setting up a test bed, or even using software to determine the workings of the concept in theory.

Validating the concept is not enough for the innovator, is it? The golden million dollar (or billion?) idea is still in a concept stage, though some degree of its efficacy has been established, it still remains as a theoretical phenomenon. The innovator’s job is not done yet. Developing the proof of concept to a prototype stage is always a challenge. There are multiple iterations of the prototype and different innovators use differing terminology to describe the various stages of their iterations. Looks-like prototype, alpha prototype, functional prototype, beta prototype, etc. are common ways to describe the stage of development to others—often these terms are used in different ways depending on the engineering background of the audience. However, the point remains that prototype is undergoing change and moving towards what would be essentially a final product. What started out as an idea and was serially changed in aspect, content and shape over time, is heading towards a final product. The essential aspect of this metamorphosis is technology development.

A final product needs to meet certain criteria before it is accepted in the market. Often these criteria vary depending on the type of solution—from regulatory certifications to intellectual property rights. These criteria are important to not only drive adoption by buyers and scale the business, but also to legitimately sell the product in the first place. Regulatory approval, depending on the geography, is essential to be able to market and sell the final product. Especially for medical devices, the safety of the patient is paramount. This is echoed by regulatory bodies, most notably the US FDA and European CE, which sets standards and evaluates the product for use in the clinical setting. In most countries, an innovator (now an entrepreneur), would need the approval of either these regulatory agencies, or the relevant agency of the country to be able to get the final product used in the clinical setting.

Another important aspect in the innovator’s journey is to deal with the intellectual property rights and implications of the novel solution being built. Innovators often struggle with questions such as—is what we are doing considered novel by law? Can we file a patent for this? Do we want to file a patent for this? Where do we file a patent? How do we go about it? Is it expensive? Where does the patent apply? Do we have patent rights internationally? The answers to these questions obviously depend on the specific situation that the innovator is in and the plan that the innovator has going forward.

With the final product developed, with regulatory approval considered, with intellectual property implications thought of, is it enough to move forward to the next stage? Somewhere in this development process, the business aspect has to be evaluated. Firstly, at the initial idea stage—does this idea even have a market potential? Does this new technology solution make business sense? Answering some of those questions—either externally or internally, gives the innovator some confidence to move ahead. Given that there is market potential for this new solution, what is the best way to go about it? What is business model? How big is the market in monetary terms? In number of units and buyers? And what strategy does one use to go about ensuring that this idea, nay final product, sees the light of day and is actually used to solve someone’s problem?

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