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Human physiology of different races is basically the same. Diseases that affect our bodies also tend to behave similarly regardless of race. There are exceptions of course, but in general, this is the truth. This presents a unique opportunity for health tech startups. A technology for diagnosing or treating a disease will function around the world relatively unchanged. While the business models for bringing it to market vary by country, the technology itself will not. Building innovative technologies to solve deep problems in healthcare is difficult. It would be more difficult to have to build it differently in different countries. Fortunately, this is usually unnecessary.
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So how can health tech startups take advantage of this and take their technology global? For the purposes of this blog, I will limit myself to diagnostic technologies, but the general idea applies to other areas of healthcare as well.
The first step to gaining global recognition and access to multiple markets is conducting solid clinical studies. Independent research is the only way to prove that technology is safe to use and has the intended results. Many startups have failed (one of which was in the news again recently in a high-profile criminal trial) because it either didn’t do enough research or falsified its findings. bad idea! Publishing these studies in journals and conferences is also important for gaining recognition.
The next step in the process is regulatory certification. Unfortunately, this cannot be thought of after the technology has been built. Quality control processes need to be implemented from day one. The standard followed is ISO 13485. It ensures traceability of design decisions, implementation itself and quality testing. The process is neither difficult nor hinders rapid and agile development. But it is notoriously difficult to modify it in post. The sooner we start implementing the process, the better for future success.
Certifications from international regulatory bodies make the technology readily accepted globally. CE Mark (for the European Union) and US FDA (for the US) are the most sought after certifications. Both involve conducting rigorous clinical studies to prove their effectiveness, as well as a range of other tests, such as the technology’s safety and usability. Both are similar to trial by fire. If the technology passes these litmus papers, it’s truly world-class.
The CE mark allows access to the EU, and the US FDA to the US (which also happens to be the largest healthcare market in the world). Most other countries, with a few exceptions (such as China), accept at least one of these as sufficient proof of quality and efficacy. While registration is required in many countries, if you have at least one of these certifications, minimal paperwork is required and often no new clinical research is required.
Technologies from emerging economies such as India have clear advantages over those from advanced economies. Development costs are generally lower, as are production costs. This is obvious – it needs to sell in the often price-sensitive domestic market. A world-class product or technology built in such an environment has the potential to completely disrupt the market and displace leaders (often from advanced economies). This has happened many times in other industries, such as automotive. Now is the time to replicate this in healthcare. I think Indian startups are up to the challenge.
