Comprehensive Report of Unmet Clinical Needs in India
The BioDesign Process
Identify, Invent and Implement
It consists of 3 phases Identify, Invent and Implement. Of these 3 this Fellowship was focused only on the first. Over the course of the year over 30,000 person-hours were spent immersed in a tertiary healthcare setting as well as 10,000 person-hours in rural healthcare settings across India. The hundreds of needs were filtered with rigorous objectivity. This intense and iterative process involves exploring epidemiology, criticality, technical complexity, competitor analysis and regulatory obstacles. Ultimately we narrowed down to 10 needs in each therapy area most promising needs which have a major impact on health.
The Filtering Process
3 Levels of Filtering to reach the Top 10 Needs
The first level of filtering eliminated all those needs that were redundant, process related or that were pharmaceutical needs.
The second level of filtering used the information collected in the observation docket to whittle the list of needs down. This level of filtering focuses on the severity of the clinical need (in the perception of observers and clinicians) and the frequency of the problem during the clinical immersion. It was then validated through incidence and prevalence data via a detailed literature review experience.
The third level of filtering evaluated the technical complexity of the solutions available,
the regulatory landscape and the buyer environment.