We were attending function related to the Start-up Ecosystem in India and the discussion turned to Factors holding back scale and success of health care start-up in India. Following are a few tips that could help focus on the solutions related to regulatory:-
- Manage the regulatory challenges at the design stage – some of the projects lost priority as the present regulatory challenges will delay the project launch. Apart from regulatory one should also look at the local government focus on the social and economic issues like plastic waste and waste of electrical and electronics equipment in case of a single use device.
- Product design to address regulatory challenges – Most of the regulatory challenges can be addressed at the design stage. Regulatory challenges are more of opportunities to build a product pipeline. Cleaning and Sterilization cost is high for developed countries whereas developing countries are more inclined to reusing the products. There are fixed components and variable components that when organized can build into the products pipeline.
- Technology mapping to regulatory challenges – It is critical to ensure that you understand the technology challenges and map the timelines as per the implementation process. In one of the products that we are working on the capacitance sensors is a promising approach but the ultrasonic sensors are much widely accepted. The design is made by exploring the technologies finding unique case scenarios, design product to accommodate both the sensors and create a product pipeline focused on multiple applications.
- Approach for substantial Equivalence – Following the least cumbersome approach needs to be explored simultaneously. Partnering with manufacturers and importers with similar product lines will help speed the access and penetration to the market. We suggest partnering with people who have already been in the market with similar products to gain access to the market and distribution network.
Creating new products in a regulated market is always challenging.