Puneeth K S
Centre for Product Design and Manufacturing, Indian Institute of Science, Bengaluru
The market in India for Medical Devices are highly dependent on imports than indigenous manufacturing and export due to various reasons. Also the indigenous manufacturing is highly dependent on MSMEs which are not technologically advanced due to various constraints. To understand this situation a study was carried considering different factory elements like productivity, cost and Quality in the direction of fulfillment of certification worthiness, using different methods at 3 local medical device manufacturers.
Study resulted in various observations and common issues between all 3 manufacturers in the area of Inspection, Assembly, Resource, Environment and People. There are other common issues relating to training, documentation and data extraction from legacy machines. The outcome can be solved by Smart technological intervention which will increase the value of product with better productivity and increase in quality and make it certified worthy. The work might also contribute towards influencing in modifying regulatory framework and policies.