Principal Consultant | LIFESIGNALS
Senior level management executive with more than 28 years of experience in the areas of R&D/Engineering, Product Development, Operations Management, Mergers & Integration and International Business Development in healthcare domain, in multi-national companies based in India & USA.
Expertise in setting up, nurturing and building R&D / Product development teams with diverse expertise for development of active medical device meeting various international regulatory requirements (CE, 510(K), PMA). Also, specialized in setting up & managing medical device manufacturing facilities meeting the necessary international Quality System Regulation (e.g. ISO13485, 21CFR820).
In his previous organization, managed multiple R&D centers and manufacturing facilities based in USA, India & Malaysia. He also setup & managed R&D Center in Bangalore, India consisting of engineers/scientist for NPI & value engineering of medical devices in the areas of Resuscitation (AED), Diagnostic Cardiology (EKG machine, stress, Holter systems), Vital Sign monitoring (pulse-oximeters, patient monitors) & Vascular diagnostics. These devices were among the top three international brands in their respective product category (e.g. Cardiac Science, Criticare Systems, Burdick, Quinton, Unetixs, Faichney). Previously, he managed an SBU (small business unit) which was part of an export division in India’s well-known FMCG multinational company.
He is also the co-founder of a Medical device startup involved in solving one of the holy grail problems of vital sign monitoring. He holds patent in non-mercury clinical thermometry.
At LifeSignals, Inc (formerly known as HMicro, Inc), he brings-in the Medical device expertise for development of products & solutions using its silicon platform and helped in successfully getting 510(K) for its Wireless Disposable Patch.