Lean Six Sigma for Clinical Trials Excellence and Regulation

Subject Significance:

The expertise in clinical trials of a medical device or drug is from its inception companies conducting trials realize this or have begun to realize this in the product life cycle. The regulatory compliance from FDA, EU or ISO 13485 has mandated strict compliance guidelines through their Quality System Regulations (QSR) and this is advantageous to recognize the importance of quality and rigid regulations right from the incubation to the growth of a medical product and bring out a competitive edge in the medical device industry. This incorporates operational excellence and best achieved by elimination of waste and reducing cost, yet maintaining quality and adhering to strict regulations. 


DMAIC is the standard tool to study the requirements for effective improvement, better quality designs, better medical device product capabilities and competencies and in general focused themselves on achieving compliance with product design control or after market analysis. With a preliminary SWOT analysis, the strengths and weaknesses that emerges are predominantly inherent to functional capabilities of the working system and that the weaknesses have to be turned into strengths by external opportunities and minimizing threats. 

The completed clinical trials using Lean show that lean is an advanced planning tool and the way forward. VoC is the silver lining to success and companies that listen to the customers in their production house have a higher chance of success. Lean helps to create improved work approach and generate more revenues.