The healthcare industry is rapidly evolving. All the changes taking place in the healthcare industry would not be possible without the support of quality diagnostics which has important implications for patient care, research, and policy. On a global scale, efficiency optimization has always been a challenge for clinical diagnostics.

We spoke to Mr. Shashank Pawitwar about the quality of clinical diagnostics and how to ensure compliance and efficiency. Mr. Shashank is currently working as an expert in the Quality Assurance, R&D at Beckman Coulter Inc. in Miami, Florida. Having a background in research, planning, critical thinking, and a multitude of industry-related skills, Shashank’s approach goes far beyond the ordinary in terms of having a visionary perspective that seeks to transform the world of clinical diagnostics at its core.

“The ultimate objective of compliance in Medical Device industry is to ensure that companies follow Quality Management Systems (QMS) throughout the process - from R&D to Manufacturing to Distribution and Servicing - that ensures adherence to agency regulations.” – said Pawitwar.

While trying to explain the essence of his work, Shashank shared that coming from a research background and having acquired expertise in quality assurance, he always focused not only on product-related issues at hand but also on examining the process systems, identifying gaps in the existing process, and implementing additional countermeasures related to processes under Business Units across North America.

As a leading expert in the field, Mr. Shashank’s role is to ensure that the product is in compliance with required established regulations. “If there is any miss or potential gap within existing products in the market, they are tackled immediately with a complaint, implementing corrections.” – he shared. “Another aspect includes focusing on integrating the learnings with continuous improvement in the current process. This improves not only the existing products but also any product to come into the market down the line. The sheer impact of this process in terms of efficiency and more importantly, in safeguarding people’s health, is absolutely essential.” – he added.

Shashank’s words resonated with a far-reaching understanding of the industry when he mentioned that it is critical to look at the bigger picture and build a process that can target the “poke-yoke” system. He also emphasized the creation of a foolproof process that not only rectifies immediate issues but strengthens the entire diagnostic process, ensuring accuracy and efficiency.

Shashank’s journey navigates beyond just diagnostics, taking into account the empowerment of patients, support to doctors, and the creation of a healthier society. His story is more than just a memoir of professional expertise and is a testament to the transformative power of innovation in the healthcare landscape, ensuring a better and healthier future for the masses.

Understanding Epilepsy: Triggers, Identification, and Management - National Epilepsy Day 2023

Managing Epilepsy: Lifestyle Strategies for Prevention and Coping