The Medical Device market in India has just started to develop and there are huge opportunities in this field. In fact, a large amount of venture capital and government funding also goes towards the Healthcare Sector. However, with a majority inclined towards venturing into Apps and Software only a few entrepreneurs or innovators are seen delving into Hardware Innovation. This is predominantly because the Med-Device Product Development Life cycle in long, stringent and has a lot of regulatory requirements. Pune based IZiel Healthcare works with Investors & Entrepreneurs and helps such companies to develop these devices faster, first time right and in-line with all the regulatory requirements. They help them mitigate risk and save time and cost, ensuring appropriate use of Investor’s Money. Throwing light on, Ankur Naik, Managing Director, IZiel Healthcare, speaks, “Companies in the engineering domain in India have the ‘Move on, chalta hai’ attitude and that does
not work in the medical device space. It is all about attention to detail and getting it right the first time by developing and following a stringent process. At IZiel, that is what we focus on and it has delivered successful results.”
IZiel Healthcare is one of the few companies in India with expertise in Product Development & Remediation for Medical Devices
Founded in January 2016, IZiel’s strong foundation is built on competence, sound management practices and commitment to customer satisfaction and with the help of its competent team and its Statistical & Data Driven Methodology they ensure accelerated launch of products with guaranteed success. Explaining further, Ankur says, “All Employees are Design for Six Sigma (DFSS) – Black Belt Level Trained with a thorough understanding of documentation, risk management and the regulatory framework of the Healthcare Industry”.
Delivering Value added Outcomes
Recognizing engineers as biggest assets and key to success, IZiel offers solutions in two main areas – Product & Process Development and the other is in Product Remediation. For Product Remediation, the company works
with medical device companies facing 483’s and warning letters while for Product & Process Development, they work with new and current medical device startups in India and USA. IZiel has also initiated discussions to partner with premier academic institutions such as the IITs to develop synergies, conduct workshops and help them validate ideas in the initial stage. Sarvesh Mutha, Director IZiel Group says “Start-Ups and companies in India wanting to venture into the medical device and healthcare sector need to understand that this sector is not similar to the other engineering sector such as the automotive sector. While the core fundamental skills are the same, companies that will be successful are the ones that understand the intricacies of this sector and are willing to invest the time and efforts needed. Many customers underestimate the process, regulatory requirements and time needed to develop a Class II / III medical device and submit for approval in the US, Japan and Europe. IZiel provides guidance and solutions here. The Indian Medical Device market is at an early nascent stage and we are putting in all our efforts towards helping this industry become mature and world class.”
