Interview with Dr Sastri about the Indian Medical Device Industry
Medical Equipment & Automation
January – March 2009
Dr. Vinny Sastri, Ph.D., is the President of WINNOVIA® LLC. His firm provides customized, sustainable solutions, strategies and training in new product development, quality management and high performance materials. His areas of expertise include design controls, process validation, and FDA and ISO Quality Systems for medical devices, quality management, manufacturing and material selection. WINOVIA LLC employs the Six Sigma and Design for Six Sigma philosophy with the goal of strategic market penetration, improving product and process quality, streamlining business processes, reducing operational costs, and increasing revenues and profits for its clients. Excerpts from his interview.
How do you see the opportunities of Indian Medical Device Manufacturers in the Global market?
The global medical device industry is estimated to be about 150 – 170 million USD. I think there is an enormous opportunity for the fledgling Indian Medical Device Manufacturers in this space, selling to both the Indian and the global markets. However, it is important, that the products are safe, effective and of very high quality and that they comply with and all the respective regulations.
Please brief us about the recent trend in Medical Device Industry?
Cost reduction is definitely on the radar screen of most medical device companies. The healthcare industry is facing extreme pressures for cutting costs which in turn are being transferred to suppliers and manufacturers of medical devices. That being said, higher end devices are still sold at respectable profit margins. Due to the increase of minimally invasive procedures, devices are becoming smaller, have more functionality and higher performance requirements and are using more and more electronics. The importance of electromagnetic shielding, electrostatic dissipation, thermal management, conductivity, chemical resistance and biocompatibility are thus becoming more important. Other trends are the use of antimicrobials and the incorporation of nanotechnology into medical devices.
What are the services being provided by WINOVIA?
WINOVIA works with medical device companies to asses their quality systems and provide recommendations for improvement and change if required. We also provide extensive consulting and training in the implementation of quality systems, product development and design controls, manufacturing and process validation and the incorporation and integration of effective risk management processes and tools into the product life cycle. We also incorporate the Six Sigma principles if needed. Our main goal is to provide companies self sustaining, effective systems, procedures and processes that make them both profitable and compliant.
How your company can assist Indian manufacturers in exploring their venture in Global Market?
I think the most value that WINOVIA can provide is to work with the leadership of medical device companies to formulate and implement effective, sustainable quality systems across their organizations customized to their requirements. Such systems would make not only good business sense but will also meet all compliance needs.
Do you wish to elaborate the need of Six Sigma philosophy for Medical Device Industry?
The new process validation guidelines and FDA’s thinking on the evolution of process validation emphasizes the need for more rigor, the need to truly understand one’s products and processes, and the need to incorporate “quality by design” into the quality systems. This means that organizations must be able to use good science, data, and experimentation to identify the true sources of variability and control those parameters during production. The identification and control of the sources of variation are the basic tenets of Six Sigma. Thus Six Sigma is a perfect fit in process validation and the overall quality systems for medical device organizations.
You are in the faculty of Association for the Advancement of Medical Instrumentation (AAMI) that provides training on FDA Quality Systems Regulation and Industry Practice to the medical device industry. Can you outline the Indian scenario?
I train medical device organizations and personnel on the FDA 21 CFR Parts 820 Quality System Regulations for Medical Devices along with other AAMI and FDA trainers. Training is both open to the public and can be done “in-house” for individual companies. Any company that wants to sell its medical devices into the United States must comply with this regulation. They must understand all the different aspects of the regulation and what they would need to do to implement, comply, and, successfully pass an FDA inspection.
How do you assess the growth of the medical equipment market in India?
I think that is rather slow right now, but more and more companies are springing up. The growth rate of the medical device industry is thus pretty good in India, but in terms of numbers, still small.
Where do our Medical Device Industry stands in terms of quality?
That is difficult to say as I am familiar with only a small number of medical device companies. Many medical device companies are not selling into the United States yet and some are selling into Europe. However, I do think that the Indian Medical Device Industry must promote and market itself to the world as an industry that is very capable of manufacturing high quality products.
What are the major bottlenecks the manufacturing sector is facing today?
Cost pressures are driving companies to either outsource or improve the efficiencies and profitability of their operations. They are also putting pressure on their suppliers to reduce costs of their raw materials and components. On the compliance side, manufacturers must assure the regulatory bodies that their manufacturing process are validated and continue to produce safe effective, consistent and high quality products. Validating manufacturing processes is often seen as a major bottleneck by most device companies.
What kind of government support would help the manufacturing sector of medical devices and equipments?
The government must provide incentives to the medical device industry and start-up companies as this could be a very profitable and high growth industry in India. They must also promote the Indian medical device industry in global tradeshows and industry events and make the world perceive India as a viable, cost effective place to design and manufacture all types of medical devices.
How do you view the scope for exports for Indian manufactured medical devices?
The United States, Japan and Europe make up about 85% of the global medical device market. The opportunity to sell into these markets with high quality, cost competitive or lower cost products is enormous. In addition, almost 70% of the medical devices used in India is imported. Here again, there is an opportunity for Indian medical device manufacturers to sell into the national market. India has the talent and the resources and I hope that the Indian medical device industry will grow and flourish.
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