My name is Benjamin Arazy and I am the President & CEO of Arazy Group Consultants Inc., an international consultancy spanning several continents, assisting medical device companies with regulatory compliance submissions as they enter new markets. Founded twenty years ago, we now operate in over 100 countries around the world. We have been serving early start-up, medium-sized, and top 100 multinational MedTech companies, and the greatest lesson we have learned through our practice is this:
The future of a medical or diagnostic device manufacturer does not depend only on their ability to innovate; it depends also on their ability to get their products to market.
All medical devices present a common challenge: a medical device is only valuable when it’s available. To be available, a device must be approved and every market requires its own approval. Without pre-market approval, no device can be sold, no revenue can be generated, and no growth can be achieved. In spite of this, the practice of regulatory affairs has not changed for more than 40 years. It remains a fragmented, costly, and inefficient process, managed manually and mostly through local distributors or consulting services.