Arazy Group Consultants
Accelerating MedTech Product Approval, Globally

Regulatory bodies oversee the approval of innovative medtech devices across each country. Their regulations are put in place to ensure patient safety against the risks and limitations that accompany the devices’ application, design, manufacturing, and packaging. Arazy Group Consultants is focused on providing medical device manufacturers the assistance they need to be able to register and roll out their product quickly in any market, with LICENSALE, the company’s proprietary licensing tool. This ultimately accelerates the accessibility and availability of medtech devices for physicians and patients all around the world.

High cost of operations, lack of regulatory intelligence and control of IP, and communication barriers, are amongst the pain points that fuelled the wide adoption and popularity of LICENSALE. Arazy Group began as a compliance consultancy that helped medical device manufacturers to register and have their products approved for market entry. They witnessed firsthand, how cumbersome of a process it was, and had developed their in-house tool to streamline corresponding workflows. The idea to make the tool readily available for medtech manufacturers spurred the innovation within LICENSALE – Global Medtech Registration System.

In the words of Arazy Group’s President and CEO Benjamin Arazy, “LICENSALE analyzes compliance data and implements machine learning to manage the medical and IVD device registration process, across 140 global markets. It eliminates redundancy, optimizes efficiency, and focuses human expertise where it is needed most.” The solution’s proprietary technology allows device makers to reduce the standard, 12-step medical device registration life-cycle into five steps. The product line inquestion can be selected and filtered based on marketing status, and a color-coded map shows the current registration status across different jurisdictions globally, making the whole process much easier. LICENSALE uses information from previous registrations to minimize the process required for future registrations.

LICENSALE analyzes compliance data and implements machine learning to manage the medical and IVD device registration process, across 140 global markets

Thus, the more one uses the offering, the more efficient and cost-effective their market approval processes will become. The offering also provides legal, commercial, and operational benefits beyond providing an actionable birds-eye view of product registrations. Users get to retain ownership of licenses and confidentiality of IP, and the system supports RnD by providing accurate compliance and sales advancement information that fosters better alignment between regulatory and commercial strategies.

Benjamin cites the case of a client called OraSure, an American manufacturer of in-vitro diagnostics products, who had developed a self-test HIV diagnostic kit which is currently sold in the US. With the support of the prestigious Bill & Melinda Gates Foundation, the client intended to bring that product into third world country markets, mostly in Africa. However, to do so, they had to make changes in the configurations of the product so that it could be more affordable in those countries. Arazy Group is in the process of carrying this product from the U.S and bringing it to physicians and patients in about 40 countries around the world. This is a big win in terms of the humanitarian aspect and in addition, to the pain points associated with handling multiple registrations of the same product in multiple countries. The complexities with countries that had established regulations, or others with none, were tricky to maneuver, but with Arazy Group, the company was able to work directly with governments, to establish routes to bring the kit to market.

With the kind of global presence that Arazy Group and LICENSALE have, they envision to add more clients to their fold, while sharpening the edge of their offering. The company is going to release their next-generation LICENSALE2.0, which would bring a modern, user-friendly interface, for an even more simplified and automated regulatory approval process, advanced data analysis, and reporting, packaged in this state of the art, next-generation Global Medtech Registration Management System. With a lot of statistical information and data, V2.0 will allow clients to plan their products’ extension globally and the management of their overall activities in various markets.