THE BACKGROUND

In August 2012, Arazy Group was approached by Elekta, which provides clinical solutions for the entire spectrum of care in oncology, neurosurgery, radiosurgery, and radiotherapy for precision treatment of cancer and brain disorders. Elekta solutions in oncology and neurosurgery are used in 6000 hospitals globally, and every day more than 100 000 patients receive diagnosis, treatment, or follow‐up with the help of the company’s solutions.

Today, the scale and structure of Elekta is such that the sales and marketing of their medical devices takes place in over 100 countries worldwide. In the past, Elekta focused mainly on major markets of the world, including Europe, North America, and countries like Brazil and China. As the company also increased its focus on smaller emerging markets, it became necessary to improve and broaden the regulatory intelligence within the company while also looking for innovative solutions in order to provide access to new markets with minimum demand on the regulatory team within Elekta.

THE CHALLENGE

The increased focus on emerging markets created new challenges for Elekta’s regulatory portfolio. At the most basic level, the regulatory intelligence required to obtain licenses in specialized markets needed to be developed. Furthermore, many countries demand that registration be carried out through local offices, distributors, and/or through a local authorized representatives. In some cases, Elekta’s presence in those countries did not yet exist.

The breadth and scale of many Elekta devices requires not just registration of multiple devices at once, but the expectation that installation take place within a reasonable time frame, particularly for devices that may take months to install. For example, radiation therapy treatments necessitate stringent safety regulations; in many cases, radiation therapy devices must be housed in purpose built facilities that protect the surrounding environment from radiation exposure. It may take months to construct such facilities. In some cases, the devices make up whole portions of a hospital or clinic and, consequently, licenses must be obtained as soon as possible.

Since some of these devices represent a significant investment for a medical facility, sometimes costing millions of euros, expectations to complete the process quickly are high. In order to meet these needs, especially in the case of specific contracts, specialized regulatory knowledge is essential to expedite registration, paving the way for smooth sale and installation.

To complicate the situation further, due to the breadth of Elekta’s portfolio, it is often difficult to foresee which devices should be introduced to which market at which time. In some cases, Elekta’s products address a specific need. In other cases, it is prudent to register the entire range of Elekta’s devices to meet more general demands. In each case, regulatory concerns can hinder marketing priorities.

Elekta needed to register multiple devices in multiple markets, simultaneously. They needed the infrastructure, regulatory intelligence, and expertise to obtain market access in a diverse range of countries and regions that were outside of their usual regulatory purview. They also needed to meet their regulatory mandate: “to assure predictable and sustainable market access.”

THE PROCESS

Jon Yard, Elekta’s Director of QA & RA for the EU & AFLAME (Africa, Latin America, & the Middle East), states, “When we do a project with Arazy Group, the LICENSALE.COM™ system is the backbone of the registration process. In markets where Elekta uses the services of Arazy Group, it is LICENSALE.COM™ and Arazy Group project managers that enable registration to occur in accordance with Elekta’s objectives. LICENSALE.COM™ meets the long-term demands of Elekta because it provides the regulatory flexibility necessary to meet the priorities of Elekta’s sales teams.”

At the core of the LICENSALE.COM™ application is GRIMS™ (Global Regulatory Intelligence Management System). The system provides regulatory intelligence relating to specific registration requirements in individual countries for a particular device. GRIMS™ links these requirements to qualified Arazy Group experts from around the world who review the documents provided by the manufacturer for compliance with the set of requirements. The system manages the application preparation, which is then submitted to the relevant regulatory agency by Arazy Group’s local authorized representative in each country.

Once approved, Arazy Group will hold the marketing license on the manufacturer’s behalf and the manufacturer, therefore, maintains ownership of the license. Moreover, integration between GRIMS™, the professional experts, and local resources enables any post marketing regulatory services required to maintain the licenses in the event of regulatory changes or upgraded versions of the device. This process can be applied to all medical devices and repeated for unlimited numbers of applications in multiple countries as required.

THE RESULT

Since Elekta began working with Arazy Group in August 2012, regulatory and product registration services for 78 different types of medical devices had been provided in countries such as Russia, Kazakhstan, Macedonia, Israel, Egypt, Yemen, Jordan, the United Arab Emirates, Saudi Arabia, Bahrain, Cuba, and Honduras, with many other projects on the horizon. The number of registration projects managed by Arazy is constantly climbing as Elekta reaps the benefits of establishing a global registration partner. “Without Arazy Group,” says Mr. Yard, “Elekta would need to be dealing with many different registration partners, each with their own way of working.”

As a result of the increased market access, Elekta will expand its regulatory department to address the exponentially expanding opportunities of emerging markets. However, with Arazy Group, the regulatory burden is significantly reduced, according to Mr. Yard, as much of the groundwork associated to the preparation and filing of the submission is contracted through Arazy Group.

“Contracting Arazy Group means that we work with a small group of regulatory professionals and we are able to develop relationships based on trust,” continued Mr. Yard. “Arazy Group’s approach to regulatory affairs and goals with regards to emerging markets are wholly in line with Elekta’s long-term goals. We are able to approach new opportunities with confidence that we can find a solution to the challenge.”

THE BACKGROUND

Luminex Corporation (NASDAQ: LMNX) is a biotechnology company based in Austin, Texas, USA with offices in Madison, WI, , Canada, China, Japan, and the Netherlands. Luminex develops, manufactures, and markets products like the Multi-Analyte Profiling (xMAP) technology, which allows simultaneous analysis of up to 500 bioassays from a small sample volume and is being used within various segments of the life sciences industry, including the fields of drug discovery and development, clinical diagnostics, genetic analysis, bio-defense, food safety, and biomedical research.

With USA FDA clearance, CE Mark, Health Canada approval, PMDA notification, and CFDA approval, Luminex was looking to expand their business into new markets. Their sales team developed a strategic plan for a set of target countries. The regulatory department was tasked with evaluating partners for registration of their high-class in vitro diagnostic devices.

THE CHALLENGE

The first element to consider was global coverage. Though Luminex has several international offices, they did not have a presence in their target countries or plans to dedicate the necessary resources required to set up local offices. As such, they needed to arrange for authorized representatives in each market in order to initiate registration with the local authorities as mandated by local laws and regulations. In addition, the required level of regulatory intelligence for each of these markets, as well as knowledge of the local infrastructure and bureaucracy, constituted another potentially expensive and complicated drain on internal resources.

“We wanted one point of reference that we could trust to contract for these different regions instead of dealing with multiple distributors,” explains Senior Regulatory Affairs Manager Anna Le Bars.

In their selection, Luminex was looking to achieve the following:

• Contract a company that offers registration and representation in all their target markets
• Maintain ownership and control of all their licenses in each market
• Maintain independence from distributors
• Preserve the confidentiality of their proprietary information
• Establish a relationship of trust with this company
• Secure post-market support and infrastructure for reporting and potential adverse events
• Utilize a registration system that could easily adapt to Luminex’s internal regulatory department

THE SELECTION PROCESS

Arazy Group Consultants Inc. was the partner that stood out from the competition on all points, providing global representation in 80 countries when first contracted in 2011 and expanding to 103 countries by mid-2014. Arazy Group offers complete regulatory life-cycle solutions including up-to-date regulatory intelligence, product compliance consultation, license application preparation and submission, and post-market support including license renewals.

Most importantly, all the services of Arazy Group are offered through LICENSALE.COM™, the online registration system for medical and IVD devices, under one system, one contract, one currency, and one language. LICENSALE.COM™ is an advanced technology service that streamlines, simplifies, and expedites global regulatory affairs for a predictable, fixed fee.

The functionalities of LICENSALE.COM™ exceeded Luminex’s expectations. “The LICENSALE.COM™ system works wonders for us,” says Ms. Le Bars. “We were pleasantly surprised to find that training was short and the portal was very easy to use and navigate for finding applications and uploading documents. LICENSALE.COM™ makes it easier to compile all the documentation required for registration and it’s easy to just go to the portal and check for files and status reports.”

In a fast-paced work environment, the regulatory team at Luminex also found the system convenient for communication. “You can log in from anywhere and the information is right there: which documents are needed and which are currently under review, which submissions have been made and where are they in the approval process, and most importantly, expected approval dates. When we need to report the status of projects to our management, being able to see project updates directly in the portal means that I don’t have to spend time following up with project managers and associates,” notes Ms. Le Bars.

“It was very important to us to build a relationship of trust with any company we hired. One of our biggest concerns in our international expansion was having to deal with multiple distributors, some of which may even be working with our competitors,” comments Ms. Le Bars.

THE RESULT

Luminex has obtained eight approvals for several devices in Mexico, Singapore, and South Korea with 28 more applications underway in all their target markets. Overall, Arazy Group has processed multiple product registrations in multiple markets, license renewals and transfers, authorized representative services, and some market surveillance for Luminex.

“Working with Luminex and their amazing line of IVD products gave us the opportunity to prove that our service technology and regulatory know-how, integrated within LICENSALE.COM™, are as effective for complex IVD device registration as they are for medical devices,” says Benny Arazy, President and CEO of Arazy Group. “We are very pleased to see Luminex’s confidence in Arazy Group expressed through the additional registration projects that continue to be initiated as we increase the number of new countries of which our services are being offered.”

“We have been happy with our relationship with Arazy Group,” concludes Ms. Le Bars. “Our account manager is a real pleasure to work with and he is very responsive, which is great because we often have to move quickly on projects. It’s also unusual for executives to be involved, but whenever we needed them, Arazy Group executives always respond to our inquiries quickly and it seems like the company really cares. Arazy Group has been instrumental in the commercialization of our IVD medical devices. Their expertise has allowed our company to successfully obtain product approval and expand access to our technology in three new markets over the past three years, with three additional markets underway.”