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THE ELEKTA CASE STUDY: 76 PRODUCTS, 16 COUNTRIES, 12 MONTHS

by Adi Burton | Jul 31, 2013

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."


ABOUT ELEKTA AB

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives. The company's corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAb ($6.4MM Market Cap). For more information, visit http://www.elekta.com.


ABOUT ARAZY GROUP CONSULTANTS INC.

Arazy Group Consultants Inc. is a global, multifaceted regulatory affairs firm that provides all types of medical device manufacturers with client-specific solutions throughout the product life cycle – from early development to post-market activities. With over 18 years of expertise, our experienced consultants are responsible for the successful registration of thousands of medical devices in over 80 countries worldwide. Arazy Group is based in Vancouver, British Columbia, Canada and has recently opened the headquarters for Licensale.com in San Francisco, California. Our flagship service, Licensale.com, is our new, simple solution for registering medical devices globally and the only service of its kind offered to the industry.



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Category:
  • Case Studies
  • Regulatory Articles
Tags:
  • LICENSALE.COM
  • medtech
  • Elekta

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