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CASE STUDY: HOW ONE MEDTECH COMPANY IS GAINING ACCESS TO SIX NEW MARKETS WITH ONE UNIVERSAL SOLUTION

by Sophia Lindgren | Dec 11, 2014

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.”

 

ABOUT LUMINEX CORPORATION

Luminex is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays that deliver cost-effective and rapid results to clinicians and researchers. Luminex's technology is commercially available worldwide and in use in leading clinical laboratories as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. The Company is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, bio-defense research and food safety. For further information on Luminex Corporation and the latest advances in multiplexing using award winning technology, please visit http://www.luminexcorp.com.

ABOUT ARAZY GROUP CONSULTANTS INC.

Arazy Group Consultants Inc. is a global regulatory affairs firm providing technology services and products designed to streamline, simplify, and expedite international regulatory affairs for all types of medical and IVD devices. With 20 years of experience in the successful registration of thousands of medical devices around the globe, our service technology tools, customized management software, and integrated expert network optimize planning, process control, and resource management for the entire product regulatory life-cycle. Arazy Group is based in Vancouver, British Columbia, Canada. To learn more about Arazy Group, visit our website.




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Category:
  • Case Studies
  • Regulatory Articles
Tags:
  • Luminex
  • LICENSALE.COM

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  2. Hello | Jan 08, 2015
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