Mobile Health Manufacturers’ Global Expansion Hitting Regulatory Barriers

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TÜV Rheinland Expert to Explain Global Product Approval Process at Mobile Health Expo this October

More touchpoints slow the process.

As the mobile healthcare industry looks to expand its technology-based services globally, regulatory barriers come into sharp focus. Not understanding new or emerging markets’ import laws result in avoidable delays and skyrocketing costs. At this October’s Mobile Health Expo, TÜV Rheinland Director of Business Development Bill O’Brien will present regulatory compliance strategies to keep global product launches on schedule and within budget.

Medical device and telemedicine OEMs are under pressure to find new revenue streams, and need to learn quickly about global compliance requirements. According to a 2009 Deloitte study (“Going Global: International Outlook for Private Companies”), roughly 75 percent of surveyed manufacturers planned to expand sales into new and emerging markets across the world. About one-fourth of those companies cited compliance with local regulatory laws as their top barrier to successful market entry.

“I have learned that many manufacturers are currently struggling with a combination of multiple regulatory service providers, internal part-time personnel, and external agents. More touchpoints slow the process,” said O’Brien. “To guarantee a medical device is available for sale in multiple markets, mobile health OEMs should work with a regulatory service provider that understands the complex local regulations and has a global network in place to obtain these approvals efficiently and on schedule.”

New and emerging markets offer numerous hurdles, O’Brien adds. Some examples of these hurdles include unstable or new government policies, changable requirements, and the need for local support during the approval process. As a solution, a single-source global regulatory compliance provider has a comprehensive network with country-specific regulatory knowledge as well as support to enable a one-stop final approvals process.

Bill O'Brien is a 20-year veteran of the product testing and regulatory affairs industry with a specialty in supply chain and medical device markets. At TÜV Rheinland , he is focused on Global Market Access services, which employs the company’s global network to help clients gain access to multiple markets quickly and cost efficiently. O’Brien is a member of the International World Trade Center, the Massachusetts Biotech Council, the Society for Information Management, and the American Society for Quality.

The Mobile Health Expo will take place at the Las Vegas Convention Center in Las Vegas, Nevada from October 19-21, 2010. Visit to register or learn more about the event.

For more information about TÜV Rheinland and its Market Access services, call toll-free 1-TUV-RHEINLAND (888-743-4652) or email info(at)us(dot)tuv(dot)com.

About TÜV Rheinland

TÜV Rheinland is the worldwide leader in market access, helping businesses gain international approvals in more than 200 countries. The company delivers premier independent certification, testing, and assessment services for many industry sectors. TÜV Rheinland eases the path to compliance with technical expertise, cost-effective pricing and quick turnaround times. The $1.5 billion corporation is comprised of an international network of more than 13,300 employees in 61 countries. For more information, visit

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Renee Rosiak
Catalyst Marketing Communications
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Virginia Palmer-Skok
TUV Rheinland North American Group
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