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Execs Weigh In: Balancing the Risks and Rewards of MedTech Globalization

By Sanjay Salunkhe, iGATE Corp.

Recently, consultancy firm iGATE Corp., in collaboration with advisory firm Axendia, Inc., announced the results of an exclusive medtech executive survey that highlighted the benefits and risks resulting from the rapid growth of the global medical technology industry.

Guided by insight from a 12-member executive advisory council, the survey, "Walking the Global Tightrope: Balancing the Risks and Rewards of MedTech Globalization," polled 125 medical technology industry executives from 89 companies across 16 countries, 79% of which were decision makers with a title of manager, director, or senior executive. More than one-third of respondents represent large organizations with annual revenues exceeding $1 billion while another one-third of respondents hailed from mid-size medical technology companies. The remaining respondents represent organizations with revenues below $25 million.

Among the key findings from the survey are that 88% of medtech executives polled expect increased sales in emerging markets while 69% of respondents anticipate increased sales in developed markets. In addition, 72% of respondents cited the desire to improve the rate of product innovation as the motivation behind globalizing their businesses.

Additional findings include:

o    59% worry about maintaining consistent quality standards across internal and external sites
o    68% perceive moderate to high risk based on their current visibility into critical suppliers
o    90% would like access to real-time and on-demand data from critical suppliers, contract manufacturers, and other Tier 1 suppliers

The research also found that industry executives feel that their biggest challenges center on contending with three primary macro trends: managing sustainable global growth, supporting changing healthcare delivery models globally, and complying with tightening global regulatory environments. In fact, 65% of respondents view the global regulatory environment as the top business threat over the next three years.

And while these challenges are front and center for medtech executives, the three issues that worry industry leaders most, according to the poll, are:

o    The increasing complexity and cost of compliance in global regulatory requirements
o    The ability to ensure the quality of finished products and raw materials around the globe
o    The challenge of maintaining consistent standards across an extended network of internal and external sites

Overall, the survey found that the increasing rate of globalization has created significant opportunities, but it has also posed new challenges for the medical technology industry. In order to reap the benefits of globalization, medtech executives would be best advised to proactively mitigate risk by implementing new strategies, processes, and technologies across the life cycle of medical products in a global and outsourced environment. Suggestions for such strategies include the implementation of holistic control over governance, risk management and compliance practices, enhanced visibility across the medical technology ecosystem, and improved collaboration with all constituents in the community.

Sanjay Salunkhe is the senior vice president of product and engineering solutions at iGATE Corp., where he has led the development of industry-specific solutions for a variety of sectors, including the medical device industry.

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