The globalization of design, sourcing, manufacturing, and sales of Medical Technology (Med-Tech) has created opportunities and challenges for the entire ecosystem. To assess the impact of globalization and outsourcing in the Medical Technology Industry, Axendia conducted a survey research of 125 Medical Technology Industry Executives representing 89 different companies across 16 countries. This article provides a summary of the project’s research report entitled, “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.”

Globalization has increased demand for medical technology around the world. Nine out of 10 Industry Executives surveyed reported that they expect their business to grow in the next 3 years.

While Brand Owners are poised to capitalize on these new opportunities, they need to balance the risks and rewards of Med-Tech globalization. The growth in the volume of global partners, facilities, suppliers, and regulations, as well as the increased variety and complexity of products across a large number of countries has Industry Executives on alert. The vast majority of Executives surveyed expressed concern due to the lack of visibility and control over their global and outsourced operations.

These opportunities and challenges call for new strategies for managing Med-Tech organizations in a global and networked environment.

Key Research Findings
While Industry Executives anticipate very strong sales growth globally, emerging economies represent burgeoning marketplaces with increased sales rates over developed markets.

The top two reasons driving globalization are:

  • Supporting emerging markets with locally produced product (64%)
  • Improving the rate of innovation (63%)

Our research shows that the following globalization and outsourcing issues “keep Executives up at night:”

  • The quality of products, raw materials or services provided (60%)
  • The ability to maintain consistent quality standards across internal and external sites (59%)
  • Protecting the company’s intellectual property (49%)
  • Nearly 7 out of 10 executives rated their level of risk as moderate to high based on their current level of visibility into critical suppliers.

According to the research, Industry Executives are especially concerned about:

  • The increasingly complexity and cost of compliance in a global regulatory environment
  • 65% see the global regulatory environment as the top business threat over the next 3 years
  • The ability to ensure the quality of finished products and raw materials around the globe
  • 68% perceive moderate to high risk based on their current visibility into critical suppliers.
  • 90% would like access to real time data and on-demand data from Critical Suppliers, Contract Manufacturers, and other Tier 1 Suppliers
  • The challenge of maintaining consistent standards across internal and external sites
  • 59% worry about maintaining consistent quality standards across internal & external sites
  • 68% perceive moderate to high risk based on their current visibility into critical suppliers.

To attain the sustained benefits of globalization, we recommend that Brand Owners implement consistent strategies which capitalize on the opportunities set forth by globalization and outsourcing while proactively reducing and controlling risks. This calls for changing the business, technology, and regulatory models traditionally used in the Industry.

They include:
Holistic Control Over Governance, Risk Management and Compliance Practices
The ability to maintain consistent quality standards across internal and external sites is a top source of insomnia for industry executives. Med-Tech organizations should focus on achieving product, process, and systems excellence rather than simply ensuring “compliance”.

To address these concerns, Brand Owners should implement commercial, legal, technical, and IT frameworks that support visibility and control across the ecosystem.

Enhanced Visibility Across the Med-Tech Extended Partner Network
Executives report high risk due to poor visibility into global and outsourced operations. To address this issue, Med-Tech organizations should gain tighter control over their partner’s ecosystem - from ingredient to patent.

Brand Owners should deploy systems and technologies to provide visibility and control not only in the Supply Chain, but also in the entire Value Chain, from product design, sourcing, manufacturing, and distribution to the consumer.

Improve Collaboration with All Constituents In the Ecosystem
Effective collaboration remains the cornerstone of successful companies. In today’s global and outsourced environment success requires collaboration. Med-Tech stakeholders should welcome this changing environment, and embrace partnership, transparency, and harmonization initiatives. It means changing the relationships where interactions begin earlier in the process to support mutually beneficial outcomes. It also means engaging suppliers who are willing to share information about the product on-demand, to support efficiencies and effectiveness across the product lifecycle.

The combination of these approaches will enable Med-Tech Brand Owners to get past globalization growing pains and capitalize on the opportunities. To this end, we recommend that implementation of approaches outlined in the research report. This can improve the safety, effectiveness, and quality of products around the world regardless of where they are made.

Detailed findings from this research study in a report entitled, “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.” To request a copy of this report, please visit

This study was co-sponsored by leading companies active in the Medical Technology sector. They are (in alphabetical order): Camstar Systems Inc. (, iGATE (, and PwC ( These companies supported this research to increase the understanding of processes and systems that enable global visibility and transparency across the Life Sciences value chain.

About Axendia, Inc.
Axendia, Inc. is a leading analyst, and strategic advisory firm focused on the Life-Sciences, and Healthcare markets. We provide trusted advice to Industry Executives on Business, Regulatory, and Technology issues. Axendia professionals offer a unique combination of deep hands-on industry experience coupled with strategic vision. Axendia serves the complete ecosystem including Life-Science, and Healthcare Organizations, Technology & Service Providers, and the Investment community.

Our clients range from startups to Fortune 100. We contribute to our client’s success by providing long-range visibility, and helping them navigate the increasingly complex landscape in the Life-Sciences, and Healthcare markets. For more information, visit or contact us at

For more information, visit or contact us at , read Axendia’s blog: Life-Science Panorama at or follow us on or

Daniel R. Matlis is Founder and President of Axendia, a trusted advisor to Life-Science and Healthcare Executives on Business, Technology and Regulatory issues. Dan’s 20 years of experience in the Industry spans the entire value chain. He has been involved in projects spanning R&D, Commercial Operations, Regulatory Compliance, Business Development and Information Technology. Dan began his career at Johnson & Johnson (Ethicon), where he provided leadership in the areas of technology, regulatory compliance and business. Dan managed the development and implementation of automation and information technology and the policies and procedures required to document the system life cycle process. Dan was the Technical Owner for Computer System Compliance, Computer Integrated Manufacturing technology, and Electrical Engineering standards. Most recently, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm (acquired by GE Healthcare). Dan was influential in focusing the business on the FDA regulated industries and broadening the spectrum of solutions the firm provided to clients through organic growth, acquisitions and strategic partnerships. Dan was responsible for developing and executing strategies which achieved tenfold top and bottom line growth over 8 years. He has held positions of increasing responsibility within in Operations, Sales, Marketing, Strategic Planning and Executive Management within the organization. Dan is the author and editor of Life-Science Panorama, a Publication covering the Business, Regulatory and Technology issues facing Industry Executives. He is a frequent lecturer at Industry events and has published numerous articles on key issues facing the Life-Sciences industry.