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By Axendia Staff

It has been said that a picture is worth 1000 words, and our research team agrees.  Therefore, we have distilled some of the key findings from our Med-Tech research report into this Info-Graphic. To get a full size version of the Info-Graphic simply click on the image below.

To learn more about this report read Are Med-Tech Companies Walking the Global Tightrope?

To request a copy of this report visit: www.axendia.com/Med-Tech-Report.html

The globalization of design, sourcing, manufacturing, and sales of Medical Technology (Med-Tech) has created opportunities and challenges for the entire ecosystem. As Med-Tech Executives embrace this trend, they need to balance the risks and rewards of globalization.

These are the key findings from a major research survey of 125 Med-Tech Industry Executives representing 89 different companies across 16 countries released today by industry analyst and strategic advisory firm Axendia, Inc. The report is titled: “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.”

Industry Executives report that they must contend with three primary macro trends:

• Managing sustainable global growth
• Complying with tightening global regulatory environments
• Supporting changing healthcare delivery models globally

“Nine out of 10 Med-Tech Executives expect very strong growth in the next three years. In this context, Emerging economies represent burgeoning marketplaces, with increased sales rates over those in Developed markets,” said Daniel R. Matlis, President of Axendia. “While Med-Tech companies are poised to capitalize on these opportunities, global expansion has Industry Executives on alert. Nearly 7 out of 10 Executives reported moderate to high risk based on their level of visibility into critical suppliers,” he added.

The research revealed that Industry leaders are most worried about 3 issues:

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

Axendia’s survey of 125 Med-Tech Executives around the globe found that:

• 88% expect increased sales in Emerging markets
• 69% expect increased sales in Developed markets
• 65% see the global regulatory environment as the top business threat over the next 3 years
• 72% are globalizing to improve the rate of product innovation
• 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.
• 90% would like access to real time data and on-demand data from Critical Suppliers, Contract Manufacturers and other Tier 1 Suppliers

The top two reasons Med-Tech companies are focused on globalization are:

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

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%)

To mitigate globalization growing pains and attain sustained benefits, the Med-Tech ecosystem, according to Axendia, will need to implement new strategies, processes, and technologies to proactively manage risk across the life-cycle of Med-Tech Products in a global and outsourced environment.

These include the implementation of:

• Holistic control over governance, risk management, and compliance practices
• Enhanced visibility across the Med-Tech ecosystem
• Improved collaboration with all constituents in the ecosystem

To request a copy of this report, please visit www.axendia.com/Med-Tech-Report.html

NOTE TO EDITORS

Detailed findings from this research study as well as charts and graphs of key findings, will be available for your use with proper attribution in a report entitled, “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.”

For additional information or to schedule an interview or briefing with the study’s lead researchers, please contact Lisa George via email at lgeorge@axendia.com

Last month, I had the opportunity to meet with Richard W. Smith, Managing Director - Life Sciences and Specialty Services at FedEx.  During our meeting in NYC, we focused our discussion on FedEx’s strategic initiatives in supporting the increasing globalization of the Life Sciences industry.

Smith has a deep understanding of the valuable role logistics serve in our increasingly global and outsourced ecosystem, and he should.  He literally grew up with the business; the son of FedEx founder Frederick W. Smith.

“Customers are counting on FedEx to provide stable and predictable environmental temperatures from pickup to final delivery; otherwise shipments can freeze or overheat,” said Smith.  The largest segment of pharmaceutical product from a temperature standpoint is bulk drugs in Controlled Room Temperature (CRT) ranging from 15-25°C.

“For these shipments, especially for generics, the manufacturers or distributors are often very price conscious and do not want to incur the added cost of using expensive temp-control packing materials or specialized containers,” said Smith.  ”Instead they often opt to ship on days where the temperature is mild at origin and destination and hope that they won’t get any temperature excursions in transit,” he added.

Smith shared some real life examples of how FedEx addressed the challenges of Pharma CRT shipments:

“A large pharmaceutical company was relying on freight forwarders to transport its generic drugs that need to be protected from extreme ambient temperature fluctuations.  The company was relying on costly leased temperature controlled containers en route from India to the U.S.

Even with these measures, the pharmaceutical manufacturer was experiencing product spoilage when transit delays occurred and the temperature deviated from the CRT range. Additionally, the pallets of temperature-sensitive freight were often exposed to the outside elements and left unprotected from direct sunlight and temperature fluctuations. The company needed a more reliable, economical temperature-controlled transportation solution.

To address the issue, FedEx teamed up with AmSafe to design a thermal blanket to shield the customer’s freight from extreme temperatures and weather conditions, including rain and snow - from the origin warehouse all the way to final delivery.  Additionally, the turn-key solution includes end-to-end shipment management - without the extra management fees and customs charges that the shipper paid to freight forwarders since FedEx owns the thermal blankets. And because the cargo is transported via the FedEx Express® network on FedEx planes, transit times have also been reduced.

Combining the AmSafe thermal blanket with round-the-clock support from a dedicated team of FedEx customer service agents, shipment-status tracking capabilities and stringent operational recovery procedures, FedEx has provided the manufacturer with a cost-effective solution for keeping time-sensitive freight safe from temperature fluctuations.”

But the company didn’t stop there.  To ensure that the product CRT conditions are maintained in transits, FedEx conducted extensive temperature mapping studies to determine the appropriate default temperature settings on its Boeing 777 aircraft.

“Based on these studies, FedEx has implemented procedures to maintain temperatures on board its new B777 aircraft remain within the CRT range during flights.  So now cold chain shippers can plan accordingly with a great degree of confidence knowing that their products will be cool on the ground and in flight,” he concluded.

Richard Smith has a deep understanding of the valuable role logistics serve in connecting people and goods and creating economic growth. As the son of FedEx founder Frederick W. Smith, he literally grew up with the business watching FedEx evolve from an express shipping company to a worldwide portfolio of services. In his role as Managing Director of Life Sciences & Specialty Services, Smith provides strategic direction for developing customized logistics and supporting specialized services.

In business, the only constant is change.  New markets open up, disruptive products are developed, competitive landscapes change and internal environments must evolve to accommodate them.

Companies are looking for ways to improve product quality, customer satisfaction and profitability while at the same time dealing with increasing costs, competition and regulatory pressures.

Too often organizations address their quality and regulatory requirements by implementing modular, point solutions that meet specific needs. This approach has led to the proliferation of a wide variety of non-integrated systems that may help individual departments/divisions manage their responsibilities but have created data islands.

Disconnected systems make identifying and solving company-wide issues extremely challenging since data integration and visibility across the global organization becomes very difficult. In addition, a modular approach to quality management is an inefficient way to manage critical processes and often results in increased costs.

Utilizing an Enterprise Quality Management System (EQMS) backbone to manage quality and regulatory issues enables a broader and deeper view across the organization.  It also facilitates the early identification of issues and supports a systematic approach to address them.

By using this backbone approach, an integrated EQMS becomes an investment, instead of an expense. An enterprise quality management solution provides tangible benefits such as increased operational efficiencies, and global standardization for external and internal stakeholders and suppliers.

In an interactive discussion, Daniel R. Matlis, President of Axendia shares his perspective on this backbone approach with Mohan Ponnudurai, Industry Solutions Director at Sparta Systems.

During this session, Dan shares key takeaways from Axendia’s Brief “Developing a Quality Backbone; Improving Total Cost of Ownership with EQMS[1].” He presents strategies companies can use to lower costs and reduce exposure to product liability with a backbone approach to EQMS.  Dan also shares 10 key questions to ask when evaluating EQMS Providers.

Listen to this interactive discussion and request your copy of the companion Industry Brief sponsored by Sparta Systems, at:  http://marketo.spartasystems.com/2012-04-Webcast-TCOAxendia.html