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The ineffectiveness of IT systems may fog decision making.

Timely access to information is vital to the decision making process. Yet, the vast majority of Executives surveyed face a confidence crisis due to the lack of visibility into their supply chain.

Only 3 out of 10 Executives report that IT systems are effective for global visibility; executives also report high risk due to poor visibility into global and outsourced operations.

According to the Axendia’s research survey of 125 Medical Technology Executives, the vast majorly of expressed concern about the risk associated with their suppliers based on their lack of visibility into the supply chain. Respondents report that their highest perceived risks (73 percent) are associated with suppliers to their critical suppliers.

Nearly 3 out of 4 respondents rated their level of risk moderate to high based on their current level of visibility into Tier 2 suppliers to critical suppliers. As one Executive put it “we feel that the level of visibility goes down exponentially with every link in the supply chain.”

To learn key strategies to deploy systems and technologies that provide visibility and control across the entire Value Chain, click on this link to read the complete article.

This is an excerpt from our recently published article in MedicalDeviceSummit.

Push for growth in emerging markets like Brazil, Russia, India and China (BRIC).

For some Med-Tech Companies, growth rates in emerging markets are double, triple and in some cases 10-fold those in the US and other developed markets. This trend was clearly evident as I listened to and reviewed transcripts from Q4 2012 earnings calls from Johnson & Johnson, Boston Scientific, and Medtronic.

While emerging markets continue to present significant growth opportunities, how can med-tech companies address the variety of needs and delivery models in these markets, while addressing increasing pricing pressures in developed economies?

To learn key strategies Med-Tech Executives are utilizing to push for growth in BRICs, click on this link to read the complete article.

This is an excerpt from our recently published article in MedicalDeviceSummit.

How can med-tech organizations minimize supply chain disruptions and increase predictability resulting from events characterized by rarity, high impact and low predictability?

Black Swan events once seemed extremely rare and had little or no impact on med-tech supply chains. In recent years, however, natural disasters including super-storm Sandy in northeastern US, the earthquake and tsunami in north-east Japan, flooding in Thailand, and the ash cloud from the Grimsvotn volcano in Iceland have all had significant impact on global supply chains.

This is an excerpt from our recently published article in MedicalDeviceSummit.

To learn how to mitigate the impact of “Black Swans” events on the Supply Chain, click on this link to read the complete article.

On this Manufacturing Geek podcast, Daniel R.  Matlis of Axendia, discusses his outlook on the issues and opportunities for Medical Device Manufacturing in 2013.

This podcast includes a discussion on:

• Emerging trends for Medical Device Manufacturers
• How the US and Global economies may impact manufacturing
• How manufacturers can adjust to the Medical Device Excise Tax
• Globalization and outsourcing
• Where medical device makers should focus in 2013

Listen to the podcast in Manufacturing Geek

To stay abreast of developments on FDA’s Unique Device Identification rule (UDI) and gain a deeper understanding of its impact on the Med-Tech Industry, patients and regulators, I have been speaking with Jay Crowley, Senior Advisor for Patient Safety, in the FDA’s Center for Devices and Radiological Health.  Mr. Crowley has responsibility for implementing the Unique Device Identification requirements.

The FDA recently issued the “Unique Device Identification System” rule for comment. UDI will require the application of “serial numbers” to most medical devices. In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. This set in motion a plan calling for “optimizing meaningful data collection and analysis.”

In this article, we discuss how UDI will allow FDA to optimize meaningful data collection and analysis to enable an integrated approach to Medical Device regulation.

Q. How will UDI impact the way FDA manages Medical Device information in the future?

A. UDI is integral to the future state that the agency is working towards. UDI is going to fundamentally change the way CDRH manages information about Medical Devices.  It will change the way that systems communicate with one another and the kinds of information that we collect in different systems.

Q. Will UDI drive changes to regulation, systems and processes at the Agency?

A. There’s a lot of work going on internally as well as with external organizations trying to understand the implications of UDI:   What other systems do we need to change?  What other regulations do we need to change - such as registration or listing, pre-market, or post market surveillance and product recalls?  We are actively looking to identify and understand the impact of UDI.

Q. How does the UDI program tie into FDA-wide initiatives and systems such as Sentinel?

A. The FDA team working on Sentinel has been intricately involved with UDI because without UDI we don’t have Sentinel for devices, it doesn’t exist.  So, they are anxiously waiting the implementation of UDI.  In addition, UDI can drive registries to tie all this information together and enable us to leverage the UDI database beyond the initial static Master Data perspective. We want to be able to integrate data from various sources, to evaluate whether  a particular product contains ingredient “X” or  ascertain some critical dimension.  We can then conduct research projects for Medical Devices and utilize analytics from information systems including Sentinel or Sentinel-like systems. Knowing that we are not going to have all of the necessary pieces of information prospectively, we have designed the system to allow us to add data to the UDI database in the future to answer public health questions.

Q. To support these efforts, do you plan to Integrate UDI with other FDA systems?

A. Our goal is to integrate our adverse event reporting so that someday in the future a reporter would be able to scan a UDI on the product label as they are reporting an event.   The event would automatically transfer relevant data to the electronic health record where that device’s UDI information would be stored.  In turn that ID would be transmitted from the device itself to a report and that report would then be transmitted to the FDA.

Q. What is the vision for this integrated approach?

A. In the ideal world, the vision would be that once FDA receives product information it would be bounced against our internal systems, like the recall databases or adverse event or pre-market, and we would be able to analyze all of that product’s information.

I look forward to future discussions with Jay Crowley and hope to provide additional insight based on our interactions.

It is worth noting FDA is seeking comment on this proposal until the end of October.

We have received very positive feedback from media outlets and industry executives on our Med-Tech Research report.

We also heard that it would be helpful to have an aid to navigate the vast amount of data available in the report.

To address this need, our research team has created this Info-Graphic to serve as a roadmap to navigate through the report. 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

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.