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Last week, Google announced that it will discontinue its Google Health service citing lack of adoption and broad impact.

According to Google’s statement: “When we launched Google Health, our goal was to create a service that would give people access to their personal health and wellness information. We wanted to translate our successful consumer-centered approach from other domains to healthcare and have a real impact on the day-to-day health experiences of millions of our users.

Now, with a few years of experience, we’ve observed that Google Health is not having the broad impact that we hoped it would. There has been adoption among certain groups of users like tech-savvy patients and their caregivers, and more recently fitness and wellness enthusiasts. But we haven’t found a way to translate that limited usage into widespread adoption in the daily health routines of millions of people. That’s why we’ve made the difficult decision to discontinue the Google Health service…

In the end, while we weren’t able to create the impact we wanted with Google Health, we hope it has raised the visibility of the role of the empowered consumer in their own care. We continue to be strong believers in the role information plays in healthcare and in improving the way people manage their health, and we’re always working to improve our search quality for the millions of users who come to Google every day to get answers to their health and wellness queries.”

For its part, Microsoft has recently registered with FDA as a Medical Device Manufacturer and listed HealthVault as a Class 1 Medical Device.

It is worth noting that Microsoft’s official correspondent with the Agency is Dr. Donna-Bea Tillman, Director of Regulations and Policy, Microsoft Health Solutions Group. Dr. Tillman is the former Director of the Office of Device Evaluation at FDA.

According to the FDA half of all medical devices used in this country are imported, while 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.

In the last seven years, imports of pharmaceutical products have increased nearly 13% and devices have grown at over 10%. Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, corresponding to a 15% growth rate.

On June 20, 2011, the United States Food and Drug Administration unveiled a new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain.

“Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

“FDA has been a domestic agency that works in the international world,” commented John M. Taylor, J.D., Acting Principal Deputy Commissioner of Food and Drugs. “What we need to do is transform ourselves into a global agency that is able to work all around the world and address product issues as they arise all over the world and we need the authority to allows us to do that,” added Taylor.

To detail this transformation, the Agency issued a special report, “Pathway to Global Product Safety and Quality”

According to the report, FDA’s international operating model will rely on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.
The new approach will rest on four core building blocks:

1. FDA to partner with its counterparts worldwide to ensure and improve global product safety and quality
2. FDA and its partners to develop an international data information systems and networks to promote the sharing of data and regulatory resources.
3. FDA to develop additional information gathering with an increased focus on risk analytics
4. FDA to leverage the efforts of third parties and industry and apportion FDA resources based on risk.

Many of these issues were detailed in Axendia’s Research Report entitled “Global Supply Chain Visibility, Control & Collaboration: Business Imperative, Regulatory Necessity.”  The research report encourages Brand Owners to implement Global Supply Chain strategies to capitalize on the benefits of globalization and outsourcing while proactively reducing and controlling risks.

Request a copy of the report at:  http://www.axendia.com/2010_LS_GSC.html

Leading Life Science and Healthcare organizations, including Sanofi-Aventis, Duke Clinical Research and Telerx Marketing reported first-hand accounts of their experience with Microsoft SharePoint® -based solutions in a White Paper released today by the analyst and strategic advisory firm Axendia, Inc.  (Read the Press Release at: http://www.prweb.com//releases/2011/6/prweb8582485.htm )

To produce this White Paper, Axendia conducted one-on-one interviews with Life Science and Healthcare stakeholders currently using Microsoft SharePoint-based solutions within their organizations.

“As we conducted one-on-one interviews with key Life Science and Healthcare stakeholders, distinct themes emerged,” commented Daniel R. Matlis, President of Axendia. “IT Professionals touted its ease of deployment and integration with enterprise systems, Process Owners praised the ease of configuration and intuitive interface, while Compliance Professionals liked the ability to manage validation activities by utilizing a platform approach,” he added.

According to research participants, SharePoint provides a strong foundation that enables Life Science and Healthcare organizations to configure functionality and add Off the Shelf modules from a network of independent software vendors. This approach enables them to meet the requirements of a wide variety of users across the ecosystem. Research participants report that SharePoint-based solutions have been adopted across the Life Sciences and Healthcare ecosystem. These solutions support several functional areas including research & development, quality management, manufacturing & operations, clinical data management and customer service.

Findings from this research are available today in a new Axendia White Paper titled: “The State of SharePoint In Life Sciences and Healthcare.”

To request a copy of the White Paper, please visit www.axendia.com/SP-HCLS-WP.html