Axendia Launches Life Sciences Global Supply Chain Research Study

The globalization of manufacturing and supply of medical products has created unique and demanding challenges for the Life Sciences industry and the U.S. Food and Drug Administration alike.  In light of recent adverse events, Industry and regulators are preparing to take significant steps to secure the Global Supply Chain.

Axendia, Inc., today announced that it has launched a research study entitled, “Global Supply Chain Visibility and Security; Business Necessity, Regulatory Imperative”.   This research seeks to identify and analyze trends, requirements, and initiatives Life-Science companies are undertaking to gain deeper visibility and controls over Global Supply and Value Chains.

The study will focus on:

• Assessing current and desired states of Life Science supply chains
• Identifying key challenges facing global and outsourced ecosystems
• Outlining innovative strategies and system to enable and guide this transformation
• Provide a roadmap to achieve Global Supply Chain Visibility and Security

Axendia researchers will seek insight from industry leaders and regulators on innovative strategies and technologies, enabling supply chain visibility and security, risk mitigate, and increased business success.

The results of this study will be presented in a report detailing current and best practices in Global Supply Chain Visibility and Security in Life Sciences. The research report will include tables and charts supporting research findings. Axendia will conduct the study research, analysis and report, and retain full editorial control.

I recently had the opportunity to chat with Tom Lentz at The Johns Hopkins Hospital. Tom is Manager of IT and Finance for the Facilities Department at Hopkins.

During our discussion, I shared Axendia’s research and analysis on “Lowering the Cost of Healthcare from Inside Out”. We also discussed current pressures facing healthcare providers including the need to improve clinical outcomes and reduce costs, while ensuring compliance with a applicable regulations. In addition, the proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To respond to these new challenges, healthcare providers are seeking ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

During our session, Tom discussed how The Johns Hopkins Hospital uses its Integrated Asset and Service Management system to:

• Improve uptime to support patient care
• Control costs for procurement, maintenance, labor and materials
• Support regulatory compliance and reporting activities
• Improve internal controls with automated workflows
• Gain efficiencies by mobilizing asset management

You can participate in our conversation with Tom Lentz from The Johns Hopkins Health System, by attending our upcoming IBM / Axendia Webcast on May 18, 2010 at 9:00 AM PT / 12:00 PM ET.

To register visit: https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=201849&sessionid=1&key=76A9806CBA8B4D4E34E12787C2F454B3&partnerref=IBM02&sourcepage=register

This webcast is the second installment in our series “Lowering the cost of Healthcare from Inside Out”. You can view the inaugural webcast in this series on-demand, by visiting: http://LSP.axendia.com/2010/01/27/lowering-the-cost-of-healthcare-from-inside-out/

I hope you can join our discussion next week.

The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency’s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.

According to FDA Commissioner Margaret A. Hamburg, M.D. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day. This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects commissioner Hamburg’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. This budget also funds FDA’s new regulatory authority over cigarettes and other tobacco products.

According to the agency, four initiatives are the major highlights for the FY2011 budget increases:

Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

In our December 2009 article “What to Expect from FDA in 2010“ I stated that time would tell how the FDA’s current vision would affect industry and consumers. It is evident that through this budget request, Commissioner Hamburg is seeking the resources needed to achieve her vision for the FDA as a Public Health Agency. As she stated shortly after she took office, FDA’s role is to “Minimize Risks Through Education, Regulation, and Enforcement.”

The complete FDA FY2011 budget is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

Healthcare providers are under more pressure than ever to improve clinical outcomes and reduce costs, while ensuring compliance with a myriad of applicable regulations. The proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To meet these sometime divergent objectives, Healthcare providers must find ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

At the same time, healthcare administrators are looking for opportunities to maximize service delivery while managing the costs associated with these increasingly complex assets. Integrated Asset Management can help hospitals reduce costs, increase efficiencies and improve the quality of patient care.

To examine these issues and offer recommendations, IBM in cooperation with Axendia are proud to present a webcast entitled “Lower the Cost of Healthcare from the Inside Out”.

During this session, we discuss:

• Key business technology and regulatory trends facing the industry
• Ways to leverage the latest Asset Management solutions to improve care while controlling costs
• How healthcare organizations around the world have lowered the cost of healthcare from inside out using Asset Management solutions

To view this on-demand event, visit:
http://event.on24.com/r.htm?e=183331&s=1&k=E0A8E272CA5064F03BEDE54501F93BD5 

The FDA has initiated the process to amend its postmarket medical device reporting regulation (21 CFR Part 803) to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format.

The Agency currently processed and analyses approximately 100,000 initial individual MDRs on a paper FDA Form 3500A. According to FDA figures, shifting to mandatory eMDR would improve it’s process for collecting and analyzing postmarket medical device adverse event information.

The proposed regulatory changes would also provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. To support this, the proposed amendment to Part 803 includes modifications to the content of Form 3500A to better track information already required by FDA.

The implementation of the eMDR requirement is expected to reduce FDA annual operating costs by $1.25 million and generate industry savings of about $3.2 million.

The FDA has also issued a draft guidance document to assist industry and provide recommendations the preparation and submission of eMDRs in a manner that satisfies the requirements of the proposed regulation.

On January 26, 2010, Sparta Systems will be hosting a Seminar on eMDR at the Chicago Marriott O’Hare, in Chicago IL.

This seminar will address how medical device manufacturers can plan and prepare for a successful transition to electronic adverse event reporting. It will provide an overview and status report of the FDA’s Center for Devices and Radiological Health (CDRH) guidance, explore eMDR best practices and a successful eMDR implementation case study.

During the seminar, Axendia will provide an overview and status update on key initiatives driving FDA’s shift to eMDR. The discussion will cover background of the regulation and FDA guidance for eMDR implementation.

Ortho Clinical Diagnostics will discuss the challenges their company faced when planning for and designing transition to eMDR. They will then discuss best practices and lessons learned based on his successful eMDR implementation.

To learn more about this eMDR seminar and for registration information visit: http://www.spartasystems.com/media-center/seminars/preparing-for-emdr/

As part of the FDA’s transparency initiative, the agency seeks input from its constituents on whether inspectional observations reports (form 483) should be re-designed to make inspection findings available to the public quickly.

Form FDA-483 lists observations made during the inspection of a firm. Responding to Freedom of Information Act requests for 483s, often takes a lot of time due to the need to redact non-public information, such as trade secret and confidential commercial information, from the report.

The Agency is seeking to streamline the process required to make 483 findings available. To this end, FDA would like to re-design the inspection reports (483s) to include a summary or key findings page that could be made available to the public quickly. FDA would still review the full inspectional observation reports to redact any non-public information. 

To provide input to the agency on the re-design of Form 483, visit:  http://bit.ly/7ytaHG

Last month’s article in Life-Science Panorama entitled “Hospitals & Medical Device Manufacturers Address Interoperability with New Standard” discussed the emergence of standards and regulations around communications involving medical devices.  The article  offered what was to me a surprising claim:  “The use of these networked medical devices in a clinical context … will soon be subject to national or regional regulations [and] may not be marketed without evidence of interoperability, that is, they must not compromise the organization’s delivery of health care.” 

Having been involved with medical device interoperability standardization efforts for over a decade and watched approaches to the problem and players interested in it come and go as time went by, not much actually surprises me anymore.  But it’s quite a leap and a bit of a shock to go from “evidence of interoperability” to “[not compromising the] delivery of health care.”  Strictly speaking, interoperability is about the capability of devices to communicate with each other and make use of the shared data and nothing else.  Other properties will arguably play greater roles in assuring system integrity, e.g., reliability, usability, maintainability, availability, etc.  Interoperability is not synonymous with risk management, nor does it guarantee it. 

Still, I agree that draft standard IEC 80001 “Application of risk management to information technology (IT) networks incorporating medical devices” is expected to play a key role in assuring the system integrity necessary to realize the visions that interoperability is expected to enable.  But is IEC 80001 sufficient?

“I pose the following to clinical engineers and biomedical equipment technicians: “What would make you comfortable with supporting a request to implement aspects of critical care device functionality on an IT network?” Would being told that the network had been designed and installed according to relevant process and standards be sufficient? Or … evidence that the result of application of the processes and standards addressed functional and non-functional requirements relevant to critical care.   How much evidence do you need to support an argument that worst case failure of an ICU monitoring system … could not place a patient, or hundreds of patients, at unacceptably increased risk?” [1]

It is notable that that the risk management principles of IEC 80001 are largely inherited from IEC 14971, a more general and process-based medical device risk management standard that has primarily been applied to stand alone devices and system from single manufacturers. 

“Imagine the implications as medical devices increase their use of and dependence on networked resources, particularly in light of the rate of change and heterogeneity of clinical applications and systems implementations. This begs the question of whether anyone has examined, let alone established, the validity of extrapolating 20th-century medical technology development, assessment, and regulatory practices for the 21st-century healthcare system.” [2]

There is not enough space here to do justice to addressing the implications of the above, but for anyone interested I recommend the National Academies Press’ Software for Dependable Systems: Sufficient Evidence?, which argues:

“…the pursuit of dependability in software systems should focus on the construction and evaluation of evidence…software is guilty until proven innocent…This approach is…becoming standard in the world of systems safety, in which an explicit safety case…is  usually required… …a software system may not be declared “dependable” based
on the method by which it was constructed…Those claiming dependability for their software should therefore make available the details of their claims, criteria, and evidence…The willingness of a supplier to provide such data, and the clarity and integrity of the data that the supplier provides, will be a strong indication of its attitude to dependability”

In other words, for sufficiently complex technology, good process alone is insufficient to ensure safety and dependability.  So again I ask:  Granted that 80001 is necessary, but is it sufficient? 

1. R Schrenker, “Sufficient Evidence – Making the Case for Safety”, Biomedical Instrumentation and Technology, November – December 2008.
2. R Schrenker, “Learning from Failure – The Teachings of Petroski”, Biomedical Instrumentation and Technology, September – October 2007.

The opinions expressed in this article are those of the author(s) and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

An increasing number of medical devices are designed to exchange information electronically with other equipment using information technology networks (IT-networks) that transfer data ranging from life-critical patient parameter requiring immediate delivery and response, to general administration data and even emails containing malicious contents such as viruses.

The use of these networked medical devices in a clinical context is (or will soon be) subject to national or regional regulations.  Under these regulations, Medical devices may not be marketed without evidence of interoperability, that is, they must not compromise the organization’s delivery of health care.

To facilitate compliance with these requirements, a new standard is being launched under the auspices of the International Electrotechnical Commission (IEC) in collaboration with the International Standard Organization (ISO).  The IEC 80001-1 “Application of risk management to information technology (IT) networks incorporating medical devices” provides a framework with defined roles and responsibilities for Hospitals (called: responsible organizations), Medical Device Manufacturers and IT Suppliers to ensure the safety, effectiveness of data and system security.

On July 31st 2009 the draft International Standard IEC 80001-1 “IT Networks incorporating Medical Devices” has been published for international vote.

The standard requires the following items be addressed:

• Risk management techniques should be used before installing or connecting a medical device into an IT-network the first time as well as during the entire life cycle where a medical device is used in this context.  Aspects of removal, change or modification of equipment, items or components are addressed adequately in the same way.
• Proper design and evaluations should be conducted before the connection or removal of a medical device or other networkable components into an IT-network.  In most cases, this is out of the control of one single medical device manufacturer, and therefore the responsibility of the hospital or healthcare provider.
• The manufacturer of a medical device intended to be incorporated into an IT-network is responsible for providing relevant information about that medical device to enable the responsible organizations to manage the risk according IEC 80001-1.
• A mutual responsibility agreement shall be executed establishing clear roles and responsibilities among the parties engaged. The responsible organization is required to appoint resources to specific roles defined in this standard.  The most important of those roles is a new profession called MEDICAL IT-NETWORK RISK MANAGER. This role may be assigned to appropriate personnel within the responsible organization or to an external contractor.  The medical IT-network risk manager is responsible for ensuring that risk management is applied to address the “key properties”:
  • Safety & Effectiveness
  • Data & System Security

The new Standard IEC 80001-1 will affect Hospitals as well as IT & Medical Device providers.  If the Standard passes the international vote in 2010, it will be published before the end of that calendar year.  

To increase awareness about the standard and its impact on stakeholders, Oracle & PROSYSTEM AG will be hosting the 2nd International Symposium on this topic on September 22-23, 2009 in San Jose, California.  For additional information on the conference visit:

http://www.prosystem-usa.com/index.php?option=com_content&task=blogsection&id=4&Itemid=31

The views expressed in this article are those of the authors and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

Mr. Oliver P. Christ, Dipl.-Ing. is CEO Healthcare of PROSYSTEM AG an international consulting company for the Healthcare Industry providing multiple services concerning Risk-Management, Quality Assurance Software Validation and Usability Engineering. The company PROSYSTEM AG was founded by Mr. Oliver P. Christ together with his business partner Dr. Juergen Stettin in 1999 and is located in Hamburg, Germany having an US-based office in San Diego, California.Mr. Oliver P. Christ has been active in International Standardization for more than 19 years. In Germany he is Chairman of four National Committees two on “Human Factors / Usability for Medical Devices”, one on “Risk-Management for Medical Electrical Equipment” as well as for “Software for Medical Devices and Networked-Medical Systems”. He represents Germany within International Standard Committees on Programmable Electrical Medical Systems (since 1992), Human Factors (since 1996), Risk Management (since 1996) Software Life Cycle Processes (since 2002), and Risk-Management for IT-networks incorporating Medical Devices (2006).

He can be reached via email at: oliver.christ@prosystem-ag.com

FDA’s or Industry’s Responsibility?

 During my opening remarks at the 4th Annual Manufacturing Execution System in Life-Sciences Conference, I discussed FDA’s proposed budget increase of 166 Million Dollars and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight.

The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike.  Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time.

In the complex and ever-changing environment driven by globalization, license holders and regulators must seek out new approaches to ensure the safety of medical products.  

The Industry’s Role:

In his Keynote, Gerald Migliaccio, Pfizer’s Vice President of Quality, EHS and Agility - Pfizer Global Manufacturing, addressed Supply Chain Security from an industry perspective.

“Supply chain security is the responsibility of all parties involved in procurement, sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product,” commented Mr. Migliaccio.  “Ultimately, the marketing authorization holder(industry) is responsible for assuring that all parties in the supply chain fulfill their responsibilities for delivering safe and effective medicines to customers” he added.

According to Mr. Migliaccio, strong supply chain security strategies benefits both patients and industry by:

• Preventing Adulteration
• Preventing and Detect Counterfeits
• Preventing Product Diversion

These strategies should include the following key elements:

• Financial viability of business partners throughout supply chain
• Ethical Business practices throughout supply chain
• Physical security
• Container/freight movement security
• Personnel security

Supply Chain Quality Systems:

• Supplier / contractor evaluation and selection
• Supplier / contractor management and oversight
• Supplier / contractor management of their supply chain

Counterfeit Prevention:

• Overt measures
• Covert and semi-covert measures
• Forensic covert measures
• Counterfeit Detection
• Surveillance programs
• Support for Law Enforcement agencies

Business Intelligence: 

• Proactive analysis of pricing and supply trends to predict potential areas of criminal activity

Internal and External Collaborations:

• Cross-functional collaboration between manufacturing, quality, security, logistics, marketing and others to drive Supply Chain Security efforts
• Industry collaboration through PhRMA, EFPIA, ISPE, and industry coalitions, such as RX-360
• Collaboration with suppliers, contract manufacturers, transporters and distributors
• Collaboration with Law Enforcement and Regulatory Authorities

The Agency’s Role: 

For its part, the FDA plans to increase its oversight of the Supply Chain to ensure safety and security.  This will prevent harm to the public by achieving greater compliance with safety standards, detecting and correcting safety risks.

• FDA is proposing a budget increase of $166,433,000 and 346 FTEs to improve medical product Supply Chain Safety and Security.
• FDA will increase medical product safety and security by enhancing oversight of entities in the supply chain.
• FDA will use traditional and innovative mechanisms that include FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities.

YARDLEY, PA. and WOBURN, MA., July 15, 2009  — Axendia, Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives in the pharmaceutical and biotech industries, today announced that Christine Moore, Ph.D. Deputy Director,Office of New Drug Quality Assessment, CDER, FDA will provide the Keynote Address at the 4th Annual Manufacturing Execution System Congress.

Dr. Moore’s address will provide an Update on the Agency’s Implementation of Quality by Design including:

• History of Quality-by-Design (QbD) and update on ICH guidance and major initiatives
• FDA experience with New Drug Applications (NDAs) including the CMC Pilot program
• Considerations for QbD submissions and applications
• Scientific and regulatory gaps in implementing QbD

“FDA initiatives such as Quality by Design (QbD) and Total Product Lifecycle (TPLC) management provide a springboard for Life-Science organizations to speed innovation, improve quality and lower costs while supporting compliance to regulatory requirements,” commented Daniel R. Matlis, returning Congress Chair and President of Axendia.  “Manufacturing Execution and other Operational systems play a foundational role on the road to QbD and TPLC, enabling forward thinking Life-Science Organizations to meet and surpass today’s challenges,” added Matlis.

“We are delighted to have leading industry companies, including Eli Lilly, Pfizer, Wyeth, Merck, Abbott, Bristol-Myers Squibb, Cordis-Johnson&Johnson, and Biotronic sharing experiences and best practices at the congress” commented Sharon Langan, Senior Program Manager for The Center for Business Intelligence. “This is the premier event for lean manufacturing and manufacturing execution systems in the pharmaceutical, biotech and medical device industries,” added Langan.

Constituents at the congress discuss current approaches to maximize MES returns and improve quality, manufacturing efficiency, and control while meeting increasing regulatory requirements
For detailed information about the 4th Annual MES for Life Sciences Congress visit www.cbinet.com/mes

About CBI Research, Inc.
Founded in 1994 in Massachusetts, CBI Research, Inc. is dedicated to developing market-driven, unbiased conferences in pharmaceuticals\biotech, medical devices, risk and insurance and managed care markets. CBI Research, Inc. offers conferences and summits that serve senior executives and government officials by providing a unique platform for highly focused content and presentation. As a delegate, speaker or sponsor, you receive timely information on the latest investment opportunities, business strategies, domestic and international regulatory issues, operations and applied technologies. Our events provide you with concrete, real life examples that you can begin to apply at your organization immediately for significant impact on costs and revenue. Plus, there are extensive opportunities for networking and discussion with senior policy and decision makers. Additional information on CBI Research can be found at www.cbinet.com

About Axendia, Inc.
Axendia is a leading analyst and strategic advisory firm focused on the Life-Sciences and Healthcare markets. We provide trusted advice to Life-Science 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 Life-Science Eco-System including Life-Science 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 ever-changing landscape in the Life-Sciences and Healthcare markets. For more information, visit www.axendia.com or contact us at info@axendia.com. To stay informed on Industry trends, read Axendia’s Life-Science Panorama, a Journal for Industry Executives, at http://lsp.axendia.com