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By Daniel R. Matlis

Innovation is the lifeblood of the medical device industry. Managing the Total Product Life Cycle (TPLC) could enable medical device manufactures to lower costs while increasing quality. 

To determine the industry’s adoption of a Total Product Life Cycle approach, as advocated by FDA, Axendia ™ , in cooperation with Cambashi and FDAnews launched a major research project.
This study entitled, Managing the Total Product Lifecycle: Lowering Costs While Increasing Quality, will examine the transformation from waterfall processes to more concurrent and collaborative processes. 

This study will:

• identify major challenges associated with managing the Total Product Lifecycle
• uncover the transitional issues facing medical device organizations and their ecosystem, including globally distributed production, outsourced operations, suppliers, distributors and trading partners
• describe innovative strategies, best practices, and technologies that medical device companies should consider to achieve quality and cost benefits
• characterize the current state of the medical device industry and provide insight into how industry leaders are meeting today’s challenges

 To be a part of this important industry research and share your perspectives on Medical Device trends, complete the survey by clicking on the link below:

http://www.surveymethods.com/EndUser.aspx?E6C2AEB0E0A6B0BD  The survey will be open from April 2 until April 14th. 

Note: Individual responses will remain strictly confidential.

Survey respondents will receive the final report as an aid to enable their transformation from disconnected “silo” processes to holistic end-to-end product approaches, plus valuable related reports. 

The results of this survey will be released at the Sixth Annual Medical Device Quality Congress June 3-5 in Cambridge, MA in a special session on the research, Managing the Total Product Lifecycle:  Lowering Costs while Increasing Quality.  This research ties in closely with this year’s conference theme, “Leading the Way to Better Performance With Quality Systems Compliance”. 

To learn more about this research visit: http://axendia.com/blog/managing-the-tplc/

The research is co-sponsored by five companies – all of which are active in the Medical Device industry.  These companies provide deep and diverse expertise in medical devices practices and provide design, product lifecycle management, production, quality, and related software and services to the industry as well as management consulting services to leverage applications appropriately.  Working together, these underwriting sponsors hope to increase the medical device market’s understanding of how to reduce risks and improve compliance and profitability. 

Research Sponsors for the study are: management and technology consulting firm BearingPoint (www.bearingpoint.com), enterprise manufacturing and quality software provider Camstar Systems (www.camstar.com ), product lifecycle management (PLM) software innovator Dassault Systèmes Enovia (www.3ds.com) with its medical device industry PLM partner Integware (www.integware.com), and PLM and enterprise content management software provider PTC (www.ptc.com).

The analysis and report will be prepared by Axendia and Cambashi, which retain full editorial control.

By Daniel R. Matlis  

Today, we are pleased to announce the availability of findings from our research study on “Quality Management System trends in Life Sciences”.This research study, sponsored by Camstar, identified the impact of current Quality Management System (QMS) implementations in the Life-Sciences industry and their effects on product quality, regulatory risk and adverse event exposure across the global enterprise. 

Over 125 companies, covering small, mid-size, and Fortune 100 Life-Science organizations participated in the study. They represented the full spectrum of medical device, pharmaceutical, biotech and diagnostic organizations. The study revealed that many Life Sciences companies are employing reactive approaches to quality, using QMS primarily to manage and document compliance to FDA regulations. This compliance-first philosophy seems to be an obstacle to achieving real, long-lasting quality gains. Quality does not result from simply meeting regulatory requirements. Rather, compliance should be a natural outcome of executing well defined and understood processes.

We are sharing in-depth findings, analysis and conclusions from this research study in a Research Alert and a series of online Executive Briefings.To read the Research Alert and view the first Executive Briefing in our series click on this link: http://lsp.axendia.com/qms-trends/

The “Quality Management System trends in Life Sciences” research study was sponsored by Camstar Systems.

© 2009 Axendia, Inc. All Rights Reserved. Reproduction and distribution of this publication in any form without prior written permission is forbidden. The information contained herein is a result of primary research conducted by Axendia and has been obtained from sources believed to be reliable. The opinions expressed herein reflect the information available at the time of publication and are subject to change without notice. 

 

 

The FDA is currently shifting its organizational and technology infrastructures to facilitate electronic interactions with the companies it regulates.

Results from this Axendia research, commissioned by MasterControl, are now available in a Whitepaper entitled: The Future of the FDA: Operating in an “Electronic World”

This Whitepaper details FDA’s movement to electronic interactions and is based on interviews with key FDA officials who shared major transformational activities that:

• Promise to usher in a new era of electronic interactions between the FDA and its constituents 
• Move towards working in an environment where all regulated product information comes in electronically, whether it be product quality, manufacturing, pre-market, or post market data

To download The Future of the FDA: Operating in an “Electronic World” Whitepaper and read the accompanying FDA’s e-Transformation Initiatives article series visit: http://lsp.axendia.com/fda-e-transformation-study/

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

Highlights from Axendia’s FDA e-Transformation Study - Part III

By Daniel R. Matlis

In this series of articles, we are sharing key insights and conclusions from our “FDA e-Transformation Initiatives” research study. 

In Part One of this series, we shared our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics. Part Two, highlights four key findings from this study.
 
To read the complete series visit: http://lsp.axendia.com/fda-e-transformation-study/

FDA’s Target Enterprise Architecture

In this, our third installment, we report on the FDA’s Target Enterprise Architecture

To meet its e-Transformation objective, the Agency is poised to deploy a new Target Enterprise Architecture (EA). FDA’s EA is part of the Health and Human Services (HHS) Enterprise infrastructure

This initiative provides a standard approach to strategize, architect, invest and implement a business-driven plan to achieve the desired end-state. 

The Target Enterprise Architecture (EA) provides FDA with a business-driven plan that describes the desired end-state for its business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.

 

The primary purpose of the Target EA is to effectively plan a course for achieving the FDA’s strategic vision and goals. It is one element in a broader set of interrelated activities that collectively enable the FDA managers and staff to define a vision, develop strategies and plans for achieving the vision, make resource decisions, implement strategies and evaluate performance.              

By defining the end-state from several distinctive perspectives (e.g. business, data, etc.), the Target EA will also provide stakeholders with a view into the complex relationships that exist among these different perspectives.  For example, the Target EA will provide insight into how a particular need translates into a set of target FDA business processes, and how those business processes will be supported by a common set of technologies.

Specific objectives of the FDA’s Enterprise Architecture are to:

Improve Program Performance
The overarching benefit of the Target EA is that it provides opportunities to improve the efficiency and effectiveness of the FDA’s programs. It ensures that data is optimized in support of the business, and applications and technology solutions are driven by business needs. It also allows FDA to more readily share services/data across organizational and functional lines.

Improve Interoperability
The Target EA establishes enterprise-wide standards that promote platform and vendor independence, enabling greater interoperability across disparate applications, both internal and external.

Improve Utilization of Resources
The Target EA reduces system development and operation and maintenance costs by eliminating duplicative investments, promoting sharing of common services, and establishing Agency-wide standards.

Accelerate System Implementation
The Target EA equips the Agency’s system developers and architects with an inventory of component-based services from which to choose that provide well defined functionality, thus maximizing reuse and portability of previously developed processes, components, code, etc.

Simplify Investment Decisions
The Target EA provides a view from strategy to business function to technology, allowing decision-makers to be able to more quickly assess the relative value of initiatives, and to identify duplicative and misaligned initiatives.

FDA’s Target Enterprise Architecture will provide a concrete framework on which to build solid applications. Figure 2 provides a detailed list of initiatives currently underway to modernize the agency’s infrastructure.

 

 

 

 

The FDA has an ambitious plan to transform the way it interacts with its constituents.  Thorough planning and a solid foundation are critical to the success of this transformation.       

I think Dr. Donna-Bea Tillman, Director of the Office of Device Evaluation CDRH, said it well. “We don’t want to pave the cow-path. The real promise of Electronic Review lies beyond simply receiving submissions in electronic format”     

 

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

 

 

 

Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.           

Highlights from Axendia’s FDA e-Transformation Study - Part II

By Daniel R. Matlis

In this series of articles, we are sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study.  

We began the “FDA e-Transformation” series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics, to understand the Agency’s rationale and strategy for e-Transformation.  We also discussed how the FDA is pursuing a future where all regulated product information is electronic.

(To read the first article in the series, click on this link: FDA Pursuing a Future Where All Regulated Product Information Is Electronic )

In this installment of the “FDA e-Transformation” series, we highlight four key findings from this study:

• FDA’s e-Transformation drivers
• A new organizational e-Structure
• Don’t want to pave the cow-path
• Building  on a strong foundation: open-consensus based data standards

FDA’s e-Transformation drivers

Historically, interactions between FDA and the companies it regulates involved the creation, printing and delivery of volumes of paper documents. These documents may have been delivered as part of an application or reviewed onsite in the course of an inspection.

Over the last few years, FDA and the industry have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations.

A new organizational e-Structure

At the center of the agency’s e-transformation is the “Bioinformatics Board” (BiB).

The FDA established the BIB in order to achieve its goal for a modern, well-integrated, reliable, efficient and affordable information infrastructure to support the Agency’s administrative and regulatory business operations.

The BiB reports directly to the FDA Management Council.  The Board, in coordination with the Office of Information Management (OIM) determines the information management (IM) strategy for the agency.

 

 

 

 

    

      

•  The BiB works under a strategic framework for automation established by the Commissioner and implemented by the FDA Management Council. 
• The BiB coordinates and oversees all activities and decisions related to business automation planning, acquisition, and implementation throughout FDA, and ensure that the activities related to its charge are communicated to all levels of the Agency.
• The BiB also ensures coordination of activities among FDA representatives particularly with regard to business process planning and regulatory policies. These include the FDA Regulation Policy Council, the FDA Data Standards Council, and the Enterprise Architecture Review Board,.  The BIB also interacts with other federal health informatics initiatives such as the Federal Health Architecture program.

“We don’t want to pave the cow-path”…

…“The real promise of Electronic Review lies beyond simply receiving submissions in electronic format” commented Donna-Bea Tillman, Ph.D, Director of the Office of Device Evaluation CDRH.

The Agency is poised to provide a new target Enterprise Architecture (EA). This Target EA will provide a business-driven plan that describes the desired end-state for the FDA’s business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.

The primary purpose of the Target EA is to effectively plan a course for achieving the FDA’s strategic vision and goals. It is one element in a broader set of interrelated activities that collectively enable the FDA managers and staff to define a vision, develop strategies and plans for achieving the vision, make resource decisions, implement strategies and evaluate performance.

By defining the end-state from several distinctive perspectives (e.g. business, data, etc.), the Target EA will also provide stakeholders with a view into the complex relationships that exist among these different perspectives.

Building on a strong foundation: open-consensus based data standards

The FDA recognizes the importance of, and is committed to using open-consensus based data standards for regulatory submissions.

 

 

 

 

              

FDA divides data standards into two broad categories: exchange standards and terminology standards.  

• Exchange standards provide a consistent way to exchange information between organizations and computer systems. Exchange standards help ensure that the sending and the receiving system both understand unambiguously what information is being exchanged. For example, Structured Product Labeling (SPL) is an exchange standard for product information.
• Terminology standards, on the other hand, provide a consistent way to describe concepts. For example, the Unique Ingredient Identifiers (UNII), developed by FDA, provides a consistent way to describe substances in foods and drugs.

The agency is putting its money, where its mouth is

In November 2008, the FDA announced the award of up to $2.5 Billion in contracts to Modernize Information Technology over the next ten years. This award supports the cornerstone of FDA’s Information Technology and Bioinformatics initiatives, which include extensive IT modernization programs encompassing data management, data warehousing, IT infrastructure and IT security.

The benefits of FDA’s e-transformation could be “game changing”. Imagine conducting a label negotiation in real-time with FDA review staff, being able to cooperate and mark up documents in real time, or the possibility of reviewing SOPs and Batch record electronically with an investigator.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com   

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

 

Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia. 

Highlights from Axendia’s “FDA e-Transformation” Study

By Daniel R. Matlis

Axendia has recently completed a research study on FDA’s e-Transformation Initiatives. The study identified key organizational and technology initiatives the Agency is undertaking to advance ongoing electronic communication and interactions with the companies it regulates.

We will be sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study in a series of articles.  

To understand the Agency’s rationale and strategy for e-Transformation, we begin this series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics.  During our conversation, Dr. Oliva discusses transformational activities that promise to usher a new era of electronic interactions between the Agency and its constituents. 

The Janus Initiative

In Roman mythology, Janus was the god of gates, doors, doorways, beginnings and endings.  He was frequently used to symbolize change and transitions such as the progression of past to future, of one condition to another, of one vision to another.

This is a very fitting name, based on FDA’s intent for the Janus Initiative.

Axendia’s Life-Science Panorama Journal (LSP): What is the FDA’s Janus Initiative?

Dr. Oliva: Janus is a high level strategy to better manage structured scientific data for all FDA regulated products. Janus is an Agency-wide initiative to be used by all the centers at the FDA.

A key goal for Janus is to standardize data as they come in though the FDA’s electronic submission gateway.

The initial phase of Janus is to build a study data warehouse to host subject level data about clinical trials.

LSP: How will the Janus initiative impact electronic interactions between FDA and the companies it regulates?

Dr. Oliva: The goal for Janus is to provide a single repository for study data.  Sponsors would submit study reports as well as the data sets of the study used in human trials (be it a drug, biologic, device trial).

Janus will also provide standard modern and user friendly visualization, data mining and analytics tools. These tools will enable FDA to analyze data not only within a particular study, but across studies and applications as well as perform comparative analyses be it across multiple devices in the same therapeutic class or drugs across pharmacological class.
Janus will enable the FDA to:

• Establish an enterprise-wide data architecture and standards that facilitate the integration of structured scientific data from a wide variety of internal and external sources to create large-scale data-sharing infrastructures to support clinical trials, post-marketing, registration activities, and manufacturing life-cycle activities;

• Develop the standards-based scientific data exchange networks that are needed to ensure the quality, safety, and efficacy of medical and consumer products as defined by FDA’s regulatory mandate;Create structured scientific data repositories that support the acquisition, validation, integration, and extraction of data from the increasingly large and complex datasets received by the Agency;
• Make use of enhanced analytical, mathematical, visualization, and other computational tools and techniques that enable reviewers to search, model, and analyze data to conduct better safety and efficacy analyses.

LSP: Today, FDA Centers use different structures and formats for their applications, how will Janus work with these differing formats?

Dr. Oliva: Regardless of how the data come into FDA, (e.g. NDA, BLA, PMA) every center and each application type will have its own structure and format, but the study data will look the same across all the centers once standardized.  The Agency is relying very heavily on standards from organizations such as CDISC and HL7.
 
LSP: What is FDA’s involvement in the development of these standards?
 
Dr. Oliva: FDA is actively involved in the development of standards. We want these standards to be useful, not just for FDA, but for the regulated industry. Standards should meet industry’s business needs and processes so that they work for everybody not just FDA.

These Standards must support electronic reporting of information utilizing common variable name and, terminology code lists of observations. The standards must be flexible enough to model or represent study data that is generated across different studies type, whether it be for a device, drug, biologic or dietary supplement.

The Agency is also working on global applications harmonization with organizations like ICH and GHTF.

LSP: We can’t discuss Electronic interactions between industry and the FDA without touching on Part 11. How will FDA incorporated part 11 into some of the initiatives we have been discussing?

Dr. Oliva: Part 11 is very much in a state of flux. Part 11 only provides for voluntary submission of electronic data. In other words, companies may chose to submit electronically instead of paper, but we still receive study data on paper, and study data submitted on paper is very difficult to review.

Part 11 is not adequate to support Janus. We are proposing new regulation to require electronic submission of study data in a standardized format. The first application of the proposed rule we already announced would cover studies on drugs and biologics.

The long term goal is for all study data across the entire Agency to come in electronically and in a standardized format.

To realize the Janus vision, FDA must require all Industry/Agency interactions be electronic and that’s where additional regulation beyond Part 11 would be required.

LSP: What does the future hold for electronic interactions between FDA and Industry?

Dr. Oliva: I think it’s fair to say that Agency is actively moving toward an electronic world where all regulated product information comes in electronically. I couldn’t tell when that is going to happen, but certainly there are active discussion underway to move to an all electronic submission environment for all FDA regulated product information whether it be, Product quality, Manufacturing, Pre-market, Post market data.

Janus promises to usher a new era where interactions between the agency and its constituents (i.e. industry, and consumers) will be conducted primarily through electronic means.

The promise of electronic interaction would benefit everyone, but “the proof is in the pudding”.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc. 

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.

Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.

Issues for the Supreme Court to Consider - Part II

 By:Iana DeSouza, Esq. and Judith Meritz, Esq.

On November 3rd 2008, counsel for Wyeth Pharmaceuticals and for Vermont resident Diane Levine presented oral arguments to the Supreme Court of the United States. 

In Part One of this series, we covered the key issues the Supreme Court will need to consider in this case. Specifically, whether the FDA or a Jury should determine Drug Safety Standards? 

Part Two of the Wyeth v. Levine series covers issues the Supreme Court may consider in light of the election of President-elect Obama and the state of the US economy.

The Obama Paradigm of Information and Patient Safety

On January 20, 2009, President-Elect Barack Obama will be sworn in and will focus on using technology to manage information, requiring full transparency regarding quality of care and promoting patient safety.  According to Obama’s plan to lower health care costs for Americans, the Obama administration is expected to spend $10 billion dollars over the next 5 years on Health Care Information Technology.

Preparing for this Obama paradigm of information and patient safety, the Court may decide that Wyeth did not do all that it could have to utilize available information regarding the drug’s risks to ensure patient safety. The Court may decide to hold Wyeth out as an example, to the community of  pharmaceutical and health care providers of a company that failed to adequately protect patients due to its delinquent  use of information. As  Levine argued in her brief, possibly, Wyeth knew of the serious risks and could have added a stronger warning or instruction against the IV-push injection method even after the drug was approved by FDA. If the Court agrees that Wyeth had access to greater specific information about Phenergan and the IV push method than the FDA, then the Court may find Wyeth responsible for Levine’s amputated arm. Moreover, since Wyeth is responsible for drafting the label on the drug, the Court could also decide that ultimately it was Wyeth’s responsibility to strengthen the warning even absent a mandate from the FDA to do so.

However, the Court may instead accept Wyeth’s response that it complied with all of the laws and regulations by disclosing to the FDA all of the information in its possession. Moreover, Wyeth relied on the FDA’s concurrence that the warnings were adequate. Wyeth complied with FDA’s instructions to include prominent warnings that IV administration required extreme care or gangrene requiring amputation was likely to follow. The Court may find that Wyeth did all it was required to do to prevent patients from suffering any harm. The Court may agree that it would be unreasonable to expect Wyeth to go above and beyond the required FDA standard safety warnings since the FDA, currently, is the ultimate standard for drug approvals.

Can the Current U.S. Economy Afford More State Claims?

Moreover, as Levine’s counsel asserted in their brief, permitting state actions would incentivize drug manufacturers to stay abreast of all potential injuries stemming from their products. However, how much would this cost? If Wyeth was responsible to protect against every potential harm that could result from its drug, how much more would that cost the drug companies to research, manufacture and market these drugs? How much more would Medicare and Medicaid have to pay for these drugs? And at the bottom line, how much more would that cost middle America, already barely able to afford the cost of drug prescriptions?

As America stands today in a slowing economy with many Americans who struggle to purchase their medications, a Court decision permitting state actions against drug manufacturers may continue to drive this economy into a deeper hole. If every patient who suffered any side effect or harm from a drug sued the drug manufacturer, would these companies be able to afford to research and develop the next new drug? Ultimately, a decision in favor of state actions, might also affect the development of our pipeline of medications available to the American public. Is permitting state actions against drug companies truly in the best interest of this country and should this enter into the Court’s analysis?

As we await a decision from the Court, these are just a few of the issues that the Court may consider in its adjudication.  Ultimately, the Court will decide whether the FDA’s approval of a drug should preempt state tort actions brought against a drug manufacturer based on an unintended side effect suffered by one patient which was caused by a drug that has helped millions of patients.

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.

Iana DeSouza Esq. is an associate in the Health Law Practice Group at Blank Rome LLP. She concentrates her practice on healthcare with a focus on FDA compliance, licensure, certification, accreditation, contract drafting and negotiation, fraud and abuse, and corporate transactions.

Ms. DeSouza provides counsel to clients regarding due diligence for new acquisitions, business ventures, and strategic partnerships. She also advises clients on all aspects of regulatory affairs and governmental compliance including quality assurance, product labeling, registrations, recalls, the handling of adverse events, security breach and consumer notifications. Prior to this position, she obtained pharmaceutical industry experience while working for a global drug manufacturer.

Judith K. Meritz, Esq. is a partner in the Health Law Practice Group at Blank Rome LLP.  She concentrates her practice in FDA compliance counseling in the areas of drugs, devices and biologics. She also offers regulatory expertise in the areas of DEA, OSHA, DOT and EPA.

Judith Meritz served as Assistant General Counsel for the American Red Cross responsible for regulatory affairs.  In this capacity, she was the chief counsel to the Biomedical Services group providing guidance to ARC headquarters staff, as well as field blood regions and national testing labs, with particular emphasis on compliance with FDA regulations and the FDA Amended Consent Decree.