January 19, 2010
ST. PAUL, MINN.--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ) today announced it has successfully completed its second interoperability testing process for the company's Merlin.net™ Patient Care Network, an Internet-based repository of patient and implantable device data. The company also announced today that the Merlin.net PCN is the first medical device network to be awarded ISO 27001 certification, a stringent worldwide information security standard.
"Due to recent legislation and the changing health care environment, electronic health records (EHRs) and hospital efficiency are key issues for our customers. As the use of EHRs become central to healthcare delivery and quality, secure data transportability is becoming even more critical and as a result, connectivity is a key priority for our company," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "Receiving recognition from these two organizations demonstrates to our medical industry stakeholders the high standards St. Jude Medical has set for both the security and efficiency of our patient care network."
ISO 27001 Certification
BSI Management Systems, an international standards, testing, registration and certification organization, has awarded St. Jude Medical the information security certification ISO/IEC 27001:2005. This ISO certification recognizes that St. Jude Medical's Merlin.net PCN has established processes and standards that maintain the strictest levels of confidentiality, integrity and availability for its customers. The Merlin.net PCN is the first CRM device data network to be recognized with this certification.
ISO/IEC 27001:2005 is an information security management system (ISMS) standard, published in October 2005 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It has become the gold standard in information security across a broad range of industries, with 96 U.S. companies earning certification. The standard specifies the methodology to enable a business to establish, implement, operate, monitor, review, maintain and improve effective information security.
ISO is the world's largest developer and publisher of international standards. It is a non-governmental network of national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. IEC is a not-for-profit, non-governmental international standards organization, also headquartered in Geneva, Switzerland, that prepares and publishes International Standards for all electrical, electronic and related technologies. It currently has over 130 member countries.
IHE Connectathon
During the week of Jan. 11, St. Jude Medical participated in the IHE (Integrating the Healthcare Enterprise) Connectathon testing of the Implantable Device Cardiac Observation profile. This testing demonstrated the ability for the Merlin.net PCN to connect to third-party EHR systems using defined industry standards. Support for this profile allows physicians and hospitals to seamlessly share data from one system to another, thereby increasing productivity, providing tools for improved clinical decision making and quality of care, and eliminating redundant medical device management systems.
In 2007, St. Jude Medical was the first manufacturer of CRM devices to test a product for conformance with an IHE interconnectivity profile. This year, St Jude Medical became the first Cardiac Rhythm Management vendor to successfully complete Connectathon testing of the Implantable Device Cardiac Observation (IDCO) profile for a second time. In this round of testing, St. Jude Medical connected with EHR vendors including Epic, General Electric, NextGen and Medical Micrographics.
The testing process, established by the IHE, is an initiative promoting the adoption of standards that enable healthcare information to be shared seamlessly across clinical settings. The testing took place during the annual IHE Connectathon in Chicago. The organization's goal is to drive standards for interoperability, increasing efficiency and reducing cost to healthcare customers, such as those in the cardiology, radiology and laboratory markets.
About the Merlin.Net Patient Care Network (PCN)
Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data are included in the patient's comprehensive personal health record.
With immediate access to patient information through the secure Merlin.net PCN website, physicians can remotely monitor and assess patient device data and determine the level of care needed. Alert notification delivery times can be customized to fit in with physician determined clinic hours, including any after-hours processes the clinic might provide.
In addition to meeting the ISO/IEC 27001:2005 standard, the Merlin.net PCN system adheres to patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The Merlin.net PCN was recognized as a silver winner of the 2009 Medical Design Excellence Awards, an award competition that is organized and presented by Canon Communications LLC and is the only awards program that exclusively recognizes contributions and advances in the design of medical products.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
27 Januari 2010
Getting The Most From Preclinical Imaging
Life Science Leader, January 2010
The pharmaceutical industry continues to actively adopt imaging technologies to accelerate the
drug discovery process. Imaging methods such as magnetic resonance imaging (MRI), positron
emission tomography (PET), single photon emission computed tomography (SPECT), computed
tomography (CT), and in vivo optical imaging offer important and valuable improvements over
traditional drug discovery methods.
These improvements include providing earlier and more highly predictive in vivo data, facilitating clinical translation, and yielding highly quantitative information from the more realistic models of disease that are becoming increasingly available.
However, success in a preclinical discovery imaging program goes beyond the initial steps of
purchasing and installing the imaging equipment and hiring the skilled experts to run it. Imaging can be successful at advancing the drug discovery process only when a detailed and thoughtfully considered plan of action is soundly and strategically designed and applied.
One of the obstacles to achieving a significant ROI on imaging technology in the preclinical arena is optimization of the animal-to-animal imaging “throughput” without compromising data quality.
Since the hourly cost of imaging is dominated by large depreciation costs, imaging throughput
critically drives cost and ROI potential and also places limits on the timeline and scope of each study. An increase in animal-to-animal throughput is generally at the cost of resolution and sensitivity, one or both of which may already be limited, particularly in small animals where preclinical imaging is generally centered.
The converse is that state-of-the-art imaging hardware and protocols that enhance sensitivity or
resolution can be translated to increased throughput. It is therefore critical in an imaging program to be able to rapidly install, develop, and validate the latest hardware and software
advancements. Tools for automation of image data handling, backup, archiving, and
postprocessing also have the potential for maximizing effective data throughput. What’s more,
design of support systems for imaging — including animal preparation, anesthesia, and dosing
apparatus — can critically affect the efficiency of image data generation and the quality and
reproducibility of the image data itself and must be part of a larger plan in the installation and operation of in vivo imaging technologies. A further obstacle to the optimal use of preclinical imaging is the increasingly high rates of data generation that have occurred in parallel with imaging technology advancements.
Daily generation of gigabytes and even terabytes of data can mire the very process it was originally designed to accelerate. A network infrastructure that facilitates rapid data transfer, access, backup, and archiving must be a key part of the planning for an imaging program and not an afterthought. Facilitation of rapid and high-quality image reconstruction, segmentation, rendering, and quantification through state-of-the-art workstations and software packages are also needed.
The lifetime of each image after acquisition and before final quantification heavily influences the effective throughput and timelines related to the imaging process.
biosecurity concerns
Strategies must also be implemented for prevention of animal cross-contamination (biosecurity)
and for personnel safety concerns. Strictly conforming to the highest level biosecurity and safety can end up costing as much as the imaging equipment itself. If not thoroughly and optimally planned, both biosecurity and safety also have the potential to limit the efficiency and power of the imaging protocols. Occupational health and safety issues are a particular concern for PET, SPECT, and CT, which involve ionizing radiation. Maximization of imaging throughput, personnel safety, and biosecurity can appear to create insurmountable conflicts. All are critically related to design and layout of the lab, vivarium, radiation shielding, and support systems for anesthesia, dosing, and animal handling.
Biosecurity is a particularly pressing issue for an imaging lab, especially for the specific pathogenfree environments generally required for oncology models. If not carefully considered, the imaging lab could be a weak link in the in vivo operations of a discovery organization. Again, design of the lab and implementation of support equipment and procedures for preventing animal-to-animal contamination and for decontamination of imaging equipment is a key consideration for a successful and high-quality imaging program.
The previously mentioned obstacles have the potential to decouple a state-of-the-art imaging
center from delivering increased power and efficiency in the discovery process. However, these
obstacles also have a key similarity — their solution. Without a doubt, the single greatest asset for a successful imaging program is experience, first in the experts running and driving the program, but also in the depth of experience across animal models, therapeutic strategies, and imaging probes and protocols. By bringing together imaging and discovery experts seamlessly,
these requirements can be realized quickly and effectively, and in the process, limit potential
obstacles. Preclinical discovery imaging can then yield maximal benefit in the efficiency and
accuracy of the drug discovery process, as well as in the uniqueness of the data procured and
the questions answered. Only when approached in this way can preclinical imaging accelerate
the drug discovery process in the most cost-effective and efficient manner possible.
The pharmaceutical industry continues to actively adopt imaging technologies to accelerate the
drug discovery process. Imaging methods such as magnetic resonance imaging (MRI), positron
emission tomography (PET), single photon emission computed tomography (SPECT), computed
tomography (CT), and in vivo optical imaging offer important and valuable improvements over
traditional drug discovery methods.
These improvements include providing earlier and more highly predictive in vivo data, facilitating clinical translation, and yielding highly quantitative information from the more realistic models of disease that are becoming increasingly available.
However, success in a preclinical discovery imaging program goes beyond the initial steps of
purchasing and installing the imaging equipment and hiring the skilled experts to run it. Imaging can be successful at advancing the drug discovery process only when a detailed and thoughtfully considered plan of action is soundly and strategically designed and applied.
One of the obstacles to achieving a significant ROI on imaging technology in the preclinical arena is optimization of the animal-to-animal imaging “throughput” without compromising data quality.
Since the hourly cost of imaging is dominated by large depreciation costs, imaging throughput
critically drives cost and ROI potential and also places limits on the timeline and scope of each study. An increase in animal-to-animal throughput is generally at the cost of resolution and sensitivity, one or both of which may already be limited, particularly in small animals where preclinical imaging is generally centered.
The converse is that state-of-the-art imaging hardware and protocols that enhance sensitivity or
resolution can be translated to increased throughput. It is therefore critical in an imaging program to be able to rapidly install, develop, and validate the latest hardware and software
advancements. Tools for automation of image data handling, backup, archiving, and
postprocessing also have the potential for maximizing effective data throughput. What’s more,
design of support systems for imaging — including animal preparation, anesthesia, and dosing
apparatus — can critically affect the efficiency of image data generation and the quality and
reproducibility of the image data itself and must be part of a larger plan in the installation and operation of in vivo imaging technologies. A further obstacle to the optimal use of preclinical imaging is the increasingly high rates of data generation that have occurred in parallel with imaging technology advancements.
Daily generation of gigabytes and even terabytes of data can mire the very process it was originally designed to accelerate. A network infrastructure that facilitates rapid data transfer, access, backup, and archiving must be a key part of the planning for an imaging program and not an afterthought. Facilitation of rapid and high-quality image reconstruction, segmentation, rendering, and quantification through state-of-the-art workstations and software packages are also needed.
The lifetime of each image after acquisition and before final quantification heavily influences the effective throughput and timelines related to the imaging process.
biosecurity concerns
Strategies must also be implemented for prevention of animal cross-contamination (biosecurity)
and for personnel safety concerns. Strictly conforming to the highest level biosecurity and safety can end up costing as much as the imaging equipment itself. If not thoroughly and optimally planned, both biosecurity and safety also have the potential to limit the efficiency and power of the imaging protocols. Occupational health and safety issues are a particular concern for PET, SPECT, and CT, which involve ionizing radiation. Maximization of imaging throughput, personnel safety, and biosecurity can appear to create insurmountable conflicts. All are critically related to design and layout of the lab, vivarium, radiation shielding, and support systems for anesthesia, dosing, and animal handling.
Biosecurity is a particularly pressing issue for an imaging lab, especially for the specific pathogenfree environments generally required for oncology models. If not carefully considered, the imaging lab could be a weak link in the in vivo operations of a discovery organization. Again, design of the lab and implementation of support equipment and procedures for preventing animal-to-animal contamination and for decontamination of imaging equipment is a key consideration for a successful and high-quality imaging program.
The previously mentioned obstacles have the potential to decouple a state-of-the-art imaging
center from delivering increased power and efficiency in the discovery process. However, these
obstacles also have a key similarity — their solution. Without a doubt, the single greatest asset for a successful imaging program is experience, first in the experts running and driving the program, but also in the depth of experience across animal models, therapeutic strategies, and imaging probes and protocols. By bringing together imaging and discovery experts seamlessly,
these requirements can be realized quickly and effectively, and in the process, limit potential
obstacles. Preclinical discovery imaging can then yield maximal benefit in the efficiency and
accuracy of the drug discovery process, as well as in the uniqueness of the data procured and
the questions answered. Only when approached in this way can preclinical imaging accelerate
the drug discovery process in the most cost-effective and efficient manner possible.
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