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CT utilization data suggest physician ownership plays role

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

An analysis of CT utilization data at a large health insurance plan suggests (more)

See on www.auntminnie.com

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Kaiser data network aims to improve cancer, heart disease outcomes

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

Kaiser Permanente plans to use $7 million to build a data network aimed at improving cancer, obesity and heart diseases outcomes this year, the health system announced this week.

See on www.fiercehealthit.com

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iRhythm’s ZIO patch outshines Holter monitor in Scripps AF study

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

See on mobihealthnews.com

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The reversal of cardiology practices: interventions that were tried in vain.

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

Prasad V, Cifu A.
Cardiovasc Diagn Ther. . 2012; 3(4):228-235.

See on www.thepreparedminds.com

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C-Pulse device designed to help patients with advanced heart failure

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

A Minnesota medical device company is developing a device to help people with class three and four heart failure without increasing the risk of blood clots.

See on medcitynews.com

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World’s first $1,000 genome enables ‘factory’ scale sequencing for population and disease studies

January 17, 2014 by 2012pharmaceutical

World’s first $1,000 genome enables ‘factory’ scale sequencing for population and disease studies

Reporter: Aviva Lev-Ari, PhD, RN

 

See on Scoop.it – Cardiovascular and vascular imaging

Illumina, Inc. announced Tuesday that its new HiSeq X Ten Sequencing System has broken the “sound barrier” of human genomics by enabling the $1,000 genome. “This platform includes dramatic technology breakthroughs that enable researchers to undertake studies of unprecedented scale by providing the throughput to sequence tens of thousands of human whole genomes in a single year in a single lab,” Illumina stated.

 

Initial customers for the HiSeq X Ten System, which will ship in Q1 2014, include Macrogen, based in Seoul, South Korea and its CLIA laboratory in Rockville, Maryland, the Broad Institute in Cambridge, Massachusetts, and the Garvan Institute of Medical Research in Sydney, Australia.

 

“For the first time, it looks like it will be possible to deliver the $1,000 genome, which is tremendously exciting,” said Eric Lander, founding director of the Broad Institute and a professor of biology at MIT. “The HiSeq X Ten should give us the ability to analyze complete genomic information from huge sample populations. Over the next few years, we have an opportunity to learn as much about the genetics of human disease as we have learned in the history of medicine.”

 

“The HiSeq X Ten is an ideal platform for scientists and institutions focused on the discovery of genotypic variation to enable a deeper understanding of human biology and genetic disease,” Illumina stated. “It can sequence tens of thousands of samples annually with high-quality, high-coverage sequencing, delivering a comprehensive catalog of human variation within and outside coding regions.”

 

HiSeq X Ten utilizes a number of advanced design features to generate massive throughput. Patterned flow cells, which contain billions of nanowells at fixed locations, combined with a new clustering chemistry deliver a significant increase in data density (6 billion clusters per run). Using state-of-the art optics and faster chemistry, HiSeq X Ten can process sequencing flow cells more quickly than ever before — generating a 10x increase in daily throughput when compared to current HiSeq 2500 performance.

 

The HiSeq X Ten is sold as a set of 10 or more ultra-high throughput sequencing systems, each generating up to 1.8 terabases (Tb) of sequencing data in less than three days or up to 600 gigabases (Gb) per day, per system, providing the throughput to sequence tens of thousands of high-quality, high-coverage genomes per year.

 

Illumina Introduces the HiSeq X™ Ten Sequencing System

 

Nature: Is the $1000 Genome for real?

 

See on www.kurzweilai.net

Posted in Advanced Computing Platform, BioIT: BioInformatics, BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics | Leave a Comment »

40 maps that explain the world

January 17, 2014 by 2012pharmaceutical

40 maps that explain the world

Reporter: Aviva Lev-Ari, PhD, RN

 

See on Scoop.it – Cardiovascular and vascular imaging

I’ve searched wide and far for maps that can reveal and surprise and inform in ways that the daily headlines might not.

See on www.washingtonpost.com

Posted in Global Market of Medical Devices Technology, Global Medical Publishers by Country, Global Partnering & Biotech Investment | Leave a Comment »

Correlation between vectorcardiographic measures and cardiac magnetic resonance imaging of the left ventricle in an implantable cardioverter defibrillator population

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

Journal of Electrocardiology

See on www.mdlinx.com

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InvisionHeart is building a small, smart 12-lead EKG device to get scans in the cloud

January 17, 2014 by 2012pharmaceutical

See on Scoop.it – Cardiovascular and vascular imaging

A Nashville entrepreneur is hoping his smaller and smarter 12 lead EKG device will make it easier for doctors to share information and for patients to get care.

See on medcitynews.com

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Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

January 17, 2014 by Dror Nir

Why should Quality Assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

 Reporter: Dror Nir, PhD

Converting life-science innovations into useful products involves allocation of significant resources to handling of regulatory processes. A typical approach that makes the management of these processes difficult and awkward is starting your project and later patching it with a QA system. It then becomes a source of sever headaches to many people who need to live and operate according to such patch.
I hope that the following post by Rina will inspire you all.
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making sure you have put in place something to address that requirement. This may easily result in a quality system that feels like a patchwork. Compliant, perhaps, but most certainly awkward and difficult to sustain.
The second most common mistake is to not ask yourself how software tools can help in setting up the quality system. “We already have MS Word, MS Excel, email, and we can always print a document and have it signed.” This is only a solution if you think that the quality system is a one-off activity. In the longer run, the system turns out to be a constant struggle with non-integrated elements that have no cohesion.
A better way to address compliance is to:
  1. Accept the fact that the quality system is a long term commitment and that it is very demanding.
  2. Assume that the right software tools do help.
  3. Think strategically, reviewing the whole standard, and try to identify the different areas, in respect to what type of software would help address those.
Real life example: A company maintains an Excel list of all corrective actions. The date of effectiveness check is filled in manually. A QA engineer needs to review the Excel spreadsheet once a week to identify which effectiveness checks are due. Last audit revealed that in most cases, effectiveness checks were not followed up.
Real life question: Meetings and other events are registered in a calendar and you are reminded when they are due. Wouldn’t it be easier if effectiveness checks due dates were also linked to a calendar? Putting those dates in Excel does not make more sense than putting your meetings in Excel…..
What follows is how we can divide the ISO-13485:2003 in regard to the type of software features which can help us. You do not need to be an IT expert to follow the logic or the explanation – if you know the standard and see my examples hopefully you will get the idea.
In any case, I put here the complete mapping of the ISO into the different categories I describe. I also mention the main Atlassian tools we use to address each area. In future posts we will dive deeper into each of those categories and provide more details on exactly how we achieve easy and sustainable, compliance.
So, as promised, these are the various categories that appear in the ISO 13485:2003:
  1. Document management: These are the various requirements relating to the procedures, manuals, and device related documents you need to have, and how they should be handled within the organization. The ISO elaborates in quite a detailed manner about how the controlled documents needs to be approved, who should access them, etc. Confluence is the key tool we use to handle all these requirements.
  2. Procedures and records are the evidence that the organization lives up to its quality system: The various procedures and work instructions should be followed consistently on a daily basis, forms or other records should be collected as evidence. Some examples (with reference to the standard section):
    • Training( 6.2.2).
    • Customer complaints: (8.5.1).
    • Corrective and preventive actions: (8.5.2, 8.5.3)
    • Subcontractor approvals( 7.4.1)
    • Purchasing forms( 7.4.1).

Those records may be created as electronic or physical paper forms which need to be completed by the authorized person. However, a much better way is to implement an automatic workflow that makes it easier for the team to create, follow, and document all the various tasks they need to do. Such a workflow can automatically schedule tasks, remind and alert, thus triggering better compliance to the quality system and at the same time automatically creating the required records. This is a double win. JIRA® is our tool of choice and it provides a state-of-the-art solution to everything related to forms and workflows.

  1. Design control: Some of the issues covered by section 7 of the ISO 13485 require quite advanced control along several phases of design and development. The risk mitigation measures and the product requirements should be, for example, verified in the product verification stage. This verification, or the test file, could be written as a simple Word or Excel document, but a far better implementation is to create it within JIRA. The advantage of JIRA here is the various reporting that it allows once the data is in and the fact that it can connect directly into the work scheduling of the various team members. JIRA is the principal tool we use for design control. Confluence can be used in some advanced implementations. If the medical device involves software, then the development suite from Atlassian can be implemented to provide a complete software life cycle management suite.
  2. Manufacturing and product traceability: Some requirements relate to your manufacturing setup. Depending on the scale and type of manufacturing, specialized ERP may be the best option. When manufacturing is more basic and does not call for a full blown manufacturing facility, JIRA can handle the requirements of the standard.
  3. Monitoring and improving: A key theme of the standard is the need of the organization to measure and improve (for example, section 8.2.3). The nice thing is that the framework we have put in place to support the other categories, if done correctly, should provide us with the reports, alerts, and statistics we need. Indeed, all the processes we have implemented in JIRA, as well as the various elements we have implemented in Confluence, may easily be collected and displayed in practically endless variations of reports and dashboards.
Requirement (Article) Requirement type
4.Quality management system – 1.General requirements Non specific
4.Quality management system – 2.Documentation requirements – 1.General Document management
4.Quality management system – 2.Documentation requirements – 2.Quality manual Document management
4.Quality management system – 2.Documentation requirements – 3.Control of documents Document management
4.Quality management system – 2.Documentation requirements – 4.Control of records Procedures and records
5.Management responsibility – 1.Management commitment Document management
5.Management responsibility – 2.Customer focus Non specific
5.Management responsibility – 3.Quality policy Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 1.Quality objectives Monitoring and ongoing improvement
5.Management responsibility – 4.Planning – 2.Quality management system planning Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 1.Responsibility and authority Document management
5.Management responsibility – 5.Responsibility, authority and communication – 2.Management representative Monitoring and ongoing improvement
5.Management responsibility – 5.Responsibility, authority and communication – 3.Internal communication Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 1.General Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 2.Review input Monitoring and ongoing improvement
5.Management responsibility – 6.Management review – 3.Review output Monitoring and ongoing improvement
6.Resource management – 1.Provision of resources Non specific
6.Resource management – 2.Human resources – 1.General Procedures and records
6.Resource management – 2.Human resources – 2.Competence, awareness and training Procedures and records
6.Resource management – 3.Infrastructure Manufacturing and product traceability
6.Resource management – 4.Work environment Non specific
7.Product realization – 1.Planning of product realization Design control
7.Product realization – 2.Customer-related processes – 1.Determination of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 2.Review of requirements related to the product Design control
7.Product realization – 2.Customer-related processes – 3.Customer communication Design control
7.Product realization – 3.Design and development – 1.Design and development planning Design control
7.Product realization – 3.Design and development – 1.Design and development input Design control
7.Product realization – 3.Design and development – 3.Design and development outputs Design control
7.Product realization – 3.Design and development – 4.Design and development review Design control
7.Product realization – 3.Design and development – 5.Design and development verification Design control
7.Product realization – 3.Design and development – 6.Design and development validation Design control
7.Product realization – 3.Design and development – 7.Control of design and development changes Design control
7.Product realization – 4.Purchasing – 1.Purchasing process Procedures and records
7.Product realization – 4.Purchasing – 2.Purchasing information Procedures and records
7.Product realization – 4.Purchasing – 3.Verification of purchased product Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 1.General requirements Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 1.Cleanliness of product and contamination control Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2.Control of production and service provision: Specific requirements – 2.Installation ativities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 2. – 3.Servicing activities Procedures and records
7.Product realization – 5.Production and service provision – 1.Control of production and service provision – 3.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 1.General requirements Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 2.Validation of processes for production and service provision – 2.Particular requirements for sterile medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 1.Identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Traceability – 1.General Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 2.Particular requirements for active implantable medical devices and implantable medical devices Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 3. Identification and traceability – 3.Status identification Manufacturing and product traceability
7.Product realization – 5.Production and service provision – 4.Customer property Non specific
7.Product realization – 5.Production and service provision – 5.Preservation of product Procedures and records
7.Product realization – 6.Control of monitoring and measuring devices Manufacturing and product traceability
8.Measurement, analysis and improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 1.Feedback Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 2.Internal audit Procedures and records
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 3.Monitoring and measurement of processes Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 1. General requirements Design control
8.Measurement, analysis and improvement – 2.Monitoring and measurement – 4.Monitoring and measurement of product – 2.Particular requirement for active implantable medical devices and implantable medical devices Procedures and records
8.Measurement, analysis and improvement – 3.Control of nonconforming product Procedures and records
8.Measurement, analysis and improvement – 4.Aalysis of data Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 1.General Monitoring and ongoing improvement
8.Measurement, analysis and improvement – 5.Improvement – 2.Corrective action Procedures and records
8.Measurement, analysis and improvement – 5.Improvement – 3.Preventive action Procedures and records

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