Category Archives: Technology

13Mar/17
CyberSecurity

CYBERSECURITY RISKS IN MEDICAL DEVICES ARE REAL

By: Eric M. Luyer, Market Research Analyst 

The Healthcare Industry Has a New Set of Threats on Its Hands

PPP_IGLOB_CLP_Global_Computer_Network_Red_Color_Pencil_HEXConnected medical devices-like other computer systems-can be vulnerable to security breaches and have a potential major impact on safety and effectiveness of the device.  Specifically, in a healthcare environment, this vulnerability increases asmedical devices and medical equipment are becoming more connected through the internet to other medical devices, patients and/or to hospital networks (also referred to as the Internet of Medical Things).

To address the cybersecurity threat, in December 2016 FDA issued Guidance on Postmarket Management of Cybersecurity in Medical Devices.

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08Mar/17
Supply-Chain-Squares (3)

QUALITY MANAGEMENT ACROSS YOUR GLOBAL SUPPLY CHAIN

How Can the Cloud Help with Data Integrity and Quality Issues Across your Global Supply Chain?

REGISTER TODAY
Date: MARCH 22, 2017
Time: 1:30 PM EST

All your data used to be close by — under your control — and easily monitored. Now, as you outsource more and more, your direct control on quality is weakened. By using a cloud based solution you can take back control. You can monitor your quality metrics in real time wherever they’re being generated and head off issues way before an FDA investigator even sets foot in your facility.

In this session, you will learn how to:

  • Drive enhanced product quality at reduced costs and risks while assuring compliance with all applicable regulatory requirements
  • Leverage modern quality systems to improve visibility, control and collaboration across your supply chain
  • Shift from just documents to also including data to support quality metrics across global and externalized supply chain networks
  • Reduce inspection frequency and risk through modern quality systems and real-time quality metrics
  • Reduce data integrity risks before they occur
  • Sleep better at night!

Attend the Webinar – Sponsored by Veeva

28Feb/17
online-survey

Medical Device Industry Survey

Do Medical Device Manufacturers Have a Culture of Innovation and Quality?

Help Us Find Out!

Flat line alert on a heart monitor - 3d render on detail pixellated screeen

  • Are you Manufacturing Innovative Medical Devices?
  • Is your company building a culture of innovation and quality?
  • How do your actions compare with your peers?

To find answers to these and other questions of interest to the medical device community, we are asking for your participation in this global research study.

The survey also seeks to understand:

  • What practical steps medical manufacturers are taking to evolve their quality practices
  • The role of automation in supporting best practices for compliance and quality
  • How manufacturers are incorporating smart, connected sensors across their product portfolio
  • The impact of the Internet of Things (IoT) on medical device manufacturers

As a survey participant, you may register to receive a complimentary copy of the research report.  Please Note: All individuals responses will be kept strictly confidential and only aggregated data will be used.

Follow this link to begin the survey.

This primary research is being conducted by Axendia and sponsored by PTC.

24Feb/17
wp image biovia

Data Integrity White Paper Alert

FreeAnalystWP

TURN YOUR DATA INTO KNOWLEDGE

Sound data is the foundation to good decisions and good science.  In the Life-Science industry patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients, brand equity and reputations have the potential to suffer greatly without a strong data integrity foundation.

What is Data Integrity?

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12Dec/16
veeva-logo

Unifying Applications to Drive Effectiveness, Efficiency and Compliant Collaboration

By: Sandra K. Rodriguez, Market Analyst

Using a Cloud Platform to Connect the Life Science Value Chain

Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud platforms to drive effectiveness and efficiency throughout the value chain.  These organizations are unifying applications that support the total product lifecycle in a compliant manner, without losing sight of what matters most – product quality.

This shift from disconnected point solutions to a platform approach became clear at the Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on October 17-19, 2016, where I joined over 600 attendees representing 154 companies.  Client presentations ranged from start-up to multi-national Life-Science companies including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here.

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating the five-year birthday of Vault.  This was my first time covering the event and I was immediately surprised by the opening keynote delivered by Peter Gassner, CEO at Veeva Systems.  He revealed that over the past three years, the company has consistently doubled its customer base across all three of its product offerings – Vault Clinical, Vault Quality and Vault Regulatory.  Sessions were offered across all three areas including a track on platforms and a focus on small and mid-size organizations. Continue reading