Category Archives: Latest

03May/17
Insanity Image

White Paper: Is Innovation Without Transformation Insanity?

By: Ellyn McMullin, Research Asssociate and Daniel R. Matlis, President

Are You Transforming Your Business or Merely Digitizing Process?

To fast-track the transformation of ideas into innovative products, pharma and biotech companies need to be open to new ideas and aware of new systems and technologies. Simply digitizing existing processes is accelerated insanity!

The costs of bringing a new drug to market is high, especially when you factor in the many candidates that do not make it. In this white paper, Axendia suggests an approach that will consistently create and deliver high quality products to market while reducing cost and improving ROI in today’s competitive marketplace.

Today’s challenge is not the availability of the technology but the rather the need for vision and leadership, knowhow and discipline to drive transformation.

Download this free white paper to learn now.

25Apr/17
Supply-Chain-Squares (3)

Quality Management Across Your Global Supply Chain

By: Sandra K. Rodriguez, Market Analyst

Learn How to Take Back Control of Quality – On Demand Webinar

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017.  Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments.  Topics of discussion included:

  • Globalization and Outsourcing Trends in Life-Sciences
  • Regulatory Expectations for Outsourcing
  • Quality Metrics and Data Integrity
  • The Paradigm Shift in Quality Management
  • How to Source Quality Data and Benefits of a Cloud QMS
  • Modernizing Quality Management
  • Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike.  Read More.

The webinar is also available on demand.

05Apr/17
Europe Conf

CLOSED LOOP PRODUCT LIFECYCLE MANAGEMENT

By: Eric M. Luyer, Market Research Analyst and Daniel R. Matlis, President

What Does it Mean to Medical Device Manufacturers?

Digital Transformation was the key topic at the PTC European Forum, held November 15th in Stuttgart, Germany.  Part of the day was devoted to clarifying how the Internet of Things (IoT) and Augmented Reality (AR), in relation to digital transformation, benefit decision-making processes.

We are living in a time where it seems like everyone and everything is getting connected using technology concepts such as IoT.  At the same time, there is a strong focus on improving product quality and value.  However, the products or related services are getting more complex and the market requires product delivery be on request.

PTC Europe ImageIt is interesting to hear and learn how new concepts and technologies such as IoT and augmented reality (AR) can be used specifically in the medical device industry: to drive success with the ability to create, produce and market innovative and value driven products to market quickly.

Certainly, in a global market, proactive strategies are needed to support improved product quality and patient outcomes while supporting compliance with applicable regulatory requirements.

Continue reading

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