Category Archives: Latest

04Dec/18
veeva logo

Veeva is Building the Life Sciences Cloud with High Speed and Velocity

Veeva 2018 Summit Event Brief

By: Daniel R. Matlis, President

Introduction

“We are building the industry cloud for life sciences,” said Peter Gassner, president and CEO of Veeva during his keynote at the company’s summit in Philadelphia. “We want the industry and your company to be more efficient and effective – supporting your journey to improve and extend human life,” Gassner added.

The event brought together more than 1,400 life science professionals and experts showcasing the latest advancements for speeding product development in the industry.

Right Speed, Right Velocity

“Speed is one of Veeva’s core values,” said Gassner. I have a slightly different perspective.  I took Gassner aside and explained that Axendia’s analysis of the company shows that Veeva is operating at the right velocity – not simply at high speed.

veeva imageUnfortunately, our industry is ripe with examples where companies have adopted systems at breakneck speed – often to mitigate a regulatory finding, only to realize the application brought them in the wrong direction.  Testament to the ‘right speed, wrong velocity approach’ are the multitude of QMS point solutions that were implemented as a reaction to 483’s and warning letters.

Veeva has been moving with speed in the right direction; working closely with their industry customers to provide mature, preconfigured out-of-the-box suites of unified applications on a single cloud platform that support key areas across the entire product lifecycle.

Veeva has become a strategic technology partner to more than 675 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is focused on customer success through its commitment to innovation and product excellence.

My interactions with industry executives at the Summit confirm that Veeva is enabling life science companies to realize the benefits of a modern, cloud-based architecture and mobile applications for critical business functions – without compromising on industry-specific functionality or regulatory compliance.

To learn how Bristol-Myers Squibb, Gilead and Sysmex America are using Veeva’s cloud for life sciences.

Register to receive the full event brief.

 

26Nov/18
quality

FDA’s Medical Device Enforcement and Quality Report

FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance

The Report highlights:

  • Annual device inspections have increased 46% since 2007
  • The annual number of foreign device inspections have increased 243%  since 2007
  • The Agency is taking a targeted, risk-based enforcement approach to address specific device areas of concern.  Case studies mentioned in the report are:
    • Infusion Pumps
    • Automated External Defibrillators
    • Radiation Therapy Devices
  • From 2008 to 2007, 82% of firms corrected observed violations on follow-up inspections.
  • The FDA is also continuing to promote device quality through the Case for Quality initiative.

For related reading based on our involvement with the Case for Quality, please see:

FDA Driving Industry “Beyond Compliance” to Promote Manufacturing Quality

Is Compliance an Obstacle to Quality?

What is FDA Thinking? We Asked, They Answered!

The Case for Quality Voluntary Pilot Program

 Quality Metrics Program Update

15Nov/18
IoT Image

See Who’s Soaring to the Cloud in Support of Quality and Compliance

Companies Are Taking a Cloud-First Approach

By: Daniel R. Matlis, President and Sandra K. Rodriguez, Market Analyst

Life-Science organizations have implemented on premise electronic Quality Management Systems (QMS) for decades to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings and in response to the “Whack-a-Mole” relationship between Industry and Regulators.

WHACK A MOLE

As a result, many companies implemented “Paper on Glass”, simply duplicating existing paper quality processes in electronic QMS. This approach created an environment of a mixed bag of disparate eQMS installations throughout the enterprise that have high degrees of customization. Now, IT and quality teams are faced with the daunting challenge of upgrading, migrating, and validating outdated legacy on premise QMS systems.

However, based on Axendia’s primary research on the adoption of Cloud QMS in the Life-Science Industry, we quickly determined that companies large and small, are taking a different course and are soaring to the modern cloud.

Our latest Voice of the Customer Report highlights interviews with 10 industry executives and represents 3 innovative Cloud QMS vendors.  This comprehensive reports outlines:

  • Why Cloud is No Longer Taboo
  • Clouds Come in Many Shapes and Sizes – Not All Clouds are Created Equal
  • Executive Accounts of Cloud QMS
  • Why Life-Science Companies Are Moving to the Cloud
  • End-To-End Cloud QMS Capabilities
  • The Pros, Cons and Pitfalls to Avoid
  • Recommendations and Thoughts to Consider

You are welcome to download your complimentary preview here.

To request the full report, please contact: Axendia Research.

05Nov/18
GoogleGlass_OR

Augmented Reality in Today’s Operating Rooms – Update

Novarad’s OpenSight Augmented Reality System

By: Eric M. Luyer, Sr. Market Analyst

In June 2016, I wrote an article around the use of Augmented Reality in Today’s Operating Rooms and I used the example of Google Glass as a new technology that helps improve surgical efficiencies and aiding compliance and education.  Another great example of Augmented Reality being used in surgery was announced last week when Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company’s augmented reality headset and is the first solution for Microsoft HoloLens 510(k) cleared by the FDA for medical use.

Building upon decades of Novarad’s experience in image processing, OpenSight renders 2D, 3D and 4D images of patients interactively, while accurately overlaying them directly onto the patients’ body during surgery. The system lets clinicians see both the 3D patient image from previous scans, as well as the patient physically in front of them. OpenSight was designed to help surgeons plan for an operation and gives clinicians the tools to highlight specific body parts as well as structures that should be avoided during the procedure, according to the company. For more, see the press release.

Image Courtesy of Novarad

Image Courtesy of Novarad

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04Oct/18
EU MDR Infographics Header copy

EU MDR – New Rules Require Greater Traceability, Data Transparency

Webinar Now Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.  Medical device companies are set to experience an enormous impact on all phases of the CE mark process including Design, Manufacturer Obligations, Evidence Collection, Conformity Assessment, Registration and Post Market Surveillance and Vigilance.

The schedule is aggressive – the rules will apply to some previously unregulated products and there will be no grandfathering of previously approved medical devices.  Controls on notified bodies that can approve the marketing of medical devices and the reporting on clinical trials will also be tightened.  Once devices are available for use on the market, manufacturers will be obligated to collect performance data to support tighter post-market surveillance requirements.  In addition, a new system will apply to in vitro diagnostic medical devices.

Concerns are quickly mounting throughout the industry.  We interviewed executives to determine what steps they were taking to prepare for the looming May 2020 deadline.  We heard:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “Our challenge is showing management what the cost is per product from a compliance standpoint”
  • “Imagine tracking down paper records for products from the 60s and 70s!”
  • “We will probably have to do a complete revamp of technical files to do resubmission”
  • “Our organization is behind on the IT curve. It will likely take three to four years to implement a robust global product data management system like that to support EU MDR”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

In a recent webinar sponsored by Sparta Systems, we discussed why Digital Transformation is a necessary journey for EU MDR compliance and beyond. The recording is now available on-demand.

It is important to note that MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both EU MDR and IVDR until full readiness of the system has been achieved.”  However, Med-Tech companies must begin to take a long view on EU MDR now and begin their digital transformation journey to support EU MDR and beyond.

Is your organization ready to achieve sustainable, positive disruption? Contact us today.