Category Archives: Supply Chain

15May/19
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Supply Chain Visibility: A Regulatory Necessity and Business Imperative

Brand owners are legally responsible for the safety, efficacy and quality of their products

By: Daniel R. Matlis, President

The globalization of life science products has created unique opportunities and demanding challenges for both industry and regulators.

The globalization and outsourcing of life science products began in the late 1990s. At the time, life science companies began to evaluate their core competencies and decided to outsource non-core competency functions. The primary reason for this trend was to lower costs.

Globalization has also opened new markets for life science products worldwide, with emerging economies representing fresh markets. Concurrently, issues with supply chain security became the responsibility of all parties involved in the procurement/sourcing, manufacturing, packaging and distribution of raw materials, intermediates, and final product to deliver safe and effective medicines to customers.

Recommendations for a New Supply Network Paradigm
Supply chain dynamics are prompting life science companies to seek innovative approaches that improve product safety while simultaneously enhancing clinical outcomes, reducing costs and risks, and ensuring regulatory compliance. To attain the sustained benefits of globalization, the life science products ecosystem must implement a new paradigm to manage global supply chains.

770_mainCompanies must implement new strategies while proactively reducing and controlling risks. This calls for changing the business, technology, and regulatory models traditionally used in the industry. The three key components to managing this shift are on-demand visibility, supply network control, and collaboration.

Continue Reading This Article in Medical Product Outsourcing

14Jun/18
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Thriving in a World Where the Only Certainty is UNCERTAINTY

By Daniel R. Matlis, President

“The only certainty is UNCERTAINTY” declared Anton Chilton, QAD’s Chief of Global Field Operations, during his opening remarks at QAD Explore 2018 in Dallas last month.

“The pace of change is accelerating and if you can’t keep up, you’ll struggle to survive,” said Carter Lloyds, QAD’s Chief Marketing Officer.

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To keep up with the accelerating rate of change and cope with uncertainty, organizations must become an “agile and effective enterprise” was a key theme at QAD Explore 2018.

Continue reading

13Mar/18
connected-world

Did We Predict the Future?

Free White Paper: Balancing the Risks and Rewards of Globalization

By: Sandra K. Rodriguez, Market Analyst

Axendia conducted a research study assessing the opportunities and challenges of Globalization across the Med-Tech ecosystem.

We learned Med-Tech Executives were primary concerned with:

  • Complying with an increasingly complex regulatory environment
  • Ensuring the quality of products and raw materials across the globe
  • Maintaining consistent standards across an extended network of internal sites and external partners

Executives reported the TOP business threat is the changing regulatory environment (65%).

Considering that massive regulatory changes are impacting Med-Tech today, they were correct.  Recent guidance documents include:

  • ISO 13485:2016
  • ISO9001:2017
  • Unique Device Identifier (UDI)
  • EU MDR and EU IVDR
  • Real World Evidence (RWE) challenges

Also significant were risks associated with geopolitical unrest and natural disasters (43%). At the time of the survey, Japan’s earthquake and tsunami were fresh in the memories of industry executives.  More recently, Hurricane Maria quickly gained the attention of the FDA. Within 30 days of the storm making landfall in Puerto Rico, the agency identified 50 types of devices that it deemed critically important.  The agency indicated in a press release that it was particularly concerned about the potential shortage of blood-related devices.   Other current day geopolitical events affecting industry include Brexit, tensions on the Korean peninsula, and NAFTA re-negotiations that are far from being completed. Continue reading

07Feb/18
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Modernizing Quality Management with Veeva Vault QMS

Veeva Systems Analyst Brief

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality at Veeva Systems.  Veeva Systems (www.veeva.com) is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers – companies who own Veeva Vault QualityDocs or Vault QMS – continue to increase in numbers and now include five of the top 20 largest pharmaceutical companies. Launched just a little over a year ago, more than 40 companies have selected Vault QMS ­— and is quickly displacing its competitors.

Historically, quality management solutions have been implemented in a reactionary manner, were on premise, and required extensive configuration to meet user requirements.  “The success of Vault QMS rests on the fact that we are committed to providing best practices, not just infinite configurability,” said Jovanis.  “The true value in using the Vault Quality Suite of applications is that they support end-to-end processes across functional areas and internal and external stakeholders for greater visibility and control,” he added. Continue reading

11Jan/18
2017 Year end review

Award Winning Year for Axendia – Looking at the 2018 Crystal Ball

By Daniel R. Matlis

2017 has been an exceptional year for Axendia.  We were recognized by CIOReview magazine as one of the 20 Most Promising Pharma and Life Sciences Solution Providers.  We also had the opportunity to address audiences around the globe, including Asia, Europe, North and South America.

Our analysts had the privilege to provide insight and trusted advice to leaders across the Life Science and Healthcare ecosystems including executives in industry, technology & service providers as well as policy makers and regulators.
In the last year we advised our clients on critical topics such as: