Tag Archives: Supply Chain


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


Two Black Swans, One Devastated Region

A Hurricane Named Maria 

By:  Sandra K. Rodriguez, Market Analyst

Disclaimer:  Being based in Puerto Rico, I lived through Irma and Maria; however best practices recommendations apply to anywhere in the world that may suffer a catastrophic event.

A black swan event is one that is extremely rare and unlikely.  Hurricane Irma stormed through the Caribbean on September 6, 2017.  Two weeks later, on September 20, 2017, Hurricane Maria made landfall in Puerto Rico and collided with the supply chains of leading life science companies who have a manufacturing presence on the island.

Scott Gottlieb, M.D., Commissioner of the FDA, took notice immediately and issued a press release within five days to address how the agency would help the island recover and what steps should be taken to avoid critical drug supply shortages for US citizens residing on the island and the US mainland.  Gottlieb wrote, “News coverage has touched on an issue about which we at FDA are very concerned and we are working around the clock to address – the potential for shortages of critical life-saving and life-sustaining drugs needed by patients on and off the island.” Continue reading