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
- 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