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.
Developing a medical device platform was a high priority for Med-Tech companies in both developed and emerging markets (67% and 49% respectively). Taking a cue from the automotive industry, Life Science companies should also take a ‘platform approach’ in order to offer a continuum of products based on a single platform designed to meet global requirement and healthcare delivery models, levels of sophistication, customer needs and market cost constraints. This approach also allows companies to build on the successes of previous generation products and apply continuous improvements using their own device as a predicate.
Did we predict the future? In 2012 we looked at the research data and stand by our key findings and recommendations. The report was based on a survey of 125 industry professionals from 85 different companies, representing 16 countries. Our recommendations and considerations still hold true today. As globalization and outsourcing continue to increase, Life-Science companies must:
- Maintain holistic control over governance, risk management and compliance practices
- Enhance their visibility across an extended partner network
- Improve collaboration with all constituents in the healthcare system
As one executive told us, “we feel that the level of visibility goes down exponentially with every link in the supply chain.” Nearly 70% of survey respondents indicated their suppliers have made process changes (frequently or occasionally) without their prior knowledge. Other key findings include:
- 63% reported using paper-based systems to support global visibility across their supply chain
- 61% indicated greater cross-functional team collaboration would help them improve managing in a global/outsourced environment and 57% selected better use of technology
Fast-forward to current day and little has changed. Our recent report on The Future of Change and Configuration Management in Med-Tech shows that:
- 66% reported using paper-based systems to manage their change and configuration management process
- 53% indicated greater cross-functional team collaboration and 61% indicated better use of technology would help improve change and configuration management processes.
Axendia has conducted numerous research studies since our report on balancing the risk and rewards of Med-Tech globalization in 2012. Download the free white paper here.
We also welcome you to access The Future of Change and Configuration Management in Med-Tech report here.
Are regulatory agencies still industry’s biggest disruptor? 62% of survey respondents who participated in our most recent report on Driving a Culture of Innovation and Quality in the Medical Device Manufacturing Ecosystem said “Yes”. Access the report here.