Innovation drives the advancement of health care. Far from a random moment of inspiration, successful innovation follows a disciplined development path. Before new technologies can reach the clinic, careful planning to define and complete the right preclinical studies with the right models is vital to satisfy the needs of key stakeholders and propel the program to the next stage.
Accessing the capital-rich, innovation-friendly US digital health market remains a key priority for healthtech executives the world over - but to achieve success, it is essential for companies to understand and plan for the US market's complex and evolving regulatory environment.
The global pandemic has created a defining moment for the digital health sector, as many digital health tools and services once considered “nice-to-haves” have transformed into necessities for the delivery of patient care.
Medical device materials are an important determinant of the “biocompatibility” (biological safety) of a medical device. However, the US FDA and EU Notified Bodies consider biocompatibility to involve more than just the device materials.
Clinical data requirements have strengthen under the MDR, to avoid market disruption and to help ensure legacy and new products reach EU customers, it is critical that manufacturers know the different methods available to collect clinical data and the importance to collect the appropriate data.
The medical device industry in the United States is world's largest with an expected market size of over $200bn by 2023. For US companies, early market access planning is crucial and, while it might not be the first target market for companies from other countries, its size means it can’t be ignored. However, there are many challenges and hurdles in accessing the market beyond just gaining regulatory clearance and careful planning is required to achieve success.
As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech businesses, and their investors, need to develop their strategy for navigating their way through the evolving landscape.