Medtech companies are increasingly grappling with significant business risks related to the management and protection of patient device data. As the industry intensifies its collection, transmission, storage and analysis of confidential patient data, it faces heightened scrutiny from various stakeholders. Investors, both before and after committing funds, are now demanding clear demonstrations of robust cybersecurity capabilities. This scrutiny extends to the highest levels of corporate governance, with executives and board members intensifying their focus on ensuring that, at the very least, essential business operations are securely managed.
Additionally, cyber insurance providers are setting stringent prerequisites for foundational cybersecurity measures before offering coverage, reflecting the growing recognition of these risks. Compounding these challenges are evolving regulatory landscapes. New Food and Drug Administration (FDA) regulations and U.S. Securities and Exchange Commission (SEC) cyber disclosure mandates are placing additional burdens on medtech companies. These regulations not only increase the complexity of compliance but also underscore the critical…
