Cybersecurity is becoming a non-negotiable aspect in the medical device industry, but many companies are not adequately prepared to address it.
Since the PATCH Act came into effect, cybersecurity requirements have become crucial for FDA approval, including aspects like cryptographic key management and secure update pathways.
Most companies are still allocating minimal budgets for cybersecurity, not fully understanding or accounting for the complex security needs of medical devices.
The article emphasizes the need for separate focus and investment in product security compared to corporate security, highlighting the unique challenges and requirements in the medical device field.