Good Clinical Practice (GCP) rules are there to protect patients and make sure studies are ethical and accurate — but sometimes it feels like there’s more focus on paperwork than patients. While the system works, it can also slow down innovation.
Do you think GCP guidelines strike the right balance between safety and efficiency, or is it time to rethink how they’re applied?
The regulatory process for medical device development is often seen as either a gold standard for safety or a paperwork nightmare for innovators. On one hand, strict regulatory frameworks such as those enforced by the FDA ensure that only safe, effective, and high-quality devices reach patients. On the other hand, the extensive documentation, testing, and approval procedures can slow innovation and increase development costs. Many startups struggle to navigate the complex compliance requirements, leading to delays or project abandonment. Ultimately, while these regulations protect public health, finding a balance between safety and innovation remains a major challenge in the medical device industry.
