The medical device session at the NextLevel Medical Affairs Leaders Forum was ripe with new perceptions on how best to navigate the changing regulatory environment. In our latest blog post, Dr Janine Collins, MBBS, LLM, highlights the top five key takeaways for medical affairs professionals.
time and motion for medical devices
Cost-containment pressures in healthcare have led to more stringent requirements to demonstrate evidence of incremental value versus standard of care (SOC) by regulators and payers alike. Real-world evidence related to patterns and outcomes of care that complement traditional efficacy and safety data is increasingly warranted to ensure successful market access and product uptake, not only for biopharmaceutical products, but also for medical devices.