The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. The regulatory environment is continuously changing. Change is driven by globalization, accelerated advancements in science and technology coupled with an ability to advance cures for patients, improve patient safety leading to avoidance of unnecessary incidents. There is an ongoing rise in the sophistication and demands of patients, consumers and regulators. As patients’ and consumers’ expectations evolve, they are demanding a more patient-centric experience and more information shared regarding their conditions and treatments. Trial participants will be seen as collaborators in clinical research rather than subjects. The life sciences and healthcare industries are going through a period of unprecedented regulatory change impacting pharmaceuticals, medical devices, in-vitro diagnostics and healthcare organizations for the benefit of patients. The ability to respond to regulatory requirements swiftly, effectively and efficiently is vital to both a company’s reputation and viability commercially. The transition from current requirements to new requirements can be challenging, especially for companies with disparate systems and data sets that are siloed and now need to be aligned and aggregated.
This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.
Medidata looked at some of the themes of which management of medical device data is critical to driving insights and accelerated product development which brings innovation and new treatments for patients and consumers.