Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.
One of the biggest pain points facing Clinical Trial timelines today is the booklet labeling process. Labels are the last component needed before packaging can be completed, and there is often a late-in-the-game scramble to get booklet labels to the packager quick enough to avoid patient impact. Booklet labels tend to be an exasperating component.
Advances in technology over the past decade have catapulted the world forward in every aspect of our economies. The network of shared knowledge is growing exponentially and with it, new breakthroughs in drug development are constantly evolving. What has not changed however, is the 20 year patent life on new drug discoveries. As a new drug developer, you face daunting odds to bring your drug to market in a safe and just as importantly, timely manner in the eyes of the stakeholders.