The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), published in May 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market.
Bringing a new medical treatment to market is a challenging process - one that is not always fruitful. It is estimated that clinical development programs fail four times out of five. Although a clinical trial can fail for many reasons, poor trial design is often the main cause for failure.
Insourcing or outsourcing in clinical trials is a late-breaking topic. Despite other branches of trade such as the automotive industry where large companies are experiencing a comeback of insourcing, the conduct of clinical trials are mostly outsourced to contract research organizations (CROs).
The pharmaceutical and medical device industries continuously look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. A fundamental requirement for informed decision-making and reliable performance reporting is the consolidation of all collected information, often heterogeneous and disparate, into one location where they can be linked together for analysis.
Discovery and development of novel therapeutics to address society’s unmet medical needs is the ultimate goal of research-driven pharmaceutical companies. Despite industry efforts, success rates in oncology have been declining over time. More and more device-based therapies and interventions are being developed however, delivering promising results in cancer diagnostics and treatment.
If sponsors want to enroll and retain patients, they must take steps to mediate the information overload & falsehoods that their patients are exposed to and continue to establish trusting relationships with them. Using the correct guidance as a road map, sponsors can work to drive recruitment, enrollment and completion of their trials with more robust data at a lower cost and reach their goals of regulatory approval at a faster rate.
Ensuring proper data protection in a clinical trial is a demanding & expensive process, one that may leave an organization vulnerable to data breaches, resulting in steep fines and penalties.
Whether you are a first-time inventor with a novel idea emerging from an unmet need in patient care or a large manufacturer with a rich history in bringing medical devices to the market, the thrill of being at the forefront of an innovative concept is both exhilarating and overwhelming. The development of a successful medical product not only requires optimized engineering design efforts, but also clinical, regulatory, marketing and business expertise.
When being introduced to the world of market access and health economics, the staggering number of abbreviations can be overwhelming: HTA, QALY, DRG... What should we make of all these terms? And more importantly, how should we interpret them in this dynamic healthcare environment?