More than a year has passed since 25th May 2017 and the start of the three-year transition period from the Medical Devices Directive (93/42/EEC) and Directive 90/385/EEC on active implantable medical devices (AIMDD) to the Medical Devices Regulation (EU 2017/745).But what does this mean for businesses with products currently on…
24 September 2018 – A doctor’s experience of dealing with acute trauma on the battlefield is being used to help improve the lives of critically ill civilian patients in intensive care units (ICUs). Dr Charlotte Small and the critical care research team at the Queen Elizabeth Hospital Birmingham (QEHB) in the…
This month’s Manufacturing Medicines Industry Partnership (MMIP) conference – Propelling growth: taking the next step in innovative medicines manufacturing – took place at an exciting time for the pharma industry. Advanced therapies (ATs) – such as cell therapies in which patients are treated with living cells – have been under development for…
When pharmaceutical companies launch a new product, often it is a combination of a new drug in an existing, proven delivery device. Because all new pharma products have full regulatory scrutiny, it is important to make sure the medical device design history file (DHF) is up to date and meets…
Light has become a powerful medical tool. Continuing advances in the understanding of biological interactions with light, and newly developing light technologies, have given rise to a wide range of light-based therapies. As a physicist, I use light to study and modify the properties of materials down to the nanoscale.…
The rise of connected devices and the variety of information they can generate is set to drive an increase in patient adherence to therapies. Our trials have shown that remote and hidden sensing of actual user behaviour can uncover unexpected and significant opportunities to improve the patient experience.So how can…
As part of our review of the new European Medical Devices Regulation (MDR) earlier this year, one of the topics that caught our eye was the expansion and clarification of the rules regarding clinical data for medical devices.The difference between a clinical investigation and a clinical evaluation Many people colloquially…
The new European Medical Devices Regulation (MDR) introduced by the European Commission (EC) has led to a lot of discussion around the implications for getting products on to the European market. But what about products that are already on the market? What does the new regulation mean for these so-called…
The words ‘post-market surveillance’ (PMS) appear 129 times in the new European Medical Devices Regulation (MDR). This repetition is not accidental. The requirements for manufacturers to ‘actively and systematically’ gather, record and analyse relevant data for the lifetime of each device they market is work most companies had not been…
Regenerative medicine and cell therapies have long been hailed as the holy-grail of medical treatment. Treatments that use the patient’s own cells to fight disease or regenerate damaged tissues sound like science fiction, however in research institutions around the world this is exactly what is happening 1, 2. For now though,…
Reflections on two themes from the day; – Usability: Continuity from marketing, through R&D, to regulatory– Connected devices and systems: Realising the benefits Usability: Continuity from marketing, through R&D, to regulatoryWe were struck by the frequency at which we heard terms like “usability,” “workflow” and “seamless integration” during presentations on…
It’s important to realise that beyond the realm of classical engineering principles lays the softer, squishier world of biology and medicine. By being intimately familiar with human anatomy, biomedical engineers are able to more rapidly question whether their concepts are truly viable prior to embarking on further development, using an…