This week, I presented in a collaborative webinar with Cook Medical’s David Chadwick, Director of Regulatory Affairs, covering the best practise when applying materials data and predicate device information in healthcare. The healthcare industry faces a colossal task when choosing materials for use in new or existing medical devices. For those unfamiliar with the medical industry, the number of factors which need to be carefully considered when selecting a material for use in the human body can seem overwhelming; engineering properties, biocompatibility, effect of sterilization treatments, material-drug interactions, regulatory approval processes such as FDA approval and CE Marking, just to name a few.
Completely new materials in the field of implantable devices are a rare occurrence. This is because of the heavy regulatory burden placed on implantable medical devices to ensure that they are safe and effective for use in the specified application. There has to be a very good reason to invest in the cost of qualifying a new material over the ones that have a long standing history in the field. However, one group of materials that seem likely to cross that boundary and have been gaining increasing attention in recent years are bioabsorbable magnesium alloys. But what are these alloys and why are they gaining such attention? Continue reading
There are some things that nature just gets right. Take bone, for example. This typically has an elastic modulus similar to concrete, but is 10 times stronger in compression and around 50 times stronger in tension. It has a compressive strength similar to stainless steel, but is three times lighter. Not only that, but as a living tissue, it can adapt to meet property requirements. Bones in the legs, such as the femur and tibia, are typically much stronger than bones found in the arm, for example. And its properties aren’t fixed: the graph below shows how bones change in behavior with age, as explored within Granta’s Human Biological Materials database. What’s more, bones adapt depending on external conditions – a constant challenge in space as bones weaken if they are not loaded (as happens in zero-gravity). Continue reading