In this issue

Last month, disgraced biotech founder Elizabeth Holmes was found guilty on four charges of defrauding investors for marketing and selling diagnostic tests that didn’t work. While the faulty tests sold under Theranos's brand name put patients at risk, the case shone a spotlight on a loophole in FDA regulation surrounding lab-developed tests. We spoke to Liz Richardson, who directs the healthcare products project at PEW Charitable Trust - one of the organisations calling for the FDA and Congress to address this flaw alongside thought leaders and regulators - to discuss the loophole that enabled Theranos’ tests to get to market and why it needs to be closed for the good of patients.

February 28 marks Rare Disease Day, so in this issue, we also take a look at some of the unmet needs that patients with rare diseases face while accessing medical devices for their conditions. It turns out that the situation for medical devices for rare diseases is even more dire than that for accessing treatments. Thankfully, the launch of a working group from The International Rare Disease Research Consortium could change that.

Elsewhere we explore one of the most exciting technologies to emerge in healthcare over the past decade - 3D printing. The tech has the potential to revolutionalise drug and device manufacturing by allowing products to be printed essentially next to a patient’s hospital bedside, tailored to them. But, the FDA still has some questions around what the regulation would look like for point-of-care manufacturing specifically pertaining to medical devices. We look at some of the ways 3D printing for PoC device manufacturing could be a gamechanger for personalised patient care, and also some of the potential safety and regulatory concerns.

Read on for all this, as well as the latest medical device industry comment, data and analysis from GlobalData.

Kezia Parkins, editor