Articles

Necessary action is being taken to reduce costs through mandatory implementation of EMR/EHR, maintenance of minimum medical loss ratios for hospitals, and an overall emphasis on cost effectiveness. Many healthcare organisations have uses some form of outsourcing, offshoring or a mix of both. Read more

Social media and the internet are increasingly been used as a means to sell illegal and counterfeit drugs, a UN drugs agency has warned. This comes in the wake of a recent industry alarm when fake batches of the cancer drug Avastin came onto the US market increasing fears about drug safety. A recent report by MarkMonitor estimated that online counterfeit sales cost businesses $135 billion (£87 billion) in revenue in 2011. Read more

The Institute of Medicine has called for a new regulatory framework to replaced 510(k), urging the FDA to invest in the development of a system featuring both premarket clearance and improved post-market surveillance. "The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one," the committee noted in the report. Read more

In the past year, firms across Europe have been coming to terms with the EU Medical Device Directive (MDD) after an initially shaky start. Some firms questioned that lack of guidance offered to accompany the new regulations, but now those questions have been answered, many have to get down to the difficult task of making the changes required to ensure that existing products comply with the new rules, Read more

Pharma IQ provides you with a quick update of the activities of the Top 10 players in medical equipment and supplies market in 2011. Read more

"From my perspective the major challenge is the missing alignment or harmonisation in the global devices market; we are duplicating a lot of work such as testing and documentation without adding additional safety, but just doing it differently, " Read more

The average cost of bringing a 510(k) – or premarket notification – product to market was placed at $31 million (£19.8 million), with 77 percent of this going on the FDA approval project. Medical devices considered to be high risk cost $94 million to take to market, with 80 per cent of this being spent on FDA approval linked activities. Read more

Efforts are also underway to reduce the levels of power used for wireless medical devices. The Holst Centre and Imec have been working on ways to do this by combining their specialist fields of nanotechnology and wireless technology. Earlier this year the companies were awarded the Frost & Sullivan Award for Technology Innovation for their wearable electrocardiograph (ECG) energy harvesting solution. Made from a thermoelectric material, the device converts body heat to an electric current, which is then transferred to any energy storage system. The power is then used to drive the "autonomous wearable electrocardiography (ECG) system and a radio which transmits the ECG signal real-time to a base station". Read more