THIS MONTH
Complement activation standard
A new method for evaluating complement activation has been approved by the American Society for Testing Materials. F2567, Practice For Testing For Classical Pathway Complement Activation in Serum by Solid Materials, was developed as a result of industry requests to FDA for guidance on how to acceptably perform complement activation analysis on materials intended for use in blood or tissue-contacting medical devices. F2567 deals with the classical pathway of activation, whereby the presence of antibodies caught in the device material are responsible. F1984 and F2065 are two separate standards that apply to the other main pathways of complement activation in the body: whole and alterative pathway complement activation. These and the new standard will help any company anticipating or already conducting biocompatibility studies for submission of product applications to FDA. www.astm.org
Growing demand for biomaterials
US demand for biocompatible materials will increase by 6.6% annually to reach US$3.7 billion in 2010, says a report by The Freedonia Group. The strongest growth is likely to be in synthetic polymers and ceramics; polyvinyl chloride is predicted to expand at below average rate because of concerns over di(2-ethylhexyl) phthalate plasticiser migration. The increasing use of hyaluronic acid and collagen for cosmetic implants, orthopaedics and wound management is expected to make them the most successful natural polymers. It is suggested that many implantable devices will continue to be partially or completely constructed from biocompatible metals, including the predicted growth leader, titanium and its alloys. www.freedonia.com
Irish clinical trials must increase
More medical technology clinical trials should be conducted in Ireland says the Cross Sectoral Clinical Trials Taskforce in its report to the Irish Minister for Health. The group claims that the Irish population is not benefiting as it should from new medical advances. The report calls for a trebling of funding to finance its recommendations. These include an increase in the numbers of clinicians with protected time for research, an increase in the number of experienced clinical trials nurses, a dedicated ethics committee for medical devices and the establishment of a central point of contact for clinical trials.
www.ibec.ie
Closing the gap
The Cooksey Review, which has been endorsed by the UK Chancellor of the Exchequer Gordon Brown, recommends a long-term strategic approach to the way research and development and innovation are translated into health-care delivery. Currently, the UK Government has no way of signalling its health priorities to the industry. The newly established Office for Strategic Coordination of Health Research will be responsible for communicating those priorities to the market. The review also requests additional funding to set up local strategic procurement to support the introduction of new technologies. www.abhi.org.uk
More jobs in Germany
The German medtech sector has again created more jobs in 2006. Of the 118 companies taking part in the trade association BVMed‘s survey, 46% say they have increased the jobs they have available. In 2005, this figure was 36%. Jobs in the medical technology sector rose from 108,000 to 111,000, according to official employment statistics. This is despite a difficult economic environment. The association says that only 35% of the companies surveyed are expecting better results than in 2005, attributing this to the doctors’ strike and increasing pressure on prices in the hospital sector. www.bvmed.de
Reaching too far
Certain assays will no longer be available as a result of the new chemical regulation, REACH, which has been approved by the European Parliament. This is the warning issued by the European Diagnostic Manufacturers Association (EDMA), which highlighted the possible serious consequences for patients. EDMA wants an effective programme established to avoid unnecessary disruption of diagnostic assays for patients, and larger annual health-care budgets to address the cost implications that REACH will have for the industry. More than 30,000 chemical substances are affected. www.edma-ivd.be
Lack of nano safety
The US Food and Drug Administration (FDA) is too poor to acquire the necessary nanotech expertise it needs, according to a study published by the Woodrow Wilson Center for Scholars. FDA's budget for 2007 is reportedly less than half what is required to regulate conventional products, let alone nanotechonologies. As a result potentially dangerous nanomaterials could appear in medical devices and food packaging, says the study. www.newscientist.com
