INDUSTRY NEWS Frugal device technology
Technologies that could save the lives of millions of people living in the developing world were unveiled at a conference in September, organised by the Institution of Mechanical Engineers (IMECH). The event, “Appropriate Healthcare Technologies for Developing Countries: Low-cost, frugal technology medical devices,” showcased the vital role engineering can play in delivering better, more effective health care to people living in extreme poverty. Dr Patrick Finlay, Chairman of the Biomedical Engineering Association at IMECH, said, “The key term here is ‘appropriate’ – these new technologies have to be designed to work effectively in developing countries.” Expensive and diffi cult to replace parts, the need for a constant electricity supply, a lack of trained operators or their unsuitability to rough terrain
are all factors that prevent the developing world from using many standard medical technologies. He continued, “In the developed world, it takes years for a manufacturer to demonstrate that a new medical device or drug is safe and effective due to the approvals process. In the developing world, priorities are different: if lives can be saved by a quick and cheap innovation, even if results are not perfect, the device should be made available.”
The innovative designs include a simple, mobile centrifuge system that extends the life of blood for testing from two to eight hours and allows rapid diagnostic tests for diseases including hepatitis B and C, syphilis and typhoid fever regardless of electricity or infrastructure. The developer Centricycle is initially targeting India, where one-in-three people lack access to healthcare.
www.imeche.org.uk;
http://centricycle.org/
Ready for a surprise visit?
Unannounced visits from Notifi ed Bodies are going to be part of life for med-tech manufacturers in the EU. Are you prepared for when the inspectors come calling? The unannounced audit will be additional to the regular assessment cycle and at least one day by two auditors.
Manufacturers are advised to begin preparations for the new requirements. Notifi ed Body BSI is preparing a BSI policy for the process and conduct of unannounced audits, which will be to the manufacturer or one of its critical subcontractors or suppliers of crucial components.
http://medicaldevices.bsigroup.com
www.med-techinnovation.com
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microlumen.com to learn more.
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