Med-Tech Innovation Industry News
INDUSTRY NEWS Four steps to help SMEs
Eucomed, the European medical technology association, is calling for new EU polices to support small and medium- sized enterprises (SMEs). The central role of SMEs in novel technology innovation means they are vital to the future prosperity of the industry and to meeting emerging medical needs. Making some relatively minor, but critically important, interventions now, says Eucomed, would radically improve the business environment for these companies and enable them to develop and grow. SMEs make up 80% of the medical technology industry, which depends on a healthy stream of SMEs to develop new ideas and create new technologies. Research conducted by 12 national industry associations shows there are 7000 SMEs in Europe and their business operations are challenged by a number of barriers. Eucomed makes four recommendations to address these in its latest position paper, European Health and SMEs: Big Challenges, Small and Medium Sized Solutions. It asks for a transparent programme of market surveillance by Member States targeting specific product groups to ensure a level playing field for EU and imported medical devices. Currently, it is not evident that they receive the same regulatory oversight from Authorities. Regulation currently inhibits the commercialisation of novel technology. Eucomed wants a “smarter” regulatory process so that novel technologies can be commercialised faster to give patients faster access to innovative treatments. There is also a need for easier processes for applying for EU R&D funding programmes, including options that allow
Creating future entrepreneurs
The Irish Medical Devices Association (IMDA) is supporting a new national, inter-institutional Fellowship programme, which is modelled on the Biodesign programme offered at Stanford University, Palo Alto, California, USA.
The BioInnovate training programme, which begins in August 2011, gives Fellows access to Ireland’s leading academic researchers and facilities. It offers a unique opportunity to experience an intensive clinical immersion in a teaching hospital, identify potential medical device development opportunities and obtain expert advice and guidance from industrial mentors and serial entrepreneurs. Sharon Higgins, IMDA’s Director said, “The programme develops an understanding of the complex nature of innovating medical technologies, from identifying clinical need through inventing and planning the implementation of a marketable solution. It will further strengthen the culture of innovation and entrepreneurship which exists in Ireland.” The programme will have two multi-disciplinary Fellowship teams of
four Fellows. One team will reside in Galway and one team in Dublin. Both will work in the clinical area of cardiology- interventional and surgical procedures.
www.nuigalway.ie/bioinnovate
08 ¦ April 2011
SMEs to effectively access these funds.
Finding good distributors abroad is often one of the biggest barriers to growth for a SME. Eucomed wants proactive sharing of information by Member State Competent Authorities on market access models and distribution channels. This will improve the business environment for SMEs and enlarge the overall market within the EU.
www.eucomed.be
Safer devices required
The National Patient Safety Agency (NPSA) is recommending that the NHS phases out ambulatory syringe drivers with rate settings in millimetres within five years to reduce the potential of harm to patients. These systems require manual calculation to set the correct rate of administration, which introduces the risk of error.
It wants the NHS to employ ambulatory syringe drivers with rate settings in millilitres. These also have safety features such as alarms that activate if the syringe is not securely fitted and larger internal memory. This guidance has been produced following 167 patient safety incidents, between 1 January 2005 and 30 June 2010, which includes eight fatalities.
Also, starting in 2012, it wants all spinal (intrathecal) bolus doses and lumbar puncture samples performed using syringes, needles and other devices with connectors that cannot connect with intravenous luer connectors. Other requirements related to safer connectors for a number of procedures, including epidurals begin in 2013. See the website for details.
www.nrls.npsa.nhs.uk/resources/type/alerts
www.med-techinnovation.com
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