Med-Tech Innovation Products and Services
PRODUCTS AND SERVICES Materials documentation service
Applied Silicone, a supplier of implantable silicone material, is offering material compendia that detail the physical, chemical and biological testing of the raw material specific to each long-term implantable silicone product offered by the company. This service provides the user with an extensive summary of the supporting documentation that is available, in electronic format, for regulatory review and submissions for Class II and Class III medical devices. Material compendia allow device manufacturers to avoid redundant
pre-clinical physical, chemical and biocompatibility testing of the material for regulatory submissions such as 510(k)s, IDEs and pre- market notifications. Each compendium is an organised summary of physical property data, chemical properties and the biological testing conducted on each product. The documentation is supported with references to corresponding Master Files registered with the US Food and Drug Administration. For international medical device submissions, the compendium is customised to address the requirements set forth by regulatory bodies in the country of submission. To learn more about the company’s products and services and to preview a sample compendium index visit its website. Applied Silicone Corp. tel. +353 (0)86 8953 049,
www.appliedsilicone.com
Novel technique unveiled
Design and development company Team Consulting has unveiled an innovative concept that has the potential to address two significant unmet clinical needs: early detection of cancer regrowth following surgery and detection of infection within chronic wounds. The new technology, called Spatial Reach, gives clinicians the ability to non-invasively monitor the site of an internal tumour excision or a chronic wound. Once a site has been analysed, the same platform can then be used to deliver highly targeted therapy to the precise areas where treatment is required, to kill remaining cancer cells or to treat wound infections. This is done without exposing nearby tissue directly to chemotherapy agents or to unnecessary antibiotics. The technology works by utilising low-cost hollow fibre tubing
currently used for haemodialysis alongside specially engineered hardware and software. A continuous spiral or zig-zag pattern of the porous hollow fibre tubing is placed into or onto the target area. The tubing is filled with saline and the surgical site can be closed or a dressing can be applied as normal. With the tubing in place any biomarkers of cancer or infection can diffuse into the tube. The presence of cancer regrowth or infection can then be monitored by pumping out and analysing the column of fluid. When the sample is passed through a handheld reader, healthcare professionals can see not only whether cancer or infection is present, but exactly where it is in three dimensions.
Having analysed the sample, the Spatial Reach platform can then be
run “in reverse” so that chemotherapy or an antibiotic can be delivered back to just those areas within the wound where it is required. Slugs
www.med-techinnovation.com September/October 2013 ¦ 39
of chemotherapy or antibiotic are pumped back by the device into the tubing, interspersed with saline, so that the therapy ends up adjacent to the infection or cancer. The drug can then diffuse out of the porous tubing and only treats the targeted region. This allows chemotherapy to be used without causing damage to healthy tissue. It will also allow antibiotics to be delivered that can treat superbugs such as MRSA, which are too toxic to be given to vulnerable patients systemically. Dr Ben Wicks, Head of Critical Care at the company commented, “Spatial Reach is an early-stage concept but it offers significant benefits to surgeons, healthcare professionals and patients. The feedback from industry experts has been very positive.” The company used the recent AdvaMed meeting in Washington to further talks with industry players. Team Consulting
tel. +44 (0)1799 532 700,
www.team-consulting.com Contract manufacturing expansion
Europlaz Technologies has doubled its capacity for technical injection moulding and cleanroom assembly by taking control of an additional building within its existing industrial estate in Southminster, Essex. The space will add extra production, cleanroom and warehouse capacity. The company offers contract cleanroom manufacturing, R&D, design and engineering and QA/QC services. Its expertise
is in plastic injection moulded components, sub-assemblies, finished medical devices and packaging solutions. Europlaz Technologies Ltd tel. +44 (0)1621 773 471,
www.europlaz.co.uk
Metal finishing services
Finishing Techniques has expanded its subcontract services. The long- time UK exclusive supplier of Otec deburring and polishing machines has brought together under one roof five technologies to provide a one-stop shop for metal finishing services. The technologies are stream finishing, vibratory, disc finishing, drag finishing and centrifugal tumbling. When capital budgets are under pressure, investment in a full range of machine technologies may not be justified. Therefore, subcontracting
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