Med-Tech Innovation Product and Services
PRODUCTS AND SERVICES Ultrasonics smoothes the edges
In a growing number of products, including wound dressings and compresses, high integrity sealed edges are being achieved by ultrasonic technology, applied using a principle known as Cut’n’Seal. For these products, which can often be multi-layered, it is important to eliminate the risk of de-lamination and frayed or sharp edges.
The Cut’n’Seal principle employs ultrasonic energy to cut or punch out components from a range of thermoplastic and
synthetic materials, whilst at the same time sealing the edges and, if required, joining the individual component to a secondary item.
Applications The process can be applied to a variety of substrates including very thin synthetic melt blown or spun bond flexible materials, thicker soft materials, specialist skin coated technical foam products and injection moulded substrates. The vibrations produced by the ultrasonic system cause a cutting effect through the single or multi-layer substrates, against a support anvil, which incorporates the required cutting contour. The instantaneous heat produced in the cutting zone results in a sealing weld along the cutting edge and a smooth edge finish. Multi-layer substrates or laminates are also collated and fused into one smooth edge. This smooth edge, however, is far more than just an aesthetic finish. On items such as medical compresses, which are made up of perhaps five individual layers, the sealed edge ensures that there will be no frayed
New innovation incubator offering
Creganna-Tactx Medical’s new office in Cleveland Clinic’s, Global Cardiovascular Innovation Centre (GCIC) in the US is designed to support companies commercialising innovative technology. The company’s presence in the incubator will provide product development services to early stage companies and also link its customers to leaders in medical innovation and healthcare delivery. Randall Sword, Business Development, said, “This move strategically positions Creganna-Tactx Medical to offer our customers complete support along the full product lifecycle. Working with Cleveland Clinic’s GCIC, we can help bridge the gap between the designer and end-user physician in the development process.” This service will be bolstered by the company’s recent joint venture with Boston Biomedical Associates, which will work with Creganna- Tactx Medical to support customers with clinical, regulatory and quality affairs. Creganna-Tactx Medical specialises in the design and manufacture of minimally and less invasive delivery and access devices.
Creganna-Tactx Medical tel. +353 (0)91 757 801,
www.cregannatactx.com
40 ¦ April 2011
edges or loose threads and that the individual layers do not delaminate. These features are important on a range of items, including components such as filters and respiratory masks. The process can be used where flexible textile filter layers need to be joined to thin rigid substrates, as in the case of medical filter membranes or face mask nose valves. The process rule for ultrasonic Cut’n’Seal is that some layers of the
product must be thermoplastic, or at least have 30% thermoplastic content. Inter-layers of non-thermoplastic material, for example, special paper layers within specialist filtration products, can be accommodated by the fusing of other thermoplastic layers. Cutting through specialist products without sealing, can be achieved on materials that do not have any thermoplastic layers, where edge quality is difficult with alternative methods.
Advantages over traditional sealing This ultrasonic process eliminates many of the issues that result from the use of alternative technologies. Using heat to cut and seal can often leave unsightly discolouration on the product and an uneven or rough surface finish along the edges. Mechanical cutting knives or blades are prone to edge wear and damage. This can lead to inconsistent product quality and the resultant system downtime associated with tool changes, as well as unacceptable damage to delicate products. The very nature of the ultrasonic process means that it is measurable, it can be process limit controlled and statistically analysed within standard PC packages. This is a major benefit in applications that are safety critical in nature or require validation. Additional benefits of this ultrasonic process include the elimination of consumables and reduced environmental issues associated with recycling or the disposal of chemicals, as required with certain adhesives. The efficiency of the process with its “on demand” delivery helps to reduce energy costs compared with heat options.
Information supplied by Martin Frost, UK Sales Manager, Telsonic UK Ltd, tel. +44 (0)1202 697 340,
www.telsonic.com
Software development help
High integrity software must be developed using a documented lifecycle process that complies with ISO EN 62304. Any lifecycle chosen to meet this standard should follow best practice and meet the needs of design complexity that is inherent in software development. The TraceIT quality process created by Trosolwg Systems and Software does just that, say its developers. The software house offers a range of options for deploying a process compliant with ISO EN 62304. It offers TraceIT for companies wishing to implement an off-the-shelf documented process. Its Packaged Quality Service provides additional support throughout implementation of TraceIT quality process.
Its Bespoke Quality Service provides a tailored solution to match specific business needs, which can include include customisation of the process and a Software Development Plan to interface seamlessly with the client’s quality system. For those who prefer to outsource, it offers a full software development service.
Trosolwg Systems and Software tel. +44 (0)1267 267 068,
www.trosolwg.co.uk
www.med-techinnovation.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54