Improving Global Quality of Life

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the HRI report which accounted for 64% of global MD&D product sales in 2004; cardiovascular disease, musculo-sketetal disease, cancer, dental care, urology and renal conditions, diabetes, respiratory/ pulmonary conditions, gastrointestinal disease, ophthalmic conditions, and hearing impairment and diseases of the ear (otology). Of these, cardiovascular disease related components accounted for over 19.2%. The Orthopaedic sector had a $26 billion global marketplace in 2006. Both the spine and trauma sectors experienced the significant growth in 2006. The following are some of the trends that affect materials joining for the medical market. 9.16.1 Hot topics Miniaturisation: One continuing trend in the medical device market is the expansion of Minimally Invasive Surgery (MIS) procedures. Expansion of the MIS market is due in large part to replacement procedures for conventional, open surgery, treatment methods. The percentage of MIS procedures (as a percentage of all surgical interventions) is expected to increase from the current level of 15- 20% to about 70% by 2010. Increased use of MIS in emerging markets of the Pacific Rim and Latin America are likely to contribute significantly to this growth. As more and more surgical procedures migrate to less invasive approaches, the drive to minimise the size of the medical devices will continue. New materials: Another important trend in the medical devices market is the increasing use of biocompatible metals for the design and fabrication of surgical and implantable devices. Because there is a drive to minimise the size of the devices for MIS or interventional cardiology procedures or for implantation, medical device designers frequently must develop methods to directly join two dissimilar metal materials. Key considerations in this joining include the biocompatibility and resistance to bio-corrosion not only for the base metals, but for also any intermetallics formed by the joining process. The radiopacity of the metals and/or intermetallics is also a concern, as the surgeon must be able to use radiography to monitor the position of the devices within the body during the procedure. Increasing performance requirements: For implantable devices, fatigue life of the joint is extremely important, since the device is often left in the body and therefore must not fail for the remainder of the patient’s life. Other key concerns are corrosion of the component, due to the environment and the ability to use magnetic resonance imaging (MRI) after surgery; since metal and other materials properties could interfere with the ability to use MRI as a medical diagnostic tool. Cost control: Medical device manufacturers are increasingly outsourcing manufacturing and assembly of their products to contract manufacturers. One reason behind this shift is cost pressure; specialised labour can be expensive for the assembly of sophisticated medical devices. Laser welded blood bag Medical devices cover a very broad range of products from very simple sealed bags to very complex ‘active’ implants. In general, medical devices, whether temporary or permanent, used externally or inside the body, are becoming more complex and sophisticated both in terms of their performance specification and structural complexity. As a consequence, many devices in current use are multi-component and require assembly in production. Joining is one of the key issues. Medical devices, whether used outside the body (e.g. instrumentation, control systems or surgical tools) or inside the body for diagnostic monitoring or therapeutic purposes (e.g. sensors, catheters, pacemakers or prostheses) usually consist of many materials which may need to be joined. 144 Improving Global Quality of Life Through Optimum Use and Innovation of Welding and Joining Technologies
9 Needs and challenges of major industry sectors for future applications A range of processes are used for joining, including mechanical fasteners, welding, brazing, soldering and adhesive bonding. The choice of process tends to be made on an assessment of the materials, joint design, mechanical/environmental performance and cost. Unique features of the medical device field are that most products need to be tolerant to sterilisation techniques (e.g. autoclave, radiation) and some require surfacing techniques to make them biocompatible or anti-soiling. Additionally, the technology employed in these devices is developing very rapidly and assembly techniques (e.g. joining) have to adapt accordingly. Welding techniques are currently used on a range of products such as: Laser welding of precision instruments and hermetically sealed cases/ packages. Benefits: Low distortion, Reduced machining, Reduced thickness of casing/ materials. Arc welding catheter guide wires. Benefits: Rapid heating/cooling cycle allowing the joining of difficult materials and heat sensitive devices. Cardiac pacemakerlaser welded case Ultrasonic and thermosonic welding for electronic device interconnection. Benefits: High speed, Low temperature, Reliable. Resistance welding for heated catheter tools. Benefits: No additional materials, Will withstand high temperatures. Laser welding polymer fluid transfer devices (e.g. blood and colostomy bags, lab-on-a-chip): Benefits: Rapid assembly, no additional materials (e.g. adhesives), Recycled–improved sustainability, Avoids cross contamination and enables. Welding PEEK optima for orthopaedic joints: Benefits: Replace adhesive, which reduces number of materials, retains material properties and avoids re-qualification. “Welding” processes are now also being adapted to provide surface engineering and 3D shape generation e.g. Laser Direct Metal Deposition – orthopaedic and dental implant generation, customisation or surface texturing. Electron Beam surface texturing/sculpting - enhance implant to bone attachment, provide drug release surfaces. Thermal/Cold Spray - orthopaedic implant coatings (e.g. hydroxyapatite) to enable bonding to the bone. The new medical products that welding assists in manufacturing can have a profoundly beneficial effect on patient life-style, well being and reduce healthcare costs: Surface Orthopaedic hip joint engineering can extend implant life, miniaturisation can reduce surgical trauma. Smart implants/monitoring systems can restore a more active life and reduce time in hospitals. Challenges include: increased miniaturisation, “smarter” systems, longer life implants, improved surface coating (e.g. bio-implant and wear-resistant interfaces). Through Optimum Use and Innovation of Welding and Joining Technologies Improving Global Quality of Life 145
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Improving Global Quality of Life Th
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Foreword Dr Baldev Raj Mr Chris Sma
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In alphabetical order (Continued) D
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6.3 Job, skill, career and competen
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9.6.3 Welding processes and challen
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Executive summary “ Welding is an
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Editors’ Preface Improving Global
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Scope and objectives 1 an important
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Welding industry 2.in the world 2.1
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2.2 Today’s welding industry and
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2 Welding industry in the world IIW
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3.welding Signifi cance of and join
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3.3 Welding and joining in sustaina
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An example of the value of welding
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16 Improving Global Quality of Life
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4. Needs and challenges in welding
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Welding thick walled steel componen
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The trend towards light-weight desi
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Up-to-date, titanium alloys have be
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Needs for weight reduction in aircr
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Finally, testing of welds will be e
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As another most important item, the
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In order to make the developments i
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Reduction and/or elimination of dis
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5. Needs and challenges in welding
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The productivity in EB welding has
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The potential applications are for
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5.2 Higher automation, productivity
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In submerged arc welding one can re
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From a practical perspective, the n
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Acceptance levels are not included
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5.5 NDT and structural health monit
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IIW can help companies to get their
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6. Needs and challenges in health,
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welder against Cr6 is a very import
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is considerable national concern fo
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important in meeting needs with res
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7. Legal codes, rules and standardi
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In national or regional legal codes
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7.4.2 Optimum laws Laws applying in
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IIW needs to help ISO and others cl
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structures. It is unlikely in the s
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8. Needs and challenges for global
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infrastructure to develop multiple
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Table 8.1 Key actions and key activ
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9.7.1 Hot topics ..................
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New discoveries tend to be in deepw
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Proved reserves at end 2004 Trillio
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easily weldable, the life expectanc
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9.1.3 Hot topics Reducing negative
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Following these codes assures initi
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