IIW White Paper

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.

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.

Laser welded blood bag

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Through Optimum Use and Innovation of Welding and Joining Technologies

Improving Global Quality of Life