SMT007 Magazine

SMT-July2016

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114 SMT Magazine • July 2016 by Carl Lincoln INTEGRATED TECHNOLOGIES LTD It's an exciting time to be part of the glob- al medical device industry; a large percentage of companies have found opportunities for growth, investment in medical device research has increased and there has been a surge in col- laborations, which have led to significant tech- nological advancements. In recent years, the regulatory landscape for medical devices has become more and more risk- focused with the aim of ensuring patient safety by taking a process rather than product-based approach. When you look closely at manufac- turing processes for critical parts, such as PCBs, the specific challenges encountered mean that companies often bring in a trusted medical elec- tronics manufacturing partner to negate risk. Electronics are at the heart of a medical de- vice and are responsible (alongside the software and firmware) for correct, safe and continued operation. If a medical device fails in the field, patients can't be treated or diagnosed and that is a serious problem. This leads to a high level of business risk for the legal manufacturer (the business that is outsourcing) as they will incur the costs of replacing or repairing the device and may have fines or compensation clauses in their supply contracts. A challenge for medical EMS providers is the need for continual supply. Once a medical de- vice has become part of clinical practice there is an expectation from users that it will always be available where needed. Electronics have a rela- tively short lifespan and so an EMS provider can provide added value by helping their customers to manage these risks by implementing obsoles- cence mitigation strategies. Medical electronics manufacturers must also be able to manage change control and it is vital that changes made to the design of a How to Overcome Medical Electronics Manufacturing Challenges

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