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118 SMT Magazine • July 2016 protect your business and your customers in the future. FIVE: What's your capacity? Could you handle increased orders as I grow? Your manufacturer may be able to produce the volume of PCBs that you need now, but will they still be suitable in future? You need to consider whether you want to go through the process of knowledge transfer, re-training and re-validating when your vol- umes increase or whether you would rather se- lect a manufacturer that can grow with you. You should also ask your manufacturer how flexible they are. Do they insist on minimum order quantities? What fixed forecasts will they hold you to? Could they still meet lead times if you double your order quantity? SIX: Could you meet our device-specific requirements? If your device has any specific requirements such as flexible PCBs, multi-layer boards or un- common storage conditions, don't assume that every PCB manufacturer has these capabilities. If you find a perfect fit but they don't have everything, ask if they would be willing to in- vest—this is also a good test of their commit- ment to you as a customer. SEVEN: What do you have in place for ESD protection? Electrostatic discharge, the sudden transfer of electricity from one object to another, can damage components. The smallest amount that can be felt by a human (when you touch some- thing and feel an electric shock) is around 2000 volts, but sensitive electronic components can be damaged by as little as 20 volts of static elec- tricity. There are a multitude of measures that a PCB manufacturer can put in place to mitigate the risks of ESD damaging your boards and they should be able to demonstrate them to you. EIGHT: Can you provide supply chain management? Can your manufacturer take on value- added activities such as supply chain man- agement? There are more burdens in this area than you might think, examples include au- diting suppliers, negotiating prices and RoHS compliance. If your business isn't geared up for sourcing and handling components you may be better off outsourcing this to your manufacturer too. Plus, they will already have good relationships with component suppliers and might be able to get preferential terms. NINE: What is your critical parts inspec- tion protocol? According to the requirements of ISO 13485, if your critical parts list includes components on your PCB, these need to be inspected at goods- in and recorded by the manufacturer. A special- ist medical device PCB manufacturer will have this built in to their process, whereas a general EMS company may not. TEN: What's your obsolescence mitiga- tion process? Component obsolescence is something that cannot be avoided but can be managed. Can your PCB manufacturer help you with strategies such as re-designs, bulk buys and last-time buys to avoid any breaks in supply? If not, you're likely to lose money and be left with few op- tions. Now you know what to ask, you can start looking for your ideal PCB manufacturer. Forg- ing an effective relationship with your suppli- er can help drive your business forward and contribute to success—so it's important to get it right. You want to know that your supplier has the expertise, experience, facilities and ca- pability to meet, and even surpass, your ex- pectations. SMT Carl Lincoln is a marketing and business development coordinator at Integrated Technologies Ltd. HOW TO OVERCOME MEDICAL ELECTRONICS MANUFACTURING CHALLENGES

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