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Balancing Risk Key to Development

When developing processes and designs for medical devices, risk is a key factor to keep in mind at all times, according to Tom Wrobel and John Blix of Boston Scientific. They spoke at the MD&M conference session "Development of the Perfect Medical Device." They advised balancing risk against four factors: quality, speed to market, product performance, and cost.

Depending on the device, there will be different levels of risk management. When thinking about risk and quality, companies should ask themselves, "Do we have effective controls?" The quality of the device must be absolute, and the processes must ensure that quality. For speed-to-market considerations, companies want to be aggressive, but they must also be realistic. When thinking about product performance, companies must make sure that their products deliver real benefits, and end-users need to be able to see the value of the product. Finally, cost must be considered. Companies must evaluate whether they can consistently produce products that meet specifications, and whether they can make that process profitable for them. "The real question to ask," said Wrobel, "is how much risk you are willing to take for each item. Then plan your process with those decisions in mind."

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