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Lower Cost and Faster Product Approval Through Proper Software Design Controls

2013-02-21 22:05:55

The market success of a medical device depends in large part on how well its software is programmed. Focusing heavily on the device while treating the software as an afterthought can lead to costly recalls and liability concerns.


Medical devices have become a vital part of the global healthcare market, with more than 2,000 premarket notifications, or 510(k)s, approved for marketing in the first three quarters of 2007 (CBER 2007). Of these, 39 are biological devices such as diagnostic assays, rapid tests, and cell separation systems.


The U.S. Food and Drug Administration must ensure a device is safe and effective while determining whether it is either legally equivalent to a previously approved device or represents a new category. Whether applying for a 510(k) or a premarket authorization (PMA), the burden falls on the manufacturer to ensure the entire product suite meets FDA standards. All too often, manufacturers, particularly startups and companies new to software development, focus on the device to be submitted for approval while paying little attention to the accompanying software required for analysis and quality control. This proves to be a costly and time-consuming mistake, as software rework, patching, and even complete rewrites often result.


Given that most medical devices contain software, successful submission of a 510(k) rests heavily on the manufacturer’s ability to demonstrate that the software will perform as required. The FDA’s Center for Devices and Radiological Health (CDRH) has developed guidance to help manufacturers clear this regulatory hurdle, but because of the wide range of devices that fall under CDRH purview, the guidance is necessarily vague (CDRH 2002). This gives a great deal of discretion to a 510(k) reviewer or an onsite auditor in deciding whether the device and software will perform as they should.



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