3 Critical Considerations for Evaluating Off-the-Shelf Software for Medical Devices

The rapid pace of technology innovation has led to the medical device sector becoming an integral part of the healthcare industry, delivering benefits such as reduced patient recovery time and lower cost of instruments. Unfortunately, the average time-to-market for a medical device still falls between 3-7 years.   In order to speed time-to-market, medical device manufacturers form strategic partnerships to leverage commercially available, off-the shelf components and software from vendors, and manufacturers augment their development teams with third-party professional services. When evaluating software vendors, medical device manufacturers must mitigate three critical risk factors: clinical risk, human factor risk, and cybersecurity risk. As a result, manufacturers would be wise to understand the impact of these three risk factors, and the considerations they should make when choosing the right software partners to get to market faster and safer.    Clinical Risk Clinical risk is a risk that the device does not work as intended by the manufacturer. The stakes are as high as can be here, because if a device does not work as intended, patients will be at risk of serious (or even deadly) harm. For example, consider an infusion pump that is set to deliver a pain medication, such as dopamine, at a certain dose rate. If the pump malfunctions by delivering the drug at a higher rate than programmed, the patient could face significant harm â...
Source: MDDI - Category: Medical Devices Authors: Tags: Software & D Source Type: news