Mark Crawford, Contributing Writer09.07.18
Market demands are pressuring medical device manufacturers (MDMs) to increase complexity and functionality, miniaturize, and meet tighter time-to-market requirements. Although they prefer to use proven and tested materials and designs, MDMs also realize they must adopt new and/or unfamiliar technologies to stay competitive—without compromising product quality.
Another pressure comes from regulatory agencies around the world, which are establishing more stringent rules for documenting development processes, including electronics (for example, EU MDR and IEC 60601-1-2 4th Edition for electromechanical devices). Global supply chain irregularities for key sub-components such as high-energy capacitors can also be a problem.
Insurance coverage is yet another driver in the medical device market, which can impact innovation and development costs. MDMs seek unit price reductions on component systems in an effort to offset shrinking insurance coverage—thereby creating more pressure on their contract manufacturers (CMs) to automate and invest in new architectures to support improved production capabilities.
These co
Another pressure comes from regulatory agencies around the world, which are establishing more stringent rules for documenting development processes, including electronics (for example, EU MDR and IEC 60601-1-2 4th Edition for electromechanical devices). Global supply chain irregularities for key sub-components such as high-energy capacitors can also be a problem.
Insurance coverage is yet another driver in the medical device market, which can impact innovation and development costs. MDMs seek unit price reductions on component systems in an effort to offset shrinking insurance coverage—thereby creating more pressure on their contract manufacturers (CMs) to automate and invest in new architectures to support improved production capabilities.
These co
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