High-tech electronics product complexity continues to grow as innovators add new features to fend off global competitors and participate in increasingly segmented market niches. Technology and medical products are leveraging Moore’s Law coupled with advancements in areas such as sensors, lasers, and displays to add features and functions at a rapid pace. All kinds of products, like Wi-Fi enabled teakettles and Bluetooth door locks, incorporate an increasing amount of electronic and software components.
Software now constitutes a significant amount of the development effort for most electronics product companies and plays an expanding role in many other industries. It is critical for mechanical, electrical, and software engineering teams to collaborate more effectively during early NPD to eliminate quality and functionality issues during NPI. As a case in point, the design of a cell phone enclosure must be closely coordinated with the antenna design to achieve wireless coverage requirements while also meeting electromagnetic emissions regulations. Furthermore, ensuring designs can be consistently built to specifications requires paying closer attention to design for manufacturability (DFM) practices.
Medical device electronics manufacturers face even more NPDI (NPD and NPI) challenges due to growing global regulatory and legal compliance burdens. The European Union (EU) recently adopted two new regulations that will force medical device manufacturers to provide substantially more clinical evidence to support claims of safety and performance. And, of course, the EU is just one of an increasing number of issuers of standards and regulations.
Other regulations and directives come from the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), Underwriters Laboratories (UL), CSA Group, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Waste Electrical and Electronic Equipment Directive (WEEE Directive), and Conflict Minerals. Today, managing product development processes while maintaining compliant systems and processes requires greater visibility and sharing of information throughout the product release process than ever before.