E-BOOKS &
WHITEPAPERS

As digital transformation continues to rise, the traditional process of product development from idea to market is happening at an unprecedented pace. By integrating ERP and PLM systems, your teams can work more efficiently, with complete transparency, instant updates, and collaboration from anywhere. This gives product development teams and manufacturers greater control over reducing costs and creating smarter products. Factories are achieving higher levels of efficiency and performance by minimizing waste and scrap and adopting more sustainable practices.

The defense and aerospace market beckons to many product companies seeking to diversify, but also demands regulatory compliance in addition to the quality, product development efficiency, and technological innovations customers expect. Many product design and manufacturing companies in this market provide products subject to export regulations, including International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR), requiring compliance in technical data handling and access.

With the increasing demand for smarter, more connected products and global competition at an all-time high, manufacturers must rethink traditional product development practices and embrace more modern approaches if they want to get ahead. The days of working in silos and with manual processes are no longer feasible if you’re looking to deliver highly sophisticated products ahead of the competition. In this e-book, we explore how cloud-native product development solutions provide manufacturers with a framework to get products to market faster through agile, efficient, and connected processes.

As electric vehicles (EVs) become more mainstream and demand for more sustainable transportation modes continues to rise, manufacturers are scrambling to innovate fast and gain a competitive edge. However, many quickly realize that they are not well-equipped to deal with the increasing product complexity, stringent regulatory requirements, and rising customer demands that come with getting new products to market. In this e-book we share insights on how the adoption of new digital approaches can help you navigate these challenges and achieve commercialization and compliance success.

In the wake of the pandemic, manufacturers have experienced product shipment delays, quality issues, increased customer complaints, lost revenue, and the inability to gain first-mover advantages. So how can companies better navigate future disruptions and continue to thrive? In this whitepaper, we explore how the adoption of enterprise cloud-based solutions and other technologies enable product manufacturers to quickly adapt to change and make the necessary digital transformation to compete in today’s global economy. We also provide some key steps that you can take to ensure your digital transformation success.

Our guide provides the collective wisdom of many people who over decades of experience have been involved in every aspect of software for business needs—from identifying requirements, selecting, purchasing, implementing, using, and expanding software installations, to selling software, and even killing failed software projects. We’ve written the guide we wish someone had given us for our early software search projects. This guide is designed to help you buy the right software for any business need—from product development and quality processes to manufacturing operations, finance, design, and digital marketing.

Do you have a set roadmap for certifying your devices under the European Union (EU) Medical Device Regulation (MDR)? If you currently market and sell medical devices in the European Economic Area (EEA) or are planning to do so in the near future—now is the time to put the proper measures and systems in place to ensure compliance. On May 25, 2017, the European Commission published the Medical Device Regulation (MDR) 2017/7451,2, which introduced an expansive set of new rules for how medical devices are regulated in the European Union.

If you currently market and sell in vitro diagnostic medical devices in the European Economic Area (EEA) or are planning to do so in the near future—now is the time to get up to speed with the new In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure compliance. Published on May 25, 2017, the IVDR 2017/7461,2 introduced an expansive set of new rules for how in vitro diagnostic devices are regulated in the European Union (EU).

Audit resilience means being able to provide evidence that your company follows compliant practices. Challenges include regulations that vary year to year or across geographies. When suppliers are key to your product development and release, you need them to comply as well. Building disciplined processes with audit awareness from the beginning will ensure you have the practices, data, and people to ensure success in on-site and remote audits. In this e-book, we share ideas on how to prepare for audits so that you can demonstrate you follow compliant practices.

Getting products to market can involve multiple teams, various stakeholders, a network of partners and suppliers, and thousands of hours of work. In addition, economic and political disruptions, unanticipated industry shifts, or a move to remote-based work can pose threats to your new product development (NPD) and new product introduction (NPI) timeline. In this e-book, we share ideas based on real-world insights to effectively manage product development processes to reach your product milestone goals.

Advances in digitalization, artificial intelligence and the Internet of Things (IoT) are connecting products to people in new ways. Apps, sensors, and social platforms are integrating products and customer ecosystems. This report is based on a series of interviews with senior leaders at six leading-edge organizations in healthcare, consumer electronics, and autonomous vehicle technologies. Read this report to see how new technologies are changing the face of product innovation.

Capturing the business benefits of Cloud PLM and QMS: In this white paper, we explore the benefits of cloud software systems aimed at helping companies design and deliver high-quality products. In particular, we look at the benefits and ROI for cloud-based product lifecycle management (PLM) and quality management system (QMS) solutions. Both solutions provide companies with the necessary product and quality record control needed to effectively convert ideas to products in these challenging times.

Connecting product information and teams Is vital to success during new product development (NPD) and new product introduction (NPI). As companies pick up the pace of innovation to meet customer demand, they need to reduce costs and ensure regulatory compliance to stay ahead of increased global competition. In this whitepaper, we explain how to accelerate your product launch processes with cloud-based PLM and QMS solutions.

For medical device companies, having a rock-solid approach to quality is a prerequisite for success and innovation. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, new market requirements, and device complexities evolve, so does the weight of the burdens these leaders face. Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

The rapid evolution of technology and outsourced manufacturing has created new opportunities, but also new challenges and risks. You don't have to look very far to see how poor product design and development can impact your company and customers. Working with dispersed teams and supply chain partners requires collaboration around the latest bill of materials (BOM) to reduce production errors and shipping delays. Read how Arena provides a more intelligent way to control, share, and release accurate BOMs.

To continually prepare for supply chain disruptions, you need to continually evolve. Newer technologies like the Internet of Things (IoT), cloud and edge computing, and advanced data analytics are creating new opportunities. Sharing information efficiently with your supply chain partners ensures the fast delivery of high-quality products. Improving collaboration during new product development and introduction enables dispersed teams to optimize product launches and overcome supply chain shocks.

As products continue to get smarter and more connected, they also become more complex with mechanical, electrical, and software components interacting in more sophisticated ways. We explore how new technologies are advancing product development and what's possible. Read this brief to learn how leading-edge companies are redefining the next wave of product innovation.

Achieving and maintaining regulatory compliance is an imposing hurdle for many medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in costly delays, warning letters, and business closure. Today’s manufacturers must establish proper design controls to demonstrate devices are safe and effective for their intended uses. Read this whitepaper to see how product-centric QMS enables better design controls.

Today’s manufacturers must create, manage, and track thousands of parts throughout the new product development (NPD) process. According to an independent study by EMA Design Automation, every time a new part is added to a company’s library, it can cost thousands of dollars to qualify, design, and roll out. That's why choosing the right part numbering scheme to reference your parts is critical to your success. Read how part numbering best-practices can help you avoid costly mistakes.

Medical device companies must overcome many hurdles to get safe, high-quality products to market. Establishing and maintaining an effective quality management system (QMS) to satisfy both the FDA and ISO is critical. And, when the system is software-based, the manufacturer must also demonstrate and provide evidence or validate that it meets the requirements to consistently deliver safe, high-quality devices to market. Read this whitepaper to see how Cloud QMS simplifies software validation.

Connected technologies have changed product development dramatically. Fewer products involve mechanical-only designs as companies try to leverage many new technologies aimed at connecting people, data, and products. As more products are built with sensors, software, and electronics, all designs—not just mechanical ones—must interact seamlessly. Global design and supply chain partners must collaborate in real time to maintain a competitive edge in the quest to deliver innovative products to market rapidly.

Medical device manufacturers and their supply chains must get their products to market quickly, while facing new technological challenges, global competition, and the need to mitigate risks. Medical devices introduce even more challenges as companies strive to navigate the ever-evolving regulatory landscape including FDA 21 CFR Part 11 and Part 820, ISO 13485, and environmental compliance regulations. Read how a product-centric quality management system (QMS) enables traceability and continuous improvement.

The lifeblood for getting new products to market, or improving existing ones, is engineering change management. Streamlining processes enables dispersed teams to create, review, and approve new or existing designs faster. Engineering, quality, purchasing, manufacturing, and supply chain partners must be able to work together seamlessly to design, develop, test, build, and ship high-quality products to customers effectively. Learn how to overcome key challenges in this whitepaper.

Quality systems for companies regulated by the FDA must follow current good manufacturing practices to comply with 21 CFR part 820 regulations. Medical device companies must also adhere to ISO 13485 and demonstrate their ability to meet customer and regulatory requirements. Until recently, you could choose only one type of quality management system (QMS) to simplify compliance. Arena’s product-centric QMS enables you to optimize quality management in the context of managing the entire product record.

Many high-tech electronics and medical device companies are developing smart devices leveraging the Internet of Things (IoT). These connected devices have more electronics, sensors, and software that require design teams to work together throughout the product lifecycle to ensure interoperability. Arena provides a single source of product design truth to keep dispersed teams and supply chains on the same page, and speed new product development (NPD) and new product introduction (NPI).