Yanmar Energy System faced significant challenges with their legacy document management system (DMS) and standalone spreadsheets. The disparate systems made it difficult to store and retrieve critical customer and product data efficiently. As the business grew, interdepartmental storage and retrieval of customer-specific data became increasingly ineffective. The lack of a unified file server led to issues such as accidental deletion of files and complex compliance and approval documentation. The company needed a more effective and economical solution to manage their extensive product lifecycles, which could extend up to 30 years for power generation systems.

Spartan Motors faced the challenge of standardizing cross-functional processes across multiple product lines and locations to achieve greater consistency, efficiency, and responsiveness. The company relied on SolidWorks CAD software for product design and SolidWorks Enterprise PDM for managing CAD files and drawings, but had numerous stand-alone, custom databases for other product-related information. This fragmented system led to inefficiencies and a lack of company-wide visibility. Spartan needed a scalable enterprise PLM solution that would not impact SolidWorks users or require the replacement of their existing SolidWorks Enterprise PDM environment.

Amtech Electrocircuits faced the challenge of managing both direct and indirect costs in a highly complex and custom environment. The company needed to optimize purchasing, balance inventory levels, and maximize process yield while tracking and managing customer requirements. Additionally, they had to ensure compliance with standards like ISO 9000, APQP, and FMEA. The complexity was further compounded by the need to manage multiple Approved Manufacturer Lists (AMLs) for different customers, which required careful planning and sourcing to avoid excess inventory and maintain economies of scale.

Launching innovative new products on time while ensuring quality and profitability targets are achieved is critical in any industry. Businesses must contend with increasingly narrow windows of opportunity in the marketplace, intensifying competition, growing compliance complexity, cost pressures, and shorter development cycles—while also striving to improve quality. With so much at stake, industry-leading companies like the Freudenberg Group are continually seeking to improve new product introduction, quality compliance, and risk management in order to satisfy customers and achieve profitable growth. Several years ago, executives at Freudenberg recognized that the $7 billion company’s competitive success hinged on achieving better visibility and improved collaboration across its global facilities.

Several years ago, Structural Concepts' growth began to accelerate, causing business processes to experience difficulties. The company was becoming a victim of its own success, with a lack of visibility into ongoing client projects adversely affecting its ability to meet customer deadline commitments. Additionally, the engineering lead time for new orders was increasingly being challenged by competitors. Executives realized the need to transform the engineer-to-order development into a configuration-oriented process based on platforms to streamline the new business proposal estimation, quoting, and engineering required.

Fox Electronics, a global leader in frequency control products, faced the challenge of maintaining high standards of quality and efficiency while striving for continuous process improvements. The company needed to reduce cycle times for faster delivery and ensure compliance with stringent industry standards. Additionally, Fox Electronics required a robust system to manage the complexity of international shipping processes and integrate various internal and external systems to meet the unique needs of customers worldwide.

The most urgent issue for Alessi was project management. At Alessi, the definition and introduction of each new product is a project and each project involves several different people from a variety of disciplines inside and outside the company. In the high turn, multi-season retail environment, effective project management is critical. Prior to implementing Aras, relevant part data was stored in the PDM system while all related information and documentation was handled through a set of ad-hoc tools and descriptive files stored in an array of shared folders.

Management’s goal was to maintain Ogihara’s competitive advantage, and at the same time, enable compliance to the ISO/TS16949 quality systems standard. Quality systems standards compel companies to gain control over strategic corporate quality processes, including Corrective Action / Preventive Action (CAPA), Supplier Corrective Action Requests (SCAR), customer issue management, nonconformance management, defect tracking, document management & control, and product realization or Advanced Product Quality Planning (APQP) during development ─ all core processes that support corporate-wide quality and customer satisfaction. As business grew at Ogihara, management recognized the need to unify the existing combination of systems that support these critical processes. Doing so would ensure streamlined product quality improvement and achieve more effective compliance processes to support future business growth. The Quality group and IT organization at Ogihara worked together to find a solution that would unify the company’s quality management and compliance processes without incurring significant costs. Given the evolving nature of compliance requirements and customer demands, IT also recognized the need for a flexible solution that would easily extend to new processes and scale to support an enterprise wide deployment. Finally, Ogihara employees, supplier partners, and customers needed to be able to participate in an increasing number of automated business processes for better collaboration and faster issue resolution.

The Deutsche Blisterunion (DBU) faced significant challenges in managing the protocols for manufacturing patient-individual blister packs. The traditional paper-based system was time-consuming, prone to errors, and inefficient. The manual process of issuing medication in hospitals, old people’s homes, and other care facilities was not only labor-intensive but also increased the risk of medication and dosage errors. The need for a more streamlined, error-free, and efficient process was evident. Additionally, the DBU required a solution that could ensure the legal validity and security of the manufacturing protocols, which are critical in the pharmaceutical industry. The challenge was to find a system that could automate the document management and production processes while ensuring compliance with legal requirements for electronic signatures.

MEGA Brands needed to develop new products with superior quality within stringent cost targets. Additionally, to support continued growth, the company had to improve global coordination and visibility throughout the New Product Development & Introduction (NPDI) process with a specific emphasis on quality. The company faced significant global growth goals and fierce international competition, driving their new product innovation strategy and emphasis on quality and cost.

Kolcraft Enterprises, Inc., a leading manufacturer of baby products, faced significant challenges in managing its extensive product lines and the related components, documents, drawings, specifications, and requirements. The company's in-house Product Specification System (PSS) had served well for many years, but as product lines expanded and customization increased, Kolcraft realized it needed a more robust solution to manage the many facets of its highly sophisticated product lifecycle. The manual process of managing product updates across every bill of material (BOM) was time-consuming and inconsistent, making it impossible to ensure that every affected product was always up to date. Kolcraft needed an automated BOM to update and manage changes to each variation on a base product, as well as the base product itself, by discipline: Engineering, Fashion, and Marketing.

ACCO Brands aimed to improve innovation, collaboration, and standardize product life cycle management (PLM) to speed time to market, reduce costs, and enhance product quality. The company identified several areas for improvement, including product change processes, document collaboration, and supplier corrective actions. The product change process took an average of two months for final approval, and document collaboration was hindered by separate document management systems for each major supplier. This led to inconsistent versions, miscommunications, mistakes, and lost time. Corrective actions were also slow, relying on phone calls and emails, making it difficult to implement closed-loop corrections quickly.

Following waves of growth and expansion, Kinnerton's process for new product development and introduction (NPDI) had grown overly complex and unpredictable. Employees from various departments lacked visibility into the overall process and struggled to manage the huge volumes of documents associated with such a wide range of products. This extended the early phase of production and forced product teams to compress the later stages of the NPDI process, creating financial risks. Kinnerton needed to find a way to get its product information and NPDI process under better control to get new products into production faster and cut out the 'firefighting' late in the process.

Kawasaki Heavy Industries (KHI) faced significant challenges in managing product information and processes across its diverse industrial segments. Each segment had developed its own systems for CAD data management, requirements management, and other engineering processes, leading to inefficiencies and increased costs. The lack of real-time communication and collaboration between departments further exacerbated the problem, making it time-consuming to share product information across disciplines. KHI needed a unified PLM platform to support its engineering business company-wide, streamline new product development, and optimize system-related costs.

The University of Washington faced the challenge of managing over 12 million square feet of facilities across three campuses, which included classrooms, offices, laboratories, and dormitories. The need for both new construction and ongoing maintenance required ready access to relevant facilities information to ensure proper management. Additionally, since the events of 9/11, real-time access to visual facilities information in times of crisis became critical for saving lives and ensuring that first responders had the necessary information to act safely and effectively. The university's facilities management organization envisioned an enterprise solution to manage critical facilities information securely online for better access, visibility, and control. The wide range of different files, documents, and data required for construction and ongoing maintenance, along with configuration information for various systems, necessitated a powerful solution capable of handling vast amounts of data and file relationships.

The variety in cabin design possibilities leads to complexity and rising production costs. The catalog used for cabin configuration is constantly being extended with new types of seats, fittings, and systems, such as in-flight entertainment and lighting systems. After the approval of new versions of the catalog, aircraft manufacturers typically provide their customers with updates in paper format. At this stage, the Pacelab catalog needs to be updated and the details of the cabin elements integrated into a single process. In addition to the multiple versions of the catalog and sales offers, information on lifecycle management needs to be updated. A sophisticated configuration system is needed to manage all of these requirements. The catalog not only contains all the data on cabin components and the related 2D and 3D visualization files, but also all the configuration regulations from the aviation safety authorities.

Growing product complexity and the need to unify data across multiple systems were major challenges for Carlisle Brake & Friction. The company faced difficulties in integrating product data between various standalone systems, leading to bottlenecks in managing complexity, global security, and data version control. Additionally, compliance with International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) was crucial due to their military OEM customers. The company needed a solution to streamline ISO/TS certification audits, provide a global platform for R&D test management, and reduce the time from customer request to solution.

As a highly regulated medical device company, Potrero needed to ensure compliance with the International Standardization Organization (ISO), Food and Drug Administration (FDA), and European Union (EU) to achieve commercialization success. “I was brought on to evaluate quality processes and systems as we prepared to launch our first product because we didn’t have a system that was robust enough for new product introduction and compliance processes,” stated Sanjay Banerjee, COO for Potrero Medical. “We had FDA clearance, but our product was not commercialized yet and our current manual processes would not scale or hold up to the scrutiny of audits.” Product and quality information was managed using paper-based processes where bills of materials (BOMs) were documented on paper and then uploaded into a manufacturing system. Engineering change orders (ECOs) were also reviewed manually with limited supplier communication. The team at Potrero needed a scalable quality management system (QMS) that could support their growing product development and compliance needs while helping them address and pass audits.

As a visionary company in the clean tech industry, FreeWire needed to stay ahead of the competition and get high-quality products to market quickly. Using spreadsheets, shared drives, and other manual processes to manage product development, engineering changes, and bills of materials (BOMs) made it difficult to share the latest design information. As the business grew, the need to collaborate with contract manufacturers (CMs) in real time became essential to avoid quality issues and launch delays. FreeWire needed a single, centralized solution to keep everyone on the same page and eliminate confusion around the latest design.

As the number one solar tracker supplier worldwide, Nextracker has doubled its global manufacturing capacity to 300 megawatts per week to serve expanding customer demand. Rapid growth, coupled with the need to collaborate with a global team, meant Nextracker needed to modify its product development practices. The company did not have a single source to track and manage its engineering design and development processes. Product information was tracked manually in workbooks, spreadsheets, and personal file folders, requiring too much reliance on tribal knowledge. With normal employee turnover, process and design information would be lost. “We had to be able to iterate quickly on designs, track changes, and link related product information to scale and speed marketability,” stated Ratana Lee, NPI Archivist for Nextracker.

Kim’s quality experience includes setting up companies’ quality management systems, hosting FDA and third-party audits, and auditing medical device manufacturers, having been a lead auditor for a European Notified Body. She has also filed many FDA 510(k) submissions resulting in clearances and obtained CE marks for various products. According to Khoe, the benefits of contracting with Apical include real dividends in production of effective product, reduced development time, lower overhead count, and quicker regulatory approvals—all to enable a delivered complete project. “Contracting with Apical to efficiently handle the design, prototyping, and manufacturing eliminates your need to organize a staff to support these efforts,” says Khoe. Prior to working at Apical, Khoe successfully implemented Arena for several international companies. To meet FDA and other regulations, Khoe knew she must be able to manage information in a controlled and secure manner to show evidence of compliance and avoid costly consequences, penalties, and brand damage. Early in her career, Khoe experienced the pain and burden of inefficient paper-based manual processes, which led to increased compliance risks and exposure caused by misplaced critical documentation that made it hard to prove mandatory compliance. Khoe and CEO Bruno Strul agree that having a product lifecycle management (PLM) system by itself—while an upgrade from manual processes—can still present problems if the PLM system is disconnected from the quality management system. The lack of visibility with siloed systems creates problems that can start snowballing fast. The classic case is when key crossfunctional team members are unaware of changes due to insufficient transparency—and a problem only presents itself just before shipping to market.

According to David Sangster, Chief Operating Officer at Nutanix, his team is responsible for fulfillment, logistics, quality, reliability, new product introduction, and launching product into volume production. The company also outsources all of its manufacturing needs. “We work with many suppliers including contract manufacturers, distributors, and key technology partners,” said Sangster. “We also use a platform approach to product design and a configure-to-order (CTO) process to reduce SKU (stock keeping unit) proliferation and the need for additional engineering.” Sangster stated that the number and frequency of changes inherent in the product development activity, as well as data sharing among partners, had become problematic. Unfortunately, his team was stuck relying on Excel spreadsheets and email to address these manufacturing challenges. “It’s embarrassing to admit, but we had a number of instances where the suppliers built the wrong version of the product,” said Sangster. “It was ‘rev A’ all right, but the ‘wrong’ rev A.” Issues with rework, which included extra procurement, build, and test cycles, also increased delays and were becoming a significant impediment to the company’s total time to market (TTM) objective, which he found “totally unacceptable.” Sangster admitted change control was his “number one problem.” His priority was finding a solution to manage BOM integrity in order to reduce shipping delays and product errors. “A wrong product number in your BOM can completely blow your quarter and make for a very unpleasant conversation with your CEO and the Board,” he confessed.

Kinsa, a company focused on stopping the spread of illness through innovative smart thermometers, faced challenges in managing product and quality data as they scaled. Initially using Microsoft Office for tracking, they quickly realized the need for more scalable solutions. The company experienced system proliferation and duplication, with separate systems for ticketing, customer communication, and FAQ management, leading to inefficiencies. Regulatory requirements for traceability and transparency in the customer complaint process further complicated their operations.

RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. Innovation drives the team’s product development. At the same time, RefleXion adheres to the highest quality and compliance standards for life sciences companies. Almost from the beginning of product design, RefleXion knew they needed the support of a product realization platform that would grow with the team, the product, and their path through medical device compliance. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months. With fast team growth and continued product design progress, RefleXion needs everyone in sync.

When evaluating solutions, Pulse Biosciences knew what they needed—one place for all product lifecycle and quality management processes. Guneet Bhogal, Quality Assurance Specialist, shares, “We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.” For medical device companies like Pulse Biosciences, predictability and consistency are not only good, but critical. Prior to implementing Arena, Pulse Biosciences’ product processes were paper-based, and the team expended extensive efforts to track everything manually and ensure compliance.

Enphase Energy, an engineering-driven company specializing in solar power solutions, faced the challenge of managing product processes systematically from its early startup days. The company needed a stable platform to handle product development and quality processes internally and across its complex supply chain. As Enphase grew, the need for a robust system to manage design for manufacturability (DFM) and ensure quality and cost goals became critical. The company also required a solution to streamline its document control and analytics processes, which were previously time-consuming and prone to becoming outdated quickly.

As an FDA-regulated company, IntraOp must not only design and produce a complex product with electro, mechanical, and software components, but do so while meeting all FDA 21 CFR 820, EU Medical Device Directive (MDD), ISO 13485, Health Canada, and other regulations requirements. So IntraOp needed more than a system to manage all the product details, changes to product, and collaboration efforts with the teams. They also needed a quality management solution to ensure absolute regulatory compliance. IntraOp chose the Arena platform for both product and quality management. After IntraOp implemented Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day insights into quality process progress as well as provide confidence that they can meet regulatory requirements.

As a rapidly growing company, Kymeta is moving fast with multiple products and diverse markets, including land, sea, air, and connected cars. Product and quality management are top priorities, so the company needed an enterprise platform to scale from pre-production startup to commercial shipping with a global supply chain. Kymeta utilizes Arena’s product realization platform for product and quality management processes. Kymeta has placed priority on visibility of processes for measuring progress against company priorities. First, Kymeta implemented Arena to manage connected product and quality processes from NPD through to production release. Then, with Arena Analytics, the team gained integrated analysis of all these activities, particularly product change analysis during the critical new product introduction timeframe.

Efficiently managing complex product information for the development of their gas analyzers while meeting environmental and quality systems compliance was key to Picarro’s new product introduction (NPI) goals. Silos of information and the lack of traceability, visibility, and manageability associated with manual processes were ongoing challenges for Picarro and hindered their NPI objectives. Part information was managed within spreadsheets, and files were managed on both employee desktops and shared network folders. The company needed to improve change control and establish a central system for all product information.

Spectranetix began as an innovative and agile engineering company focused on turning customer problems into solutions, moving from concept to prototype at a rapid pace. The company has perfected research and system design, actively championing open architecture and standards so customers have flexibility and adaptability. Spectranetix recently has applied adaptability to its own business model, extending its services into building and delivering technologies to the market. The move has paid dividends, with a recent acquisition by Pacific Defense and a growing list of commercialized products in addition to their continued custom design services. During concept and prototype phases of product development, rapid-fire creativity and problem-solving are key. Control over product definition is minimal. Spectranetix quickly realized that with the expansion of the company’s scope to manufacturing, people, processes, and systems would be needed. With product commercialization came additional requirements, specifically from Spectranetix’s defense customers. Spectranetix needed to have a secure, controlled process for managing product, undergoing customer risk-based assessment audits, and demonstrating thorough configuration management practices.