Looking to Accelerate New Product Introductions (NPIs)? Here’s How Modern PLM Software with an Integrated QMS Can Help

The incorporation of digital technologies has enabled businesses – especially in sectors like medical devices and manufacturing – to innovate faster and introduce new products and services quickly into the marketplace. However, the number of failures is equally significant, leading to loss of revenues, customers, and brand reputation.

Six key reasons why products fail include:

Reason #1: Mismatch with Customer Needs: A product is developed to solve a customer's pain point. A lack of understanding of the customer's needs can lead to the product not meeting its purpose and, therefore, not being accepted in the market, even if it has innovative features.

Reason #2: Faulty Design: Sometimes, the product design itself has issues. There could be other reasons, too, such as poor security, aesthetics, or leaving out key features.

Reason #3: Noncompliance: The final product or some of the components used may not meet the quality standards and/or regulatory requirements – leading to warning letters and product recalls.

Reason #4: Incorrect Pricing: The product pricing must also be right - neither too costly, intimidating customers, nor too cheap, raising doubts about its quality and life.

Reason #5: Lack of Product-Market Fit: A product's success depends on its release in the right markets with the right pricing. However great the product may be, a lack of understanding of potential customers can also lead to its rejection.

Lack of Differentiation: There must be a compelling reason why a customer must choose one product over another. If your product does not have a unique selling proposition, it is likely to fail.

Reason #6: Poor Risk Assessment: Risk assessment is important to establish controls and mitigate risks to product performance, quality, safety, and business. Without a robust risk management strategy, the product is likely to fail. It is therefore important to assess product risk, quality risk, and safety risk through a well-integrated risk management strategy.

Next-Generation PLM Software for Innovation, Quality, and Faster Time-to-Market

Integrating quality at every stage of the product life cycle is essential for designing, developing, and delivering products that meet customer requirements and aspirations while being compliant and cost-effective. Often, quality comes in at the testing stage to ensure the product meets the specifications, but it may be too late by then. Any error will require wastage and rework, costing not only money but time and effort as well.

Quality must be integrated right at the beginning – right from the concept development stage – and must be integrated into the workflow across design, development, manufacturing, procurement, testing, delivery, servicing, and complaints handling. Each step of the product manufacturing process can provide inputs upstream, and gain insights from processes downstream for continuous improvement.

4 factors affecting product quality and compliance include:

• Factor #1: Gathering Inputs Early: For instance, at the conceptual, design, and development stage, inputs from manufacturing, procurement, and customer service can help with a better understanding of customer needs, the limitations and capabilities of the manufacturing to convert design into product, the availability of the right raw materials in the required quality and quantity, and the market potential for the product. If the design does not meet any of these factors, it may have to be reworked to ensure the desired outcome.
• Factor #2: Efficient Change Management: The sooner these inputs are collected and the Bill of Materials (BOM)finalized, the less rework will be required at later stages. For every new change made, reviews and approvals need to be obtained before it can move on to the next stage. Therefore, minimizing changes in downstream processes will also ensure faster time-to-market. Automating change management will also speed up the review and approval process and ensure version control by providing centralized access to relevant information.
• Factor #3: Minimizing Nonconformance: Catching any deviations early in the process will reduce scrapping at a later stage. Therefore, inspecting raw materials and sample testing must be done correctly and without fail to reduce the risk of product failures. Design Controls and Requirement Traceability Matrix play a crucial role in ensuring the product and process meet the specifications. The equipment and machinery must be functioning correctly and calibrated to meet the specified requirements and minimize deviations.
• Factor #4: Ensuring Compliance: Proper documentation, trained personnel, and aligning processes and procedures with internal and external regulatory and policy requirements are essential to ensuring compliance. Conducting periodic audits, providing access to unified data for making informed decisions, and continuously improving quality management system play key roles in ensuring compliance.

5 Benefits of Streamlining your PLM Lifecycle with CQ ProductQuest with Integrated Quality Management

ComplianceQuest’s PLM Solution, ProductQuest, is integrated with its QMS built on Salesforce and is a cloud-based solution that provides manufacturers with an end-to-end view of the entire product lifecycle. This helps not only design innovative solutions, but also makes the process efficient, and improves productivity while ensuring compliance, product performance, quality, and safety.

Key benefits include:

• Benefit #1 - Unified view of data: A single source of truth is critical for informed decision-making at every stage of the product development lifecycle. By providing an integrated platform, ProductQuest integrated with QMS provides all stakeholders with a unified view of data from across the enterprise systems such as ERP, CAD, CRM, SCM, etc., which provides insights for ensuring product quality and performance right from the word go.
• Benefit #2 - Automation of Key Processes: Right from risk management to change management, supplier management, documentation and training, audits, and inspections, all processes are automated. This improves the efficiency and accuracy of the processes and their outcomes, respectively. This also removes the potential errors caused by manual intervention and frees up resources to focus on innovation and continuous improvement.
• Benefit #3: Collaboration and Communication: By providing a unified platform, it also helps all stakeholders to communicate and collaborate on a single platform. This minimizes the risk of delays due to emails being buried among other communications, version mismatches, and the need to update documents in multiple locations. Alerts and notifications ensure timely authorization and approval. Centralization of documents also provides an audit trail and improved visibility and transparency.
• Benefit #4: Design Controls and Traceability: One of the requirements of product development is design control and requirement traceability for compliance purposes. By using the integrated platform from ComplianceQuest, access to all relevant documents such as BOM and Design History Files (DHF) ensures traceability.
• Benefit #5: Compliance: In a globalized supply chain scenario, managing the different regulatory needs of the different geographies a manufacturer operates can be challenging. ComplianceQuest’s integrated ProductQuest with QMS ensures local and global compliance. Any changes to regulations can also be a challenge to keep track of, and processes may need to be modified to suit new regulatory requirements. CQ solution enables this through automation and centralized control of processes while enabling localized modifications.

As the ComplianceQuest platform improves the efficiency of processes at every stage, resources can focus on innovation and faster time-to-market without compromising on quality and improving the chances of product success.

To find out more, request a demo: www.compliancequest.com/online-demo