Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization. It includes the people, data, manufacturing, supply processes and the technical systems that are needed to get a product out the door and into the hands of stakeholders. The product lifecycle incorporates several functions within an organization including regulatory, quality assurance (QA), and chemistry, manufacturing, and controls (CMC).
PLM typically encompasses the following phases: (1) Conception – which includes requirements gathering and initial planning. (2) Design and Development – including prototyping, testing, and validation; (3) Production and Launch – including supply chain management and customer delivery; (4) Servicing – including customer support, maintenance, and repairs; and (5) End of Life (EOL) – the product exits the market.
Executing the phases of PLM efficiently can save money and achieve projected, on time revenue goals. Getting this wrong can cost millions of dollars, jeopardize trust with the patient and provide populations with an unpredictable product.
What is Process Management and how is it aligned to Product Lifecycle Management?
Process Management is central to Product Lifecycle Management (PLM). It realizes the goals of PLM by creating the structure around the product. Process management can automate and accelerate repeatable manufacturing processes like design changes, approvals, change orders, and any other applicable product workflows. It includes concepts such as project management, process design/characterization/optimization, technical implementation, and organizational change management to ensure PLM is successful.
Process management brings a systematic approach to activities performed by both people and automation. If the process is repeatable with an established logic in the organization, it can be improved with PLM-based process management.
Why is Communication and Collaboration Important to Product Lifecycle Management?
Successful PLM must utilize strong communication and collaboration across all phases. Although the product lifecycle is divided into various phases, as outlined above, each phase is not a silo and cannot be thought of separately or autonomously. This is especially important in the management of product data, change management, document management, optimization, enterprise resource planning (ERP) and customer relationship management (CRM).
PLM must also consolidate all of the product data into a single accessible and manageable resource while allowing the free flow of information between individuals and the different phases of the product lifecycle. PLM can cover these needs during the conception stage and create and manage the corresponding product data during the design and manufacturing stages.
What are typical company challenges related to Product Lifecycle Management?
Leaders in PLM have several challenges that they must address to achieve their optimized state. These include:
- Poor visibility into the end-to-end, design-to-delivery processes. Without this transparency, they are unable to proactively and quickly address any major issues to delay any downstream process activities. Further, the processes must be fully optimized to obtain any productivity or efficiency gains.
- Effective Data Governance, Management, and Reporting. Product and Process Lifecycle Management creates a lot of valuable data, but this data requires data standards and proactive oversight as part of it being stored and managed. Many companies rely on spreadsheets to store and manage data; however, immediate access to this data allows faster and more effective decision-making. Having fit-for-purpose technical tools allow users in each phase of product development to access, create and manipulate data, and report data in a consumable manner, allowing faster decision making and better management of costs.
- Assurance of quality and regulatory compliance with traceability through design, development, testing, and manufacturing. The continuing evolution of regulatory expectations will require proactive compliance activities from the PLM teams. By being effective and proactive at compliance, this will help manage any potential: time to market challenges, delays in product design, and workflow interruptions.
- Innovation within each critical process step. Innovation must be infused into each critical process step so that technology, automation, augmented reality, or analytics are considered and integrated into how daily PLM work is being done? Innovation is considered the secret sauce to enhancing a PLM process. The approaches identified must align to company goals and budgets, as a start.
What are some Product Lifecycle Management best practices organizations are pursuing?
There are several approaches that companies are pursuing to continually improve the PLM capability. Below are a few examples:
- Clear and Logical Strategy. Organizational alignment with respect to PLM – what are the key drivers, challenges, financial considerations, technology needs/constraints, data needs/constraints, resource needs/constraints and current state of the organization. All of these factors, along with others, will be critical in determining how best to drive and evolve the PLM approach over time.
- PLM Technology and Data Strategy. Organizations need tools that will allow them immediate access to data for immediate decision making. Given the volume of data, spreadsheets will no longer suffice. A Manufacturing PLM software system can be used to manage a product and its aligned data throughout all the stages of the product lifecycle. While primarily used by design and engineering teams working with CAD data, a PLM system can provide visibility into the product design process and potentially enhance decision-making for all business stakeholders. Having an aligned data strategy will help ensure that data quality is being addressed so that decisions can be made based on accurate and trust-worthy data.
- Workflow Automation. Companies can significantly reduce time-to-manufacturing and have driven down production costs by automating both the rules of workflow and the management of lifecycle states. An enterprise approach to process management can unify the major elements of design, manufacturing planning, and resources into a common system. Configuration-specific processes become easier to launch and manage, and manufacturing processes are more easily aligned with their related engineering tasks.
- Strong Project Management Organization. In order to realize the above goals, there must be a strong project management group, a PMO, that is able to identify, design, prioritize, deliver, and govern projects that support PLM. In addition, being able to move a product through the lifecycle requires proactive project management, capable of immediately addressing any issues and risks so that downstream challenges are effectively communicated and quickly resolved.
From conception to end of life (EOL), the successful management of a product during its lifecycle will ensure that high quality and cost-effective products are produced without budget overruns, delays, or design failures. Managing the product lifecycle can be complicated. But effectively defining the processes to identify efficiencies, choosing the right technology tools to enhance data transparency, reporting, and decision-making, and collaborating with the appropriate partners will help lead to PLM success.
To learn more about ProPharma Group and how we can support your programs, contact us.