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.
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.
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.
Leaders in PLM have several challenges that they must address to achieve their optimized state. These include:
There are several approaches that companies are pursuing to continually improve the PLM capability. Below are a few examples:
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.
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