Merck's Secondary Packaging Development Process

By David Yao
Senior Project Engineer, Merck

Merck’s secondary packaging development process has undertaken a new and improved approach. By using a novel process of insight and discovery that fully engages target patients, the company develops truly customer-centric market packages that are user friendly and that facilitate patient compliance. The revamped secondary packaging development process is also in alignment with Merck Manufacturing’s new product commercialization model, which is aimed to enhance the commercialization of life-saving pharmaceutical products.

Figure 1. The Rxapid communication model can be used to streamline decision-making. (click to enlarge)

Merck’s secondary packaging development process is referred to internally as Product Definition Part B (PDPB). This process is intended to provide a detailed description of each secondary package configuration (including style, counts, literature/inserts, etc.) for a new product in development to be launched worldwide. The intended secondary packaging may vary by market region depending on individual regional marketing needs and regulations. These needs and regulations can be met through the use of either standard (can be supported by existing packaging and operation capabilities) or nonstandard secondary package configurations. 

The PDPB core team membership is cross-divisional and consists of a product development team leader and representatives from supply-chain management, global marketing, and legal.  Representatives from procurement, external manufacturing, quality, and research can be added to the core team as deemed necessary.

Figure 2 (click to enlarge)

With the goal of supporting Merck’s new product commercialization model, the team identified speed to market and a robust packaging development process as key objectives for the PDPB redesign process. The improved PDPB process is highly flexible with its initiation and finalization both highly dependent upon an individual drug product development process and can be customized to better respond to the potential of an accelerated product development timeline. The RxAPID communication model is instituted in the new process in order to ensure streamlined decision-making and clear accountability during packaging development (see Figure 1). The Packaging Technology (PT) department is the PDPB process owner, and the individual PT engineer supporting the product development has the “Recommend” role. It is this engineer’s responsibility to collect the inputs from the PDPB core team and make a recommendation to the worldwide brand leader; this leader, in turn, has the final decision rights to the proposed package configuration.

Secondary package needs assessment for a new product in development is initiated once the PDPB core team is formed. The goal is to initiate and review Voice-of-Customers (VOC) surveys from all key stakeholders, analyze known market and regulatory needs of the product, and determine whether the secondary packaging needs can be supported by either standard or nonstandard package configurations. Key components to this assessment consist of these six main categories:

1. Marketing needs assessment.
2. Packaging description assessment.
3. Regulatory assessment.
4. Technology assessment.*
5. Financial assessment.
6. Project timeline assessment.
*Communication with internal (and external) packaging sites to ensure capabilities to supply with detailed project plans of assessment to final project execution.

Figure 3 (click to enlarge)

If the desired secondary package is considered to be nonstandard based on these assessments, PT and marketing will develop a Nonstandard Secondary Packaging Development Plan. This includes a description of the intended secondary packages along with market needs assessment, package trade-off analysis, financial assessment, and legal and regulatory consideration.

The market needs assessment can be a significant undertaking with input required from all segments of the supply chain in addition to the payer, the prescriber, and the consumer (see Figure 2). To better capture consumers’ true packaging needs, carefully planned market research efforts are required in key global reference markets. Through interactions with consumers in home and group settings, potential designs can be captured on the spot based on feedback from target consumers (see Figure 3). Often, these ideas can build upon each other synergistically and help to create the ultimate package.

Figure 4 (click to enlarge)

The Nonstandard Secondary Packaging Development Plan will also provide milestone dates for integrating the nonstandard secondary package development activities with key product development dates. The worldwide brand leader has to sign off this development plan to confirm the stated rationales as well as acknowledge the potential financial commitment to the further development of the nonstandard secondary package configuration.

Figure 5. KJ Analysis is used to group customer and business requirements. (click to enlarge)

Next steps for the team include using a set of Six Sigma–based decision-making tools to aid the package trade-off analysis, which is one of the most critical attributes in the entire PDPB process (see Figure 4). The use of KJ Analysis (see Figure 5), QFD, and Pugh Matrix (see Figure 6) is designed to facilitate an objective evaluation of various packaging options based on the VOC, market research, regulatory impact, technical feasibility, financial impact, and project timeline. KJ Analysis is used to clarify and group these customer and business requirements in order to identify new, unique, difficult (NUD) attributes for the product.  These requirements are then ranked and prioritized by QFD. The Pugh Method is then applied to drive toward the best possible solution for addressing the NUD items by comparing the various proposed secondary packages with the standard package design based on the selection criteria derived from the prioritized functional requirements.

Figure 6. The Pugh Method is used to help packagers address new, unique, and difficult attributes of a product. (click to enlarge)

This improved PDPB process supports Merck’s new product commercialization model, speed-to-market, and robust packaging development with the intent to delight the customer. This new approach will enhance the quality of the end product, allowing product differentiation, increasing compliance, and putting patients first by transforming validated business objectives and consumer preferences through package innovation.