Progressive Gating
Business Product Lifecycle Management (B-PLM) Process
The B-PLM Process provides critical business-side product development support and can increase the probability of successfully launching a new medical device product. Deployed early in a new organization’s life, the biggest value in utilizing this process is keeping your product development functions adapting to an ever-evolving marketplace, creating strategies for success in key areas such as sourcing and manufacturing, and ensuring that spending is strategic and under control. Electing to utilize the B-PLM Process installs key pillars and valuable organizational plans to these functions, reviewed and approved at the end of the appropriate stage.
Below, a slide show has been developed to create a visual understanding of the B-PLM Process. This process is meant to operate adjunctively to design control phases and reviews. The combination of design control phasing and the B-PLM process can be looked at, wholistically, as an end-to-end Stage Gate process. The goal is to create stability and confidence in navigating the development of your emerging product through the rigors of regulatory requirements (remaining in control of design work and transfer to production) but also using guardrails (Progressive Gating Tools) executed throughout the B-PLM Process.
The expected result is your emerging product reaching the market with an accurately predicted market position, pricing, operational readiness for launch, among many other key metrics, providing confidence of returned value to internal stakeholders, early investors, and prospective investors.
Each slide below provides specific information on the process flow, with the first slide visually describing the full B-PLM process. Subsequent slides describe the process as it progresses in sequence with design control. As Stage Gate work progresses wholistically, a single gate (red triangle shown on the slides) provides an opportunity for your leadership team to decide if product development is ready to proceed further, considering all aspects of the project, both technical and from a business perspective.
Each slide beyond the full process slide shows B-PLM deliverables, due at the B-PLM Review. These start as Tools, offered by Progressive Gating, and when executed become deliverables. Progressive Gating is pleased to offer these tools, available in tiers aligning with your organization’s state of growth. The deliverables list is color coded to provide clarity for which Tier the tool originates. Tiers 2 and 3 provide added tools from the previous tier.
NOTE: Advance the slides either direction using the arrows located at the bottom corners of the slide deck.
Shown above is the full B-PLM Process as it sequences with design control activities. Refer to the legend at the bottom of the slide for an understanding of B-PLM Process symbols. Advance the slides to see how the process flows through all stages of product development.
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The initiation of a project with the intent of developing a new product is a critical exercise, both within design control and the B-PLM Process. This B-PLM stage is referred to as "PI" and is where the Business Case and Charter are drafted. These two items make up two of the three "pillar" deliverables within the B-PLM Process. For very small organizations, a "Light" version of the Business Case template is also provided.
Once a project has initiated, design work progresses and the team works on the Value Proposition (VP) stage deliverables. The Value Proposition deliverable is the third of the three pillar deliverables. The VP Gate Review provides an opportunity to baseline the Business Case and Charter and introduce to the organization a concise understanding of value the new product brings. These can be characterized as value to the clinic, the industry, internal customers (sales force, etc.), and investors, among other areas. In VP, a Sourcing Plan and a Global Marketing Plan are drafted for early review by leadership.
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Once VP has completed, and with design input work continuing, focus moves to the New Product Approved (NPA) stage. Here, further work continues on earlier deliverables, with a draft created for the Operations/Manufacturing Plan. Once the design input has completed, the NPA Gate Review is held to complete the NPA stage. Here, updates to the three pillar deliverables are reviewed, the Sourcing Plan is baselined, and a draft of the Operations/Manufacturing Plan made available to leadership. Completion of the NPA Gate Review provides an opportunity for leadership to approve the Gate Exit (see red triangle) enabling the project to move to the next phase of design control and the next stage in the B-PLM process.
The Market Introduction (MI) stage provides deep focus on market planning. The Global Marketing Plan is developed further to a baseline, with drafts of the Regional and Local Marketing Plans created. To assist with this exercise, Progressive Gating provides a Marketing Deliverables Checklist template that correlates activities to the planned work. For medical devices requiring service in the field, the Service Plan is drafted for leadership review.
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Once the MI Gate Review has completed, and with design output work progressing, focus moves to the New Product Committed (NPC) stage. Here, further work continues on the Operations/Manufacturing Plan for approval at the NPC Gate Review. Other deliverables developed in this stage are the Design Validation Master Plan the First Articles, Material Qualification Plan, and the Usability Plan. A Product Naming deliverable is drafted.
Once the design output phase has completed, the NPC Gate Review is held to complete the NPC stage. Here, updates to prior deliverables are reviewed/approved along with the NPC deliverables previously described.
Completion of the NPC Gate Review provides an opportunity for leadership to approve the Gate Exit (see red triangle) enabling the project to move to the next phase of design control and the next stage in the B-PLM process. Alternatively, leadership can pause the project if financial control has been lost, execution is underperforming, among other possible circumstances.
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Once NPC has completed, and with design V&V progressing, focus moves to the Product Goals Met (PGM) stage. Deliverables developed in this stage are the Process Validation Master Plan, the Limited Market Release Plan (draft, and only if an LMR is anticipated), a Usability Validation Report, and selection of the commercial name (Product Naming). Once the design V&V phase has completed, the PGM Gate Review is held to complete the PGM stage. Also provided in this review can be review/approval of updates to prior deliverables as shown in the slide above.
Completion of the PGM Gate Review provides an opportunity for leadership to approve the Gate Exit (see red triangle) enabling the project to move to the next phase of design control and the next stage in the B-PLM process. Alternatively, leadership can pause the project if financial control has been lost, execution is underperforming, among other possible circumstances.
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Once PGM has completed, and with design transfer to production continuing, focus moves to the Launch Readiness (LR) stage. The LR stage, within the wholistic PLM Stage Gate process, is extremely important to the business. Capital spending has been ramping up, and other company resources consumed getting to this point in the PLM process. Prior Gate Exit decisions have allowed development (and spending) to proceed, or, in some cases, cease work if leadership is not satisfied with the conditions of the market, internal spending is not in control, and/or internal performance is not acceptable.
The LR stage pulls it all together as the final business exercise to ensure launch is successful. Here, all of the marketing deliverables are brought to a condition to be deemed "launch ready", as are the service deliverables and the LMR Plan. New deliverables for LR are a First Articles, Material Qualification Report, Post Market Surveillance Plan, and a draft of the End-of-Life Plan (if there's a predicate product in the field).
The LR Gate Review is the point where the organization is deemed ready for launch, only awaiting regulatory approvals. The deliverables described previously are reviewed by leadership in addition to a comprehensive Launch Schedule.
Completion of the LR Gate Review provides an opportunity for leadership to internally approve the newly developed medical device product as ready for launch, from a business readiness standpoint.
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Once LR has completed, and regulatory approvals anticipated or coming in, the Project Closure stage executes. The End-of-Life plan is finalized and a Project Closure Report is completed. The Project Closure Report provides important value to the company such as lessons learned, across all functions, along the rigorous PLM pathway. As new product development starts again, translating these lessons learned can provide great value in terms of cost savings, best practices, supplier selection, etc.
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