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B-PLM Tools

The execution of the B-PLM Process is enabled by Tools that Progressive Gating can provide. These Tools are provided in the form of stage-executed templates and the following Global Documents: B-PLM Process Guide, Gate Review template and Decision Form. Templates executed within the B-PLM Process become deliverables reviewed and approved at B-PLM Stage Gate Reviews*.

As indicated in Who We Help, the B-PLM Process is provided FREE of charge. It's our way of supporting the industry and the emergence of break-through products.

Progressive Gating offers deployment of Tools across tiered offering, each tier aligning with, by your selection, your organization’s growth condition. Progressive Gating would be glad to advise you in that selection. Please review the Tier descriptions provided below, along with descriptions of the Tools offered by Stage. Previews of the Tool table of contents and section content are provided as a sneak peek.

As a bonus, Add-on Tools will soon be available that focus on equipment development installation and qualifications.

*B-PLM Stages and Gate Reviews are not associated with design control. Please review the B-PLM Process

Tier 1: Essentials

Tier 1 is the start of laying the building blocks of the B-PLM Process. This tier brings in essential pillars templates Business Case, Value Proposition, and a project Charter. Together with essential organizational plan templates, the start of a solid B-PLM foundation for your organization is created.

Please review the descriptions provided for each tool offered. They are broken out first by Global Documents, then tools available by Stage (PI, VP, NPA, MI, and NPC). Previews of each tool by table of contents and section content are provided as a sneak peek.

This B-PLM Process Guide provides detailed instructions to execute the process, assuring consistent, efficient, and effective B-PLM Gate Reviews.

This process guide details activities and reviews from Project Initiation (PI) through to Launch Readiness (LR).

It is important to state that this B-PLM process guide is not part of design control. It only provides guidance for the execution of deliverables within the B-PLM process.

The B-PLM Business Case template provides a critical opportunity for a company, intending on developing a new product, to document the financial basis for the new product through various key metrics. See the Table of Contents preview.

The Business Case is a pillar to the B-PLM process. It is meant to be drafted early in the process and presented at the Project Initiation (PI) Gate Review, baselined at the Value Proposition Stage (VP) Gate Review, with updates to the Business Case reviewed carefully during subsequent Gate Reviews. As the project moves through later stages and into launch readiness, the financial investment grows substantially, increasing importance of an accurate Business Case.

Continuous Business Case review at the Gate Reviews provides the most important guard rail, recognizing best estimates of development costs (and in later reviews, realized costs) and balanced against newest information on market size, pricing, etc. This diligence provides LT confidence in confirming launch readiness and eventual value returned to the company and investors.

The Word version of the Business Case template is a comprehensive document, encompassing all areas in need of consideration. A large amount of detail is typically included in the Word version, forming an important pillar to the B-PLM Process.

A Powerpoint version is also offered as a simpler way of documenting the Business Case if the needed content is not extensive (market is basic, the device is simple, etc.). Additionally, the Powerpoint template can be used as a way to convey the major points of the Word version for presentations and Gate Reviews.

As described above, the B-PLM Business Case template is a valuable B-PLM Tool, a pillar to the process as a whole.

Creation of, and continuous updates to, the Business Case using the provided B-PLM template requires key inputs from Core Team members, allocated support resources within the company, and/or external consultants.

A RACI guide (Responsible, Accountable, Consulted, Informed) is provided by Progressive Gating as an organizational tool. The RACI details ownership for each major section of the Business Case, functions consulted, and functions or leadership informed.

B-PLM Global Documents

Project Initiation (PI)

The Gate Review Presentation template provides the basis for conducting your Gate Review meeting. It enables the Core Team to walk the Leadership Team through the status of the B-PLM deliverables executed during the Stage leading up to the Gate Review.

The presentation template also records action items, agreements on any deviations, and document whether the Gate Review was a success, or if more work remains.

It is important to state that this B-PLM template is not part of design control. It only supports the presentation of deliverable status within the B-PLM process.

Content preview is coming soon...

The Gate Review Decision Form template provides a record of decisions made during, and at the conclusion, of the Gate Review.

The form records the names and signatures of the Leadership Team (LT), the Core Team (CT) and Project Manager (PM).

The form further provides opportunities to record outcomes of the review, specifics of what the LT is agreeing to, Action Items, and Allowed Deviations.

It is important to state that this B-PLM form is not part of design control. It only supports documentation of deliverables status within the B-PLM process.

The B-PLM Charter formally authorizes the initiation and structure of the project. It also provides the Project Manager with the authority to plan and apply organizational resources. See the Table of Contents preview.

The Charter is a pillar to the B-PLM process. It is meant to be drafted early in the process and presented at the Project Initiation (PI) Gate Review, baselined at the Value Proposition (VP) Gate Review, with updates to the Charter reviewed for approval at subsequent Gate Reviews. As the project moves through stages of the process, scope changes can become a source of cost impacts along with updates to cost (spend) vs. the original budget.

Accordingly, continuous Charter review at the Gate Reviews provides a key guard rail, heading off "scope creep", highlighting a need to dig deeper into cost overruns, and re-evaluate documented assumptions and constraints.

The B-PLM Value Proposition creates a value-based justification for proceeding with a product development project. The justification is developed through establishing value propositions by focusing on direct clinical value, core values (patient experiences, device users, sales & marketing effectiveness), company operational value, and bottom-line value to the business (Business Case). See the Table of Contents preview.

The Value Proposition deliverable is a pillar to the B-PLM process. It is meant to be introduced at the Value Proposition (VP) Gate Review, with updates reviewed during subsequent Gate Reviews.

Accordingly, continuous Value Proposition review at the Gate Reviews provides a key guard rail, ensuring values documented at the start of the project remain, or changes to the Value Proposition are accepted by the LT allowing the project to continue.

The B-PLM Sourcing Plan provides an early start aligning sourcing objectives, understanding the type of suppliers needed throughout the product development process, selection criteria for strategic and preferred suppliers, and establishing a supplier qualification process. See the Table of Contents preview including other activities key to a robust sourcing plan.

The Sourcing Plan deliverable is drafted and for review at the Value Proposition (VP) Gate Review, and baselined at the New Product Approved (NPA) Gate Review. Updates are reviewed during subsequent Gate Reviews, through to launch, and maintained after launch.

Value Proposition (VP)

The B-PLM Global Marketing Plan forms the basis of the where the product fits into the market, the customers it will serve, how it'll be positioned and priced for successful launches by geography, and details all the strategies and Key Performance Indicators (KPIs) for successful launch. See the Table of Contents preview.

The Global Marketing Plan deliverable is drafted and reviewed throughout the Value Proposition (VP) and New Product Approved (NPA) stages and baselined at the Marketing Introduction (MI) Gate Review. Updates are reviewed during subsequent Gate Reviews, with the final version launch-ready at the Launch Readiness (LR) Gate Review.

The Global Marketing Plan continues as a living document after launch based on lessons learned and changes in market conditions.

Market Introduction (MI)

As described previously, the B-PLM Global Marketing Plan forms the basis of how the product will be positioned for market, pricing, customer targets, etc. The Marketing Deliverables Checklist provides a clear, categorized checklist to ensure activities are completed in time for launch. This deliverable further establishes the key Launch Criteria as defined by the marketing team and confirmed by the LT.

The Marketing Deliverables Checklist deliverable is reviewed and approved at the Marketing Introduction (MI) Gate Review and used, functionally, at the Launch Readiness (LR) Gate Review as a tool to confirm that all of the key Launch Criteria have been satisfied.

The B-PLM Operations and Manufacturing Plan provides a clear operations road map for how the product will be manufactured, supplied, and supported throughout its lifecycle. This is accomplished through metric-driven objectives, categorically identified manufacturing requirements, strategies, and Key Performance Indicators (KPIs). See the Table of Contents preview.

The Operations and Manufacturing Plan deliverable is drafted for review at the New Product Approved (NPA) Gate Review, and baselined at the New Product Committed (NPC) Gate Review. Updates are reviewed at the Product Goals Met (PGM) Gate Review, with the final version launch-ready at the Launch Readiness (LR) Gate Review.

New Product Approved (NPA)

New Product Committed (NPC)

The B-PLM Design Validation Master Plan documents the scope and provides a clear plan for validating the design of the new product. Strategies through all required areas are documented with objective(s) and expected outputs. Functional ownership is defined and protocols are detailed across all required validation areas. An attachment is provided serving as a trace matrix for tracking execution of all testing in support of identified requirements.

The Design Validation Master Plan deliverable is reviewed and approved at the New Product Committed (NPC) Gate Review.

B-PLM Global Documents

New Product Committed (NPC)

Launch Readiness (LR)

Tier 2 adds to the arsenal of Tools that Tier 1 has started. In Tier 1, the building blocks of the B-PLM Process were set. Tier 2 completes the foundation through adding a Core Team Guide to the Global Documents, and adding in important templates focused strengthening readiness for launch.

Together with what has been deployed in Tier 1, a solid B-PLM foundation has been created for your emerging organization.

Please review the descriptions provided for each Tier 2 tool. They are broken out by the addition to Global Documents, and tools added by Stage (MI, NPC, PGM, LR, and PC). A verbal preview of each tool is provided as this tier remains in development. Availability is estimated as Q1 2027.

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Tier 2: Foundational

Market Introduction (MI)

Product Goals Met (PGM)

Project Closure (PC)

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B-PLM Global Documents

New Product Committed (NPC)

Launch Readiness (LR)

Tier 3 provides an advanced level of structure to the B-PLM Process. Tools that Tier 1 and Tier 2 put in place a foundation for your B-PLM Process, and Tier 3 takes things to an even higher level of safeguarding your organization's financial confidence executing PLM.

Tier 3 adds in additional templates focused strengthening readiness for launch, operational readiness, and preparing for service needs of your product in the field.

Please review the descriptions provided for each Tier 3 tool. They are broken out by tools added by Stage (MI, NPC, PGM, and LR). A verbal preview of each tool is provided. This tier remains in development. Availability is estimated as Q2 2027.

Content to be added...

Tier 3: Advanced

Market Introduction (MI)

Product Goals Met (PGM)

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B-PLM Tools, Equipment Development Add-ons

Capital spending is a major area of focus as product lifecycle management advances. As the project steps through early phases of PLM, capital spending increases every step of the way in the form of: labs, cleanroom/space design, engineering, and construction; custom equipment development; OTS equipment procurement; and several other areas of spend.

Deploying these Add-on processes and tools into your organization through the B-PLM Process not only creates structure, best practices and guardrails are also established to control spending through oversight and checks along the way.

Please review the descriptions provided for each Add-on tool. They are broken out by Global Documents (topic-specific process flows) and execution tools added to the NPC Stage. A verbal preview of each tool is provided. The Add-on offering remains in development. Availability is expected in 2027.

Global Documents

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New Product Committed (NPC)

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