D = Draft Version of Deliverable
F = Final Version of Deliverable
if Deliverable included in DHF it needs to be signed
U = Updated Version of Deliverable
needs re-signing if original signed
No = Deliverable not required - needs justification Stages

Preconcept
High level assessment of market opportunity & enabling technologies G0

Concept
Demonstrate clinical and economic value
Develop thorough understanding of user needs
Select one concept for further development G1

Development
Develop a robust product design that can be consistently manufactured at scale G2

Verification
Confirm that Design Outputs meets Design Inputs G3

Validation
Confirm that Design Outputs meets User Needs
Confirm manufacturing targets are met
Ready to sell. G4

Launch
Monitor
- sales
- quality
- inventory
Celebrate
Close Project G5

Assessment of the market to include: market size, CAGR, margins, competitive landscape, strategic fit, channels of distribution Market Opportunity Analysis

Global Strategic Marketing to compile and present market and financial assessment, Clinical, Regulatory and Reimbursement overview, risk assessment critical assumptions, proposed project timeline with potential entry recommendations, project costs, technical development, and regulatory pathways. Includes P&L with estimated 7 yr. global revenue, COGS, ASP and NPV on opportunity
Business Case

This is a technical review of either the explore activities completed during Concept or the technology readiness after Development, There should be a technology development plan for the project coming out of the Concept phase. Conduct a review with a cross funtional team and at least one independent reviewer. The review must be documented and at a minimum the documentation should include who attended, a discussion summary, any decisions made and pending action items.
Technology Assessment

Build list of IP opportunities and IP competitive environment
IP Landscape Assessment

Meeting to gather all organizational resources identified to support the project for the first time, in order to kick off the project.
Include Team Wheel, & Communication Plan Project Kickoff with Team

Outlines project description, scope, risks, and financial information. It allows the Project Leader to apply organizational resources to the project. Project Charter

The PDP RACI that has been modified to fit the project (process involves project team scaling the PDP RACI template to best represent the deliverables specific to their project). This is a signed off document that is approved by the Design Excellence Board.
Approved RACI

how do you plan to develop the product?
Design & Development Plan

The Design History File (DHF) is a compilation of records that contain the history of a product(s) design and development. The DHF contains and/or references records necessary to establish compliance with the design plan as governed by the design control process per PR-11490. DHF records provide the fundamental basis for subsequent changes, improvements, line extensions, and investigations.
Establish Design History File (DHF)

Voice of Customer plan to frame out questions that need to be answered, and identify who we need to speak with to fill knowledge gaps or validate assumptions
Voice of Customer Plan

Outlines intended interaction between intended users and device system. Each interaction is a market requirement that shall be validated. Input document to UFMEA and all usability testing protocols. Attachment to MRS.
Use Case Specification

evaluation of functional and physical characteristics of competitors
State of the art (SOTA) Review

Document that summarizes market/user needs with detailed description of requirements
Include review of predicate/similar device MRS Market Requirements Specification (MRS)

Report that establishes the claims that will need to be made in order to successfully enter the market. Also, details evidence that will be required in order to make these claims
Product Claims Matrix

The drawings can present the details of the design to either a brainstorming session or for VOC field work. These drawings should augment the discussion about the design and convey the various attributes of the designs. The drawings can be utilized quickly to gain feedback in early design stages prior to making an actual prototype.
Prototype Drawings

Build prototypes of concept(s) to test using VOC and benchtop/pre-clinical testing
Prototype Sample Build

validated test method
Test Method Development

The design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to further work. Items to be considered for inclusion: Physical tests.
Engineering simulations.
Examinations (Walk-through).

Technical Design Reviews

IFUs are required for all medical device products. The IFUs should be easily understood by the appropriate user of the device and can be enhanced through good drawings. Care guides should be considered if the product is going to be utilized outside of a clinical setting.
IFU content

Protocol for design of Formative Usability Evaluation studies. Used for evaluation of iterative design embodiments to determine which features enable safe and effective use.
Formative Usability Evaluation study

Report summarizing all human factors/usability data related to the design. Required by FDA for 510k submissions on all devices in which the user interface is new or modified, or intended users or uses were modified. Also required for all infusion pump devices and most electronic devices.
Human Factors Engineering Report

Design review that captures review of all data collected during the Concept phase as well as documentation of concept selection/reduction activities performed.
Final Concept Design Review & Selection

Applications for utility or design patents based on inventions generated by the team. Not every project will require filing of patent applications. Patent Applications

Review of unexpired patents and pending applications to third parties for potential patent infringement issues with the proposed products or methods. Freedom to Operate opinion

A UFMEA is performed to assess reasonably foreseeable use-related errors that could result in harm in order to consider how to effectively reduce the risk of those potential failures.
Each use step and subsequent potential Use Failure Modes and Causes are analyzed individually and then associated to hazards and harm severities from the product’s Hazard Analysis (HA).

Use FMEA

Overall RA strategy plan for global marketing that requires information needed for submission planning, including all countries product will be marketed and desired date of marketing.
Includes
- US, EU, Japan, Australia & Canada Global Regulatory Strategy Plan

Assessment of Packaging sterile barrier requirements around ISO11607-1
Preliminary Packaging Assessment

Technical Assessment of Sterilization needs for the product being developed
Sterilization requirement assessment 

Document describing business representatives, marketing strategy, regulatory strategy, risk-assessment, pre-clinical testing, pre- and post-market clinical trial strategy, and publication strategy.
Clinical Input Summary

Literature based clinical evaluation report describing published experience and field assurance activity for same or similar device
Clinical Evaluation Report (Lit Review)

Document that establishes the method and training requirements, if product requires new procedure or change in technique/practice
Clinical Use Training Plan

Completion and update of overall Manufacturing Plan documentation per SOP
Manufacturing Plan Review

Assessment of Energy consumption, waste stream identification, scrap generation
Sustainability Assessment

A tool that captures the risks of a project (things that could potentially happen), based on managing the processes concerned with conducting risk management planning, identification, analysis, responses, and monitoring and control on a project.
Project Risk Register

The approved estimate for the project or any work breakdown structure component or any schedule activity.
Project Budget

7 year annual sales forecast by region with global roll-up and documented assumptions, based on competitive pricing analysis
Sales Forecast

The make-or-buy decision is the act of making a strategic choice between producing an item internally (in-house) or buying it externally (from an outside supplier - also referred to as outsourcing). Make v Buy Recommendation

Otherwise know as the User Requirements Specification (URS). A specification(s) documenting the user requirements and all the necessary information to design, build and validate a machine or process. Capital Equipment Specification

Verification of vendor having equipment & capability to meet our requirements.
This is a report Capital Equipment Supplier Assessment

Detailed estimate for use in the appropriation request and for project cost control Capital Estimate

A document which details the design requirements of the product(s) proposed for development. It describes the final product concept in design engineering terms. The PRS is developed from Market Requirements, including external customer requirements and internal marketing requirements, and additional design guidance documents. The PRS should be used as a guide for creating the Verification and Validation Test Plan. Each requirement in the PRS must be tested during Validation which must be reflected in the Design Traceability Matrix.
Product Requirements Specification (PRS)

Drawings to document the specifics of the design. As the design progresses, more details are added to the drawing to clarify the design. Drawings: Assembly, Subassembly, Components

This includes planning for long leadtime items such as Audits and Supplier Quality Agreements.
Supplier Qualification Plan

Cost of Goods Sold Definition for the product (COM + Distribution Costs + Sterilization Costs)
Product COGS

Including Quality Requirements
Supplier Quality Agreement

Formal process to provide potential vendors the information they need to determine their price and commercial terms and conditions and verify that supplier can meet HYH demand Request for Quotes & Proposals

End to end assessment of significant supply chain complexity causing future risk for service interruption
Supply Chain Risk Assessment

Review of Country of Origin designation for all proposed product packaging
Country of Origin Assessment

Labeling that is a physical component of the device (not part of packaging or IFU) that indicates functional markings and branding.
Device Artwork & Labeling

Green Folder artwork approval process for labeling in GPS system. Established IFU and labeling content is made into draft artwork, proofread and distributed to cross functional team for review/approval.
Packaging Artwork & Labeling

Packaging specifications for printed and unprinted package components created in GPS system. Packing Standards for finished products created in GPS system.
Packaging Specifications

This is a formal review focused on the manufacturability of product design, equipment and process. It should include ease of assembly from a product design perspective, operator consistancy and ease of use, yield risks and throughput limitations. Conduct a review with a cross funtional team and at least one independent reviewer. The review must be documented. At a minimum the documentation should include who attended, a discussion summary, any decisions made and pending action items.
Design for Manufacturing Review

Engineering builds during Development phase to minimize/eliminate technical risks identified by the Development Iteration Plan Engineering Sample Builds

define the product requirements and quality level Finished Product Specifications

Conduct a review with a cross funtional team and at least one independent reviewer. The focus will be on a dimensional analysis of each component and it's mating part or parts. Interferance or Gaps found during the anlysis should be highlighted even if they don't affect fit or functionality. The review must be documented. At a minimum the documentation should include who attended, a discussion summary, any decisions made and pending action items. Tolerance Stackup Analysis Report

A traceability matrix is a document, that correlates requirements documents to design and testing to determine the completeness of the relationship.
Design Traceability Matrix

Test Method Validations are needed to ensure tha the test method can be conducted repeatedly and reproducibly to find issues with the product that are not related to the test method.
Test Method Validation

Appropriation request with completed appropriation identification write up, estimate summary, write-off schedule, project timeline, project checklist, and finanical analysis.
Capital Appropriation Request

Sequence of production steps and interactions
Process Flow Chart

Development of equipment position and layout in relation to all other equipment in the manufacturing area; should be completed in CAD version of plant layout
Equipment Layout / Floor Plan

This analysis consists of the assessment of multi-year customer demand and production volume requirements to meet the forecasted demand. The company's actual production capacity is weighed against the new volume requirements to see if the demand can be met with the current production capacity.
Capacity Analysis: Internal + External

Proof of Principle work, URS, RFQ, design package including software/DFM to meet manufacturing requirements(This work is typically expensed to R&D at the time the work is performed)
Equipment Design / Build - Pilot

Develop and implementation of all required environmental (temp, humidity etc) raw material, WIP and FG Storage and transportation Transportation & Storage Requirements

Development of transportation lane plans for RM, WIP, FG; Deliverable - SAP Master Data setup for existing transportation routes or establishing new transportation routes Logistics Plan: FG, WIP, RM

Assessment of any new materials associated with manufacture of the new product for safe handling and storage; Any new materials should be evaluated by site EHS Leader for safety and Safety Data Sheet(s). Also, should evaluate if specific EHS Training is needed.
EHS Assessment

The receiving facility is prepped with all necessary building modifications and upgrades for the new manufactuing process.
Facility Assessment & Upgrade

Verification that equipment meets all specifications and acceptance criteria on the vendor's floor, including FAI check
Factory Acceptance Test (FAT)

Deliverable involves all activities related to demonstrating product reliability. It includes
- setting appropriate reliability targets.
- developing reliability test plan including sample size calculation
- determination of how best to conduct test (component or system)
- conducting reliability tests
- calculation of system reliability
- demonstration of reliability target Product Reliability Assessment

Creation, review and approval of all standard operating procedures, work instructions and job aids related to product manufacturing Work Instructions & Job Aids - Mfg

Creation of Design History Record documentation standards for manufacturing and product release Device History Record - Mfg

Process to:
Review the proposed design and gain agreement that the design is mature enough to initiate design verification and design validation activities
Design Freeze Design Review

Plant report of Bio Burden levels
Bio Burden Test Report

Review and approve the study results.
Product Safety Test Report

Labeling and management of investigational product including appropriate Regulatory documentation, test data and labels are complete and approved in an appropriate binder to release product for clinicals.
Product Build for Clinicals

Approved Green Folder artwork is sent to outside agency for translation process into other languages.
IFU Translation

Contractural document that further defines the relationship between HYH and the supplier, above and beyond the requirements of a purchase order. Supply agreements are not always required. Procurement will make the decision with team input, on whether the Supply Agreement is needed.
Supply Agreement

Maintenance schedules and requirements proceduralized and inputted into SAP
Equipment Maintenance Schedule update

Release of codes in SAP so production orders can be created for the product; making sure code is saleable Code Release (SAP system)

A business portfolio process, with input from key cross-functional resources, in which leadership approves a project moving into the Verification Lock (phase). Validation Gate Exit

Verification that equipment meets all specifications and acceptance criteria on the plant floor (usually a requirement for releasing final payment to the equipment vendor)
Site Acceptance Test Report (SAT)

Validation reports are a detailed accounts of every aspect of the build and subsequent testing of a subject unit under test. Reports should be written such that others could repeate the build and testing you are documenting. Design Validation Report

Stability reports are reports that summarize shelf life aging data collected as described in stability protocol(s). Stability testing is considered Design Validation and should be documented in a separate report from baseline Design Verification and baseline Design Validation (i.e., simulated use) testing. Accelerated aging reports/revisions are typically written/owned by the New Product Development team while real time aging reports/revisions can be owned by the Sustaining Engineering team.
Stability Report(s)

Approved package design validations routed, conducted for adherence to ISO 11607-1 requirements.
Packaging Design Validation Report(s)

Results from the pivotal clinical study presented in order to receive regulatory approval.
Pivotal Clinical Study Report

Equipment qualification output report
Process Validation IQ Reports

Completion and approval of Operational Qualification reports including any deviations
Process Validation OQ Reports

Completion and approval of Performance Qualification reports including any deviations
Process Validation PQ Reports

Checklist that:
1) confirms that product can be produced predictably and
2) confirms whether quality control capabilities are transferred to the operating organization. Design Transfer Checklist

Training requirements for all personnel involved with the manufacturing of the product (operator, QA, maintenance, etc.)
Manufacturing Personnel Training

Initial launch production build
Launch Build

Initial launch quantity arrival at all distribution centers
Launch Inventory at DC

Appropriate 510K, non-510K, PMA or NDA submission

510K submission includes effectiveness data to show equivalence to a currently marketed device.
For a 510K need: Standards Data Report for 510(K)s form FDA 3654; Device Description (Pictures, Drawings); Predicate Device Comparison; Performance Data; Biocompatibility; Sterilization Method and Validation; Proposed DFU; Proposed Labeling; Data to Support Expiration; Human Factors Summary; Software Testing Requirements and Validation.
A Letter To File must be included if 510K is not required

Pre-Market Approval (PMA) submission is required for devices that support or sustain human life.
For a PMA need: IDE; Preclinical Studies; Clinical Studies; Animal Studies; FDA Meeting; Device Description (Pictures, Drawings); FDA Audit; Performance Data; Biocompatibility; Sterilization Method and Validation; Proposed DFU; Proposed Labeling; Data to Support Expiration; Human Factors Summary; Software Testing Requirements and Validation

New Drug Application (NDA) application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
For a NDA need: Manufacturing Description; Validation Reports; FDA Audit of Manufacturer; Facility Diagram; Performance Data; Proposed DFU; Proposed Labeling; Data to Support Expiration US Submission 

Letter stating a submission is approved and product can be distributed.
US Approval Letter (from FDA)

Documented evidence that demonstrates conformity of a product to the appropriate European Directive. Technical File is required to distribute product in EU and must be reviewed and approved by the Notified Body.
May require a BSI audit Technical File Submission

The CE mark shows that a product meets the current EU legislation and can be marketed in EU. The ISO certificates are issued by the notified body in order for the CE Mark to be applied.
CE Mark / ISO Certificate

Submission to regulatory agency that may include conformance to recognized standards and performance data.
RoW Submission

Letter stating a submission is approved and product can be distributed.
RoW Approval Letter

Educational training on product to ensure proper customer service
Customer Service Training

Full training to sales organization on market opportunity, competitive landscape, customer targeting, talk tracks and role plays, to include certification test.
Sales Training

For products with new trademarks, review of proposed trademarks to avoid potential trademark infringement issues. Not every project will require a trademark search and clearance.
Trademark Clearance

A business portfolio process, with input from key cross-functional resources, in which leadership approves a project moving into the Validation Lock (phase).
Launch Gate Exit

Plan for continued waste elimination and productivity improvement to meet COGS target Continuous Improvement Plan

Compilation of project team feedback on what they learned from execution of the project (positive and negative). Lessons Learned are reviewed to identify opportunities for continuous improvement within the organization.
Lessons Learned

Method (meeting, checklist, etc..) to indicates that the project has completed all activities/deliverables defined within its scope.
The project is formally closed and resources are now available to work on other projects.
Project Close