Aptus Group Solutions
Product Requirements Clarity
R&D | Design
Transfer to Manufacturing
Production Setup
Spending a little more time on clarifying the product & end-user requirements speeds up the entire development cycle (concept thru production release).
Having market expertise is super important but often the obvious questions don’t get asked. An expert knows how, where, when and why of a product or procedure. The expert is usually in the fray of meeting sales goals and responding prompty to field issues. They rarely get a pause to as open ended questions, “what would you (end-user) wish this could do? If you had it all your way what would do?
A good start isn’t just about our morning routine, it applies to product creation.
Some products require more rigor that others. There are two broad Product Development Paths:
Consumer Product (5 Phase to Product Release)
Few Industry/Regulatory Requirements, no critical to life requirements, lower perforance requirement, low risk
5 Phases of Consumer Product Development
Phase 1 – Define Product Specification
Align all stakeholders towards a product vision. Translate Project Needs (User, Device), and Technical & Regulatory Requirements into actionable Design Specifications.
Phase 2 – Functional Development
Functional development of the product through iterative cycles of ideation, engineering, prototyping, and qualifying tests.
Phase 3 – Design Development
Translation of the prototyped hardware, software, UI, softgoods, etc., into an integrated product. Refine the design intent through cycles of creative design and engineering. This involves determining physical constraints and user interface goals and integration into a singular manufacturable embodiment. Function testing, Verification will be done to confirmation and provide confidence of the design direction.
Phase 4 – Production Design Development
Refinement of design based on product & manufacturing requirements, volume targets, and production process selection.
Phase 5 – Manufacturing Interface and Production Release
Provide the design specification package to manufacturers, receive their quotes, and choose suppliers. Collaborate with the manufacturer(s) to optimize product to the manufacturing process.
High Performance/Critical/Medical/Aerospace Product (7 Phases to Product Release)
High performance/high risk requirement. Products with strict industry, regulatory requirments and validations. Products critical to human life or safety. Products that could cause concerns for property or environmental damage.
7 Phases of High Performance Product Release
Phase 1 – Needs Capture
Identify all the Needs:
1. Product
a) What is required for the Product to provide safe and effective treatment.
b) Patient conditions
c) Environmental
d) Define “safe and effective treatment”
2. Users
a) Who are the users
i. Trained medical staff
ii. Patients themselves
iii. Transient care givers
iv. Outpatient, in office, in controlled medical facility, at home
3. Industry
a) What regulatory and industry standards and protocols apply
b) ISO
c) Medical, aerospace, automotive, Coast Guard, Military, etc
Phase 2 – Design Inputs/Outputs
Build Traceability Matrix:
|
Needs |
Std/Spec |
Design Input |
Design Output |
Measured Output |
How Measured |
By Who |
Date Tested |
|
1) Must… |
ISO ###### |
Qualitative (General or Spec callout) |
Quantitative (measurable or observable) |
data |
Calipers, micrometers, visual, etc |
Tester name |
DDMMYYY |
|
2) Should…. |
ASTM #### |
|
|
|
|
|
|
Must be signed by ALL stakeholders (CEO, CFO, Sales, Marketing, Engineering, Quality, Manufacturing, etc..
Phase 3 – Design Development / Qualifications Testing
Integration of Human Factors, ID and Engineering in to initial CAD work and prototyped hardware, software, UI, softgoods, etc. Refine the design intent through cycles of creative design and engineering. Qualifying testing will confirm proof of design direction. Portions of the design that can satisfy Verification testing will also be completed at this time.
Phase 4 – Functional (Production Equivalent)/Verification Testing
Refinement of design based on product & manufacturing requirements, volume targets, and production process selection. Looks-like/Works-like prototypes will be built to finalize all Verifications Testing, with Reports.
Phase 5 – Production Release
Provide the design specification package to manufacturers, receive their quotes, and choose suppliers. Collaborate with the manufacturer(s) to optimize product to the manufacturing process.
- All tooling is purchased.
- T-1 parts proved
- T-1 or higher parts & assemblies made available for Validations testing.
- Packaging tested and finalized
- All labeling finalized (packaging, IFU)
Phase 6 – Verification Finalized/ Validation Start
With production or equivalent commence and finalize all Validation Testing and Reports. With this the Tracability Matrix can be completed and signed off by all Stakeholders.
Phase 7 – Production Stabilization
- All Assembly instructions verified
- Packaging tested and finalized
- IO,PO,QO completed.
Phase 8- Production Release
- All Sales & Marketing Personnel trained
- All Sales & Marketing literature released
- All Sales & Marketing support established
Phase 9- Post Release Production Monitoring
- Until EOL (end of life), company stakeholders will request user feedback on production performance and make all required improvements regarding safe and effective performance.
- As EOL approached inform market segment of EOL and future support.
- Inform market segment of new release.