OUR PROCESS OVERVIEW
Our Simplified 3 Phase Process
Proven accelerated phase development process
1
FEASIBILITY AND PROTOTYPE
IP assistance and regulatory strategy
Regulatory pre-submissions and early
FDA communicationSpecification development
Product brainstorming and concepts development
Tradeoff analysis and ranking of concepts
Project planning and risk assessment
Formulating intended use to identify initial regulatory classification and pathway
Technical Feasibility
First "in form factor" design
Risk assessment
FDA communications/ pre-submissions
2
ALPHA
Refined design
Design verification
Design transfer
Risk assessment
Confirmation of regulatory strategy, QMS and design control support, identification of pre-clinical/clinical testing requirements, vendor management
Industrial Design
3
BETA
Refined design
Design validation
Pilot build
Risk assessment
Process capability studies
Product labeling, IFs, operation manuals, etc.
P3PD Services
Concept Development
We will help you develop your concept - from imagining new product features to performing a thorough trade-off analysis. Let’s go further together!
Verification & Validation
P3PD specializes in the testing and validation of medical-grade products, that is anchored in industry-leading standards.
IP & Regulatory Strategy
With us, regulatory and IP strategy becomes a catalyst for success, propelling your products towards a future of compliance and success.
Early Stage Manufacturing
From prototype to production P3PD’s early-stage manufacturing expertise, precision and scalability brings innovative concepts to life.
Product Prototyping
Our on-site capabilities transform design concepts into tangible prototypes with unparalleled speed and precision.
STARTING WITH YOUR INSPIRATION
Phase Three Product Development (P3PD) has simplified the product development process in the life science and medical device industries.
Arthur’s Rock - Fort Collins