Our Process
5-Phase Development Planning
Phase Milestones
-
Execute
NDA -
Idea
Discussion -
Discovery
Meeting -
Project
Schedule -
Project
Budget -
Design
Proposal
Phase Milestones
-
Intellectual
Property
Review -
Regulatory
Review -
Product
Requirements
Document -
Initial
Industrial
Design -
Evaluation
of
Risk -
Inputs
Document
Phase Milestones
-
Feasibility
CAD -
Output
Document -
Proof of
Concept -
Design for
Production
Proposal -
Risk vs
Cost Benefits -
Build vs
License
Phase Milestones
-
Design for
Production -
Production
Tooling -
Production
Prototypes -
Testing
Protocols -
Verification
Testing
Phase Milestones
-
Packaging &
Labeling -
Final
Production
Sampling -
Clinical
Validation -
Finalize Risk &
Design Documents -
Complete
Design
File -
Regulatory
Filing
Design Services
- Product Development Consulting
- Discovery Packages
- Patent Drawings
- Industrial Design
- Project Cost and Schedule Planning
- Preliminary 3D CAD for Visual Presentations
- Animations
- Verification Testing
- Mechanical Design
- In-house Prototyping (SLA, Polyjet, FDM)
- Verification and Validation Planning
- Risk Assessments
- Manufacturing Drawings
- Technical Document Preparation
- Design Control per ISO 13485 and 21 CFR 82.30
- Design History File Preparation
Design Resources
- SolidWorks Design Automation Software
- Rhino Computer Aided Graphics Software
- Finite Element Analysis Software (for SolidWorks)
- Computational Flow Dynamics Software (for SolidWorks)
- Visualize Rendering Software
- V-Ray Rendering Software
- PDM Software (for SolidWorks)
- PoserPro Human Modeling Software
- Premiere Pro by Adobe
- Photoshop CC by Adobe
- Animate by Adobe
- Audition by Adobe
- Unity Virtual Environment Software
- Wrike Collaboration Software
- Wrike Project Management Software
3D Printing and Evaluation Services
In-house prototyping capabilities*
- Polyjet digital ABS
- Polyjet polypropylene-like
- Polyjet ABS-like with colors
- Polyjet acrylic-like
- Polyjet multi-shore hardness
- Polyjet biocompatible (medical grade)
- Polyjet multi-color, multi-material prints**
- SLA silicone-like
- SLA biocompatible (medical grade)
- SLA single print colors
- FDM ABS
- 3-Axis Routing
*Large format and other 3D printing material and prototyping services available though external resources
**Limited colors and material options
In-house evaluation capabilities
- Leak testing
- Low-pressure testing
- Flow testing
- Adhesive testing
- Force testing
- Cycle testing
- Aging studies
- Custom testing setups
External testing available
- Cytotoxicity testing
- Extractable and leachable testing
- Sterilization verification
- Other external testing available
- Electrical engineering
Rates
Hourly Work
$250
/hr
flat rate
For-profit clients services under 40 hours
- :45 Discovery call - No Charge.
- No-charge or reduced-fee work available on a limited bases to non-profit clinical inventors and institutions seeking discovery and feasibility work in order to assist in raising project awareness and development capital.
- Paid or Granted hourly work includes use of all in-house resources required to complete work including 3D printers and lab equipment.
Discovery Session
$500-$1500
Preliminary meeting to determine scope and costs
- Pre-meeting research and ideation for meeting.
- Up to 2-hour Discovery meeting with multiple disciplines as required.
- Post-meeting project plan and cost outline for potential investors discussions.
Project Work
By Proposal
(typically over 40 hours)
- May require a Discovery Session.
- NRE costs including time, prototyping and lab fees.
- Estimates for development capital costs and external resources (i.e. regulatory and specialty consultant fees).
- Proposals provided with time-line estimates and proposed development milestones.