Design Services
We provide design services to clients who need product and process development support for regulated devices and components.
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Technical Capabilities
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Program Management
We provide design services for clients who need product and process development support for regulated devices and components. This includes program management, with dedicated project managers, who are responsible for overseeing projects from concept development through commercialization.
Features
Rates
Design & Development Plan
Design Controls
Validation Master Plan
Project Management
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour -
Design Engineering
We provide design services for clients who need product and process development support for regulated devices and components. This includes design engineering from concept development to commercialization.Features
Rates
Electrical Engineering
Mechanical Engineering
Human Factors Engineering
Industrial Design
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour -
Prototype Engineering
We provide design services for clients who need product and process development support for regulated devices and components. This includes prototype engineering for alpha and beta prototypes.Features
Rates
Alpha Prototypes (looks like, may work like)
Beta Prototypes (looks like, works like)
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour -
Process Engineering
We provide design services for clients who need product and process development support for regulated devices and components. This includes process engineering to support new products and processes and manufacturing transfer.Features
Rates
Define Product & Process Requirements
Specify & Procure Tooling and Equipment
Process Verification & Validation (IQ, OQ, PQ)
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour -
Quality & Regulatory
We provide design services for clients who need product and process development support for regulated devices and components. This includes quality and regulatory support from our quality management team.Features
Rates
Essential Requirements & Risk Analysis
Design Control Documentation
Manufacturing Documentation
Inspection Protocols & AQLs
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour -
Material Sourcing
We provide design services for clients who need product and process development support for regulated devices and components. This includes material sourcing support for raw materials and components.Features
Rates
Advanced Flexible Materials
Chemicals
Excipients
Active Pharmaceutical Ingredients
Design Engineering............................................................................................................................................................................................................................................................Process Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$75 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$225 per hour -
Testing
We provide design services for clients who product and process development support for regulated devices and components. This includes testing in our wet and dry test labs as well as third party testing.Features
Rates
Dry Lab - Tensile Strength, Peel Strength, Elongation, Seal Integrity, Leak, Dimensional Metrology
Wet Lab - pH, Density, Viscosity, Titration, FTIR, Tensiometry, Endotoxin Testing, Shelf-life Studies
Third Party Testing
Design Engineering............................................................................................................................................................................................................................................................$225 per hourProcess Engineering............................................................................................................................................................................................................................................................$125 per hourPrototype Engineering............................................................................................................................................................................................................................................................$100 per hourProduction (NRE)............................................................................................................................................................................................................................................................$75 per hourMaterial Sourcing............................................................................................................................................................................................................................................................$100 per hourTesting............................................................................................................................................................................................................................................................$225 per hourQuality & Regulatory............................................................................................................................................................................................................................................................$100 per hour
Additional Features
The path to faster innovation requires deep technical expertise across multiple disciplines and involves more complex supply networks to access non-core capabilities. Our services enhance innovation by improving time to market, filling competency gaps, and increasing agility. We increase your likelihood of commercial success with our expertise in advanced materials, engineering, and advanced manufacturing.
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Technical Expertise
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Vertical Integration
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Risk Management
Advanced Materials
Advanced materials including flexible materials, tubing, molded components, and liquid media.
Engineering
Engineering for design and development across all commercial phases from concept generation to sustaining engineering.
Advanced Manufacturing
Advanced manufacturing, including liquid formulation, complex assembly, and process automation for regulated devices and liquid media.
End-to-End Services
End-to-end services to fill competency gaps anywhere in your commercialization process.
Integrated Services
Fully integrated services to improve responsiveness and agility during the commercialization process.
Design for Manufacturability
Expertise and alignment of design and manufacturing increases the reliability of commercial success.
Reliable Product Quality
Reliable product quality is the principal risk factor we mitigate through our quality and regulatory systems and over 40 years of experience.
Minimize Competency Gaps
Our sophisticated quality system and team provide expertise and risk mitigation by filling competency gaps in your non-core operations.
Ensure Strategic Supply
We ensure strategic supplier relationships which provide business continuity and redundancy through additional locations, capabilities, and resources.
Qualifications
Design Services
We provide design services for clients who need product and process development support for regulated devices and components.