Scaleable Engineering and Supply Chain Support for Disposable and Durable Medical Devices for Emerging Technology as well as High Growth Companies
             Operational Execution for Commercialization
 
"The Missing Piece in your Development Cycle"
Design Thinking

A silicon valley design firm called IDEO popularized the idea of "Design Thinking", with the notion of an Innovation at the Intersection of Key Domains, like Feasibility, Viability and Desirability.

 

Our thinking always starts with a Human-Centric approach, and the clinically valuable solutions from both a work flow and patient perspective.  This thinking is then supported by a review of business in order to monetize the offering, then a focus on the correct technology to allow efficient creation of the offering.

The regulating body (FDA, Notified Body, CFDA etc) is the “phantom customer”; a non paying customer, a demanding customer, but a customer none the less, with needs that must be met in order to realize any value proposition in the medical device solutions space.  Correct application of the Regulation can significantly improve the quality of a product, creating value, rather than adding costs.  We can help create that value.

Regulation

From “DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS” CDRH 1997   Accessed 11 22 2018 at:


https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
 

 
 
 
V Model Support
 
Offering

We can help you move from a concept sketch to a finished device

  • User-Centric Concept Development
  • Development Support
  • Design For Manufacturability (DFM) Analysis
  • World Class Prototyping Support
  • Supply Chain Development, including Low Cost Countries
  • Outsourced World Class Design
  • Collaboration to Ensure DFM
  • Injection Molds, Die Cast Dies, Automated Cells
  • Supply of finished parts and assemblies
  • Fortune 500 level Executive Leadership for R&D and Operations

 
We are the Missing Piece for your growing business
Let us know how we can help!

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