Medical and biotech device development is a special class of product development because of the regulatory environment. Those new to the field are often surprised about what devices are considered medical devices… Read More
While developing a product, you must take risks to achieve market success. To achieve business success with that product, it’s critical to assess and address risk as early and affordably… Read More
During product development, you must take risks to achieve market success. To also achieve business success, it’s critical for a design firm to assess and address risks as early and… Read More
The San Diego Biotech Consortium is a regional partnership of service companies dedicated to promoting best practices in product development for the Biotech industry. The Consortium offers leaders of biotech… Read More
At Simplexity, part of our work is designing embedded motion systems. As embedded motion engineers, we have to know how the smart electronics get placed within the physical structure (“embedded”)… Read More
In the early 1900s, the University of Oregon lost its Department of Engineering and Mines to Oregon Agricultural College, today known as Oregon State University, in Corvallis. Ten years ago,… Read More
At Simplexity, part of our work is designing embedded motion systems. As embedded motion engineers, we have to know how the smart electronics get placed within the physical structure (“embedded”)… Read More
I was recently asked by the Society of Women Engineers to give a talk on leadership. The organizers of the event asked me to share my story of how I went from… Read More
At Simplexity, part of our work is designing embedded motion systems. As embedded motion engineers, we have to know how the smart electronics get placed within the physical structure (“embedded”)… Read More
The prototyping process is faster and easier than ever before. The Maker Movement encourages us to build, build, build. Rapid prototyping with Arduino and 3D-printed parts and overnight shipping from… Read More
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking
Software: Full feature implementationHardware: Prototype 2 units with production-representative materials and processes
Quality: Build Quality PlanSoftware: Core functionality implementationHardware: Prototype 1 units with rapid prototyped components
Quality: Critical manufacturing process identificationSoftware: Architecture design: block, sequence and state diagramsHardware: Major Component definition & Proof of Concept subsystems build
Quality: Design for Manufacturing tradeoffs evaluation