Design Process
"A way to solve a problem in a population in order to create a favorable outcome."
What are needs statements?
This project was the MEDesign poster child, an adjustable prosthetic for growing children.
What is ADAprosthetics?
This U.S. government agency regulates medical devices.
Engineers use this three-letter abbreviation for computer-aided design.
What is CAD?
This molecule stores genetic info in humans.
What is DNA?
Conducting them helps you validate and narrow potential needs areas.
What are clinical interviews?
This professor has been MEDesign's faculty advisor for a long long time.
Who is Dr. Loeb?
The largest medical device company in the world.
What is Medtronic?
Named after an English physicist, this is the SI unit of force.
What is a newton?
This is the largest organ in the human body.
What is the skin?
Filling them out helps you understand which needs area to work on.
What are Stanford Biodesign tables?
MEDesign was founded in this year.
What is 2015?
The FDA separates medical devices into these risk-based classes.
What are Class I, Class II, and Class III?
Represented by V = IR, this law relates voltage, current, and resistance.
What is Ohm's Law?
This theory, from Darwin, says that organisms with traits better suited to their environment are more likely to survive, reproduce, and pass those traits to their offspring.
What is evolution by natural selection?
A list of quantitative features that are translated from the user needs table into specific requirements for the product.
What are design inputs?
The MEDesign co-presidents last to last year
Headquartered in Irvine, this company is best known for its SAPIEN transcatheter heart valves.
What is Edwards Lifesciences?
On a stress–strain curve, the slope of the linear elastic region represents this material property.
What is Young’s modulus?
This microscopic structure is the functional unit of the kidney.
What is a nephron?
By checking that the product matches the original user needs, often done by giving the product/prototype to the user and seeing how they interact with it.
How do you conduct validation testing on medical devices?
In this year, a MEDesign team won the UC Davis Makeathon.
What is 2018?
This common FDA pathway requires a manufacturer to show that its device is substantially equivalent to a legally marketed “predicate device.”
What is a 510(k)?
Using red and infrared light, this medical device noninvasively estimates information about a person's blood from their finger.
What is a pulse oximeter?
Despite being a vein, this blood vessel carries oxygen-rich blood to the heart.
What is the pulmonary vein?