Do you know everything there is to know about prototyping, product iteration, and manufacturing to get your medical device to market?
In this episode, Greg Paulsen, the Director of Application Engineering at Xometry, describes nuances to consider and how to leverage technology and rapid prototyping methodologies. Specifically, Greg shares his company's unique procurement and fulfillment strategies and options that help simplify and speed up the medical device process.
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Some highlights of this episode include:
- Procurement Problems: Xometry makes and fulfills on-demand custom manufactured parts for medical devices.
- Prototyping: When to start? What types to create? What are verification and validation requirements? Why consider past, present, and future iterations?
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Today’s Trends: Greg describes the evolution of materials, functions, and technologies (i.e., 3D printing, injection molding, and urethane casting).
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What problem will the medical device solve? Prototyping helps identify and define user needs, materials, form-fit-function requirements, and human factors.
- Agile/Iterative Product Development: Start early to make modifications and iterations to be flexible and leverage prototype for verification and validation.
- Material Selection: Prototyping identifies advantages and disadvantages of trying different materials to determine which to use for medical devices.
- A rapid prototype can be used for verification, if a rapid type of material can function and perform during testing and performance.
- Rapid prototyping can be used for first-run production, depending on market size. Consider low-volume vs. mass production tool due to cost and possible changes.
Related Resources:
MedTech True Quality Stories Podcast
Greenlight Guru True Quality Roadshow
Memorable Quotes From This Episode:
“We have different technologies for different levels of scale as you’re doing product development.” Greg Paulsen
“I still think there’s a lot of value in sort of crude proof-of-concept prototypes.” Jon Speer
“It is so much cheaper to find the mistake with a couple hundred dollars in prototyping vs. having to recut steele.” Greg Paulsen
“The tool doesn’t wear out, your rev does.” Greg Paulsen
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