The Use of Prototyping to Shorten Medical Device Product Development
A mentor of mine, Russ Gray, often says: “If a picture is worth a thousand words, a prototype is worth a thousand pictures.” I don’t know if he coined this phrase, but I give him credit. Very poignant.
Early on in my career as a product development engineer at Cook Medical, I understood the value of prototyping to communicate my thoughts and ideas. I usually tried to piece together off-the-shelf components and sometimes resorted to machining. I’ll never forget the “wow” experience I had when I held my first SLA prototypes. I was able to use the SLAs to “build” a looks-like product. When I handed this to my marketing counterpart, he was ready to go to the market. So, yes, prototypes can be helpful and sometimes dangerous.
MedicalDeviceLink recently posted an article “Comparing Prototype Techniques“.
“An estimated 80% of a medical device manufacturer’s profits come from products released within the last five years. Therefore accelerated product development timelines are central to profitability. A good prototyping strategy can save OEMs significant cost and time in the design of medical devices.’
Prototypes are invaluable for communication. The sooner you can figure out what the product will look like and how it will function, the better. It’s well-known and documented that design changes are significantly greater during later stages of product development.
Here is a table from the article about some different types of prototypes:
The table below gives some indication of costs and lead times for prototypes:
Posted in All, Product Development - General
February 25th, 2009 at 10:40 am
Something we have seen at Catalyst is that the SLA sample is being used as the initial assembly model to test the fit and basic function of the engineering design. Then to save time in the schedule our customers are bypassing the other prototype options and building rapid tools using our STAT or SPRInT processes.
This provides them access to 25 - 500 short-run production parts within 4-6 weeks (one tool was completed in 4 days). Since the parts are made in the correct plastic they can be used for validation, approvals or surgical trials.
We recently heard of a story where a new tumor removal device we were making was so successful in its early trials that we had to rush short-run production of 500 parts so they could build up other test devices to be used immediately because it was saving lives.
The rapid tooling options also allow for faster and lower cost engineering changes, saving additional time and budget. The SPRInT tools are capable of making tens of thousands of parts and can help bridge production while the expensive production tooling is being constructed and debugged.
February 25th, 2009 at 6:29 pm
Ryan,
Thanks for sharing your prototype experiences. As you’ve found, the goal is to get through the design process and to production quality as soon as possible.
Take care,
j