3Degrees Company Founder Mike Vasquez asked Bold Type President Jose Bohorquez on the role of 3D printing in medical device product development.
Of course, Jose said he considers 3D printing a valuable part of the product development process.
Jose, paraphrased: We’re big believers in getting user feedback as early in the process as possible. There is no better way to understand how the customer is going to interact with the product and to predict what usability challenges or mechanical risks may arise. A 3D printed model allows us to visualize how the customer will use the device and limits the potential for unexpected issues to come up later in the development process, both of which can prevent the launch of a product that customers don’t like using.
3D printing also helps inform your manufacturing process.
Make sure everything fits together first.
Anyone who’s ever taken a product to volume production knows tooling can be a very time-consuming and expensive process, and you really don’t want to identify design mistakes at that point. With 3D printing, you can be sure all components fit together as intended before moving to the production phase, eliminating the need for costly redesign and retooling – and delays in your product launch plans.
Create inexpensive molded parts.
The other scenario where 3D printing can have a powerful impact is in creating inexpensive molded parts. By using 3D printing instead of injection molding and expensive molds, you can cast urethanes or silicones more quickly and efficiently. This produces less expensive parts identical to final production parts. You can complete user testing and clinical trials and fit testing and everything else much more accurately than in the past.
Mitigate risk.
There are also some regulatory benefits to using a 3D printed prototype. FDA expects to see documentation of good design controls and complete risk assessments as part of your 510k submission. 3D printing makes it possible to take early user feedback, usability studies, fit testing and more that will help you create a risk mitigation strategy fully in compliance with FDA requirements.
3D at Bold Type
Yes, in developing wireless connected medical devices from proof-of-concept prototypes to hardware, software, mechanical housings, and embedded firmware, we can create a 3D printed model of your design concept. There are so many reasons why it makes sense for us – and for you.
If you don’t think 3D printing is a valuable part of the product development cycle, you risk costly errors and launch delays – and we should talk. Bold Type™