In a recent blog, we discussed the benefits of rapid prototyping with on-site 3D printing and machining capabilities. The same “need for speed” applies to pre-clinical modeling and bench testing.
Rapid prototype iterations save time only if each can be quickly tested and verified (or not). The prototyping team should be working closely with the bench testing team to keep the cycle of design/create/test/verify moving as quickly as possible.
The first step to speeding up bench testing is the development of a clinically relevant anatomical model that can be used for prototype testing. Be sure your R&D team has deep experience with pre-clinical research so device performance and safety can be solidly proven prior to clinical trials.
In this pre-clinical testing phase, if clinical conditions and relevant anatomy is not accurately replicated, it is easy to create false positives or negatives when testing the prototypes. As you can imagine, bringing a product to design freeze based on false information is going to cost not only money but valuable time.
Your R&D team should understand how to recreate patient anatomy using 3D CAD technology. From there, experienced medical device development engineers must understand which modeling materials will most accurately represent the type of tissue they are trying to model. Technicians should have experience with casting and injection molding of accurate anatomical models. Often this work is outsourced, but your results will be better (and faster) with on-site development by experienced engineers and technicians.
It’s not simply the device/therapy delivery that must be replicated, but the access. Is the device or therapy being delivered to the heart, kidney, lungs, etc.? How will the device access the appropriate internal organ or area of the anatomy? Is a therapy being delivered, or is it a device that will be extracted after use or implanted long term? All of these are critical questions for accurately replicating clinical conditions. Without the precision of a well-developed bench test, you will not be evaluating your prototypes accurately.
Parallel development of pre-clinical modeling saves time and money. The project plan should include early development of the anatomical model, so it is ready to go as the first prototypes are completed and ready for testing. The speed of prototyping and accuracy of pre-clinical testing will keep your development moving at a rapid pace.
An excellent pre-clinical bench top modeling plan can also minimize, or even replace, animal testing. With accurate pre-clinical models using the right materials, a product can be proven safe and quickly brought to verification without costly and time-consuming lab research.
When you are ready to put your medical device development on hyper-speed, REV.1 Engineering is ready to step in as your full service, 2x Faster R&D team. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at info@rev1engineering.com.