You bring up a crucial fact that I’ve learned at length about through courses and practical experience. I’ve learned that catching issues early in a process saves a lot of time and money. More importantly, it keeps risks lower than they would be if corners were cut during research and development, preventing further intervention that could make things more complicated and costly.

Here’s a recent example regarding model simulation versus physical testing. For one of my CAD courses, I was tasked with creating a prototype to present to the class at the end of the semester. This included designing, testing, and fabricating the prototype. My group decided to create a novel arm exoskeleton that would support a recovering patient’s arm while also providing additional strength through linear actuators. To test the strength of the material, we conducted a finite element simulation in SolidWorks, applying a point load to the joints between different segments of the assembly. We noticed that the original design would have been too weak, and printing it would’ve delayed us from our deadline. We redesigned the component, and it passed our criteria. However, the printed prototype was slightly weaker than the simulated version, mostly due to material artifacts affecting its integrity.

Lesson learned: Physical studies provide a realistic way to confirm or deny a hypothesis, while simulations are cost-effective and mostly accurate, but are highly generalized without external environmental factors. The same could be said about animal studies; while expensive and time-consuming in the short run, they provide physiological evidence that reduces human risk in the long run. Computer models might give a general idea of a product’s potential performance, but they too cannot reflect environmental responses the way physical experiments can.

I agree with both of you that pre-clinical research protects patients and eventually saves time and money, but I believe that their credibility-building value is also crucial. Without strong pre-clinical data, regulators, physicians, and even investors won't proceed with a project, thus trust is just as important at this stage as safety.

The ethical balance is an additional important aspect. Although research on animals provides physiological insights, they also create ethical questions. Because of this, there is a rising movement toward hybrid approaches, which use lab models to refine ideas before moving onto animal research. This could reduce costs and animal use while still generating the kind of physiological data regulators expect. Do you think these new technologies will eventually make animal studies less central, or just serve as complementary tools?

I agree, preclinical research is crucial in making sure the safety before going through human trials. This is especially true for medical devices that could be a serious threat if something goes wrong. I do believe that animal testing has been doing well I do think it is important to integrate new approaches due to ethical concerns and keeping up with a quickly developing world. I believe these new methods can provide faster results at times and predict human responses better. I do not think animal testing can be eliminated yet but I think new methods should be integrated.

I agree with you that without animal studies or other experiments, human testing would be too risky. To answer your question, I think companies should work toward a balance between the two approaches of animal testing and lab models/computer simulations. Animal testing has been the standard for many decades and can provide valuable information about how a medical device interacts with living tissues. However, animal studies may not always perfectly predict human responses, and they raise ethical concerns. On the other hand, lab models and computer simulations are becoming increasingly advanced and can sometimes offer faster, safer, and more cost-effective information. Computer models are however only as good as the assumptions and algorithms of the model and thus have limitations.

I think that companies should continue using animal studies where necessary but use computer alternatives as a complementary role. Over time, as simulations become more reliable, they could significantly reduce the need for animal studies, leading to more efficient, ethical, and cheaper pre-clinical research.

I think companies should focus on developing lab models and simulations on most projects. I can be a sucker for animals, but I do understand that it is necessary sometimes. Developing lab models can lead to a more predictable and standardized plan for future development. For instance, an organ on a chip is a relatively new development that could be a better alternative in the future to analyzing diseases and ailments versus animal testing. The models not only reduce the ethical aspect and concerns of animal studies, but they can be tailored to mimic our own human biology/anatomy a lot more closely. This could lead to even more reliable results and predictability when developing treatments for others.

With that said, animal testing still plays a crucial role in identifying risks that said lab models might not be able to show, especially when analyzing a whole body interaction.

I agree that labs need to be highly test oriented. Ive learned that even the slightest change in process could completely change the results of the tested product. One of the key factors I forget time and time again is that the real world is much less perfect than the ideal theoretical world highlighting the necessity to test in animals before introduction into a human test subject.

By nature, developing medical solutions from person to person is a risky path. Medications are highly volatile, especially if you consider how different one person is to the next. We can look in history at thalidomide, a drug notorious for its negative side effects in woman specifically in week 3-5 of pregnancy. While the developers of this drug did do their testing, they clearly weren't thorough enough which lead to a disaster. 

The point of this anecdote is to show that even though cruel, thorough testing of anything medical needs to happen on animals before real human interaction with a drug to find even the tiniest or nuanced flaw in the product.

I do agree with the next step for pre-clinical research before testing on humans is the substitution of animal testing with computer simulations, but in reality I don't think this will be happening any time in the near future (hopefully I'm wrong). One reason why I think this is immunological responses may not be able to be fully predicted yet with computer simulations. Software is pretty good with predicting the mechanical stresses a device can face in the body, and chemical interactions can be well predicted if most interacting species are known. With the immune system, I don't believe it is fully feasible to have a computer simulate all the possible reactions that can occur. Different organisms can have slightly different immunological responses. Regulatory is a big part of why this tech may not be ready. Convincing the FDA that a pure computer simulation is as effective as an animal test seems really unreasonable at this point in time, and even in the near future. As organ-on-a-chip develops, maybe these issues will resolve themselves. Computer simulations could be used to optimize a model for animal testing though. This can reduce the amount of animals needed for testing which is more ethical than pure animal testing.

I agree that pre-clinical research is a critical safety checkpoint in medical device development as I am sure most would. Using human subjects to immediately test something new without immense knowledge on the consequences of those actions is what we primarily see in movies today to bring light to monsters in our world that have done so in the past. As I have said in another post, animal studies have historically been a cornerstone in technological developments primarily in medical devices and we just don't have the technology to completely rid them from the pursuit of scientific advancements yet. However, companies should not stop to continue improving lab models and computer simulations so that one day we can leave the animals alone. With the current state of animal testing and simulations to obtain useful data, there should be a blend. Corners should not be cut in this field and consequences on the well being of animal subjects should be heavily considered at all times. I am curious if we will ever rid animals in our testings though or at least our near future.