One part of pre-clinical work that really interests me is biocompatibility. A device might be well-designed and mechanically strong, but if the body reacts badly to the material, the device will fail. Pre-clinical studies are the first place researchers can see how the body actually responds to a new material.
I think this raises an important question about material choice. Companies could stick to proven “safe” materials to lower the chance of problems, but that might limit innovation. On the other hand, using new materials could create devices with significantly better performance. Still, it also means taking greater risks and relying on pre-clinical studies to identify any potential issues.
What do you think is the smarter approach: designing with safer, well-known materials from the start, or taking risks with new materials to push innovation forward?
I think pushing forward with development is crucial for any kind of research and innovation. However, a balance between safety and innovation must be found. Pre-clinical research exists for a reason, and this pre-clinical research can allow for new materials to be tested. Research after developing the product will allow for new technologies and materials to be checked. Ensuring patients who undergo this study understand the possible risks and are extremely well-informed of every aspect of the study that they need to ethically know is crucial to allow for innovation to happen safely. Thus, I think there is no "smarter" approach per se, but there are two different approaches that can be implemented based on the situation and the patient. The safer approach can be used for patients who do not want to participate in new innovation studies, and patients who are eligible for the study can be treated with the innovative approaches.
Ensuring the pre-clinical research is thorough is key to patient safety and definitely should be used for both approaches. In 2010, Johnson & Johnson had to recall their hip implants (the DePuy ASR XL Acetabular System hip implant and the DePuy ASR Hip Resurfacing System) globally because they were failing from metal-on-metal friction that released particles into the bloodstream. This led patients to need revision surgery. This happened relatively recently, but there have been many advancements in technology since 2010 that allow for safer product release. What do you think about the current regulations regarding testing innovative materials? Do you think there needs to be any changes to allow for faster implementation of new materials?
Link to Article: https://www.nytimes.com/2010/08/27/business/27hip.html#:~:text=Aug.,the%20F.D.A .'s%20concerns.)
Citation:
The New York Times, "Johnson & Johnson Recalls Hip Implant, Citing Risks," published August 26, 2010.
The choice between novel and tested materials ultimately comes down to balancing the benefits versus the risks a company is willing to take to gain from a market. Materials that are already proven are most likely mass-produced in some capacity, so having a stable supply of material with alternative vendors is almost guaranteed. For projects on the market, this is critical. For new device development, working with established materials can make the regulatory process more straight-forward, reducing costs and time. Novel materials can be a "money pit" in a way that the development costs can be immense. If the material turns out to fail in regulatory, companies might not be able to handle the financial cost associated with it. It comes down to the company to choose which path is the best for them based on long-term goals. Innovation for novel materials takes a significant amount of time. As mentioned, a lot of time is spent on regulatory work for novel materials. I believe that this process shouldn't be rushed, especially for materials designed to be used within the body. Corner cutting can lead to recalls and loss in credibility, which can be detrimental for a company.
