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.

I agree with the points mentioned above about why it is financially safer, since using materials already in the market have a stable supply, reduces costs and times, and prevents financial downfall in the future. However, I think it is still important to sometimes take risks with new materials which can allow future researchers and engineers to have more material options when designing future devices. An example I think of is dental implants, which can have a range of materials, such as titanium, alumina, ceramic, etc. All of these materials offer different advantages and disadvantages in areas such as aesthetics, durability, properties in certain applications, biocompatibility, etc. If researchers decided to just stick to one material to be safe, such as titanium, then innovations such as using alumina for dental implants for its biocompatibility and durability would have never been done. Having a wider range of materials available allows engineers to chose the material that best fits their customer needs and requirements instead of relying on one material that might have many limitations. Also customers can have more options to pick from based on their needs. So even if a new material cannot be used immediately in a new device, research should be done to allow more options for that device in the future and allow more advancements.

I agree that we need to innovate‚ but I do not therefore agree that we should shorten the testing process to get new materials to patients more quickly․ A better way forward is a more risk-based and efficient testing process․Pre-clinical testing before subjecting a medical device to human trials can help assess biological risks using laboratory tests and materials evaluations․ The FDA‚ however‚ focuses on the completed device and its preparation and processing‚ not simply whether a particular material has previously been judged "safe․" Are all new materials subject to increased scrutiny? Or‚ does it depend on the duration and location of contact with the body? When a new device contains a new material that is similar to an existing material with a good safety record‚ are manufacturers allowed to rely more on existing data?Supporting existing evidence where appropriate is important‚ but new materials should still be analyzed for manufacturing‚ sterilization‚ degradation‚ and body contact to avoid stifling innovation without compromising patient safety․

I feel that there should be a healthy balance as to knowing when to apply either methods of playing it safe or being risky. When I say this I do agree that companies to stay competitive have to be willing to be innovative and pushing to have the most cutting edge devices to market. The cost of being risky should be a reflection of the companies ability to sustain such research and regulations. Many times it is much more predictable to apply safer methods that have been reproduced and accepted through the FDA one to know how to navigate the landscape and have more definitive and predictable results and reel in investors. As discussed in the module this week on biocompatibility and how big its role is with product development we saw that chronic inflammation and integrity when implants are installed are some of the biggest barriers in design. The risk for trying new materials definitely needs ample research and tests to ensure its safety and compatibility so that a company is certain they didn't cut corners and provided a material that is on par or better with the current standards for designated devices. I sure we all can agree that a design as great or innovative as can be without providing a proper immune response is not worth risking patients well being.

Posted by: @atmeh-njit

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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?

When determining whether a company should use an established material or risk using a new one, there are some questions a developer or manager must consider. These questions may include but are not limited to the following:

• How does our device plan to improve on other similar devices (if applicable) ?
  • The project team may be able to achieve this scope without deviating from established biomaterials
• How well do the industry-standard biomaterials for this application perform with the device?
  • If it ain't broke ...
• Are there any biomaterials that have promising pre-clinical research results, that indicate it would helpful for the devices application?
  • It's easier to build off of existing research than start from scratch

For the most part industry research is usually dictated by the budget and time allotted. If there is no reason to pick a new material, then it's probably a bad idea for your project to spend some of the limited time and money you have to developing a new one. However, that does not mean there is never an instance where incorporating a new material into the device is appropriate. When it happens, it is likely an incremental change made to an existing biomaterial, to change a single or small handful of characteristics of that material to increase biocompatibility. In the end an engineering decision like this is a business decision in disguise, and the decision that keeps existing processes and logistics is often the cheaper and more digestible for executives.

When it comes to taking risks, it's about a 50/50 chance of success. Companies can stick to the materials they know are safe, which keeps the business running, just not as fast as it could go if they took more risks. A new material has a lot of uncertainty and is not guaranteed to make them money. I think it depends on the company, what the material is, and whether the new material actually saves them money or makes the device work better. Most companies won't take a big risk unless there's something in it for them, especially since a bad material can lead to lawsuits and hurt their name. I also don't think it has to be one or the other. A lot of devices use a material like titanium that already has years of safety data, and only change the coating on the surface. That way the testing only has to focus on the new part instead of the whole device.

The smarter approach really depends on the overall goal of the company. If the company has made a product that is reliable and successful they should continue using the same materials and production process. As the saying goes, there is no need to fix something that isn’t broken. For a company to start exploring new materials it will cost them time, money, and effort that they may not have or want to waste. On the other hand, if it’s a company just getting into a field they would really have to weigh their options. Taking risks with a new material can give them a competitive edge in a potentially oversaturated market, but it will be a far more laborious undertaking. The company would have to undergo rigorous preclinical and clinical testing to determine the capabilities and potential risks of the new material. Using well-established materials makes the company's job much easier by giving them a framework of how the materials work and would interact. Personally, I feel like a company in a time crunch or with limited resources should go the “safe” route while a company with more flexibility could dedicate some of their resources to investigating the use of new materials. Another option could be for the company to work on other projects while also collaborating with a university research lab that can do the labor-intensive work of testing the material on in-vitro and in-vivo models. 

Medical device development has a lot of steps and requirements, and I think each phase is important for making sure the final device is safe to use. I didn’t realize how many different parts of the process have to be considered, from the first idea all the way to monitoring the device after it is already on the market. I also think the preclinical stage is especially important because it gives the developers a chance to find problems before the device is used by patients. Testing the device and making sure it works the way it is supposed to can help prevent bigger problems later in the process. I found it interesting that organizations like NAMSA can support companies with different types of preclinical research. Medical devices can be very different depending on what part of the body they are being used for, so I can see why having experience with different areas would be helpful. Overall, I think the development process may take a lot of time, but each step has a purpose in making sure the device is safe and effective before it reaches patients.