From a project management standpoint, one factor I would look for in a biomaterial is how outdated the material is. Although previous posts have mentioned that using new biomaterials may be risky, I think the opposite side of the spectrum is also risky, in which an outdated biomaterial is used. If an outdated biomaterial is used, not only may it be difficult to obtain, but the market demand for it isn't so high. Therefore, in the biomaterials selection process, one needs to carefully assess the need for the specific biomaterial and which biomaterials have replaced it in terms of popularity or effectiveness. The project may not be of much use if the literature search on biomaterials is only focused on the early developments and not the later developments. The project manager would likely face difficulties in getting the project approved if the biomaterial isn't appealing to the market.
An example of this can be seen in the development of contact lens, in which the use of acrylic glass in contact lenses used to be popular, but now, most contact lenses use hydrogels for greater comfort. The hydrogel material is more widely used, so it wouldn't make sense to choose the more outdated biomaterial in creating contact lenses.
All what have been said make a good points, but for me when talking about project management stand point, the most important part is money, time, and same specs. we all agree that Biomaterials must be compatible with the human body and to be the right choice to do what is intended to do, but from management stand point they will look at the availability of that materials, who the vendors are, how much time they need to deliver the amount needed, does the material they offer go with the specs we need, and getting at least 2 other vendors if anything went wrong with the main one who offers the same material.
The two topics of project management and pre-clinical research are actually pretty closely related depending on the project itself. In the scenario you gave us, you asked how important pre-clinical research is in delaying or helping a project along. Let's say the project that is being worked on is a hip replacement. If there is no pre-clinical research and the biomaterial chosen cobalt and chromium. You will find that you will run into a whole lot of trouble. Since no research was done, the scientist/researchers would have no idea that long term exposure to cobalt in the body will lead to metallosis, or metal poisoning. This will significantly delay the progression of this project. On the other hand, if research was done, the researchers would know about the risk of metallosis caused by cobalt and chromium and choose a more stable biomaterial such as titanium.
There is a lot of rules and pressure that comes with choosing one biomaterial over another. A Project manager should consider many aspects while choosing the right biomaterial for the specific case. A human body is very complex, so introducing a material that is going to "live" in the body and interact with bodily functions is a risk that should be well studied and prepared for. One factor that comes into play while choosing the right biomaterial is the human body compatibility. A biomaterial can be long lasting and compatible in some cases of the body and not the others. For instance, a biomaterial used for the heart is completely different from a biomaterial used for the bones. The material in both cases differs in all aspects. So, choosing the right material depends on the situation in the body. Furthermore, prior body testing is required to ensure that the material is compatible with the body it is being used on because each body reacts differently. Project managers should know the risks associated with using the biomaterial and if it is degradable or not. These aspects are necessary for having a smooth and effective project that leads to successful results. If time and money is spent on a project that made errors in deciding for the accurate biomaterial could be a great loss for the company. Therefore, following all the regulations and aspects that go with the body function, money, time and risks associated with the project, creates a successful and effective choice of biomaterial for the project.
From a project management standpoint, one factor I would look for in a biomaterial is how outdated the material is. Although previous posts have mentioned that using new biomaterials may be risky, I think the opposite side of the spectrum is also risky, in which an outdated biomaterial is used. If an outdated biomaterial is used, not only may it be difficult to obtain, but the market demand for it isn't so high. Therefore, in the biomaterials selection process, one needs to carefully assess the need for the specific biomaterial and which biomaterials have replaced it in terms of popularity or effectiveness. The project may not be of much use if the literature search on biomaterials is only focused on the early developments and not the later developments. The project manager would likely face difficulties in getting the project approved if the biomaterial isn't appealing to the market.
An example of this can be seen in the development of contact lens, in which the use of acrylic glass in contact lenses used to be popular, but now, most contact lenses use hydrogels for greater comfort. The hydrogel material is more widely used, so it wouldn't make sense to choose the more outdated biomaterial in creating contact lenses.
I think there is one more thing to consider in terms of using outdated biomaterial versus brand new ones. Yes, outdated logically mean inferior, but some outdated biomaterials in our time are still superior to some newly developed ones. The simplest example of this would make the fillings for cavities. Let's talk about two different types of them. To put it simply, the oldest one is the grey colored one, and the other one is the white-colored one, which resembles to be real when you are smiling, etc. In my knowledge, the oldest one, which is the gray-colored one, is still the best one in terms of function. I am not saying that white-colored ones always leads to trouble. I have a filling in white, but It needs to be administered from a talented dentist, and not only that, but the material must be a high-quality one. Unfortuinently, not all dentist offices are using high-quality material. Still, since its FDA approved and technically, it is legal to do so, and almost no patient will ever check the material used within their mouths. To sum up, finding new biomaterials is essential, especially in terms of companies making some money, but the point is that just because it is new, it doesn't mean it is superior.
Biomaterial selection must be given careful consideration when it comes to project management. Like others have said, the material one selects could affect the cost and/or the schedule. I believe that this part must be thoroughly thought out very early in the project management process. When it comes to project management, I have experienced some of the difficulties and aspects of having to incorporate material selection. In the actual schedule, you must include testing of different materials and these testing could take some time depending on how many materials are being tested. More than this, materials are not necessarily cheap and can add to the overall cost of a project. In my personal situation, we had researched the use of titanium at one point but could not move forward as it could not be afforded and machined as needed with our budget and resources. Furthermore, this is just for material selection. With biomaterials, more testing, such as some of the biocompatibility testing discussed in the lectures, could be necessary. Therefore, it is important to consider biomaterial selection early on and plan for it as it can have major effects on the cost and schedule of a project.
There are obvious factors that will dictate which biomaterial we choose for out medical device, like biocompatibility, tissue mimicry, low toxicity, and other. However, I think the factor that would have an impact on the smoothness of the project would depend on how much research and literature is already done on a material. Has the material been used for a similar device or function, are there related occurrences that support or negatively impact the material. I think the answers to the questions listed would make the study portion of the device development more cumbersome for the project manager; ultimately, there may be more studies that need to be done or further research to establish the material as biocompatible and safe. In addition, if the material is newer, there will be more stringent legality and regulatory factors that the project manager has to think about. How will the FDA or ISO take the new material being used. On the other hand, if one is using a well established material, then the process would be smoother.
Up until now we have talked about two big topics: project management and pre-clinical research. There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk about how your biomaterial selection might affect your project from a project management standpoint.
Think about that for a minute. How would choosing one biomaterial over another affect how smoothly (or not) your project goes?
Give us your reasoning on what factors you would look for in a biomaterial and what those factors can do for helping or delaying a project.
Aside from the cost, lead time, suitability, and sustainability of a material, it is very important for it to be workable. Using a material that is difficult to work with could cause flaws in manufacturing and in turn extensive scraps. When selecting a material it's important to consider how easily you can work with the material. Here's a bit of a wild example, and highly improbable: using glass to manufacture catheters, among a million other reasons, is a bad idea because it's highly likely to break even before it makes it into its packaging.
If you select polymers then you will certainly need implantation, genotoxicity, system toxicity, irritation, sensitization, and cytotoxicity test. Test like these are provided by many companies, and the delivery time can vary. Therefore, as the project manager you have to plan accordingly so that your project is not held up on the account of a contractor. Your contractors may also need raw material. This needs to be taken into account.
If I were involved with a medical device development project, biomaterial selection would be important. Choosing the right biomaterial is important for project success. Biomaterial selection involves a number of tests to ensure safety for the end users. Depending on the application, biomaterial best suited for a specific project should be determined by ability to pass the litany of tests that would be mandated under ISO. Other factors to consider would be availability, accessibility, and cost. All these factors would play an important role in project cost, deadlines, and ultimately project success. It is extremely important to identify and secure the correct biomaterial for any given medical device project.
Up until now we have talked about two big topics: project management and pre-clinical research. There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk about how your biomaterial selection might affect your project from a project management standpoint.
Think about that for a minute. How would choosing one biomaterial over another affect how smoothly (or not) your project goes?
Give us your reasoning on what factors you would look for in a biomaterial and what those factors can do for helping or delaying a project.
During the selection of biomaterials for a medical device it is important that ISO regulatory guidelines are followed in ISO regulation 10993. Specifically, the part which references the selection and comparison between different biomaterials detailing why a selection for one should be chosen over others, is shown in part 1 of ISO 10993. In the instance in which perhaps the wrong material was chosen in the biomaterial selection process despite prior research stating that the material should be fine, then major setbacks can occur. Depending how far along the development cycle the device has gone, the amount of time, money, and resources lost will vary. Ultimately, this will cause project management of the device to become heavily impacted. If there is a certain date which the product must be rolled out or a budget which needs to be followed, then both these aspects of the project will have to be reevaluated and if it is severe enough, it may even shut down the entire project itself. Therefore, it is always beneficial for the sake of the science behind the device, and the management of the project for things to be thorough.
Putting in the due diligence when determining your material selection is key for any project, but it is especially so when you're interfacing it with the human body. Biomaterials not only need to have favorable mechanical properties, but they must also contribute to the desired function of the device. External or surface-level devices may be less dire than implantable devices, but nonetheless, if a biomaterial does not respond well, it could be incredibly harmful.
Mechanical properties must be determined for a biomaterial and compared to the tissue that it will interface with. At the very least, material data must be found on both the tissue and biomaterial to predict how they will react physically with each other. Biomaterials can show similar mechanical behavior with tissue but may not be biocompatible, which is why a significant amount of testing is involved to determine this as well. Manufacturability of the biomaterial must also be determined if you plan on mass producing the product you're developing.
From a project management standpoint, it is important for the biomaterial to react accordingly but also be feasible to produce and manufacture. This can take an extensive amount of time in the initial stages of a project, but it is a crucial step to take no matter how invasive the device is.
Choosing a biomaterial is crucial to the entire experiment and plays a role in the timeline for management. Factors that could effect overall is how long will the process be to make the material, research if the material will be accepted or rejected by the body, conduct research on how the material behaves long time, mechanical testings, and more.
If a ceramic (specifically porcelain) for a tooth implant is being chosen for instance, the process to make a ceramic is lengthy, and involves engineers who have experience in working with a more delicate material. Also the engineers need to understand how to combine not only one, but to materials together. They need to find a balance amongst both materials, and see why choosing the screw to go into the bone, rather than only a ceramic tooth is best. If they were only to focus on the ceramic as being a tooth and also what mends the tooth to the jaw, the tooth would not be able to hold into the jaw, potentially break, and cause damage.
Same goes for if they tried making a metal tooth, it would hold, but destroy the other teeth around because it is too hard. In this case, the researchers would need to choose both materials meticulously over others to use, and also would have to make a timeline of how the porcelain needs to be made, then the screw, then putting them together, running tests, and more. If a screw wasn’t ready or failed tests it would put bath the project, or vice versa if the porcelain wasn’t ready, it would effect the entirety of the project. The Porcelain ceramic and the metal would firstly have to be biocompatible to the body, work with each other (when put together), and additionally pass a frequency of mechanical tests. Tests would have to be done to see if the screw and bone function well, allowing bone and cell growth, along with if the ceramic tooth doesn’t break or decay. Additionally, if all was successful but too expensive, alternative approaches would have to be made, but not cutting so many corners that the research is invalid.
The choice of the material can affect the duration and cost of the device in terms of regulation. Choosing a new biomaterial that was not used before will increase the testing duration for the biomaterial to test its compatibility with the body and for the whole system to test its success in providing the desired results.
The choice of the biomaterial can change the classification of the medical device and make it harder to get it approved by the FDA. For instance, A medical device can be classified as Class III instead of Class II because of the choice of material. If the biomaterial was not used before in a similar medial device that will require additional testing to satisfy the FDA requirements
Selecting the right material for a project is crucial from a project management standpoint to prevent project delays later on. In this week’s lecture, Dr. Simon discussed how biocompatibility varies depending on what part of the body your device is interacting with. One of the principles of ISO 10993-1 states that selection and evaluation of materials/device requires structured plan of assessment. Using this principle and structured assessment to select the right biomaterial helps prevent unexpected pitfalls to surface during testing or other stages of the project development. Furthermore, it is important to weigh the pros and cons of the different materials, historical clinical data, and existing toxicological or bio safety data on the materials. By studying historical data, the researcher can identify what has worked and what has not worked in the past. From a project management standpoint this saves a lot of time. Another factor I would consider when looking for a biomaterial are ASTM standards and mechanical modulus of materials. I would select a material with a similar mechanical modulus to the tissue or bone that the medical device is being engineered for. Studying these different factors and doing sufficient research early on could prevent wasted time that could result from performing incorrect tests.
