From the perspective of the project manager facilitating the selection of a biomaterial is a crucial component to the overall success or failure of the project. The first point of contact would be with all key players on the project to set the guidelines and objectives of achieving the correct selection of biomaterials. Research the materials on the market and identify reliable and trustworthy manufacturers. Learn the integrity of the manufacture and the select biomaterial under the use of International Standard ISO 10993-1 FDA advisory recommendations and standards for biological medical devices. It is important to know if there is a new biomaterial to market and you consider using it to evaluate the data of the in-vitro, and pre-clinical testing to see the results. Doing all the grunt work of research, evaluation, and cost analysis, as well as risk assessment in the planning stage, is an investment that will yield a return instead of unforeseen costs.
The factors to consider for aiding in or delaying the project would be the cost of material, the availability of the material in the quantity you need at specific time intervals. Recently with the Covid-19 pandemic, now the war, high inflation rates, and all of the fluctuation with gas prices logistics would be a high priority factor for making the decision on selection of biomaterial. Who and where are your suppliers of biomaterials?
Reference:
Newman, J. P. (2007). Fundamental considerations for biomaterial selection - MIT. Retrieved March 9, 2022, from https://www.mit.edu/~jpnewman/doc/newman_2007_ieee-potentials.pdf
The single greatest decision on many projects is selecting a vendor to provide software or services. The methods used for soliciting, evaluating, and negotiating with vendors, however, are often not reviewed later for their impact on the eventual success of the project. This is especially the case when the decision process has not been done, which is when the results of the decisions made are most likely to result in problems during project execution. Project management and sustainability are both currently considered hot topics by managers. In fact, there is an increasing interest in developing and proving new managerial practices for project management (PM), and principles of sustainability dominate every context of business and organizational management. Therefore, the integration of these two fields represents the future for project-based organizations. Projects are influenced by the environment in which they are carried out, but they also contribute to the change of the same environment. From a sustainability perspective, the project delivery phase and the final deliverable produce impacts that could be particularly advantageous in the present but could have negative effects for many stakeholders in future scenarios. In other words, to produce the deliverables for which it was undertaken, each project uses energy and produces social, economic, and environmental impacts, which define the degree of sustainability of the project as a whole. Sustainability creates a community vision that respects the prudent use of natural resources to ensure that present generations can achieve a high degree of economic security, and can achieve democracy and popular participation in community control while preserving the integrity of the ecological system and of life. The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and profit” show the balance or harmony between economic, social, and environmental aspects. These three pillars, however, are not stable but are influenced by constant movement due to social, political, economic, and environmental pressures, which produce their effects when the pillars link together. According to Gimenez et al. and Kleindorfer et al., sustainability integrates social, environmental, and economic responsibility in order to create a rational use of present resources without compromising the ability of future generations to satisfy their needs.The link between project and sustainability, even if under-examined, is evident. Projects are based on temporary endeavors that, consuming resources, deliver beneficial objectives. Sustainability defines criteria for proper use of resources and for the evaluation of outputs in terms of economic, social, and environmental impacts. The traditional project management approach allocates and exploits these resources, seeking the optimal combination of time, cost, and quality performances, to maximize the benefits of stakeholders. This approach has proven to be very reductionist over time because it does not consider wide-ranging social and environmental issues, which are sustainability challenges. Furthermore, there is often a mismatch of evaluation between project success and project management success that limits the real integration of these sustainability issues; in fact, project success is next to the idea of effectiveness (achieved vs. targeted objectives), while project management success is next to the idea of efficiency (consumed resources vs. achieved targets). This generates some relevant trade-offs for project managers. Sustainability, as a field of study, can provide project management with new perspectives, supporting project managers in their decision-making about planning, management, and control of the resources assigned to the project, considering the economic, social, and environmental impacts of not only the project life cycle, but also the asset’s life cycle and the life cycle of the products this asset produces. The objective would be to ensure that decisions made are in the best interest of the clients, but without harming society and the environment. For this reason, a sustainable approach would be particularly well suited to major projects that consume large quantities of materials and energy, and the products which have lifelong impacts on the economy, society, and the natural environment. Project delays have a severe effect on the project financials. After all, resources are finite; no matter how abundant they are. That’s one of the stark realities of multi-project management these days. Project delays cause a whole lot of issues that may impact the timeline when the milestones are nearly achieved. The biggest issue in any number of delays is stakeholders’ disapproval. Once a project's expectations are not met, chances are that the stakeholder will tank the entire project one way or another. However, project shutdowns rarely happen. When they do, it is usually because of a high influence vs high-interest stakeholder. For instance, in government building projects where legalities are not met or the contractor isn’t able to deliver on time, the project gets delayed intermittently.
@alexia-coffer you stated, The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and profit” show the balance or harmony between economic, social, and environmental aspects. These three pillars, however, are not stable but are influenced by constant movement due to social, political, economic, and environmental pressures, which produce their effects when the pillars link together. According to Gimenez et al. and Kleindorfer et al., sustainability integrates social, environmental, and economic responsibility in order to create a rational use of present resources without compromising the ability of future generations to satisfy their needs. The link between project and sustainability, even if under-examined, is evident. With all things considered now in the world climate how are these pillars responding to the war, the pandemic, and inflation?
When working on a new project, everything needs to be just right. The types of materials used, the test that needs to be run, etc. When choosing a biomaterial for a project, it takes a lot of thought to know which one is going to be just right. Some factors to look for when choosing a biomaterial are the cost of material, sensitivity to material, and longevity of the material. Depending on if the device is being made in an academic or industrial environment drives the question for money. Knowing how much the material is going to cost per unit, or how it needs to be manufactured to be affected, hits hards in certain environments. Depending on where in the body the material is going, the sensitivity of the material to tissue/blood is also going to play a major role in how fast you can reach a deadline for the project. Lastly, the longevity of the material is tied into several aspects. If the material will not last very long in the body or with tissues it will require the device to be replaced more often or render itself useless. This also plays a role in cost-effectiveness because if the longevity is not long and needs to be replaced more often then the company is spending more money on making new devices.
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.
As a project manager I think when choosing a biomaterial to work with, we must consider the following:
1) what material will accomplish the desired outcomes most effeciently?
2) what tests will need to be done to make the device safe for human use?
3) Where in or on the body will the device be used? What anatomical structures will the device interact with?
These 3 questions will give the project manger an idea of what tests would need to be done and also give an indication about he possible timeline of the project. When deciding on a biomaterial to use in making a medical device, you want to consider the science of the body for a second. If a device will be implanted within the body one should consider if the device is only coming in contact with surrounding tissues or if the device will be used arterially and be within a high pressure environment. Knowing the location of the device and what it interacts with will also help in deciding the best material to use. A material that is brittle or less inert would not be a good option for a dental implant because of the high level of forces and grinding teeth experience daily. Choosing the proper biomaterial will allow for the the project manager to create a more successful device
@shavondraleak HI Shavondra! I thought your post posed great suggestions as to what a project manager should consider when choosing a biomaterial. I didn't think about the aspect of costs as it pertained to choosing a biomaterial. As a project manager you do have to consider the budget that is established for the project. Although it would be nice to get the top of the line material for a medical device sometimes the budget doesn't allow for that. I think that deciding on what biomaterial to use, considering costs, that would make the job of the project manager a bit tricky. If a material needed may surpass the budget guidelines, should a project manager make adjustment elsewhere to accommodate for the budget? Or if it is known that a specific material works that best, should the project manager suggests an increase in the budget to the higher ups?
@lmathis having insight when it comes to choosing a medical device for biomaterial selection is suppose too compliment and give the individual the best outcomes when it comes to getting good results and improve the overall quality of life. The best selection of biomaterial comes to the biocompatibility of the medical device and the purpose it serves for the patient. For example, a person decides to get dental implants. It has to be evaluated of the medical device's biocompatibility according to the ISO 10993. Most importantly the implants need to be compatible that it will not reject the body of foreign objects.
As a project manager, I would want to ensure that the biomaterial selected for a project is compatible with the intended use of the device be it an implanted device or a surface device as well as the longevity of the device. These factors are important because they will help ensure I am following the standards and regulations set for medical devices. Choosing the wrong biomaterial could result in legal issues where the company experiences class action lawsuits against the device due to the device causing harm to consumers. Choosing the wrong biomaterial would certainly delay the project. Manufacturing must stop and the design of the device must be reassessed, an extended time to find other vendors and establish contracts occurs. Fixing an error such as choosing the wrong biomaterial is not only harmful to the consumer but costly to the company because as time is spent trying to correct the issue, more money is being spent as well.
Choosing a biomaterial for a medical device heavily affects the project management. A biomaterial can affect the schedule and timeline of a project. When will the biomaterial be available? How long will it take to obtain biomaterial? Affects on risk management include the biomaterial not being biocompatible in the device or the body. Another huge effect that biomaterials can have on a project is cost. How much of the biomaterial will be needed and how much is it projected to cost?
Choosing a biomaterial can affect a project by its biocompatibility to the human body. Suppose a company sold for hip replacement devices that was not biocompatible because it was made a polymer material. Once a test reveals that is in not biocompatible, it could delay or stop a project to replace the biomaterial. if the polymer hip replacement device is biocompatible, then you can move forward with your project.
Suppose we are designing a biomechanical implant or device. and when choosing materials, let's use two different materials and these materials should meet the required properties. In this case, the first thing I will look at will be the price of the material. I prefer the cheaper one. but we have to examine other conditions, not just in terms of price. Let's say we chose the material because it is cheap, we should pay attention to the easy availability of the material. If the material is easily available, this is an advantage for us. If there will be a procurement process that will disrupt the project, we should focus on other materials, even if they are expensive. Another factor is the usability of the material. this is about budget and production time. The material may be inexpensive, but the material may need to be processed, resulting in additional costs and time consuming. In this case, we can decide to return to the expensive material. As a result, if the materials meet the sufficient conditions, I first look at the price of the material and evaluate the conditions.
Choosing different materials for the product would affect a lot in the planning stage. I met this problem when I needed to choose the material for electrospinning for our project. We want this product to become an alternative method for healing the outer wound by covering the skin, and we want severe inflammation happens. Therefore, we need to choose polymers and solvents carefully. Considering most solvents for polymers are toxic to cells. Choosing the material and solvent for the experiment took more time than we expected because the different properties of the polymer(different polarity) require different solvents to dissolve. Since the composition of our new polymers is new, there is no previous example we could use in our experiment. It delayed our schedule to ensure all cytotoxic and solvent volatilization tests were safe for humans.
Determining a material's biocompatibility can heavily impact the success of your product. The type of material being used under the tissue is also a determining factor. If something is capable of residing within the environment it is applied, there also has to be no damaging effects to the surrounding area. In the case of implanting a hip replacement, depending on the patient's activity, I would choose one material over the other based on biocompatibility and likelihood of fracture. If one's younger and more mobile, I would choose steel or titanium alloy for the stem with UMMWPE within the acetabular cup as the material would be more resistant to the internal forces made with their movement. For the older generation, I would choose ceramic with UMMWPE within the acetabular cup as they would have lower mobility and therefore are less likely to fracture the material within. Because of those considerations, I believe the project's development would proceed without delay depending on the funding.
There are numerous factors that could influence one's decision behind selecting a biomaterial to use and really the answer to this question depends on the application. First and foremost, it is important to choose a material that will meet ones' user needs/application requirements such as biocompatibility, lifespan, or specific chemical (i.e. polarity) and physical (i.e. young's modulus) properties. Additional considerations which procurement and management may be more interested in include cost of the material, contracts with existing vendors, manufacturability, accessibility, as well as ease of storage and handling.
The selection of a biomaterial is crucial for medical device project management. Some factors to consider when selecting a biomaterial are cost, biocompatibility, and accessibility just to name a few. With cost, we have to keep in mind the upfront cost of a purchase and the materials' life cycle costs. With bio compatibility, we have to measure and test how well the device will function and be progressive for users and researchers. Through accessibility we can measure the prolonged delivery times result in project delays. In general, it is crucial to ensure that the biomaterial's biocompatibility is constant as the project progresses through its various phases when choosing a biomaterial for any medical device.
