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Discussion Topic: Biomaterial Selection

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 Josh
(@orleron)
Posts: 95
Trusted Member Admin
Topic starter
 

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.

Spiral Medical Development
www.spiralmeddev.com

 
Posted : 08/07/2019 8:41 pm
(@jonyekwere)
Posts: 27
Eminent Member
 

If I were managing a medical device project that focused on the delivery of medication to a patient, two modes of delivery I might consider would be application via surface device or implant device. The application of biomaterials to one mode or the other could significantly impact the smoothness of a project.

Employing biomaterials that are applied to a surface device could make for a project that runs much smoother than an implant device. Depending on the contact duration, an tissue implant could require triple the amount of testing required for a skin device. Not only does this introduce additional risk into the project, it would require additional investment of time and money to support the increased evaluation.

This post was modified 5 years ago by JOnyekwere
 
Posted : 10/07/2019 8:34 am
(@lmathis)
Posts: 10
Active Member
 

Choosing the best biomaterial can either make or break a research project. For instance, when developing a biomedical device to be implanted, it is important to choose a material that will not be rejected by the human body. Extensive research must be done to select the best material. 

Some factors that I would consider when choosing a biomaterial is corrosiveness, chemical stability, wear, strength, metal selection, and life of the device. If these factors are not considered, the device could potentially fail when implanted in the human body and perform the way it was not expected to perform.

 
Posted : 10/07/2019 11:38 am
(@shfrancis)
Posts: 19
Active Member
 

A common biomaterial used in knee replacement surgeries was cobalt-chromium. The acetabulum (cup) structure fits into the patient's pelvis and may be made of metal or plastic. The femoral head (ball) may be made of ceramic or cobalt-chromium. Additionally, the acetabular liner, which serves as the patient's new "cartilage", can be made of ceramic, cobalt-chromium, or polyethylene. The FDA has approved metal-on-polyethylene; ceramic-on-polyethylene; ceramic-on-ceramic; and ceramic-on-metal joint replacement devices. and all four joint combination types are presently available for implantation. 

As of August 2018, the first class lawsuit was filed against the manufacturer of a knee replacement implant. Specifically, the DePuy Knee Replacement System is alleged to cause Cobalt poisoning resulting from the metal and plastic parts (cobalt-chromium-molybdenum alloy). The symptoms of Cobalt poisoning include migraine headaches, body aches, nausea, infection and autoimmune disorder, reduced vision and amnesia. Gupta et al., (2015) supported the impact of cobalt metal sensitivity in a case study. 

I draw upon the DePuy example because this company selected FDA approved biomaterials, however, post implantation patients are experiencing a wide variety of distressing/adverse effects which reduce the quality of life of the patient. I would like to believe that extensive clinical trials (phases 1-3) and independent clinical trial research may have found these issues prior to the metal knee replacement system going to market.

Reference:

Gupta, R., Phan, D., & Schwarzkopf, R. (2015). Total Knee Arthroplasty Failure Induced by Metal Hypersensitivity. The American journal of case reports16, 542–547. doi:10.12659/AJCR.893609

 
Posted : 12/07/2019 8:08 pm
(@shfrancis)
Posts: 19
Active Member
 

Hi Letisha, what would you recommend for rigorous testing of biomaterials beyond the established FDA approval? Should there be required testing of biomaterials beyond the FDA requirements?

The examples I will provide are FDA approved Essure and FDA approved metal/cobalt joint replacement systems

This post was modified 5 years ago by shfrancis
 
Posted : 14/07/2019 3:00 pm
(@sam-doksh)
Posts: 115
Estimable Member
 

Choosing a biomaterial is very important in medical device project management, There are some factor of choosing  the biomaterial :    1- Cost : cost  must include the initial cost of purchase and the life cycle costs of materials. 2- Availability : long delivery makes delays cause project delays. 3- biocompatibility : ability of material to perform with an appropriate biological response in the body. 

 
Posted : 17/09/2019 11:48 am
(@traceymraw)
Posts: 81
Trusted Member
 

The biomaterial selection is the most important part of a project. In order for a project to succeed you would want the surface properties, strength, toughness, etc. to be most suitable for the goal of the project. For example, for a plate to repair a bone fracture you would want to use a biomaterial with the same properties as bone to avoid stress shielding. If the biomaterial doesn't interact with the tissue in the way it is intended, the project will not be successful. If corners are cut when selecting a biomaterial, this may be to save costs or use a material that is more convenient to acquire, you may compromise the properties the project requires.

 
Posted : 19/09/2019 7:40 pm
(@yifan-tao)
Posts: 39
Eminent Member
 

From the perspective of project management, I think the most important thing is that the selected biomaterials must meet the legal requirements, which means that the use of legal biomaterials is a prerequisite for the whole project. Because if the selected biomaterials do not meet the statutory standards, the whole project will fail. Secondly, among all the biological materials that meet the legal standards, I will choose materials within the budget. Because from the point of view of project management, exceeding the budget will affect the whole project process. After meeting the above two points, I will start to consider the performance of biomaterials, such as whether they are rejected by the human body, whether they are corrosion resistant, whether they are strong enough and so on.

 
Posted : 21/09/2019 11:14 am
(@sameer-rana)
Posts: 78
Trusted Member
 

Aside from the selection of a biomaterial based on the results from tests conducted during pre-clinical research, another important aspect to analyze is all the factors related to obtaining that material from a manufacturer. This aspect in particular can play a major role in the progression of the project and would require adequate project management to assure the circumstances are in favor of the project. One important factor in relation to this is determining how easily a biomaterial can be obtained from a manufacturer and at the desired quantity. For example, if the manufacturer is unable to deliver the biomaterial at a required date, the progression of a project can be greatly affected. Another factor to take into consideration is if selecting one biomaterial over another would result in the ability to choose from a greater list of suppliers who can provide the needed biomaterial. Despite this, another dilemma that arises when working with biomaterials is whether the manufacturing processes and handling of the biomaterial by a backup supplier will affect the biocompatibility of the material for its intended application. Therefore, as outlined in the third principle of ISO 10993 - 1, it is important to take into consideration the processes through which the material is manufactured as well. Overall, when selecting a biomaterial for a biomedical related project, it is important to assure that the biocompatibility of the biomaterial remains consistent throughout the progression of the project through different phases.

This post was modified 5 years ago 2 times by sameer-rana
 
Posted : 22/09/2019 4:38 pm
(@shp37njit-edu)
Posts: 30
Eminent Member
 

I believe choosing a bio-material is one of the most critical factors in determining the flow of a project. The selection of a bio-material over another depicts the number of complications in the study. For example, if  bio-material X has more adverse side effects compared to bio-material Y but X is structurally more suitable then Y, X would be the smartest choice but this would result in a longer and more expensive project. It would be more expensive because now the team has to deal with these adverse side effects from bio-material X. Another factor that affects the flow of the project is the amount of time it takes to regulate this bio-material. According to ISO 10993, which involves the selection of a bio-material, the process of manufacturing could add a large amount of time to the project which can cause a lot of problems to the flow of the project as well. Some of the main factors that I would look for in a bio-material would be a minimal inflammatory response, durability, structurally sound, and able to withstand the test of time. When thinking about all of these factors, I believe that if the biomaterial has all of these capabilities, then the project will flow smoothly and not a lot of obstacles will be in the way of the goal. 

 
Posted : 22/09/2019 5:48 pm
(@as934)
Posts: 78
Trusted Member
 

From the perspective of the project manager, the biomaterial that is chosen for a device can impact the project plan in several ways. First is whether the material is being used for the first time. If the device is made of material which is well researched in humans and is already used in many other devices, then biocompatibility testing will be easier to complete with low risk for unexpected results, making the project get completed faster. However, if the material is newer or being used in a way that is different than how it has been used in the past, more time and money will need to go into providing evidence that the material is safe to use. There is also higher risk involved that the results will not be as expected. Another factor that the project manager must take into account is the cost and availability of the material. A material that is not readily available can be expensive and hard to get. Even in the company is willing to pay the high cost of material, delays in delivery of raw material can delay product builds. If the prototype builds and  initial production builds that are used for testing are delayed, then the completion of the project will also be delayed. If this issue is identified early on by the project manager, then the R&D team can look into alternative materials that have similar properties but are easier to get and cost less.

 
Posted : 22/09/2019 7:13 pm
(@quanzi)
Posts: 25
Eminent Member
 

It is important to be precise when selecting biomaterials for a device. They behave differently and have different interactions in the body. Some are necessary for a rigid role while others are meant to have some fluidity in certain areas of the body. A stent that is placed in the heart must have some flexibility, but must be rigid enough to support the opening of the coronary artery without collapsing. It must also work in the heart without clotting and is intended to be a permanent implant. Thus it would make sense to use metal, as opposed to a ceramic or polymer, in this case. Accordingly, stents are made of a mesh, stainless-steel metal, often coated with an anticoagulant to prevent clotting. 

 

Some factors I would look for are compatibility with the tissues it will be inserted into or in contact with, and whether or not damage will occur with the introduction of material into that particular area of the body. The material must be compatible with the tissue, there must be a favorable physiological response, and surface interactions between the proteins coated on the material and those located in the body must be favorable.

 
Posted : 10/07/2020 2:19 am
(@lechichr)
Posts: 39
Eminent Member
 

So as far as biomaterials go, the selection process has both a technical perspective but from a project management perspective needs to align marketing/sales, cost, scheduling. regulatory and risk. The project manager needs to develop a collaborative process to evaluate alternatives. Individuals from multiple functional areas should be consulted and be part of the selection team.  Many individuals in this discussion have mentioned criticality of the biomaterial from a physiological or medical perspective. In an medical device company, the selection should consider existing products with significant experience on the market. Engineers love innovation and might want to use a new material in their product, but the timing of introducing new materials should be considered as part of the project. Timing can be extended significantly due to testing of the new material. Also, using new material might be more costly and the market may not support higher priced product. New materials will have a large hurdle with regulatory review and approval. Finally, risk to the organization will be higher with new materials..

Now, I do not want to leave you with a viewpoint that progress on biomaterials should be stagnated. I wanted to express a balance view of innovation in biomaterials and the potential impact the project and the organization.     

 
Posted : 15/09/2020 7:36 am
(@jal58)
Posts: 60
Trusted Member
 

My first consideration would be how the device interfaces with the human body. A prolong-use device like an implant would have to satisfy far more regulations than the surgical instruments used to the implant it. 

There is a wide knowledge base of biocompatible materials for specific applications. I would base my selection on materials with similar function and use. Data can be obtained from predicate uses of the material and can help in validating the new device.

Developing or using a new biomaterial is a far more difficult task. Data and standards might not exist for a new material, and could delay the development process.

 

 
Posted : 18/09/2020 6:51 pm
(@jmeghai)
Posts: 79
Trusted Member
 

Just like in Project Management, if you select the wrong team or skip the initial stage where all is considered including any contingencies that may arise, you find out the project is taking more time, funds and resources than excepted because there was no proper initializing of the project and what to except as well as proper planning. In Biomaterial, when creating a medical device during a pre-clinical stage, you want to make sure that all protocols needed starting from initiation of the project to actually designing and then running the study and creating a safe device. To get through the stage you have to select the appropriate Biomaterial which requires a lot - biocompatibility, testing and creating a safe device, then, you get a complete and successful project. 

Looking at this from the Project Management standpoint, when you fail to do all the due diligence required for the project, then the project as a whole takes longer time, resources and funds; especially for biomaterials, if at the initial stage there was no conducting of literature search to know what it takes and what biomaterial works together, is the material been used approved by the FDA following ISO standard, the project will possible not come to life and then funds and time would have been wasted. Just like a novice trying to program with out understanding the tools involved, what they are used for and what tools work together, they are possibly going to end up with a broken program and not achieve anything. 

Personally the factors I will consider when choosing a biomaterial will be the Tissue Properties of the materials been used and how they come together. This will help to enable a smooth sailing in the creating of any medical device. Also, surface interactions which is very important because when done wrongly, it can have adverse effect on human life. This takes longer time to study and it requires a lot of diligences because you want to get it right. It sure does delay the project because you have to consider what part of the tissues is going to come in contact with and which of the compatibility testing will be needed like Cytotoxicity, Systemic toxicity, Hemocompatibility, toxicokinetic and irritation. As far as delaying the project, if all of this ticks right then the over all project will be a success.  

 
Posted : 19/09/2020 10:19 am
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