Though I don't have any personal experience in this but I think the main pitfall in any project is delays in time. Especially this process of animal testing is time consuming. So in this scenario if the location is 1600km away you should firstly contact more different suppliers in advance s they might get out of stock sometimes. And also I think we should open our studies to more than one animal. We also have to take in account the cost of animal, transportation, maintenance and new location. But yes ofcourse outsourcing in different locations hurts the company as it gets difficult to maintain teamwork, and quality. And most important drawback is compromising on results, time and data.
The main pitfalls with outsourcing to a long-distance university would be delays in the project, as mentioned in lecture, in that "animals take time to come in when ordered". The long distance can also pose an issue to the product's integrity during transporting (blood cell-based products can lose viability over long durations of travel despite following current cryopreservation protocols). Finally the long distance aspect can inhibit the study process since a project lead/representative is not likely to always be on site at the university. This is important for a project because the university must be administered the protocol, which cannot always be put into precise writing depending on the complexity of the product. Some research must occur within an ISO cleanroom, which most likely do not have a protocol for a live virtual tour. Therefore, if the study/research site is too far, it may lead to complications along the research process, which can delay further delay the project and/or result in unforeseen costs, which can overall result in the study getting cut down. A more feasible option is to hire a contract research organization (CRO), which simply has more experience in organizing research trials as well as partnering up with more pharma-research companies, and overall performs the work at a quicker pace. Also, as mentioned in lecture, if a university has too many projects and your project is not a priority to them, it may go neglected. On the other hand, if an industry-based research facility has too many projects, then they will at least attempt to complete them in a reasonable manner.
I think this is the exact pitfall where a project manager cannot control the schedule, performance and a lot of details about the animal study. Most important one of them is the requirement of the animal that is appropriate for the experiment: the species, age, size, sex, health and so on. If the manager cannot monitor on the details of the animals, he/she cannot decide the authenticity of the lab data because it is hard and impractical to go somewhere 1000 miles away. Another consideration of pitfall is whether the university recommended by one of the team member really lives up to the demands of this experiment, is their personnel qualified? How much overlapped features does their direction of research share with this experiment? What about the administration delay that almost definitely will happen in the legal department? Those factors should be taken seriously for the precautions I am about to take.
When one is at the pre-clinical step of their research project, there are many crucial and resource-driven factors that will come against the flawless plan laid out. In cases where the research facility is 1000 miles away, these factors seem even more risky. Time, money, people, modes of transportation, ordering animals, getting the right type/species of animals, the environment, etc. Everything plays a roll in how the tests go. Even if all resources are met, there is more to what determines a test, the procedures/protocols followed, culture, permits and trainings can also vary from location to location. Making sure all of these factors and more are no hindrance are the great challenges that must be sorted out before even beginning animal testing when going to a location that is 1000 miles away.
First, I would go over the manual that came with the new biomaterial and research about it, discover the chemical name, the formulation data/report, the manufacturing info, the sterilization compatibility, etc. and inquire the manufacturer if there is any unclear info. Depending on the biomaterial and the medical device category, further checks would be applied. As many above replies mentioned, I will follow the ISO 10993 recommendation, the biological evaluation of medical devices, and apply it to my product specifications and device modifications. In order to avoid any toxicity risk, both the medical device and the new biomaterial should be studied. It is important to know whether the device would have a direct contact to Human tissue or not (in case of contacting body, knowing the duration of contact is essential). Also, I would determine whether this biomaterial would be used with a surface device (ex. mucosal membrane), an external communicating device (ex. blood path, tissue/bone/dentin), or with an implant device (tissue, blood, bone).
- A detailed evaluation of any possible biocompatibility risk should involve assessing physical characteristics (ex. mechanical, thermal, electromagnetic), that may affect the tissue negatively, in addition to the chemical toxicity testing.
(Ref. FDA.gov & Wikipedia)
Take the scenario where an animal study has been designed and as near as you can tell, the design is not flawed. That is to say, you think the design will give you no problems.
Your company outsources this animal study to a university located about 1000 mi (1600 km) away where one of the members of your research team has a lot of connections because she went to school there.
What issues or pitfalls should you guard against in a situation like this? What precautions should you take in this situation?
First off, assuming a study will have no problems is setting yourself up for failure because no matter what, issues will arise in a study. They might not always be catastrophic and completely ruin the study, but regardless, something will always happen. If the issue is minor, it can most likely be resolved over the phone or via email, but if it is a major issue, it is always good to be prepared and have a backup plan.
One of the biggest constraints in studies like this is time. Once the study is sourced to a lab and the protocol is developed, it takes time to gather the specimens, run the experiment, gather and process the data, etc. There are already enough factors that can contribute to a study going wrong, so adding another potential complication such as distance to the scenario is not a good idea. If a major issue were to occur that couldn't be resolved over the phone, it would take time to travel to the lab site and if the study is time-sensitive, the results could be compromised by the time you got there. Therefore, it would be in your best interest to choose a lab that is nearby in case anything went wrong.
In this case, we may encounter the problem that animal suppliers need time to transport animals when ordering experimental animals. In addition, animal suppliers may run out of animals. In order to prevent this situation, we need to prepare as many alternative animal suppliers as possible, so as to prevent delays in research caused by the absence of animal suppliers. Secondly, we'd better have alternate models or be able to chop off time points, so that we can deal with different pitfalls more flexibly. At the same time, we may also face the problem of insufficient time or money for study, which requires us to make correct judgments and decisions.
Any study that involves multiple partners from a distance, the laws, regulations, and practices of the partners' corresponding agencies and governments must be enforced. The situation becomes tougher in this regard with international partnerships. However, even for domestic studies, a single connection between the two organizations is not enough to rectify the partnership. Outsourcing work to an outside organization relies heavily on an excellent sense of trust and cooperation. Without these, the partnership will struggle and detract from the common results-oriented goal for the study. Dealing with animal subjects is especially fine because the potential risk and consequences are also increased. Involving two or more separate parties into one research study increases the number of people responsible for the ethics and well-being of animal subjects, and a potentially longer regulatory road ahead.
Assuming that the design will not have any flaws and will give no problems is one of the biggest mistake. This is because any design or study will have some pitfalls associated with it. There may be delays in the study due to the time taken for the animals to come in when they are ordered. This could be because sometimes animal suppliers might run out of animals which may increase the time for the animals to be delivered due to the distance. For, it is always better to have alternate supplier and alternate models or should be able to reduce the the time. Also due to the large distance it will be difficult to check the progress of the work personally which would impair the ability to see the end results and would solely be based on results sent from the lab situated far away.
In order to prevent or minimize any pitfalls, I would first make sure to place and confirm the order as soon as possible once all the details are ironed out. Some details will be the agreed rate, amount and species of the animals, age and health of the animals, and delivery date. I would also be in regular contact with the supplier to make sure that there aren't any issues with the conditions we agreed upon. As mentioned from previous posts, delays can occur in supplying and transporting the animals, especially from a provider 1000 miles away. As a precaution, I will also have at least one other supplier set aside in case the original supplier fails to pull through. There may be too large of a delay, animals being hurt during transport or deemed unfit for the experiment upon arrival, breach of contract, etc.
Ethics is another issue I would be concerned about. In preparation for the preclinical trials, I will also ensure the staff performing the surgery are all well certified and trained in performing animal studies. I would also ensure all the necessary medical equipment and medication(sterile scalpels, high-speed burr, anesthesia, antibiotics, etc.) are ready.
When you outsource the experiements there are lots of things that could go wrong. Therefore, you have to take multiple steps and make protocols for problems you see happening. The more specific and well thought out your protocol are you decrease the severity of the problems that could emerge. One problem, I had with outsourcing a project was that there was a big-time difference between the two places(Korea and the US). The time difference creates lots of time issue such as having online meetings and communication. Especially, if the project or a task is time-dependent the problems get larger. For me to decrease the time lag and difference I have set protocols to deal with these problems. I have a partner in Korea I trust who manages the project during times that I am not able to respond. And then he reports back to me. Also, since my partner and I have a similar way of thinking have similar experiences we are able to work it out. However, so far we did not have major problems yet in proceeding with the project, therefore, we will have to see if this method workout in the long run.
Pitfalls that you will encounter are delays as you don't know how long will it take to finish these tests or if the university has the animals or they has to get it from their suppliers. So you have to make sure that they have the required amount of animal and they gotten approval from the university so it won' cause problem later. You have to stay in contact with the university so they can finish your testing on time because if you are not in contact with them then you don't know what is going on as it is located 1000mi (1600km) away and you wont be able to get to them quickly. If you stay in contact then you can guide them if they have questions.
Also you might ask your company to let you stay where the university is, so you can stay on top of your research. You also have to make sure that there are no falls in your study design.
The issues that can present in this situation can arise from the vast distance between the contracting company and the outsourcing company. The main issue can be lack of communication, which can lead to misunderstandings. It is difficult to check up on the progress of the study without being at the location in person.
Another issue that may occur is delays. Delays in a study can occur for a number of reasons. If the study relies on animals, it takes time to receive a supply, due to demand and the time it takes to breed. If there is no alternate supplier, this can be a setback and affect the progress and rate of the study. Another issue is if there is not enough funding. Although the member of the research team may have connections, once the deal is solidified, it could be a more expensive endeavor.
In order to take precautions, I would ensure that there is effective communication between the outsourcer and my own company. I would appoint someone to be the liaison for my company and for the other company, and I would schedule on-site visits as well to monitor progress.
In a situation where a company outsource a Academic lab that is a distance away and the experimental design been carried out is something that requires close monitoring and attention then there can be lots of hiccups or pitfalls if not properly planned and considered ahead of time.
Distance: the first and major Pitfalls will be the distance which can hinder proper monitoring of the experiment.
Environmental conditions: If the study didn't take into consideration the climate condition or the toxicity of how the device will work on the animal when under a different climate in another region or state then the problem that was never envisaged while the study was on can then be a problem during the experiment.
Timing: Considering the distance as a problem which might lead to lack of time for a member of the team to actually travel down to monitor the experiment or also get the needed materials if it has to be shipped or mailed down. then in the process cutting corners comes in and the device does come out as well as you original planned thereby making a less quality devices.
Not enough money: this can also be a pitfall if you have to travel more than expected which was never projected into the experiment.
Precautions:
Precautions that can be taken into consideration if this experiment has to be outsourced that far are:
- you must have plans for good and reliable teams where the experiment is been outsourced or someone who can make the needed travels and that can also oversee the experiment as it goes along and provide solutions when contingencies arises.
- Enough Budget that will care for the travel expenses and materials if they have to be shipped to the location.
- Is the outcome of the experiment more than the input of the experiment. If not then the experiment will be worthless and not something to venture into. Best possible look for another alternative like a contract lab close to the teams who will be involved with the experiment.
