What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there any?
Implementing risk management is a benefit because it allows the medical device company/ manufacture to be ahead of the game. It allows them to release the warnings and side effects before anyone has a chance to experience them when the device hits the market. They are able avoid major lawsuits because of risk management.
Implementing risk management is not only ethical but also it provides context on whether a company should purse a project. The risk management process runs throughout the product life cycle starting in pre-market where experimentation begins, running throughout the product realization phase where product design controls are created and throughout the post market where marketing begins. To effectively establish a risk management process, there must be a risk management plan, an assigned risk management team, analysis and identification of risk, assessing the risk, and mitigation of risks.
The benefits to implementing a risk management assessment are endless. By identify a risk early on, design modifications can be done. It is better to make changes early on than much later in the process. It can help to prevent any failures which can prevent any major lawsuits which can be timely and expensive. While design modifications can be frustrating, it is much better to have to do that before going into testing and production.
While the benefits to implementing a risk management assessment greatly outweigh the cons, they do exist. They can be expensive and time consuming. Have to stop a process to pinpoint the risk and assess, can cause major setbacks and delays.
Risk management is just as important in my opinion and experiences in industry as the actually Research and Development phase of a project. Being able to look at potential risks associated with the product not only helps with mitigating individual failures and in the process the failure of the whole product, but it also helps with customer trust that the company has done everything in its power to extensively prevent as much as it can. By having a plan of action for each product, a company and a team can monitor the health of the project from start to finish and keep everyone and everything compliant with company protocol that they deem safe usage. The last thing a company would want is to have, say such as an implant fail and that company would face severe lawsuits and various different consequences from federal agencies and also from individual lawsuits, and not to mention lost business.
In terms of an ethical standpoint, it definetly is the right thing to do to do your due diligence to make sure that your product doesn't hurt someone else. To ensure that you have done your part to mitigate any risks that can arise from the product. Ultimately the blame would come back to you if you didn't do your part to check that your product was the best it could be and the safest it could be.
As mentioned above, there are clear advantages to risk management that makes it absolutely necessary for product development and launch. However, there are some things to watch out for. One issue is if the team goes 'down the rabbit hole' searching for risks that have a very low probability of occurring. This takes up valuable resource time and energy, therefore the project leader just has to make the executive decision that the team has identified all plausible risks and that the team has to stop searching for low probability risks. Another issue is that the risk assessment may be qualitative and subjective, so it cannot be mitigated properly or the management plan is not effective.
Some of the Advantages that a risk management assessment include that it allows for a minimization in risk and Brings awareness of all potential risks.
It also allows a company to Saves cost and time because risks are known, and allows for changes to be done earlier in a device development along with allowing the company to share this information to reduce failure of a product.
Finally, it allows for the protection of the company and its resources, since there can be a reduction of product failure and potential lawsuits.
Some of the cons could be seen that it is time consuming, which can set a project back.
Though risk management certainly has some advantages and benefits, there are some disadvantages too. If we think about automated risk management information systems that will make my statement more clear. It is not suitable for all kinds of organizations.
Firstly, using a risk management information system is that it may not be useful for all companies. These systems are only useful for companies that have a certain kind of profile. For example, if a company does not own a lot of movable and immovable property and does not use several different risk management products, the integrated system may have limited utility.
Additionally, Risk management information systems can be quite expensive. They are often sold as standalone software solutions or as solutions that can be integrated with the overall enterprise resource planning software. Also, it needs maintenance from time to time.
That's why, risk management does not bring fruitful results for all organizations all the time.
Implementing risk management is a must for any company. identifying, assessing, and solving the risks are parts of the management process. This allows the company and the team to spot potential issues about the device. The company can take precautions or could simply be ready to handle anything that could come it's way. The researchers can make early adjustments to the product before it goes public, this could also save the company’s reputation in case of any emergency. Being caught prepared almost always results in better outcomes.
Implementing a risk management assessment for a device can offer many benefits. For starters, it can allow for possible improvements to be made in order to minimize the risks. It also allows the team to get ahead in identifying side effects and ways to mitigate them. I also believe implementing a risk management assessment for a device builds credibility for the company because it shows that they understand that their product may impact patients differently. I personally do not think there are cons to implementing risk management assessments but I have seen some say that they consider it a waste of money and time. I do not think that teams should draw out this process by searching for risks that are not there or too severe and agree that that can lead to a waste of money and time, but other than that I believe implementing risk management assessments provides many benefits.
What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there are any?
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs. The risk of occurrence frequency and the likelihood that an occurrence will happen.
The benefit of implementing risk management assessment for a medical device is that you have done your due diligence and walk-in integrity as a company. Your brand can be trusted. You have support and market value and influence in the medical device field. The assessment gives you the green light or the stop sign before anything is placed on the market.
The potential con would be to lose valuable resources going down the wrong path exploring a product that has too many risks. It could be a frustrating endeavor for the product developers to run into a dead-end after investing hours of brainstorming on a product. How many good people are feed-up and abandon the project after the 15th time a product idea is rejected because of high risk?
Risk management involves the identification, understand, control, and prevent failures that can result in hazards when people use medical devices. Manufacturers are expected to identify possible hazards associated with the design in both normal and fault conditions. The risks associated with the hazards, including those resulting from user error, should be calculated in both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to acceptable levels by appropriate means. Why should we perform Risk Management?
- Risk analysis is now required by law.
- Identification of device design problems prior to distribution eliminates costs associated with recalls.
- It offers a measure of protection from product liability damage awards.
- Regulatory submissions checklists used by the FDA now call for inclusion of risk analysis.
- It is the right thing to do.
- Product Liability.
- To ensure safety of the device.
- To ensure that any unsafe device that do reach the market are promptly identified and efficiently corrected.
- Risk management system demonstrates that the manufacture providing safe device.
An overall risk management process involves the essential steps listed above. In order to manage risk, hazards must first be identified. By evaluating the potential consequences of hazards and their likelihood, a measure of risk can be estimated. This value is compared to the company's risk-acceptability criteria and, if it is too high, the risk needs to be mitigated. Because risk cannot be completely eliminated, the risk that remains must be managed. The following steps can be used in a risk management program
- Develop written definitions of what needs to be done and how to do it.
- Define responsibilities and accountability. Define what needs authorization and who is responsible for handling it.
- Define what needs authorization and who is responsible for handling it
- Define the skills and knowledge necessary to implement the system and a provision for training those who do not possess these skills.
- Develop and maintain written documentation to demonstrate conformance to policies and procedures.
- Incorporate measures to cross-check and verify that procedures are followed.
- Verify that systems are in place and functioning properly.
Advantages of Risk Management
- It encourages the company to think about its threats. In particular, risk management encourages it to analyze risks that might otherwise be overlooked.
- In clarifying the risks, it encourages the company to be better prepared. In other words, it helps the company to manage itself better.
- It lets the organization prioritize its investment and reduces internal disputes about how money should be spent.
- It reduces duplication of systems. Integration of environmental and health and safety systems are one instance.
Disadvantages of Risk Management
- Qualitative risk assessment is subjective and lacks consistency.
- Unlikely events do occur but if the risk is unlikely enough to occur is maybe better to simply retain the risk and deal with the result if the loss does in fact occur.
- Spending too much time assessing and managing unlikely risks can divert resources that could be used more profitably.
Some of the benefits of risk assessments are getting a clear picture of where your assets lie. It also allows one to identify potential threats, understand the likelihood and impact of those threats, and implement proactive processes to address and mitigate the impact. I cant think of any cons.
Implementing risk management assessment allows a company to observe any issues in their product, how it may affect the patient short term and long term, and can possibly prevent any future lawsuits because negligence. With assessments in place, the company can look over their product through for any minute details they could've missed that will effect the quality of their product. The main con I can think of when it comes to risk management assessment is that it can be tedious, and some companies may like to cut past that to get a product to market faster. Also implementing this kind of plan will cost the company money, and if the funds are tight they can do away with it completely.
There are several benefits of implementing a risk management assessment for a device. Firstly, the assessment would ultimately find specific risks that may be associated with a particular device that may not be as apparent to the naked eye. In other words, the risk management team members may be able to find small quirks that may be apparent within a certain device that could have potentially been overlooked, which could and would lead to possible recalls and shutdown of the assembly line of the company until the major or minor mistake has been corrected. Additionally, implementing a risk management assessment of a medical device could also reduce chances of having to stop production of the device overall. In other words, if major flaws are found within the medical device that could potentially causes hazardous outcomes, the company would need to stop producing the product. If the risk management assessment team is able to find consequential risks associated with the product that could ultimately be harmful, this would allow the production company to either redesign or fix any simple flaws to prevent any negative outcomes with the use of the product overall.