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To risk manage or not to risk manage?

26 Posts
26 Users
Eminent Member

Risk management is extremely important. Risk management is essential in avoiding unnecessary costs and mitigating or even eliminating unknown risks that could arise during the process of making a medical device. Risk management saves money and protects patient safety both of which should always be a priority in making any device. 

Posted : 16/04/2022 3:30 am
Eminent Member

The risk management process is the furthest thing from a waste of money and time. It is one of the most important parts, if not the most important part, of the planning process. A product that has excessive and unnecessary risks that could have been mitigated or avoided will probably not be approved, not be successful on the market, and will likely result in some lawsuits if it does make it to market. Without risk management there would be no way to ensure as much safety as possible for users and that should be the most important factor and priority of any product planning along with device effectiveness.

Posted : 16/04/2022 1:03 pm
Eminent Member

I think risk management is a very important part of the planning phase.  It really saves a lot of time in the long run. Some risks are not avoidable. And there are some things that will happen that weren’t even thought of during the planning phase. Having a plan in place during those moments really helps to tackle the situation. Just imagine something occurring that could cause hundreds of thousands in lost. Initially that kind of situation could cause someone to panic. So having a plan in place helps to better control the situation and manage it in a way that will be less stressful for all the parties involved.

Posted : 16/04/2022 2:29 pm
Eminent Member

Risk management is an important part in the planning phase. A successful risk management plan helps one to consider the full range of risks it faces. Risk management also examines the relationship between risks and the cascading impact they could have on one’s strategic goals. Risk management also helps establish the context, identifying, analyzing, evaluating, treating, monitoring, and communicating risks associated with any activity, function or process in a way that will enable organization to minimize losses and maximize opportunities. I do not think risk management is a waste of money and time if anything I think helps save money and time.

Posted : 16/04/2022 5:11 pm
Eminent Member

I do not think risk management is a waste of money and time at all! It is a very necessary part of the planning process, and no medical device should be produce with out factoring this in. In fact, having risk management in place could ultimately save a company a lot of money down the line. Having a risk management plan in place likely reduces the chances of customers suing you over your device, over something that was missed because of negligence and trying to cut corners.

Posted : 16/04/2022 11:44 pm
Eminent Member

Risk Management is very important in the work place.No matter the cost at the beginning it is a vital part in any safety plan.Because without you are risk everything you are working so hard to achieve.

Posted : 17/04/2022 2:38 am
Eminent Member
Posted by: @rajamharrison

Do you believe risk management is an important part of the planning phase?  Is it necessary or it is just a waste of money and time? Why?

Crucial. To not include risk management during the planning phase would be completely detrimental to the development of a medical device. Not being made aware of all the possible risks associated with a product could leave a company completely vulnerable to poor customer outcomes, reviews, or even risking a product not making it to the customer because it cannot pass clinical trials! Investing the money upfront to point out all of the possible risks would allow a company to be more aware of the pros and cons of their product and collaborate to make their product better and safer. 

Posted : 17/04/2022 2:55 am
Active Member

Risk management is absolutely something that needs to be assessed in the development of a medical device. While medical devices can greatly improve the quality of life of someone. It can also drastically cause harm and injury to a person as well. For example, Johnson and Johnson we sued because the use of their medical mesh device was causing women who used the product irreparable harm. They were suffering immense pain and prolapse of the mesh into the vaginal wall. The point of medical devices is to improve the quality of life. If we cannot ensure the safety of our devices, then they should not be on the market. 

Posted : 07/08/2022 4:14 pm
Eminent Member

A company must recognize potential risks. It is simpler to take precautions to prevent risks when a company is aware of the ones that might be connected to their line of work, primarily in the medical device industry. These are potential lives saving devices, so they should be managed appropriately. The business management can create a plan to limit the risks' adverse effects by being aware of the hazards. Managers will also be able to examine the risks after they have been detected and come to a rational conclusion about how to handle them. It would be borderline unethical not to have specific procedures in place.

Posted : 07/08/2022 7:56 pm
Eminent Member

Risk management is vital to the planning and execution phase. It helps businesses identify and deal with potential risks that come along in the process. As the saying goes, "proper planning prevents poor performance'' and also saves the company from a burden of issues that could have otherwise been prevented from the beginning. Risk management prevents the severity of project risks affecting the outcome of projects and helps reduce the economic impact. If there was no plan in place, it would essentially lead to companies starting back at square one each time something went wrong. Why not have a plan in place when everything is about the plan? It would be a waste of money to not have risk management in a company. Failing to anticipate risks could bring irreparable damage in the long-run, and possibly company dissolution. So again, why not have risk management when you can plan to fail but also have a plan in place to overcome the obstacles?

Posted : 08/08/2022 1:49 pm
Maya Saunders
Eminent Member

I think risk management is an important part of the planning phase. Identifying potential risks is critical to a medical device industry's success, and risk management empowers it with the tools to cope with them. A risk can easily be mitigated once it has been identified. The medical device industry can also make decisions with the help of risk management. As well as dealing aggressively with risks of high priority, progressive risk management ensures that minor risks are also addressed. As a result, management will be able to make informed decisions and ensure that the business remains profitable with the required information.


Posted : 08/08/2022 9:27 pm
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