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To risk manage or not to risk manage?

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rajamharrison
(@rajamharrison)
Eminent Member Registered

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?

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Topic starter Posted : 09/10/2021 9:03 pm
jaf22
(@jaf22)
Trusted Member Registered

In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a need for risk controls and assessments to be adequately assume safe use. I don't think this question has a gray area where it is black and white on why there is no reason that this is a waste of money or of resources within a company. 

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Posted : 08/11/2021 7:49 pm
mmd55
(@mmd55)
Trusted Member Registered
Posted by: @jaf22

In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a need for risk controls and assessments to be adequately assume safe use. I don't think this question has a gray area where it is black and white on why there is no reason that this is a waste of money or of resources within a company. 

I completely agree, risk management is crucial especially in medical devices. Working in an industry where, for some people, a product can mean life or death there is no amount of money that is wasted. Regulatory bodies exist and require that risk be assessed ... example ISO 14971. So without risk management, a medical device literally cannot get approved or make money. In addition, risk management can help capture any potential red flags that can lead to a malfunctioning device. Having a medical device with lots of problems can also lead to lawsuits/liabilities. There really is only one answer to this question and it is that risk management is incredibly important in medical device companies.

 

Thanks,

Matt

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Posted : 09/11/2021 6:00 pm
hodafattel
(@hodafattel)
Trusted Member Registered

Risk management is a very important part of the planning phase. It also continues throughout the whole project. It allows companies to prepare for the unexpected as much as possible and minimize the risks and costs before they occur. It is a way of protecting the company’s future and money. Moreover, it enables the company to better design a product that is fitted towards the customers’ needs without putting their lives in danger. Failing to recognize potential problems can have detrimental impacts in the future, so risk management optimizes the achievement of the project objective. 

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Posted : 09/11/2021 10:46 pm
cem34
(@cem34)
Eminent Member Registered
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?

Risk management is an important preventative action that one can take early on to avoid confusion as well as provide clarity to terms of a sort of guideline which one can following when taking other actions against risk. Risk analysis and risk measurement will both benefit from having a solid foundation laid out in one's risk management plan as it sets the pace for how actions should be dealt with. Therefore, as a result, it is not considered a waste of time, in the contrary, it should serve as a guideline to save time and reduce mistakes. As a result, this will also save money.

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Posted : 12/11/2021 1:13 pm
cm539
(@cassiem)
Trusted Member Registered

Risk management is absolutely important for a medical device. These devices will be used on people and/or by people. I would consider it to be unethical if there was no risk management associated within the planning phase. I read this question and the first thought I had was about surgeons taking the Hippocratic Oath. How can they treat their patients without causing harm if the medical device they use is associated with high risk? At the end of the day, risk management was developed to make devices safer for use.

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Posted : 12/11/2021 1:22 pm
ama224
(@ama224)
Trusted Member Registered

Risk management is an integral part if not one of the most pivotal sequences of the planning phase. Not just in medical devices, but in any engineered product that will be used in society. An example Dr. Simon had mentioned in the lecture was Planes, another example is cars, appliances, buildings and structures, literally anything that needs to be designed and 'engineered'. Without risk management, the safety of a product in society will always be in question, always at risk. This would cause mayhem and endless recalls and redesigns and just a glaring flaw in the design and planning phase. Hence, risk management is necessary and on the contrary would actually save companies plenty of time and money. 

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Posted : 13/11/2021 1:27 pm
Sheila Sarathy
(@sheila-sarathy)
Member

Patients usually don't even realize that they accept the risks that are associated with the medical device. Although the risk management process can be tedious, it is very essential for making sure a device functions as per its intent to save lives. Here is a good quote I found from the fda files;

"A common understanding of how FDA considers benefit and risk may better align industry’s and
FDA’s focus on actions that maximize benefit to patients, improve medical device quality, and
reduce risk to patients. "

Reference

https://www.fda.gov/files/medical%20devices/published/Factors-to-Consider-Regarding-Benefit-Risk-in-Medical-Device-Product-Availability--Compliance--and-Enforcement-Decisions---Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf

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Posted : 14/11/2021 6:35 pm
srp98
(@srp98)
Trusted Member Registered

Risk management is an extremely critical part of the planning phase. Recognizing and planning for the risk early on can allow for a smoother process overall. It is so important to identify, understand and control any failures or risks that can result in some type of hazard. By doing all of that early on in the planning phase, you can even work to prevent such failures from occurring. Putting money into accounting for risks will be less expensive than putting in money into lawsuits that will be filed as a result of any harm that occurs due to the product. Medical devices should help to diagnose and treat patients, nor harm them. Not putting in the time and money into identifying risks associated with the device will ultimately harm the patients in the long term.  

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Posted : 14/11/2021 9:09 pm
reginabarias
(@reginabarias)
Trusted Member Registered

I believe it’s one of the most important parts of the planning phase. While it may seem like a large cost to implement it is small in comparison to the possibility of law suits that could come from ignoring risks that could have been prevented early.

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Posted : 14/11/2021 11:58 pm
cb447
(@cb447)
Trusted Member Registered

Risk management is a critical part of medical device development. A medical device company is responsible for what happens to the patient using the device and as such it is vital the company understands the risk to the patient and what the potential outcomes could be. In addition, risk management is ethically the right thing to do and can also help companies determine whether or not a project is worth following through with and launching. That being said, there are some regulatory agencies around the world that are arguably taking risk management too far and requiring medical device companies to take unnecessary measures. For example, China and the EU (under MDR) are arguably two of the most stringent markets worldwide. It is debatable whether or not all of the requirements are actually necessary to prove the device is safe and efficacious. What are your thoughts on stringent regulators around the world and their ways of evaluating risk management? 

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Posted : 17/11/2021 9:00 pm
nmcbean
(@nmcbean)
Eminent Member Registered

No, I do not see risk management as a waste of money. This is probably one of the most important investments of a company. Every product has some level of risk associated with its use. In order to lower the chances of customers experiencing adverse effects, risk management is necessary. In addition, including risk management in the planning stage further improves verification and validation protocols.

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Posted : 13/04/2022 1:21 am
Leilani_Johnson
(@leilani_johnson)
Eminent Member Registered

I think that risk management is a vital part of the planning phase in the medical device industry. I also believe it is important to monitor risks throughout the post market phase as well in order to ensure patient safety and to minimize the possibilities of recalls and issues that can potentially destroy medical device companies and their credibility. I honestly do not believe any part of the planning phase is considered a waste of money because it is important to have everything in order as much as possible since the product directly impacts people and their health. 

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Posted : 13/04/2022 6:20 pm
alexbryant-harden
(@alexbryant-harden)
Eminent Member Registered

Yes, I believe that risk management is an important part of the planning phase, essentially it is very important in the whole aspect of making medical devices. Risk management is critical in avoiding unnecessary costs and mitigating unknown risks that could arise during the process of making a medical device. Ensuring patient safety should always be a number priority in making any device and should never be considered a waste of money.

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Posted : 13/04/2022 11:02 pm
shavondraleak
(@shavondraleak)
Eminent Member Registered

If you fail to plan then your plans will fail. Planning is the greatest investment of time, talent, and thought.  I believe Risk Management is a vital part of the planning phase in any product design or development, especially in medical devices. The ISO 14971 standard principle is the safety of medical devices should be judged in relation to the acceptability of risk. If Risk Management is not a part of the planning and overall lifecycle of the medical device design how can a company have integrity? Adding engineered safety components in the design of a product is a key component of maintaining safety. It is better to do these things initially then for there to be a major recall on a product after consumers are harmed.  

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Posted : 15/04/2022 12:52 am
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