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Risk Management

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(@hodafattel)
Posts: 78
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Topic starter
 

Risk management is a very important for a project so that the risks can be handled properly if encountered. There are 4 ways to manage a risk: avoidance, mitigation, acceptance, and transference. Transference is when a risk is handed off to a third party willingly. I am wondering how this can be used in the pharmaceutical or medical device industry. Can you give an example of this?

 
Posted : 15/02/2022 5:45 pm
(@pv223)
Posts: 76
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I am of the belief that in our field of medical devices, and pharmaceuticals like you mentioned, that transference is not a risk management strategy that can be used and accepted from both the patients perspective and the manufacturers perspective. These fields deal with the health and safety of the consumer and it is widely expected that when a consumer is using the product, it is because they are in need of it to either survive or improve their quality of life to a point where they can live comfortably. For example suppose a patient had a total hip arthroplasty performed and the implant ended up degrading inside the patient due to a chemical reaction and the patient ended up with an infection. Having an "insurance plan" via the transference strategy may help the patient pay off the resulting medical bills, but does nothing to improve the health of the patient and actually results in the reputation of the manufacturing company to degrade, especially if the issue becomes more prevalent. The same philosophy applies to pharmaceuticals. In this industry, the only two acceptable risk management strategies that I can see being applied are avoidance and mitigation as we should be doing everything we can to improve the life of our consumers while minimizing the amount of unintentional damage that could occur along the way. The only health related field I can see the transference strategy being applied is directly in the medical field with a doctors malpractice insurance.

 
 
Posted : 16/02/2022 7:32 pm
(@mmd55)
Posts: 80
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I agree with pv223, transference is not a feasible risk management strategy in the medical device/pharmaceutical field. Like pv223 mentioned, avoidance and mitigation are the two primarily used strategies with mitigation being preferred. In Dr. Simon's medical device development course, we learned that for medical device companies there are 3 main ways to implement risk management through mitigation.

The first, and best way, is to design out the risk. For example, a table might have sharp corners, one way to prevent someone from getting cut on the corner is to add rounds. The second way is to put up safeguards. An example of this is a retractable syringe that prevents the person using the syringe from being accidently stabbed. This is an example of a case where the risk (the needle being sharp) cannot be designed out for the device to work, so making the needle retract once a volume has been expressed is a great safeguard from accidental stabbings. The last, and least preferred way is to have warnings/trainings to make sure the person using the product understands the do's/don'ts and can avoid the risk that can't be designed out or safeguarded against.

I would love to hear if anyone knows of a transference strategy used by companies!

 

Thanks,

Matt

 
Posted : 17/02/2022 7:02 pm
(@ridmehta)
Posts: 79
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I don't see transference as negative as it may come across depending on how it is used. For instance, a company may hand off a risk to a third party to use their resources towards working on other projects. In this way the company gives business to possibly a smaller start up company while ensuring their own resources are adequately used. It may seem counter productive but in the long run it may actually be a better investment of their time and money. The other company may also be well versed in handling such risks and may able to resolve it in a shorter period of time. 

 
Posted : 17/02/2022 10:44 pm
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