Risk management is an essential part of the planning phase, embodying the principle that “a stitch in time saves nine.” By identifying and addressing potential risks early, it prevents minor issues from escalating into major setbacks, thereby saving time and…   Read more»

Risk acceptance does indeed imply a higher probability of encountering the risk, as it involves acknowledging the risk without taking any specific action to avoid or mitigate it. This approach is typically chosen when the cost or effort of other…   Read more»

I think risk acceptance does not increase the risk nor does it keep it the same. It decreases the risk, because you know it is there. If you know there is a chance it might rain. Do you bring an…   Read more»

I have seen this used in a variety of ways as well. Once can use it to characterize the risk certain materials can have in a medical device in a surgical procedure. Maybe certain materials might react a certain way…   Read more»

Risk assessments are definitely necessary for medical devices. Ideally you want to design out the risk. But, if you cannot. You can reduce the risk or add a warning about it. In everything there is risk, but you need to…   Read more»

The pros of a risk assessment far outweigh the cons. On the surface level, the cons are that these plans may result in the project taking a longer time and greater expenses. However, in the long run, these plans actually…   Read more»

Risk assessment is an essential part of the planning phase. All potential risks must be discussed so a thorough, well-thought out plan can be constructed. By doing so, the plan will run more smoothly when enacted and the risks will…   Read more»

While it may seem that companies tend to outweigh reward more than risk (due to media headlines and such), I believe that most companies outweigh the risk more. First of all, liability is of utmost important in the biotechnology industry….   Read more»

In a hypothetical situation at Cyberdyne Systems, a biotechnology firm, they encounter a critical issue in their biosecurity laboratory. The lab, which focuses on gene therapy research, houses various infectious agents, including a specially engineered influenza strain. During a routine…   Read more»

Standards in the medical device industry, such as ISO, FDA, and ASTM, incur costs due to their development, maintenance, and the need for quality and reliability. These costs cover the extensive efforts in research, drafting, and updating by expert groups….   Read more»

  Accepting a risk doesn’t necessarily raise its likelihood but means acknowledging and tolerating it when prevention or mitigation is too costly or the risk is minor. This approach suits situations where mitigation costs outweigh potential impacts, risks have low…   Read more»

The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and approaches should be taken to minimize the damage it may cause. So, within the acceptance phase,…   Read more»

Risk acceptance essentially is acknowledging but taking no action towards a risk based on certain criteria. Risk acceptance may create a higher probability of risk, but it will not guarantee the risk will occur. Rather, there are factors taken into…   Read more»

I actually questioned this myself this past weekend when creating the DID for the project Dr. Simon has assigned to us. Personally, I feel as though regulations should not cost since these regulations help ensure that devices are being designed…   Read more»

I currently work in an in vivo lab and can think of several hazards in a hazardous situation with a specific harm. We often have certain test subjects that undergo doses of radiation and other test articles. The main hazards…   Read more»

A patient is fitted for their first back brace following a scoliosis diagnosis. However during that fitting, the prosthetist/orthotist had incorrectly written the waist measurement to be significantly smaller than the patient’s true waist size. The back brace now poses…   Read more»

As a first-year master’s student, I’m exploring risk analysis in medical devices. It seems that risk assessments play a crucial role in ensuring the safety of new medical devices. While I’m still learning, it appears that conducting risk assessments, particularly…   Read more»

From what I’ve learned so far, many biotech companies do prioritize potential rewards over risks, aiming for innovation and growth. However, some also conduct thorough risk assessments to balance these factors. They might use a mix of quantitative analysis and…   Read more»