So in my perspective, I have worked in the pharmaceutical industry and many of the same points that are being taught in our class are essentially the same. The two often times coeincide with each other as each of them have an end product that is going into the body and must follow the stringent FDA requirements of safety. In my experience I have dealt with a few GLP machines that require proper safety protocols to be followed when operating such machinery to minimize any risk associated with. The one particular machinery that I have used is the Hamilton Star Automatic Pipette machine and we had to go through extensive risk mitigation training to minimize any danger associated with the device

In terms of what we did and what features are associated with the machine is as follows

Risk Avoidance- In terms of how the machinery utilizes risk avoidance, is by ensuring that every corner is rounded and avoids any injury to the user. It also has an anti-collision detection hardware that will detect if something is in its way and will stop working. In terms of the company policy, we have proper PPE when operating the device and have policy of not reaching inside the machine while it is in operation.

Risk Mitigation- To mitigate any risk that is possible, the Hamilton machine utilizes cover and guards to physically block anyone from access the deck, however this can still be bypassed to do lab work in it when necessary.

Risk Acceptance - Certain things are accepted such as the possibility of the robot to collide with the person, and or to collide with other moving parts and potentially cause an issue or error.

While working for my company, we do our best to handle risks as appropriately as possible. From an auditor point of view and our companies general view on risk, it is not satisfactory for us to accept risk for our medical devices (Intra-Aortic Balloons). Every risk that we have we try our best to mitigate the risk or, if possible, avoid the risk all together. To do this, our company has a lot of product inspections on the manufacturing line to ensure our product is tested and inspected before leaving the facility. This includes visual inspections, leak tests, inflate on pump tests, and many others that are used to make sure there are no defects to the product and no risk to releasing the product to the customers. Of course any test methods that are done in line are validated using a test method validation, to ensure the operators know what the failures are and can actively catch product that does not pass testing or inspection criteria. We also use risk avoidance a lot. For example, we have a gluing process where the glue requires 50% relative humidity to cure in 15 minutes. Of course below 50% humidity the glue still cures and can be used, but to avoid the risk of having the glue not dry in time, we only allow the gluing process to be used if the humidity in the room is above 60% humidity. This allows us some extra tolerance because we aren't using the bare minimum requirement where we could be over or under the humidity by a small amount at certain times. Of course, sometimes risk needs to be accepted, but if you can mitigate risk or avoid it all together, it looks much better in the eyes of the FDA and within the company than saying we accept the risk and accept that this may harm the product or a patient in the future.

In the medical device industry, risk management is critical to ensuring patient's safety and regulatory compliancy of both federal and international governments. Throughout the device's life cycle, possible risks must be identified, analyzed, and evaluated as part of a systematic risk management approach. Adhering strictly to industry standards, including ISO 14971, is essential to fulfilling legal and safety obligations. It is crucial to set up a strong quality management system (QMS) that incorporates risk management into the processes of product development and manufacturing. Transparency and traceability are ensured through careful recording of risk management operations, including assessments and mitigation plans. A comprehensive strategy is fostered by cross-departmental collaboration in engineering, quality assurance, regulatory affairs, and clinical trials. To detect and manage risks in practical situations, post-market surveillance, clinical assessments, and testing is necessary.

An example of avoiding risk is when a specific substance used in the urinary catheter was found to have the potential to cause allergic reactions in certain patients . The company chooses to modify the urinary catheter using a different material that is less likely to result in allergic reactions in order to reduce this risk.

Urinary tract infections associated with catheter use carry a known high risk. In order to mitigate the risk, the producer chose to apply an antimicrobial coating to the catheter's surface, which should decrease the chance of bacterial colonization.

An example of risk acceptance is when it is determined that there is little chance of a manufacturing related design flaw on the catheter's outside. The medical company chooses to take this low level risk after giving it careful thought. The visually appealing defect has no impact on the catheter's safety or functionality, and correcting it would be more expensive than helping.

As a first-year student, I lack industry experience, but here are brief hypothetical examples:

- For risk avoidance: A medical device company switches materials in a new implant to prevent known degradation issues.
- In risk mitigation: Redundant power systems are installed in a diagnostic machine to minimize potential power-related risks.
- Regarding risk acceptance: Despite minimal malfunction probabilities in a surgical tool, the company proceeds, acknowledging and preparing for such rare occurrences.

As someone who lacks industry experience it is very interesting to see everyone's experience with risk management and which circumstances they encountered with each method (risk avoidance, mitigation, and acceptance). While each method has similarities to each other, they can all be used in so many different situations. After doing some further research I have found some brief examples as seen below:

Risk Avoidance: A well-known example of risk avoidance in medical devices is the use of latex-free materials in surgical gloves to prevent allergic reactions. A latex allergy is a reaction to the proteins in the latex rubber, symptoms can range from minor skin irritation to life threatening shock, which is known as anaphylaxis. To avoid this risk entirely, many medical device manufacturers have transitioned to using non-latex materials, like nitrile or neoprene. This is a clear example of risk avoidance, where a potential hazard (latex allergy) was removed from the equation by using alternative materials. The change improved safety without compromising the functionality of the devices, and it reduced the liability associated with allergic reactions.

Risk Mitigation: A well-known example of risk mitigation in medical devices is the inclusion of alarm systems in infusion pumps to reduce the risk of over or under-infusion of medication. Infusion pumps are used to deliver precise amounts of medications to patients, so an error in the dosage amount can lead to serious health consequences. Therefore, unlike the previous risk avoidance example in which latex could be entirely eliminated, manufactures significantly lowered the risk of harm without eliminating the use of the pump itself. This approach allows for safe operation of the infusion pump while maintaining the device’s intended function, exemplifying a proactive risk mitigation strategy.

Risk Acceptance: A well-known example of risk acceptance in medical devices is seen in MRI machines with their level of noises. Due to the rapid switching of magnetic fields during the operation of a MRI machine, they can generate loud noise which could be potentially uncomfortable for the patients. However, despite efforts to reduce the noise, manufacturers eventually had to accept the risk because eliminating it would require redesigns that could compromise the machine’s imaging quality or increase costs substantially.

Risk management is extremely important to the medical device sector. Here are a few examples of each of the 4 strategies discussed in the lecture related to a hypothetical heart implant company:

Risk avoidance: A company is developing a heart implant and during the design phase, the team identifies that a certain antimicrobial agent is effective but has shown potential toxicity in preclinical testing. Instead of proceeding with this material, the company chooses to avoid this risk by switching to a material that has been proven safer.

Risk mitigation: The team discovers during testing that the antimicrobial coating may break down under certain storage conditions, reducing its effectiveness. To mitigate this, the company changes the packaging to include moisture resistant barriers and puts storage requirements on the label.

Risk acceptance: After implementing mitigation strategies, the company knows that some patients with rare conditions may break down the implant faster, reducing its effectiveness. This risk is found to be acceptable because the overall benefit to the population will outweigh the risks, which only apply to a small portion of the population.

Transference is never acceptable in the medical device industry because companies are directly responsible for the safety of their products.

In medical device companies there are a lot of ways to implement risk avoidance, mitigation and acceptance from what I learned in the field there are design changes in the medical device as a way to use biocompatible materials as a way to avoid adverse biological reaction. In other ways features like guards, alarms, and interlocks can aid in manufacturing as a way to prevent hazardous scenarios. In risk acceptance there are calculated risk benefit analysis where  it is crucial to understand whether your benefits can outweigh the residual of risks. These are all important to implement in the work for medical devices.