A medical device is my capstone project, AudIQ, which is a mobile application that trains people with hearing aid’s auditory cues. One possibility of risk of the product is the application does not control the level of sound it outputs when training. This risk can be detrimental to the user because an app that is meant to help someone’s hearing can potentially damage one’s hearing. This can even cause customers to avoid purchasing the app. My team and I managed this risk by building an algorithm that decreased the volume level to a safe setting whenever the app was opened. Moreover, we did not want to lower the voice too low that the sound was not even audible. So thus, an algorithm in the app lowered the volume to a default safe volume. This is using the avoidance technique to handle the risk. Some ways to measure the risk is to conduct a literature search on what volume is safe for hearing. Then, apply this finding in the algorithm. After the algorithm is implemented in the app, we can run the application and observe if the algorithm set the volume to a safe level when the application starts up.

Last semester in medical device course, I worked on a medical device project called Automated Chest compression machine and my role was to analyze the risk. The most common risk in this device is bone breakage (sternum, and ribs) and organ damage expected during CPR process because the worry of causing a break shouldn't deter people from helping someone in cardiac arrest. Risks can be control or mitigate by providing appropriate employee training before using the device. In the U.S, current CPR recommendation call for chest compressions to be at least five centimeters (about two inches) deep, at a rate of 100 per minute or faster. There are many factors to considered the reason for bone breakage such as age, weight, gender and if CPR performed by someone other than a doctor are more likely to end up being broken bone. The way to measure the risk must be weighed against the expected benefits, including the type of benefits, the probability of the benefits, and also account the severity of the disease device is intended to treat. All of those risks can be verified by design validation and verification process and human factors testing.

For the most part, hazard administration is the way toward measuring, or evaluating danger and after that creating methodologies to deal with the hazard. When all is said in done, the systems utilized incorporate exchanging the hazard to another gathering, staying away from the hazard, diminishing the negative effect of the hazard, and tolerating a few or the majority of the outcomes of a specific hazard. Customary hazard administration, which is examined here, concentrate on dangers coming from physical or legitimate causes ( catastrophic events or flames, mischances, demise, and claims). Money related hazard administration, then again, concentrates on dangers that can be overseen utilizing exchanged monetary instruments. Notwithstanding the sort of hazard administration, every single extensive organization have chance administration groups and little gatherings and partnerships hone casual, if not formal, chance administration.

For my Capstone Design class, my team was in charge of developing a wearable watch for autistic kids. This watch would be connected to an Android app which would be developed by us as well. The purpose of this product is to send messages to the kids while they are in class, the messages would include positive reinforcement, pay attention and negative reinforcement. This device would greatly help high functioning autistic children and adults integrate into society. These individuals tend to lack social awareness and require cues to guide them into the correct behavior. However, these individuals also tend to lack the attention to be alerted by their aide’s subtle cues (these cues tend to be small movements such as the rubbing of a chin or tapping a wrist). One possible risk of this device is that the desired frequency of the vibration of the watch calls the attention of the kid in such way that it becomes a distraction and that is not the goal of the product. The way we will make sure this problem does not occur is that we will set short and sharp set of vibrations for each command send from the app. This type of vibrations will call the attention of the user and will make him do what the command is telling me he should do. If the product fails, the possibilities won’t be as bad as other products. The worst that could happen is that the kid doesn’t feel comfortable with the watch and it is no longer used by the kid.

Let me know what you think!

Sincerely,
Roberto Pineda.

At Zimmer, I was involved with a project where the Case Development team was designing and launching a new case for a product. The case was for a total knee replacement and had compartments for all the tools a surgeon would use to conduct the surgery. As an intern, I did not have a major part in the FMEA process, but I got to work on the FMEA for part of the project. I had to look at the outer components and analyze the criticality and risk should a failure occur. We had preliminary dFMEA's available but I had to come up with additional failure locations and analyze them on the appropriate blueprint and write what was called a FIP or Feature Inspection Plan. After I wrote the FIP, I got approved by the senior QE's and higher up on the corporate ladder. To answer your question, once an area of risk was measured, we looked at the appropriate dFMEA and assigned it a number based on severity. If the component was a critical component and the severity was high, it would have to be re-designed (for the part I did, it was not a major component of the project). The risk was determined by whether or not it would affect the user in any way. Would it cause harm, irritation, etc.

I came across an article on implant dentistry, where the dental claims related to implants often have a high degree of severity. And there were several reasons illustrated for these high claim severity. One, implant dentistry is reallu expensive and costs patients anywhere from $5,000 to $40,000. Second, the patients usually have high functional and aesthetic expectations from the implants and at times they are not satisfied by the outcomes. Most of the claims reported were related to adverse outcomes, need for corrective surgery, permanent paresthesia, improper placement of implant or other less serious issues. Thus an implant risk management is strictly followed by the dentists that includes careful patient selection, thorough case planning and sound clinical technique to minimize the risks to the patients and to reduce the severity of the claims. Proper case selection includes assessing the patient's overall health and underlying diseases. Local factors such as oral hygiene, bone quality, nerve position, occlusion, periodontal status, extent of interincisal opening, keratinized gingival are analysed apart from paying attention to other factors such as use of tobacco, alcohol use, patient attitude, cooperation, homecare, reasonableness of expectations. Once, the acceptable implant candidate is determined the risk shifts to the dentist's own due diligence in planning and delivering the case.His knowledge, clinical ability and experience in implant dentistry are critical factors which determines the success of the implant. To control or mitigate the risks, a thorough
pre-surgical planning followed by good communication with the patient, advance planning to manage the choices and the complexities of implant surgery are involved. Once an informed consent is taken from the patient, a thorough documentation plays a critical role in mitigating the risks associated with the implants.

One medical device of my particular interest would be total knee replacements. One specific risk of knee replacements is loosening due to wear and tear over the years. Worst case scenario the implant would have to be removed, and a secondary replacement system will have to be implanted after resecting even more bone. Companies manage this risk by educating the surgeons on the proper surgical technique using booklets or even certification classes. The statistics on post implant success is recorded to determine if the risk prevention process has been improved.

Following up on what bnb6 said, I think that we should also discuss metal-on-metal (MoM) hip replacements and the special risks they carry. In terms of risk management, they are far less likely to be used now because the risks of use are much higher than the average hip replacement.
For example, additional risks include:
1. General hypersensitivity reaction (skin rash)
2. Cardiomyopathy
3. Neurological changes including sensory changes (auditory, or visual impairments)
4. Psychological status change (including depression or cognitive impairment)
5. Renal function impairment
6. Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold

The US FDA, as well as its equivalent in Canada, the UK, and Australia have sent warnings about this device to surgeons to the point that its use has, as it should have, declined severely.

A medical device I would consider to have significant risk, are contact lenses. Everyday millions of people (guessing, don't quote me), put contacts into their eyes instead of wearing glasses, but have you considered the risk they are taking? If the wearer fail to wash, clean/disinfect, or properly store their lenses, they risk infection. This could be small infection, or could become something more serious like keratitis (causes blindness).
Although not throughly investigated, contact users have more of a risk. The Keratitis does have an annual cost of 175 million in direct health care expenses (not limited to contact wearers).
To prevent this risk, or at least lower it. I would have people start wearing daily contacts. This would ensure there is no cleaning necessary, only proper storage and making sure your hands are clean. Without the hassle of cleaning a repeated lens, there would be less infection. Risk would have to be evaluated by the number of reported cases annually given all types of contact users to assess the effect of daily vs. monthly on preventing infection.