If I was running a risk management meeting, the first thing I would do is ask the team to review IS0 14971, because it is basically the bread and butter for risk analysis for medical devices. I would have a meeting to assess the the risk/hazards with the project team and other project managers, depending on how big this project is. As the leader…[Read more]

There are many risk management plans for different backgrounds. In the medical device industry we base our risk management plans on ISO 14971. Every time we mention risk management I think of ISO 14971, because the medical devices companies have to be comply with ISO 14971. In this industry of design, manufacturing, research and development, the…[Read more]

In my current company it all depends on which department you work for. The department I work for is a functional organization. I know most engineers in other departments are assigned to a project. In other departments they have engineers jump from one department to the next based on the projects assigned. I personally view this as both good and…[Read more]

That’s really interesting, because I believe it all depends on the company. The question can arise, why should customers and funders buy and fund your products? In my opinion, if the company has a product that they believe can make money then funding will not be an issue. I believe companies should go for a projects. If the market is right and t…[Read more]

During my undergraduate I did an internship over the summer at a medical device company that developed knee and hip replacements. The company’s customers were mainly doctors. I remember we use to get feedback from surgeons around the country on what they thought about the knee and hip replacement products. It seems medical device companies main…[Read more]

In my recent experience I worked for both matrix and functional organization structures. I found that functional organizational structures much more efficient than matrix organization structure. I am not saying matrix structures do not work, but communication was very difficult. In some cases we had to set more meetings just to going over and…[Read more]

I also prefer the functional organization structure. This structure seems like an overall structure of many companies. The employees are managed by a manager with experience in the same specialty who can understand and review the staffs work. If you’re an engineer, for a medical device company your boss would most likely be an engineer. I b…[Read more]

Those are two really big issues you brought up. How safe is the data being transmitted? What happens if the sensor is not capable of working? There are cases where sensors do not transmit correct data or do not transmit data at all. In my opinion this device should not be used in emergency. We are not sure how reliable this pill is. That is why I…[Read more]

In my opinion I feel that this is more of a drug then a device. The purpose of this drug used for schizophrenia and act as a sensor second. Patients who are taking the drug are using the sensor to monitor the patients behavior, through the reaction of the drug. Even though the overall goal is for the patients to track their information from the…[Read more]

I completely agree with you. This does have a restriction on engineers, creating new innovative ideas. Medical devices basically have to be pre-existing. This week in the lecture we learned about CDRH. The goal of CDRH is to bring innovative technologies to market, by insuring that the medical devices out in the market will advance and continue to…[Read more]

I consider that a mobile “medical” app as a medical device. If you are using that device to collect clinical data it should be considered a medical device. During my capstone project, we programmed an accelerometer and medical monitoring device. This device was connected to the user’s phone which was considered a “medical device”. In your case…[Read more]

According to the FDA the fitbit is classified as class II. It’s funny, something so small such as a fitbit runs on algorithm has to be regulated and considered to be a class II. During my capstone project we also programmed accelerometer that could count a patient’s steps and we wrote an algorithm that could tell the user if they are walking n…[Read more]

Interpersonal skills are crucial when it comes to working in the industry. We all work as teams and sometimes your peers will not agree with on another. That is why interpersonal skill are really important. In my opinion verbal communication and listening is the most important. As a team, coworkers need to have a strong ability to listen and…[Read more]

There is a clear difference between a patent and a NDA. First of all a patent is a legal document that gives you or a company a legal binding of ownership that is reinforced by penalties. The NDA is a contract that is limited. If we are comparing the two by law, a patent is far more power than NDA. NDA seems like a good security blanket but not a…[Read more]

I agree with you, lets say a company is getting sued, no verbal agreement will be taken into account in court. There is no proof that will back your claims. Only written agreements are known to be reinforce your case. In all legal matter you need written agreements because some people say one thing and do another.

Verbal agreement and Written agreement are totally different. One is more important than the other. First of all verbal agreement nothing is guaranteed. Verbal is all talk, and most of the time it is just discussion on what ideas they have and basically it is a discussion on what they will do. In my opinion nothing should be done until it is set…[Read more]

I agree with you, I also prefer the Functional organization if you are starting up a company. Yes matrix organization seems a lot more helpful, let’s say some is stuck and needs help there are many people who can help them. However there are many strict guidelines and challenges if you are just starting up. In Matrix organization there are many…[Read more]

I agree with you that communication is a major key in team work. Communicating as a team makes the work a lot easier and working as a team. If their is no communication this can lead to group conflict and finger pointing. Communicating as team is important because let’s say one member of a team is struggling. He or She can get ideas or help from…[Read more]

I believe this can go either way. In a company people build relationships with other people and they work as a team. In my opinion it is better to work with a team of individuals who are more knowledgeable in their department. However in the industry you really do not get to choose who you work with. For example let’s say you work for a large…[Read more]

As we all learned in risk management, Failure Modes and Effects Analysis (FMEA) and fault tree analysis (FTA) is a valuable tool used to evaluate errors in medical device designs. In my opinion if risk analysis evaluated earlier there is a chance where potential errors can be corrected or they can identify it later so they can correct the flaws or…[Read more]