During my capstone project unfortunately we had many critical path situations. Our project was a monitoring device, using a blood oxygen sensor, and accelerometer that can transfer data to a secure UI. Our goal was to make this monitoring device…   Read more»

A lot of companies use gantt charts, and it is a very useful tool. I believe using gantt charts for medical devices helps see the overall picture from the initiating phase to the end phase. It is helpful tool to…   Read more»

Like many have stated, some pitfall will occur. Things like holidays and days off could slow a team down. That is why many teams and companies use gantt charts, to organize their tasks. I believe as a team or an…   Read more»

I remember during my undergraduate capstone class, we had to create a budget for a grant we received. We list all the materials we needed for this project. The biggest problem was we needed sensors and that came from europe….   Read more»

I also agree with the others, the capstone class is a great example and experience of monitoring and controlling. During my project, there were many times were we fell behind schedule mainly because of our code and electrical components did…   Read more»

Risk analysis is crucial for medical device companies. Medical device companies has to be safe and service efficiently. I do not think there is a specific ratio, because the less risk companies have or more awareness the companies know about…   Read more»

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…   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…   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…   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…   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…   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….   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…   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…   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…   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…   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….   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…   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…   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…   Read more»