This is a great question. Prior to FDA or BSI audit, the quality department of the company prepares for the audit in gathering few DHRs (Device History Records). From the auditor’s perspective, he/she ensures that the company meets its own…   Read more»

I agree with most of the participants in terms of the importance of Quality Department in a medical device industry. I’ve worked as a Quality Engineer for 2 years in a medical device company and I’ve witnessed the importance of…   Read more»

Recently, in the April of 2017, Zimmer Biomet recalls Implantable Spinal Fusion Stimulators due to potential of harmful chemical which may be toxic to the tissues and organs. FDA has classified this recall as a Class I recall, most serious…   Read more»

A de Novo approach is efficient in getting the approval from the FDA and launching the products in the market rapidly. It’s used for new devices that has not been previously classified by the FDA. FDA uses a risk-based strategy…   Read more»

One of the major pitfalls that may arise in animal study is the delay in testing and the time the specimen is received from the supplier. Due to the demand for animals for many pre-clinical trials, it is important to…   Read more»

I agree with most of the participants in the posts above that there are pros and cons of academia versus industry. I believe there is a mutual relationship between the two as industry is based on the research performed by…   Read more»

There are multiple biocompatibility tests that needs to be carried out on the product prior to clinical trials. These tests must comply with the ISO 10993-1, Biological evaluation of medical devices. As per the ISO 10993 standard, biocompatibility tests include…   Read more»

During my undergraduate capstone project, we created a Gantt chart using Microsoft Project to guide us and better visualize the timeline of the project. In the Gantt chart, we divided the project into three parts, brain storming, designing, and testing…   Read more»

In my experiences, I have never worked in a project with multiple project managers. Many times, there are project leads that support various activities within a project. By having multiple project managers, it makes the communication with the team difficult….   Read more»

In my opinion, the greatest advice that I would give to incoming BME students is to network as much as possible. Networking is a key tool to get internships and co-op experience. Industry experience is important to succeeding in the…   Read more»

I agree with most of the participants in the posts above that there are pros and cons of academia versus industry. I believe there is a mutual relationship between the two as industry is based on the research performed by…   Read more»

In my opinion, I don’t think 70:30 is a good ratio of academic courses versus practical courses. Academic courses are great in terms of getting a good understanding of the concept and processes used within medical devices. However, practical courses…   Read more»

I believe this type of issue is very common in workforce and I am not surprised. If one wants to convey his or her message across, then without arguing with the upper management, should plan an alternate way. There are…   Read more»

Many people leave work due to different reasons. For some, it’s the family or the commute and sometimes it’s the employer and the salary. Employers should have a career path set up for their employees to keep them motivated and…   Read more»

This is a great question to discuss. After graduating from college, I would start working as an engineer or at least be on the technical side of a project. I believe most people choose this path to gain some experience…   Read more»

In order for a team to be motivated, the PM should consider new ideas and challenging ways on the current project. And yes I believe that the PM level of motivation directly affects the team’s productivity as the PM is…   Read more»

In my opinion, I believe the results above are not surprising. After talking with few people in the industry and seeing it myself through internships for 2 years, it’s clear that employees need to be challenged and that the employers…   Read more»

This is a really interesting topic to discuss. What motivates me is something challenging and realizing that the work I do everyday improves human life. I like it when my brain is busy doing something for a good cause or…   Read more»

During my capstone project, we had several mini projects to accomplish in order to complete our final project. For example, our project was to create a device which measures three parameters, blood glucose, activity, and oxygen rate and transfers this…   Read more»

During one of the project in my internship, I had to perform Gage R&R studies on few parts in order to validate the measuring equipment. I planned out a strategy and started working on testing out few parts. After about…   Read more»