If given the choice to open my own business, I would file my business as Limited Liability Company (LLC) over a Corporation. There are many reasons in terms of Taxes, Business Ownership, and Business Operation. In an LLC, one has the flexibility on how to file taxes. Unlike, corporation, LLC’s is treated as single taxation. On the other h…[Read more]

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 Quality System. The auditor assesses the company’s quality system and compares with the few lots rec…[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 QA/QC. I agree that due to documentation and other quality requirements may delay the project. However, it helps the…[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 type of recall. Class I recall may lead serious injuries or death. The Spinal Fusion Stimulators are used…[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 to classify the device into Class I or II. New ruling of de novo process has streamlined the entire process by m…[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 have multiple animal suppliers. Also, outsourcing an animal study 1000 miles away involves transportation cost. One must allocate…[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 academia. In academia, there is no profit or money involved and its heavy research based environment. On the other hand,…[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 cytotoxicity, sensitization, hemocompatibility, pyrogenicity, genotoxicity, and…[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 and allocated specific time for each part. During mid-semester, we realized that we missed…[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. The Project Manager has a high level of understanding from the project lead and the…[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 field. It will be very smooth transition for an individual with a co-op background and industry experience.…[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 academia. In academia, there is no profit or money involved and its heavy research based environment. On the other hand,…[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 are important as it provides you an examples of real life industry problems. Without practical c…[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 many factors that affect one’s performance by going over the limits. For example, it can put his or her job with the company i…[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 prevent them to quit. Many people also leave work is because they are tired of working on the same issue forever, the…[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 technically as an engineer and move up to management. I want to work 6-8 years as an engineer to gain more insight into the…[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 responsible for delivering the communications to the team. I believe, the PM shouldn’t have a mindset of a manager, and more of…[Read more]