The company I work for does utilize a Design Specification document as Dr. Simon had described in this week’s lecture. It includes a design matrix that traces the entire process of the design. It is a living documents therefore it can be updated as time progresses. Within each line of the DID there is at lease one line within the DSD. Each DSD l…[Read more]

From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification. Yes, this is time consuming and can be costly, but it is the cleanest way to reroute the protocols. By redoing the protocol and validation the acceptance criteria will change, but within the…[Read more]

Document History File is more useful than a Tech File in terms of traceability. Document History File is a living document, it contains any mistakes or scrapped information that were made along the process of designing the device. A Tech File only contains snapshots of the final design, it does not explain the thought process which people went…[Read more]

Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives but does not state how to enforce the law. The guidance documents are broken down into three components:
1. MEDDEV: written by the Competent…[Read more]

I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning about it the pacemaker. A pacemaker is considered in the EU as an Active Implant Medical Device. It is composed of an electrical circuit which stays…[Read more]

Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA makes the sole decision on if the medical device meets the regulations. EU regulatory is split into:
1. Competent Authority: Similar to the FDA but each country has their own Competent Authority.…[Read more]

One of the major marketing strategies used within the company I work at is the fifth P. Our products are mostly used by surgeons and physicians; therefore, the marketing group will hold meetings with hospitals to discuss the product. The customer, in our case doctors and surgeons, would provide feedback on ways to improve the device. This creates…[Read more]

Personally, I have not experienced working out a legal contract at work first hand. However, I was informed that our company had a major fall through with a legal contract with a warehouse that distributes our main products. The timeframe to finalize the contract had taken months because the legal department had to be involved. After the contract…[Read more]

Two years ago, I was working in a human performance lab that was gathering data on neuromuscular activity from patients after chemo treatments. The focus of the research was to see how chemotherapy from breast cancer survivors has affected neuromuscular activity. While working in this lab I realized the 3D printing trend which was occurring also…[Read more]

I never directly dealt with a non-compete agreement but my brother in law has. He signed the agreement two years ago and found out recently the consequences of it. When he decided to defer his contract, he was obligated to pay the company 3 months of his salary. He also needed a lawyer to complete documentation to allow him to leave the company…[Read more]

Verbal agreements much be accepted by the law, but I was always taught that “if you don’t have it in writing then it doesn’t mean anything.” This saying comes into use whenever I work on a project. Whenever I have a meeting, I make sure to have meeting minutes sent out to all participants to reinform them of the agreement and disagreements made wi…[Read more]

This course was very beneficial in learning about the different design controls, business and regulatory aspects of the medical device industry. I previously took your project management course and preferred that structure of the course over the medical device course. The simulations helped instill the lessons taught within a certain time frame…[Read more]

Based on my experience, a functional organization seems to work well in large companies. Yes, a disadvantage is the creation of silos but that can always be resolved. Having an IT, marketing, finance, quality, manufacturing departments allows the members of those departments to specialize in a specific tract within that department. Therefore,…[Read more]

I work as a product engineer at a company which has a matrix organization and the one constant is disagreements between departments. Whenever we have a major project we have meetings with the lead of each department to discuss the changes being implemented within the project. Everyone states their views and we settle any conflicts within that…[Read more]

As an undergraduate I had to form a project team for a senior design project and I formed a group with two other friends. I worked with these two friends previously on other projects and we worked extremely well with one another. We all carried a skillset in a subject such as mechanics, electrical and coding. Sometimes it is advised not to form a…[Read more]

At Getinge, the sample size is determined mostly from the risk index. Since Getinge’s main acute therapy product is Intra-aortic balloons the risk index significantly changes the sample size while running a protocol. Recently, I was helping a senior engineer deal with a CAPA on IAB leaks within the tip seal. We wrote up a protocol which had to t…[Read more]

As a co-op at Getinge I was able to work on a project associated with updating the PFMEA (process failure mode effects analysis). This one document lays out each process for creating the final medical device for each product line at Getinge. It defines the risk of each process, the probability of the risk occurring and the severity of the risk.…[Read more]

The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to mitigate, eliminate, prepare for risks which can have an economic effect on the medical device. Despite the economic toll on reducing the risks of a medical device, it is necessary to keep the saf…[Read more]

Deviations that come from the verification step of a design control always causes a havoc at work. Recently, I was trying to qualify a modified fixture for use on the production floor. The drawing was completed, the fixture was built and read for qualification. I began to execute and installation verification and function verification test to the…[Read more]

I am a production engineer at Getinge, and last week was my first time leading a design review meeting. The preparation for my design review meeting was intense since I was covering phases I-III in one meeting. I had to create a design review proposal, agenda, checklist plan. Along with getting regulatory’s feedback on the project proposal and f…[Read more]