I currently work as a Technical Writer for a company that offers healthcare technology solutions such as biomedical equipment rentals, technology management, as well as technical service for hospitals and medical facilities. Since my company is ISO 13485 certified, we…   Read more»

I have signed many NDA’s and my advice is to read the entire document carefully prior to signing. After signing, I strongly advise asking exactly what details are bound by the NDA. Sometimes an NDA covers a lot of information…   Read more»

My company recently acquired a contract which would increase our business by 35%. My department was reallocated to help build the infrastructure for the company to successfully operate this new business venture, and it all began by signing an NDA….   Read more»

I would prefer to work for a company that employs a functional organizational structure because it seems to be the most intuitive form of corporate hierarchy. I currently work as a technician for a company that follows a functional structure…   Read more»

In order to succeed in an upper management position, it is important to understand the industry. In my opinion, the best way to fully understand an industry is to work from the ground up. I had the pleasure of working…   Read more»

I currently work for a healthcare technology solutions company that provides rental service, inventory management, and technical service for medical equipment in hospitals throughout the country. The operation of this company boils down to three core branches: sales, logistics, and…   Read more»

Brainstorming is a fantastic method to quickly generate a list of potential risks, however sometimes a brainstorming session seems to hit a limit. I have found from my own experience that introducing the actual product to a brainstorming session can…   Read more»

When thinking back upon my previous projects from academia, I realize my project teams always followed the same process when performing risk management. We would initially get together as a team and have a brainstorming session in order to list…   Read more»

Another benefit of post-market surveillance is determining whether preventive actions from risk management processes have been effective. This can be done by simply reviewing the risk register along with data from the post-market surveillance and observing the frequency and impact…   Read more»

My closest experience working with design controls was when I developed a surgical stapler testing apparatus for my undergraduate senior year capstone project. My team and I implemented the twelve-step engineering design process to effectively develop our idea from concept…   Read more»

Each part of the Design Development Plan has its own importance however the scope management plan is especially important because it sets boundaries for the project. A project can have excellent communication and quality protocols however without a strong grasp…   Read more»

After a device has been released it may experience common failures that lead to a recall. When a recall is issued, the manufacturer typically investigates the failure and develops a recall remediation. This may be a software update, a component…   Read more»

The design input document and design specification document each play an important role in design controls as they are the documents that proclaim official descriptions of the design. After gathering a list of user needs and requirements, the design team…   Read more»

Verification and validation testing are performed to ensure that the project results align with the correct user needs and specifications. Rather than looking at it from the perspective of satisfying the FDA, validation and verification testing should be viewed from…   Read more»

Meetings can often cover a lot of material and if meeting minutes are not recorded then there is a decent chance that some of the topics will not be acted on after the meeting. I have participated in meetings regarding…   Read more»

In most circumstances, I advocate the “Right to Care” act due to the simple fact that this may be the last resort for terminally ill patients. Rather than focusing on the pros of this act, I would like to focus…   Read more»

I understand that placebo studies may provide the necessary research in order to advance technology and healthcare, however I believe they can sometimes be unethical. For example, if a patient is battling a vigorous disease and they believe they are…   Read more»

Clinical studies are necessary for the advancement of medical technology and medication. Assuming the application of the product provides ideal results, the primary advantage of a clinical trial is simply the access to this particular treatment over other common treatments….   Read more»

This is my first time watching “The Expert” but not my first time finding humor in certain corporate policies and norms. What makes “The Expert” funny is subtle truth behind the content. My coworkers and I laugh quite frequently at…   Read more»

I recently saw an advertisement from GoPro that did an excellent job promoting their newest line of cameras. For starters, the entire advertisement was filmed using the product that they were promoting. This was really impressive because the advertisement contained…   Read more»