In the company I work for, I’ve seen several user requirements documents as well as risk analysis forms which include user requirements embedded with defined risk levels. User requirements documents help define the product because they come from the customer’s needs. It is our job to translate the need of the customer into tangible specifications…[Read more]

Working in industry I’ve had the chance to utilize gaant charts to structure a project which is focused around transitioning our documents to the latest ISO 13485:2016 standard before audits this month. By doing so, I had to make sure that each member of the team had actions relevant to their area of expertise as well as keep them accountable and…[Read more]

Design review meetings are essential to ensure that the design adheres to both each stage of the Product Development Process as well as provide feedback per each stage. One of the design meetings I went discussed the whereabouts of the validation of the project. The meeting was held by several members of the team. One of the lead engineers…[Read more]

To add to the discussion I believe that a complete Design Control System maintains the established feedback loop where the product is documented adequately while providing room for improvement along the development stages. The FDA, as previously mentioned, looks to see that the company adheres to their procedures and that they do not stray away…[Read more]

To add to the discussion, meeting minutes allows the team to ensure that every action is accounted for. Also a missing member can be brought up to speed with the meeting minutes and then briefly supplemented with a 5-10 minute information session to clarify any questions he or she may have in base of that. Meeting minutes are also used as a legal…[Read more]

When making a gantt chart, it is crucial to have met certain criteria. In my current job, I had to develop a gaant chart in order to facilitate a steady transition of ISO 13485:2003 to 2016. There the gaant chart has allowed myself to coordinate with the project manager as well as the directors to ensure that each department is able to meet the…[Read more]

A mission statement describes the company’s reason as to why they exist. This differs from the vision statement where the company states what the future successful state of the company would be. These are important in goal-setting because they serve as the foundation for goal-oriented approach. A company or individual can utilize these two…[Read more]

Emotional Intelligence primarily focuses on how an individual is able to identify, consider and control their internal emotions as well as identify these in others. This involves various aspects of self-awareness, self-management, social awareness and relationship management that can be applicable to all aspects of everyday life.

One way to know…[Read more]

The company that I chose to focus on is Stryker Corporation. Stryker is best known for their development of orthopedic products and implants, patient handling and emergency medical equipment, to name a few. SWOT Analysis is a way of evaluating the Strengths, Weaknesses, Opportunities and Threats that affect the company. One of Stryker’s strengths…[Read more]

Main difference between a public and private company is that a public company sells a part of its business to the public through public offerings. A private company is owned by a handful of people. This handful of people usually includes the founder and other investors. Public companies often are faced with the pressure from the market they are…[Read more]

A sole proprietor owns the entire business assets as personal property, as mentioned above. With that being said, it is possible to transfer the company to another person. The sole proprietor is allowed to transfer the business by selling its tangible and intangible assets, essentially transferring the responsibilities to the new owner. Keep in…[Read more]

Personally, I have thought about the possibility of a start-up company but within the biologics/pharmaceutical side. With that being said, I would prefer to create an LLC business. With a Limited Liability Company, I am protected from any liabilities within the present or future timescale. Laws in different states regarding LLCs are also widely…[Read more]

Ways to abide to procedure for all departments can be to collaboratively implement a procedure which all voices partake in the creation of such procedure. That way, upper management involved can hear each others opinions and reach a consensus. Quality and regulatory compliance should have the final say as the goal for medical devices is to be safe…[Read more]

Quality is put in place to police R&D and other departments to ensure that effectiveness and suitability of processes are maintained across all levels. With that being said, both departments are crucial to the business. I believe that at the end of the day both departments must reach a consensus in order to continue progress. One cannot strive…[Read more]

I currently work as a Quality Engineer and still there exists some issues within the quality department. First and foremost, document control. Every procedural change or creation of procedure needs to adhere to document controls standards. Another issue is the lack of solid evidence to back up one’s claim as to why a process exists. The procedure…[Read more]

In 2015, Medline Industries, Inc. had a voluntary recall of one lot of acetaminophen tablets. The issue here was that the bottles were incorrectly labeled as showing 325mg instead of 500mg. The risk of this issue comes from possible maximum dosage intake that may lead to liver toxicity/failure. As a means to prevent and correct this error, a CAPA…[Read more]

Immunostimulating hydrogels are a combination product. Hydrogels depending on the peptide structure are chemically synthesized through peptide synthesis. Designer hydrogels can have small growth factors or biologics attached to the peptide strand that then forms into a hydrogel.…[Read more]

An antibiotic-releasing hip stem would fall under various categories including: device combined with a drug. This is due to the nature of the product. The device portion stems from the provider or carrier of the drug while the drug is the actual functional biologic attached the device. Therefore, an antibiotic-releasing stem would be a combination…[Read more]

Approaching research in an academic setting typically starts when a professor has an idea and decides to use their network to figure out possible solutions. Academic research is approached through interest and exploration. IF a professor is interested in any topic, they can explore it and find the resources to do so. Typically in industry, the…[Read more]

I believe that research done now will benefit both the short term and long term. It depends on the type of research that is being conducted however. Industry related research can be used short term if the results are met at the deadline and don’t require further investigation. However, research into the frontier of innovative medicine may take…[Read more]