My SWOT analysis of a start-up stent company is as follows: Strengths – The innovative technology and advanced material is able to enhance the performance and durability of the internal stent significantly. Having an experienced medical device design team who…   Read more»

Hi Cassie, you are absolutely correct. A sole proprietorship is indeed an unincorporated personal business, not a corporation. A sole proprietorship is essentially an extension of the individual who owns it. There’s no legal separation between the owner and the…   Read more»

Regulatory agencies like the FDA and EMA are interesting because while they are government organizations, they operate with many similarities to a business. They are responsible for ensuring the safety and efficacy of medical products and their financial structure plays…   Read more»

If I were given the opportunity to build my own business, I would focus on creating a venture rooted in innovation and adaptability and align it with current technological trends. Due to my personal interest in medical devices, my goal…   Read more»

To answer the overarching question: yes. Audits play a critical role in assessing whether QA and QC are following proper protocols. However, they are only part of a much broader system for ensuring compliance and quality. In your case, as…   Read more»

Several key challenges are met when trying to ensure medical device safety and efficacy in the face of advancing technology and shifting regulations. For example, rapid innovation, especially with complex software and connected devices, demands rigorous validation and risk management…   Read more»

I agree with the points above about the importance of quality assurance and control in ensuring a product’s safety and effectiveness throughout the production process. In addition to this, I also want to introduce the idea of continuous improvement methodologies,…   Read more»

Both product development and post-market management are critically important to the regulatory process, but they impact projects in different ways. Product development is important for ensuring medical devices are safe, effective, and meets the necessary regulatory standards before it reaches…   Read more»

The classification of an adhesive designed for interna use in medical devices on several factors, including the intended application, the materials used, and how the adhesive will interact with the body. The FDA classifies medical devices in three categories: Class…   Read more»

I think the way the FDA handled the COVID-19 vaccine rollout from 2020-2021 was a significant achievement, although it had its flaws. They were able to balance the urgency by the government and public to release a vaccine with the…   Read more»

During my undergraduate studies, I did research in a brain trauma lab where we primarily used mice and rats. For every test we wanted to run, whether it involved administering substances or inflicting injury, we had to write and submit…   Read more»

Building on the points already mentioned, another key difference lies in the documentation and reporting requirements between industry and academic research. In industry, it is essential for documentation to be detailed and structured, not only for regulatory compliance but also…   Read more»

Making sure a medical device is biocompatible for the duration of its lifecycle is crucial. This prevents adverse reactions such as inflammation or implant loosening. Manufacturers can achieve this through careful material selection, like titanium alloys, which have the ability…   Read more»

Understanding the project management phases, every phase is necessary for the project to be complete thoroughly with a successful final project. That being said, I feel that the phase that would be the most important would be the phase where…   Read more»

From my experience both in a research lab and in industry, having “too much detail” depends on the task at hand. For instance, if I am running a rodent behavior study and I have preliminary data from a previous experiment,…   Read more»

One lesson that I have learned from using Gantt charts to structure a project is leaving buffer time in as many places as possible. I would initially look into the range of time each step takes and make my baseline…   Read more»

There are two ways to look at this question – from the viewpoint of the employer and the employee. The employer may like an overqualified employee as they know they will produce good work, but at the same time, that…   Read more»

I mostly agree with the arguments that grades and GPAs are not important in industry, but at certain times in an individual’s career or in certain fields, these numbers are important. For example, if someone is trying to get a…   Read more»

When deciding between academia and industry, both the financial compensation and the long-term benefits need to be reviewed. Industry will give a significantly greater paycheck but lacks the tenure that academia offers. Working in certain industries, the work is mainly…   Read more»

Similar to other responses, I also have not had to write a lessons learned document for a job before. From the different courses and projects I have been a part of, I see it to be beneficial for a full…   Read more»