Medical Device Courses | afg28 | Activity

afg28 replied to the topic "Is the Best Medical Device Always the Best Selling Product ?" -

Mon, 19 Oct 2026 03:01:29 -0400

I think the quality of a medical device is one of the most important factors, but marketing also plays a major role in getting a product into the market. A company with better customer support, pricing, and sales relationships can… Read more»

afg28 replied to the topic "Advertising" -

Mon, 19 Oct 2026 02:57:23 -0400

One of my favorite advertisements was the Goldfish snack commercial, where they were the “snack that smiles back.” Many of the commercials built off what happened in previous ones, creating excitement around what would otherwise be a boring snack. This… Read more»

afg28 replied to the topic "Brand Coloring" -

Mon, 19 Oct 2026 02:52:50 -0400

I think a lot of the colors come from the primary colors. Many companies use red, yellow, or blue for their brand. Some of the most common companies are CocaCola, Pepsi, and McDonalds. The colors from these companies and their… Read more»

afg28 replied to the topic "Switching Between Types of Business" -

Mon, 12 Oct 2026 03:27:26 -0400

A medical device company may want to change its corporation type when it begins to grow/expand and encounter increased financial risks, regulatory requirements, or overhead expenses. A smaller startup would want to be an LLC for flexibility and protection from… Read more»

afg28 replied to the topic "Sole Proprietorship or Partnership?" -

Mon, 12 Oct 2026 03:24:13 -0400

Personally I would lean towards a sole proprietorship when starting my own business. This would allow me to maintain control over every business decision and keep the profits without having to share them with a partner. I could reinvest profits… Read more»

afg28 replied to the topic "In-House or Outsource: What’s Best for a Growing Business ?" -

Mon, 12 Oct 2026 03:21:07 -0400

I think companies need to evaluate the costs, risks, and benefits of in-house versus outsourcing. Outsourcing has the potential to reduce expenses and allow a company to focus on its core products (esp for larger companies). It can create challenges… Read more»

afg28 replied to the topic "Regulatory Compliance and Quality Assurance" -

Mon, 05 Oct 2026 00:48:53 -0400

I think one of the biggest challenges with ensuring the safety and efficacy of medical devices is keeping quality control and quality assurance processes up to date with rapidly advancing technology. Regulatory standards are constantly evolving, and I think this… Read more»

afg28 replied to the topic "Unified Quality System?" -

Mon, 05 Oct 2026 00:43:54 -0400

A unified quality system is an amazing idea. I think regulatory agencies are somewhat responsible for providing a unified quality system by providing requirements for medical devices, but there are multiple ways to meet those requirements based on the regulatory… Read more»

afg28 replied to the topic "Can Too Much Quality Control Slow Down Innovation?" -

Mon, 05 Oct 2026 00:40:08 -0400

Budget is a bigger contributor to the slow down of innovation than meeting quality assurance requirements. I’ve seen amazing innovations not pursued since the COGS was not profitable enough. Quality assurance should always be second to patient safety. In industry,… Read more»

afg28 replied to the topic "Predicate Devices and the 510(k) Process" -

Sat, 26 Sep 2026 16:32:46 -0400

Companies completely favor 510(k) submissions over PMA due to their bottom line. New innovations built on top of existing product ideas is the easiest way for companies to break into a market and make a return on their investment. By… Read more»

afg28 replied to the topic "Role of Regulatory Affairs" -

Sat, 26 Sep 2026 16:27:57 -0400

Having a regulatory affairs member apart of a medical device project team in the early stages of development moving through preconcept to concept phase is necessary. They are able to provide insight into the best pathway to approval for the… Read more»

afg28 replied to the topic "FDA rules too strict?" -

Sat, 26 Sep 2026 16:21:42 -0400

I think the FDA has set great guidelines and requirements for approval of devices. Multiple classes allow for a plethora of device types to be approved with a sufficient amount of safety and efficacy data, comparing to devices that exist… Read more»

afg28 replied to the topic "From Pre-Clinical Research to Human Trials: When Is the Evidence Enough ?" -

Sun, 20 Sep 2026 15:02:44 -0400

The FDA is the major governing body in the US that helps researchers understand what data they need to proceed with designing clinical studies. Typically each project team will have a regulatory affairs member who has either worked at the… Read more»

afg28 replied to the topic "Why Is Pre-clinical Research So Important Before Testing on Humans?" -

Sun, 20 Sep 2026 14:30:51 -0400

In my opinion, it depends on what data exists on the type of product you’re making. For example, if you are making a polypropylene mesh as a device for reinforcement, there are multiple meshes already available on the market. I… Read more»

afg28 replied to the topic "Deciding How to Perform Research in Industry" -

Sun, 20 Sep 2026 14:26:37 -0400

Coming from an industry perspective, an academic lab would never be chosen due to the lead time and communication. Many large pharmaceutical companies have sites with vivariums or specialized labs to conduct pre-clinical research. My company typically has someone I… Read more»

afg28 replied to the topic "How Can Project Management Skills Benefit You Without Being a Project Manager?" -

Mon, 14 Sep 2026 03:13:18 -0400

I think you hit the nail on the head. Being able to understand the project’s future needs and crucial milestones allow you to foresee potential factors that could lead to a delay or increase in cost. I think in some… Read more»

afg28 replied to the topic "People in a Project" -

Mon, 14 Sep 2026 03:03:28 -0400

While chemistry between team members is an important aspect of throughput, I think the main factor is trust and respect for one anther. Whether it’s delegation or split responsibilities, the trust in each team member to complete their tasks is… Read more»

afg28 replied to the topic "Teamwork in Projects" -

Mon, 14 Sep 2026 02:54:15 -0400

I think the major challenge is creating a strategy when multiple project team members opinions do not align in. Unless the project is for school, each individual is apart of a project team for a specific function and providing individual… Read more»

afg28 replied to the topic "Experience vs Education" -

Tue, 08 Sep 2026 14:36:01 -0400

Hello there. It definitely depends on the person. I currently am doing part-time graduate courses while holding a full-time position. I do not think I would be able to do a full course load. Each graduate class is demanding and… Read more»

afg28 replied to the topic "Redesigning Medical Devices" -

Tue, 08 Sep 2026 14:29:03 -0400

@randa Hey Randa, I really like your ideas to improve continuous glucose monitors. I wanted to suggest something in addition to your improvements. Do you think it would be possible to implement a prediction curve as well using machine learning?… Read more»

afg28 replied to the topic "Is AI going to control the medical Industry ?" -

Tue, 08 Sep 2026 14:23:39 -0400

Hey there! I currently work in industry and would like to provide my perspective on whether or not AI will control the medical industry. I do not think it will completely control the medical industry. I think it will allow… Read more»

afg28 replied to the topic "Academia VS Industry: What Draws You In?" -

Tue, 08 Sep 2026 14:18:39 -0400

Hello! You ask a very thought provoking question. I was in the same position when I graduated from undergrad and wanted to decide whether or not I pursue a PhD in academia or go straight into industry. I’ve come to… Read more»

afg28 became a registered member

Tue, 08 Sep 2026 13:59:13 -0400