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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

@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»