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, pricin...

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...

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...

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...

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 t...

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 (es...

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. ...

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 mu...

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 a...

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...

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 i...

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 ...

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 affai...

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...

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 ...