I couldn't agree with you more. The customer needs which are drafted need to be properly defined before developing a product, as these needs will ultimately drive the direction of the design process. ...

I think if the product met the design verification specifications but did not meet design validation, the design inputs were poorly defined to begin with. Specifications are made based off of the orig...

In my experience, it is common for devices to be further developed after launch. That can be for a variety of reasons. One of these reasons is to expand the device's indication from the original appro...

Design control is the requirements in place to set product specifications based on customer needs and completing the relevant set of tests on the product to ensure it meets those specifications. Desig...

During my time in industry, I have found it invaluable to keep meeting minutes. Conversation between project team members contributes to strategic decisions and fosters problem solving and innovation ...

In my experience, engineers can advocate and fight for the ideal final design, but the methods used for scale-up and the ultimate final product specifications and characteristics are often at the disc...

In my experience, engineers can advocate and fight for the ideal final design, but the methods used for scale-up and the ultimate final product specifications and characteristics are often at the disc...

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...