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. The design control process starts and ends…   Read more»

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 original design inputs. If the project team interpreted…   Read more»

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 approved indication. This type of…   Read more»

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. Design control processes as a whole ensure that processes…   Read more»

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 for the device/project. Without meeting minutes, it becomes very tough to…   Read more»

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 discretion of operations leadership. From pre-concept development through product…   Read more»

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 discretion of operations leadership. From pre-concept development through product…   Read more»

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»