How to take the headache out of the FDA approval process for medical devices

Simplify meeting FDA clearance requirements for medical devices

Arguably the biggest hurdle to overcome when taking a new medical device to market in the United States is getting your premarket approval. You and your product design company must imbue every step of your process with the necessary regulatory and compliance requirements to ensure the FDA submission process will be a smooth one.


Red flags to know when product development services should be outsourced

Defining how product development services should be outsourced

For researchers and entrepreneurs, taking an innovative medical device to market requires careful planning. To successfully commercialize a medical device, outsourcing key aspects to suppliers of product development services can prove highly beneficial. It frees up resources to focus on what you do well. So, how do you plan what to outsource?


Avoid these common pitfalls of medical product design

Common pitfalls of medical product design and how to avoid them

Medical product design is a complex process that involves research, product testing, clinical trials and regulatory prep work before you can even start thinking about bringing your device to market. Your research and development team must make sure the medical value proposition is innovative, helps solve a tangible medical problem and benefits both medical staff and patients. But you also need to consider pitfalls that could jeopardize your device’s commercial potential.


How do you know it is time for product reinvention?

Product reinvention: the key to a successful new medical device

In their Medical Device Innovation handbook, William K. Durfee and Paul A. Iaizo, of the University of Minnesota, give an in-depth introduction to medical device innovation. This comprehensive overview covers all facets of developing a device from idea to commercialization. Let’s look at how reinvention can help you take your device to market.