After a medical device passes the strict scrutiny of the Food and Drug Administration, it is cleared for marketing in the United States. In general, FDA approval is not withdrawn from a device so long as no material changes are made to its design or intended purpose.
The medical device industry represents a tremendous business opportunity for innovative firms. Part of the reason is demographics. In 2016, the National Institutes of Health reported that the world’s older population was growing at an “unprecedented” rate.
The medical device industry is one of the most heavily scrutinized and regulation-driven in the world. Regulatory challenges expand beyond the most sophisticated markets: Although the U.S. accounts for about 40% of the global market and Europe about 30%, high quality standards prevail in smaller blocs and nations as well.
Healthcare sector stakeholders are unlikely to change the way they operate to accommodate your new medical product unless it benefits patients and professionals alike. Similarly, your product must be future proof.
So, what steps can you take to make sure your medical product design provides value to stakeholders, both in the present day and the future?
Enticing investors with a good exit strategy for your medical device
When developing a medical device, you need to have a sound exit strategy that paints a clear financial and marketability picture for prospective investors. Your exit strategy should be heavily influenced by your product development cycle. As such, it’s important to make the right decisions as early as possible, like choosing the right prototyping services provider.
The benefits of outsourcing medical device prototyping for product development
Medical device prototyping is crucial when designing a new medical device. Without it, your concept will never materialize into a commercially viable product. It’s your opportunity to put the real-life applications of your product to the test. These are the applications, after all, that will sell your device when it’s on the market.
How to enhance your medical product design processes
Innovative medical product design requires a lot of planning to ensure an optimal product development process. It will increase your chances of successfully taking your product to market. What should you include in your medical product design plan?