One of the biggest concerns most Americans have is staying healthy. While eating less fast food and routine exercise will help you stay healthy, there may come a time when you need help from a medical device. People all over the world use medical devices from everything from checking blood sugar to regulating the functionality of their kidneys.
Last year, the Food and Drug Administration (FDA) approved around 106 new medical devices. If you have a great idea for a medical device and want to bring it to market, you need to prepare yourself for a lot of hard work. The process of getting a device manufactured and approved can be an arduous one.
Read below to find out more about this process and what you need to do to avoid problems.
Work On Protecting Your Intellectual Property
Do you already have a detailed design of your new medical device? If you answered yes, your main goal needs to be protecting this design. Some medical device inventors make the mistake of giving copies to their design to larger device manufacturers. Unfortunately, this can result in the design being stolen and sold under a new name. Instead of letting all of your hard work go down the drain, you need to work on protecting your intellectual property.
The best way to do this is by working with a lawyer who has experience with intellectual property cases and patents. With their guidance, you can get the ball rolling on filing for a patent and protecting your invention. Having the right paperwork will allow you to avoid getting taken advantage of by larger medical device corporations.
Developing a Regulatory Strategy is Imperative
One of the biggest hurdles you will face as the designer of a new medical device is getting it approved. The FDA has very strict and detailed guidelines medical device manufacturers and inventors have to follow. Before you even begin the device development process, you need to fully understand these regulations. By doing this, you can avoid developing a device that will have a hard time getting approved.
If you are unsure about certain aspects of the FDA’s regulations, seeking out the help of a consultant is probably a good idea. Working with a person who has developed a device widely used by individuals with the best health insurance plans is vital. With their guidance, you can avoid mistakes during this development process that may derail your chances of getting FDA approval.
Have a Clear Budget in Place
Some medical device developers fail to realize how important finances are to their overall vision. The development, testing and overall approval of a new medical device can be very expensive. Ignoring the need for a detailed and comprehensive budget will usually lead to disaster in the long run. If you are new to the medical device development world, then working with people with more experience is crucial.
Doing things like outsourcing lab testing of a medical device is a good way to cut costs a bit. Without the use of this outsourcing, you will have to build a lab and hire employees to do the testing needed. Before outsourcing any part of the medical device development and testing process, be sure to do your homework.
You only want to work with companies that have a track record of providing top-notch testing and development services for a reasonable price. Rushing through the hiring process may lead to mistakes being made, which is why weighing all of your options is a must before making a decision.
Establish a Need For the Device
Another important thing you need to do before developing a new medical device is establishing the need for it. With a bit of market research, you will have no problem seeing if there is a product like yours available. Even if there are similar products, don’t get deterred. Finding a new feature or approach to a pre-existing product can help you attract more attention from consumers.
Persistence Will Pay Off
While getting a new medical device approved and in the hands of consumers will be difficult, it is worth the amount of work you invest. With the help of seasoned professionals, you can avoid problems throughout this development process.