Author: Bruce Swope | Date: October 9, 2014
The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your medical device startup can bring that once-in-a-lifetime medical device idea to market.
Startups often want their product to have every possible feature they have ever thought of. But they often include features that are not critical to the way the world works. When a lot of bells and whistles are added to a brand new medical device, the timeline increases, the budget increases, and it opens up more scrutiny by the FDA. Requirement creep will be the death of the product.
Advice: Focus on the core functions the device needs to have
The device should be limited to the exact feature set that makes the device safe and effective. This will keep your costs contained so no extra financing is needed from outsiders. Limit the scope of the feature list and concentrate on the core functions to get through the FDA submission process.
If the medical device being brought to the market is something that has never been done before, odds are there are going to be a lot of problems that were not anticipated. The more unprecedented the device functions, the longer it’s going to take, the more it’s going to cost. Murphy’s Law says if something can go wrong, it will.
Advice: When planning your budget, know that it will take longer & cost more than what you think
Planning for Murphy’s Law will make it easier to move past it.
Because the FDA is focused and driven to make sure the product is safe and effective, they require a lot of documentation requiring proof that every scenario has been thought through and accounted for. There is a lot of testing and verification that needs to be done by a strict set of guidelines. If the FDA receives a poor submission package, they will reject it until all the problems have been thought through, costing way more time and money than if had been done the right way in the first place.
Advice: Deliver an airtight submission package to the FDA with someone guiding the process
Understand that the regulations in place are there to help ensure the medical devices are safe for their intended use. Trust the experience of a medical device company like Sterling Medical Devices who has a 15-year track record of successful FDA approvals.
A lot of startups bringing their ideas to the market are often used to being the smartest people in the room. Because they know what they are trying to accomplish with the device so well, they tend not to listen to the experts on the sidelines saying, “Hey, did you think about this or that?” They only want to listen to the people that are telling them what they want to hear.
Advice: Listen to the people who know this space, who have years of experience
Get the right expertise. At Sterling Medical Devices, we know how to build the kind of device you want to build. We can help you develop the product, get it through the FDA approval process, and get it on the market.
The process cannot work if the startup comes in and says, “Here’s my idea, go design it, see you in six months, I’ll love it, and we can submit it to the FDA and start generating revenue.”
Advice: Trust the process, understand what it will take to get to the end, and know that Sterling will be with you the whole time
For the process to work well there has to be a partnership. When the startup company is part of the process, they can see when we are developing things whether it fits their thought process. If it’s different, we can change it right away, and build a better product. Trust the process. Follow the steps. Sterling has been down the road so many times mean we will get your startup down the road as well.
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