Wherever you are in your product development lifecycle,
Sterling can help.
Author: Erik Hilliard | Date: August 11, 2021
Medical device startup companies play an integral role in the medical device industry. They have the ability to be nimble and take more risks on a unique product that larger, more established companies don’t often have.
But, embarking on a new venture comes with its fair share of challenges, and startup medical device companies are no exception. The path medical device startup companies take to getting their a medical device on the market is normally a long, and expensive, road. Budgets and timeline are a common enemy for all product development, and with medical device startup companies using investor money to complete, it can be even more pressing and stressful. Sterling Medical Devices has been developing medical devices since 1998, and we have seen medical device startup companies make some common mistakes.
Medical device startup companies often want to come out strong with their first product, with every advanced feature they can dream up. But adding all the bells and whistles to your device will likely increase your budget, lengthen your timeline, and subject it to added scrutiny by the Food and Drug Administration (FDA).
Our advice: We counsel startup medical device companies to focus on perfecting the core functions of the device and save the extra features for later, especially those that are not critical to how the device meets the intended use. Once the core elements are solid, then turn your attention to the added features. This will keep your investors happy, get your product to market faster, and prevent the FDA requirement creep for your device.
If yours is one of the medical device startup companies aiming to bring a device that has never been produced before to the market, the odds are greater that challenges will arise that are difficult to plan for completely. The more cutting edge and unprecedented the device is, the more time it takes to develop the technology, the extra nuance the FDA will require to review potential concerns, which lead to increased cost.
Our advice: Be aware that it will take longer and cost more than you might anticipate, and plan for it in your budget and timeframe. Understanding that technical challenges will occur, that the FDA will scrutinize your information, planning for these challenges better equips medical device startup companies to overcome them.
The FDA’s primary concern is that your product is safe and effective, and its approval process requires a lot of documentation to show it. It requires medical device startup companies to undergo a rigorous testing and verification process that is done by a strict set of guidelines. If the FDA sees potential mistakes in your submission package, it will be rejected, costing time and money. And more importantly, you do not want your medical device startup company to end up in the news because your device hurt someone, or worse.
Our advice: Submit an airtight submission package to the FDA with expert advice guiding the process. Our team at Sterling Medical Devices is made up of experts in medical device development who know how to support medical device startup companies through the FDA process. We also offer expertise in Design history files (DHF) remediation to help fill in potential gaps in technical documentation.
Leadership in medical device startup companies often consists of experts in their field or medical specialty. It can be difficult to seek or follow the advice of outsiders. Instead, they rely on those who are telling them only what they want to hear.
Our advice: Listen to the people who know this space, and who have years of experience. Seek the counsel of those with the experience you lack. Our team at Sterling Medical Devices is poised to help you every step of the way – design, development, FDA approval – and help you get your device to market.
Medical device startup companies make the mistake of thinking they can provide their design for development and get it back once it is FDA approved and ready to generate revenue. That positions you to be disappointed if your vision is not realized the way you wanted.
Our 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. The process cannot work if the medical device startup company is not an active partner. With regular collaboration, you and your team can make incremental change, and create a better product.
What medical device startup companies lack in experience, they make up for in ambition and fresh ideas. With the right support, we believe they can achieve their goals. Sterling Medical Devices has been down this road many times before, and we can help you get down the road too. Please reach out today.
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