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Common Roadblocks that Prevent Medical Devices from Reaching Market

Posted in Medical Device Development

Before you embark on your journey to create an innovative medical device, it’s important to understand the roadblocks you may face along the way. The medical device development path to success has a much slower speed limit than that of digital tech or other industries. It’s easy to get wrapped up in the feeling that you should be further along the path than you are. Let that feeling go, do your research, and develop a plan that avoids the following six common barriers when developing a medical device.

Market Analysis

First and foremost, you must determine if there is a substantial need for your idea/device. Who will be your target market? What is the competition for this device? Is there a similar product already on the market? If you’re not sure, it’d be beneficial to dig in and do more research.


Another common barrier during the medical device development process is patents. Depending on your concept, there may already be a patent covering a similar idea or device. Perform a patent search to determine whether or not you are impeding on another person’s intellectual property.  If a patent already exists, you may need to tweak your idea, or change it completely.

Since a patent search can be a difficult process, there are companies you can hire to conduct a search for you. Whether you choose to conduct the search yourself or hire a professional, it’s imperative to research patents that are already held, and which are pending to avoid legal complications.

Window of Opportunity

Like any product in any industry, there is major competition to see who can get to market first. If you miss the window of opportunity, you might have to rethink your whole device and tweak your development process. Doing market research to understand where there is a need for your product and which products are already on the market will help avoid this common roadblock.


Developing an innovative, life-saving medical device is not a cheap endeavor. With multiple iterations in prototyping, extensive testing, and clinical trials, it’s always a question of whether or not you can financially support the development process. In order to avoid this pitfall, do your research and speak with industry leaders about this process. Develop a clear understanding of what each phase will consist of and the price tag that goes along with it. This will give you substantial evidence of the potential costs associated with your project.

Is it Reimbursable?

Often, many individuals in the pre-development phase forget to question “Who will pay for this device?” and “At what price will this device be offered?” These are two of the most important questions that should be clarified before you begin the development process. The answers to these questions will guide you to the conversation of whether your device is third-party reimbursable. Meaning a hospital or healthcare provider is reimbursed by a third-party payer for the device used throughout the procedure. If a device is not third-party reimbursable, the likelihood the provider will purchase the device becomes very low.

For more information on how to avoid these common roadblocks, or for help developing your device from concept to market, contact Via Biomedical today.