Deciding to build a medical device is often a massive investment. What’s more, the outcome is never quite certain. You could wind up with something highly marketable, but whether the regulators will allow it is never entirely clear.
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With that said, numerous companies that do it successfully often make a lot of money. And so for that reason, taking the risk might be worth it. Here’s everything you need to know on how to build a medical device:
Build A Medical Device That Solves A Problem
Most medical device startups begin by identifying a problem and then creating a solution. However, they don’t go through the essential validation step, which is to check whether anyone actually needs the device.
For example, you might come up with an idea of combining ultrasound technology with AI to provide clear answers about the sex of an unborn child. But if there are already pieces of software or technology in place to do this, then it doesn’t make sense to develop it.
Validation also requires checking the regulatory code. While it is sometimes technically possible to create a device that solves a specific medical problem, the law might actually forbid it. Doctors’ unions can be strong!
Elaborate On The Technical Feasibility
You also want to think about whether the medical device you want to create is feasible. Everyone wants a laser beam that can target cancer cells. But making a technology like that work is notoriously challenging (and that’s perhaps why no one’s managed it yet).
In some cases, it’s possible to construct a device using available technology. However, the R&D costs of getting to that stage can be prohibitively high. Therefore, you’ll also want to take this factor into consideration.
Then there are the prototyping issues. Is it possible to test the device in a clinical setting in a way that reflects the capabilities of the final product?
Think About How You Will Manufacture It
Thinking about how and where you will manufacture the device is another consideration. It helps if you have facilities that can scale, according to industry expert VictoryPCB.
Remember, you may have to produce thousands of units in a short space of time if demand is high. Therefore, you need to work with skilled professionals who aren’t busy now but can deliver massive increases in output in the future.
You also want to consider the supply chain; all the small players who feed the main producers with raw materials and components. Leveraging these successfully is much more complicated and requires specialist quality control to get it right.
Consider How You Will Get Paid
You should also think about how you will get paid. Generally, you want to earn money through insurance and reimbursements, which means you should focus on getting your devices approved more generally.
If you don’t, doctors and clinics may be unwilling to use your products as much as you think they should. Look at existing coding and billing requirements and see if your product fits in. If it doesn’t, you may want to adapt your strategy.
