There are many barriers to getting your medical device to market. The standards for medical devices are extremely high, with no margin for error. While challenges come in many forms, one of the most notable for electroporation devices is the FDA approval process. One aspect of your device that can easily cause a problem is voltage control, which can easily hinder your progress and cost you money in the long run.
Pain Points During FDA Approval
It is an understatement to say there are many problems that can occur during the approvals process. FDA requirements for medical devices are specific, with no room for error. Medical device startups often face setbacks during this stage, and electroporation device developers are no different. Setbacks at this stage can include:
- Increased spend on redesign of the device
- Timeline setbacks due to approval failures
- Heavier demand for company resources that could assist other projects
Controlling Voltage for Electroporation Devices
While the FDA process evaluates many aspects of a device, one of the most prominent problems occurs with voltage control. It’s incredibly important at this stage, to be sure that you are putting out the exact voltage that you think you are.
If you haven’t validated the voltage output for your device, you cannot submit data within an FDA process. Some developers may find, upon discovering these requirements, that they don’t even have the capability to measure, test, and validate the voltage of their product. The best way to validate voltage control, and expedite FDA approval, is by utilizing an experienced partner.
Seeking Help from Minnetronix
The Minnetronix Medical team has an unmatched understanding of electroporation systems. With our expertise, you can control, measure, and validate your voltage for a streamlined approvals process. Our team offers solutions at every stage of device development, allowing for a fast-track to market for your product. See how you can accelerate your next breakthrough by contacting us.