Often consumers believe only medical professionals and engineers can enter the medical device industry. In reality, anyone with a stellar idea that could benefit the medical industry can introduce the concept of a new or more efficient medical device. Discover the five steps to take if you decide to enter this growing market sector.
Idea and Risk Consideration
From newbies to medical device component manufacturers, the process of developing a new product always starts with an idea and risk analysis. The developer researches to ensure the concept is original and viable before attempting to enter the market. Can the device be produced safely and within a reasonable budget? Is there room for profit and what approvals are required to ensure the device makes it to the market? If the answers to these questions are positive, it is time to move to the second step to enter the medical device industry.
Concept Development
Now it is time to determine whether the concept is feasible and can be turned into a profitable product consumers need and want. Think about which markets to enter and why the device would appeal to them. If the device is an original idea, file for Intellectual Property (IP) and patent it. Establish a Quality Management System (QMS) to define the procedures and formats to be used to create and market the device.
Design the Device
The third step is to put in the work and research to design the device. Often the original prototypes require updating, which is referred to as the development process. The device is tested to ensure it can stand up to its intended use. Risk management should be considered as the device becomes ready to be a marketable product. Consumers need to be able to rely on the device because it meets or exceeds their performance expectations.
Pre-Launch Validation
Before launching a new product, the manufacturer must have proof of the claims being made to show the device works as stated. Testing, research, and surveys should be performed to determine how the product is performing and what the consumers’ response is after using it. During the validation phase, essential changes are made to create a product that lives up to the claims being made about it, so consumers are satisfied. This is also the time when federal approvals are sought, such as approval from the Food and Drug Administration (FDA) to show the device is valid.
Launch the Device
The final step to enter the medical device industry is to launch the product and let everyone know about its benefits. Marketing the product means defining your target market and researching what matters to it. Sales efforts should focus on the requirements and mindset of your target market. This is also a time to perform initial research to gauge consumer response to the device and make changes as needed to create the best possible product based on what people want.
Entering the medical device industry is easier than people think, even if you have no experience in the medical field. The process starts with a great idea and the desire to develop it until it is ready to hit the market. Then research and regulatory adaption is required to create a viable device that performs as intended. With the right approach, anyone can enter this growing industry to help others and make a profit doing it.