4 Steps to Get Your Medical Device Ready for Production

As new technologies open up new frontiers for health care, the market for medical innovations is ripe for creative inventors. The global medical device market is expanding at an annual compound growth rate of 4.6 percent and will reach a value of $343 billion by 2021, Lucintel projects. Surgical and infection control, general medical devices, cardiovascular devices, and home health care are some of the areas that will see the largest growth.

There’s plenty of potentials for inventors to get in on the growing opportunities represented by these trends. But how do you get your invention off the ground and turn it from a great idea into a marketable product? Here are four steps to get your medical device out of your head and into production.

How to Take Medical Device into Market?

Medic and patient using medical device

1. Do Your Market Research

Before you invest in pursuing your medical device idea, you should do some market research to make sure there are people who will be willing to buy your invention, and also to see if anyone else has already invented something similar. Start with free general resources available from public reference materials and free online materials, such as the U.S. Census Bureau, Google’s Marketer’s Almanac, and Nielsen’s MyBestSegments. You can also study specialized medical market research reports and databases, such as those produced by SIS International Research, which provides an online guide to conducting healthcare market research.

Your market research should form the foundation of a solid business plan that details how you plan to sell your invention and finance its production. The Small Business Association provides an online guide to writing a business plan, as well as links to resources that can assist you, such as SCORE. Doing market research and developing a business plan will help ensure that your medical device development is a profitable endeavor.

2. Create a Blueprint

After you’ve identified that your device idea has a viable market, the next step is to create a blueprint. Creating a blueprint can help you visualize the details of your device and work out bugs before you actually start building it. Drawing a blueprint will also help you apply for a patent and protect your invention’s intellectual property rights.

Be sure to follow the U.S. Patent Office guidelines for drawing. You must use flexible, strong, white matte paper with specific sizes and margins and draw in black ink. Color and photographs are only permissible when needed to convey your design. You can submit drawings done by hand or by computer-assisted design (CAD).

3. Build a Prototype

Once you have a blueprint, you can build a prototype of your device. Prototyping can be expensive, but you can cut costs by using smart prototyping strategies. Hiring a rapid prototyping service that uses 3-D printing can save you significantly over traditional prototyping methods. Some specialty companies can also assist you with 3-D printing specific parts. For instance, o-ring manufacturer Apple Rubber helps clients design customized medical seals and carries an inventory of over 300 million o-rings in over 8,000 sizes, including medical-grade elastomers made of special materials such as liquid silicon rubber, Viton fluoroelastomer, and ethylene propylene. Their website includes resources to help select the right material for your product.

For some products, you can also cut prototyping costs by using cheaper materials than you would use in actual production. If the nature of your product permits, you may be able to make a working model out of clay materials such as Sculpey, plasticine-like materials such as Sugru, or hand moldable plastics such as Shapelock. This can be a cost-efficient way to develop your idea until you’re ready to use the actual materials for your final device.

4. Test Your Device

Both for safety and for marketing, it’s important to test your device before putting it into production and putting it on the market. You must follow FDA regulations when testing medical devices. Which regulations apply to you depends on the nature of your device. For instance, a heart valve is subject to stricter regulations than a toothbrush. The easiest way to test your device is to hire a company that specializes in medical device testing.

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