4 Steps To Get Your Medical Device Product Launched

Drawing inspiration from Iron Man, a Toronto startup won $35,000 in a recent competition for its innovative exoskeleton that enables children with disabilities to walk without a wheelchair. The device replaces the traditional wheelchair with a walker-like support that includes mechanical leg attachments. Using the attachments, children are able to take steps powered by the walker. The founders plan to use the $35,000 to help bring the device to market.

Medical device success stories like this are happening every day as demand for high-tech health services grows. The medical device market was worth $377.5 billion in 2016 and is expanding at a compound annual growth rate of 4.6 percent, putting it on track to reach a value of nearly $500 billion by 2022. Here are some steps to help you earn your share of this growing market and get your medical device launched.

Research Your Market

Before investing in the considerable expense involved in bringing a medical device to market, it’s crucial to do market research to verify purchase order demand for your envisioned product. Experts recommend a number of medical device industry research resources you can use to guide your research. With a number of sources, you can have firm evidence of the viability of launching a medical device product.

Your market research should form the foundation for a solid business plan outlining how you plan to sell your product and run your business. You can start with a sample business plan for medical device startups that you can use as a template to help you write your own plan. For help writing your business plan, organizations like SCORE provide detailed online resources as well as access to experienced business mentors.

Find Funding

One purpose of doing market research and writing a business plan is to persuade potential financiers that development of your device is worth investing in. While venture capital is ideal, it can also be difficult to come by, and it can be easier to attract if you’ve got a comprehensive financing plan that includes other sources of funding.

Bootstrapping by drawing from your own personal finances is the most popular method of medical device startup funding. Entering, and winning, a competition is another way to earn startup money as well as attract the interest of investors. Working with incubators and crowdfunding are two other funding methods you should consider. When it comes to approaching venture capital sources, you’ll have the most luck if you’ve previously demonstrated the commercial viability of your product by following the other steps in this article.

Build A Prototype

Building a prototype is a major step toward turning your medical device into reality. The first step is drawing a blueprint for your product. To protect your intellectual property, follow the drawing specifications required by the U.S. Patent Office. While you can submit provisional patent drawings done by hand, it’s most efficient to use a CAD digital drawing program. If you have the expertise, you can draw your own design, but in most cases, you’ll want to seek help from a prototyping firm, engineer or other experienced professional. Invention companies can also help you develop a drawing for your prototype.

Once you have a blueprint, the next step is actually building your prototype. Here it’s necessary to locate suppliers who can provide the parts you need for your design. One of the most cost-efficient ways to build your prototype is to use a supplier with 3-D printing equipment who can design custom parts to your specifications. For instance, medical seal supplier Apple Rubber has a catalog of 8,000 different sizes of o-rings made from specialized materials such as fluorocarbon that are suitable for medical use. 3-D Printing Business Directory provides listings of resources you can use to get your prototype built. Prototyping firms and invention companies can also assist you with this stage.

Test Market Your Product

Once you have a prototype, it’s time to test the commercial viability of your product with some test marketing. Test marketing can verify consumer demand for your product, as well as help you work the bugs out of your design and help you hone your understanding of your product’s sales benefits.

When test marketing medical devices, you must follow FDA consumer protection guidelines. The easiest way to do this is to hire a company that specializes in medical device trials. You will know how to make a prototype that meets your requirements as well as regulatory standards.

Doing market research, securing funding, building a prototype and test marketing your product will lay a foundation for development of your device. Once you’ve completed these steps, you’ll be well on your way to becoming a successful medical device entrepreneur.

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