The development of new medical devices accelerates with every new technological advance. In the midst of the pandemic, everyone with medical expertise is working to develop new treatments, safe and effective vaccines, and diagnostic tests. New devices, especially ventilators, were fast-tracked in the heat of the crisis. If any good can come from a global health emergency, it is that inventors working in the healthcare sector are generating new and innovative ideas at an unprecedented pace. If you’ve had your “eureka” moment and the imaginary light bulb is burning brightly, you must now learn how to turn an idea into a successful product.
Keep It to Yourself
If you want to maintain control of your idea, resist the temptation to tell all your friends about your brilliant inspiration. If the idea is as good as you think it is, someone will grab it and run. You have a lot of work to do before you can confirm that your exciting idea is actually worth pursuing.
Find Out if it Already Exists
During the overwhelming conditions that have been overtaking the healthcare community, many people have come up with great ideas to try to help. However, for a new product to be successful and patentable, it must be unique. Invest time in research about products similar to your idea before you invest money in developing the idea.
Document and Protect Your Idea
When you are satisfied that your idea is truly original and unique, make sure to document it. Put your idea, drawings, and computer-assisted designs into tangible form. Make sure your “inventor’s notebook,” journal, logbook, or lab book is tamper-proof, with dates for your notes and drawings. Keep it in a secure place. Your notebook won’t establish your right to a patent for your invention on its own, but it will provide some documentation of your process, and especially the dates you began working. When you are ready to file for a patent, the date you file will be more significant, as the “first to file” system replaces a “first to invent” system. Consult a patent attorney for advice on how to protect your idea.
You may be a great business person, but you might not be an engineer. Likewise, a biologist may need the assistance of a materials expert, or vice versa. Seek out an expert medical device design service for highly specialized devices, like microfluidic cartridges or other engineering and design assistance to fill in areas beyond your expertise. Reputable partners understand the patent application process and the critical importance of confidentiality, originality, and rules about publication that may apply. Your patent attorney can advise you on what to watch out for.
When a design is complete, the next steps are prototyping and testing. The process of making a representative example of your product can help further refine the design and prepare the product for testing. With medical devices, attention to regulatory compliance is part of the process from the start through testing, and when all is ready, clinical testing, required FDA approvals, and ultimately, manufacture and marketing.
Turning an idea into a successful product in the healthcare business is a more complex process than doing so in other industries. Solo inventors and researchers with brilliant inspirations should team up with experts who have complementary skills to speed development, protect intellectual property, and ensure the product’s safety and effectiveness.