10 Questions Novice Medical Device Inventors Should Ask

You've just had that ah-ha moment, realizing your life's calling: creating an innovative solution to a healthcare problem. But believe it or not, coming up with your idea is the easy part.

Bobby Grajewski

Even though it took large amounts of creativity, ingenuity and resourcefulness to think up a great new idea for a medical device, it takes grit, stamina and business savvy to transform it into a living, breathing product.

Through asking yourself the right kinds of questions, and consulting with vetted resources and guides, your idea will be on the path to success. To help in this regard, the team at Edison Nation Medical (Charlotte, NC) has compiled a guide for medical device inventors. This tool is intended to get inventors thinking about their project goals, while giving them a glimpse of the innovation process at large.

1. Can my idea make money?

Before you quit your day job to pursue your invention full time, it's important to understand the significant costs involved in bringing an idea to life. Many first-time inventors don't think about innovation in terms of dollars and cents, but in all actuality, it requires business acumen and a sizeable investment. From market research and product design to prototyping and legal fees, building a profitable business from your idea is complicated, so it's important to honestly ask yourself whether or not your idea is even worth the time and money.

In our experience, those who view their invention as more of a business opportunity than as their "baby" will better suited and prepared to successfully bring their product to market. To determine your idea's potential worth, ask yourself the following questions while trying your best to detach any emotions from your answers:

Additionally, if you're considering balancing an innovative passion project and your career, here are some actions to take and some to stay away from, courtesy of the Harvard Business Review:

Do:

Don't:

2. Do I own my idea?

Many inventors, rightly, question who actually has ownership over their idea. While, in general, an idea's originator is its owner, ownership rights can be assigned before or after a new innovation through various legal contracts. It's important to note that certain industries, such as higher education and healthcare, likely have their own policies relating to works created during a person's employment with them, which could result in an employer becoming your idea's owner. Before thinking about seeking patent protection, make certain that your idea is actually your own through consulting your employment contract.

3. Is my idea patentable?

Intellectual property (IP) -- which is the result of your idea or creation -- can be an intimidating subject matter to virtually anyone, seasoned or novice. The approach of Edison Nation Medical is to partner with intellectual property attorneys, providing medical inventors, at various stages of innovation, with access to information and resources about the patent application process. Across the board, inventors most frequently ask about whether or not their idea is patentable. While the answer isn't simple, there are key points that inventors should take under consideration before starting the long, expensive process of filing for patent protection.

Generally speaking, in order for an invention to be patentable, an idea needs to have a practical purpose, or "utility," while still being a novel and inventive concept. That's the basic starting point.

If your idea meets that minimum criteria, it's now time to research your concept, making sure that nothing too similar to your idea has been published or invented. To start, try searching for your idea in public databases such as the U.S. Patent and Trademark Office, the European Patent Office and using Google Patent Search.

Didn't find your invention idea anywhere else? That's a positive sign, but it doesn't necessarily mean your idea is certainly patentable. There are novelty loopholes, and there is the risk that another person may have filed for the same, or very similar, idea first. You can read about the patent application process in detail in our article, "Is Your Idea Patentable? Follow These Guidelines to Decide."

4. Should I file a patent, trademark, or copyright?

Depending on the kind of idea you're looking to protect, patent protection is not your only option. There are actually three types of intellectual property: patents, trademarks, and copyrights. Patentscan be time-consuming and costly to obtain--sometimes taking years to secure, but in order to commercialize your product, patent protection is essential.

Then, there are trademarks, which generally protect logos, symbols, or names of products from others who are then unable to use its likeness to possibly mislead consumers. Finally, there are copyrights, which stop others others from copying, adapting, distributing,  renting, or performing another's work without permission. While patent protection will likely provide more peace of mind than that of a trademark or copyright, it's important to understand all of your options before committing to the patent application process.

5. Have I shared my idea(s) with anyone?

When you think you have the next big idea in healthcare, it's natural to want to share your vision with your colleagues, friends, and pretty much anyone in between. After all, you are rightly excited and proud. But it's important to understand the potential consequences of oversharing your novel idea--especially if you have not filed for patent protection. Someone else can file a patent on your idea, or you could unintentionally take on a "co-inventor" by incorporating a friend's advice for a slight product improvement. So before filing a patent, reflect on any conversations you had regarding your idea--both online and in person--taking care that you have not said too much.

6. Have I done enough research?

Before pursuing your invention idea further, it's important to make certain that no other same or similar product exists on the market today. This will not only help you obtain patent protection more easily, but it will help you determine whether or not you actually have a market of people who will buy your product. This is the kind of research any inventor can and should undertake before putting any money toward their idea.

So what's the best way to conduct this research? First, search the Internet using a variety of keywords. Then, speak directly to your target consumers, asking them what sorts of products or improvised solutions they currently use to solve similar problems at hand. If you find that your idea is similar to their answers, but not identical to existing products, there may still be room in the marketplace for your innovation. The key to researching? Knowing what alternatives are currently available for purchase, and while taking an honest look at all these products, decide if your idea is different enough to justify further personal investment.

7. Do I have the necessary resources?

It's easy to feel overwhelmed when you're thinking about bringing an idea to life from scratch -- especially if you are a first-time inventor. Completing market research, filing a patent, building a prototype, and marketing your product are just a few of the steps that can cost an inventor significant money and time. Especially if you are a full-time medical professional, extra time is likely not readily available, making the innovation process a lot more challenging.

If you have managed to get through the patent and prototyping process, however, you've probably discovered how building a business around your idea brings another unique set of challenges, such as finding outside funding, advice, and trusted business partners. Luckily, you don't have to go through the invention process alone. You can learn from your inventor peers by finding local mentors through the United Inventors Association of America, a nonprofit that provides useful resources for inventors. You can also find new sources of funding, business development and marketing support with open innovation platforms.

8. Should I seek outside funding?

When novice inventors think about medical innovation, they're probably not thinking about the importance of business acumen. But think again. Calculating basic financials is an important first step in ensuring that you are making smart business decisions -- especially if you are debating whether or not you want to take on your invention as a full-time project. If your idea still looks financially viable after some basic calculating, it may actually warrant the investment of your time and money.

Here is a step-by-step guide to determining your idea's worth:

9. Do I have a plan to market my invention?

After much thought and consideration, you've determined that your innovative idea has the potential to make money. So what's next? It's now time to think about how you plan to market and sell your product. After all, if an inventor is unable to connect his or her product with potential buyers, there is no chance of it earning a profit and sustaining your business.

If you've decided to build a business surrounding your product or idea, you generally have the following options when it comes to selling your product: Visit a healthcare trade show to connect your product to distributors, build an eCommerce website for direct-to-consumer contact, advertise your product in industry trade publications, or find a reliable broker or submission company to do the marketing and selling for you. For full-time medical professionals, submission companies are generally a much more manageable option. They take care of everything--from filing a patent to marketing your product--after an idea is submitted and approved.

10. Should I create a non-disclosure agreement?

When an idea is being developed, tested and manufactured, the process can be rather visible. Whether you are seeking business advice, shopping around for materials or securing a manufacturer, you will likely end up sharing your innovative idea with many different people. As a result, inventors should ensure their idea--patented or unpatented--is protected throughout this process. That's where a nondisclosure (or confidentiality) agreement plays a vital role. When it's signed by multiple parties, no one can legally disclose details or benefit from your invention unless you specifically say otherwise. The document can serve as a portable asset that can be dished out when the time is right, protecting your idea with ease.

Robert Grajewski is executive director of Vanderbilt University's Innovation Center. At the writing of this article in 2015, he was president of Edison Nation Medical, a healthcare product and medical device incubator. Prior to joining Edison Nation Medical, Grajewski co-founded two online companies (Heritage Handcrafted and eCollector) and spent five years in venture capital and private equity.