The Biggest Challenges You Will Face as a Medical Device Inventor

Medical Device Inventor
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After two decades working with incredible medical entrepreneurs around the country, I would like to share with you some of the most challenging aspects of getting your new medical device invention to market.

Bear in mind that although some of these are formidable they are not in any way insurmountable.  I have personally witnessed the personal struggles and anguish of clients early on in the process who went on to make millions of dollars from their medical inventions.  Ultimately, they overcame all the speed bumps below and I would like to think I played an important role in helping them protect and profit from their ideas.

How Unique?

An inventor will need to prove to the healthcare system that his idea is not only unique but also makes a particular process or area more efficient.   If the product can save lives it has immediate value including the spin offs from eventual marketing campaigns.  Ultimately, you need to prove the idea is commercially viable.

Access to Capital

Access to venture capital or investment partners is probably one of the most difficult steps in our journey. Many of my clients relied on family, friends or the divine intervention of an angel investor to help them cross the finish line. I can share some of the cleverer ways my clients have tackled this area if you contact me using the form below this article.

Business Experience

Lack of business experience in sales, marketing, accounting and I.T., the four pillars that make up a successful company. Just because you have a good idea does not mean you know how to run a business or increase returns year upon year.

Appetite for Risk

The third is more tangential but plays a key role in long term success and centers on your appetite for risk.  At some point in your journey you will need to ignore people telling you that you’re crazy to continue down the invention path.  Instead, focus on your inner belief in your product. This may involve taking a financial risk or quitting your current job to go the final mile.

Tapping Key Players

Other factors come into play too, including be able to connect with key players and distributors in the health care arena.    I can offer key advice in this pursuit since I have an an extensive business network.

Facing Goliath

Probably one of the biggest threats to your ultimate success is the advantage bigger companies have over you.  They influence and control markets and make it more difficult to get access to capital funding.  All this red tape means it’s tricky for first-time entrepreneurs to get their products in font of key decision makers. However, David can beat Goliath and I have the clients to prove it.

The Power of Medical Patents

You have probably guessed what the final and most critical step is since you know my profession and have probably read my personal story about how I got started in patent law.
By acquiring a patent to protect your intellectual property from larger, predatory medical companies and those overseas you ensure you lock-in the long-term profits as your idea makes it into the marketplace. Unfortunately, the process of patenting your idea is much more difficult and complex in the medical arena than perhaps any other industry sector in the United States.

The Dangers of D.I.Y

Trying to complete the patent process yourself in a D.I.Y fashion is a recipe for disaster.  99.9% of inventors who try this route fail with the United States Patent Office who have zero tolerance for even the smallest filing or clerical error inside your application.  They will just send it back.

Devil in the Details

The USPTO will fanatically asses your idea to determine if it actually increases healthcare efficiencies and improves care in the overall medical system.  Due to regulatory oversight governing the medical arena, it can be a long, torturous, costly and frustrating journey if you do not engage a reputable patent attorney early on in the process.

The Triple Whammy

The USPTO will essentially ask you three questions that you MUST answer succinctly, clearly with supporting technical drawings and documents in the intellectual property application

  • Is the invention novel?
  • Is the invention useful?
  • Is the invention non-obvious?

The process above includes filing a provisional or non-provisional patent –something I will go over during our initial meeting or phone consultation.  We can also consider international patent protection that falls under the Patent Cooperation Treaty (PCT), although this may raise costs.   Do not underestimate the repercussions of filing these documents incorrectly. In fact, one tiny spelling error could ruin the future success of your idea.

Important tip: Also, be aware that any “public disclosure” of your medical device work may prevent it from being patentable. Keep your idea quiet until you have spoken to a patent attorney.  Loose lips sink ships!

Making money from your patent

This is can make or break the success of your product.  You need to decide how to make money from your product by either selling it outright or earning licensing fees from companies that are interested in your medical invention.  Ultimately you will need to connect with Presidents, CEOs and key decision makers in large healthcare companies who can be difficult to work with.    They are less interested in ‘ideas’ and more in well-developed products with supporting technical literature that can sell large amounts and quickly in a particular sector.  I have first-hand experience in this process and can help you avoid some of the mistakes made by my earlier clients as they attempted to profit from their ideas.

Final Thoughts

The above illustrates some of the key challenges and road bumps in the process. You can either make this easy or hard upon yourself depending on whether you adopt and action short or long-term thinking with regards protecting and profiting from your intellectual property.

If you are just starting out on this journey or are further along in the patent submission process I would be happy to answer any questions or concerns you may have.  You can read more about my credentials on my new inventor platform, The Patent Professor® or use the form below to contact me.

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