I remember it like it was yesterday. I was flying back home from the American-European Congress of Ophthalmic Surgery summit in Orlando in the fall of 2011, and an idea hit me. It wasn’t just a small conceptual idea; it was specific, and it was potentially revolutionary. In an instant, I had a vision of a new type of IOL that could solve the most vexing problem with IOL calculations: effective lens position. If this lens functions as intended, it will mark the end of estimating IOL powers. We will be able to dictate refractive results like never before. Ideas don’t always come like that, but when they do, it is important to know how to protect and, hopefully, develop them. Here’s my story.
To be fair, I am a bit of a closet optics geek. I have had a few previous ideas for new IOL designs, but after performing a patent search, I typically and quickly found enough prior art to dissuade me from pursuing them. This time it was different. Once I performed a patent search and nothing of substance came up, I was shocked. For the first time in my life, I was faced with the real opportunity to develop a new invention. I took about a week to consider the options. On one hand, I was a busy ophthalmologist working to build my practice while trying to balance family time with my wife and kids. I didn’t have much excess free time to devote to a new project. On the other hand, I had an idea that I thought just might be disruptive enough to change the way cataract surgery is performed. I knew the journey would be costly, but I decided that I would rather attempt and fail than to always wonder, “what if?”
A PATENT WAS FILED
The first step in my journey was to contact a regional law firm with an intellectual property focus. The firm performed a formal patent search, and after finding no significantly similar devices, I decided to file the full utility patent as soon as possible. Within about 2 months, I had filed the utility patent. During that time, I did not disclose the idea to anyone outside of my legal counsel. That was difficult, but necessary in order to retain full ownership of the idea and keep it patentable.
A COMPANY WAS FORMED
Once the patent was filed, I began making contact with some ophthalmologists who have been through this process before. I always had a nondisclosure agreement in place prior to these conversations, simply as a standard protective mechanism. These discussions were pivotal for me as these other doctors validated my idea and graciously put me in touch with other people in the industry who they thought could help. Over the next year, I began the chain of phone calls and interviews that were needed to help me assemble a highly competent team of experts. During this time, I funded the entire operation myself. After about 6 months, I recognized that in order to succeed, I needed a business partner with entrepreneurial and executive experience to continue operating this company and making progress. Through some local contacts, I was introduced to my business partner Rick Ifland. We came to an agreement, and I invited him to become the CEO while I would function as the CMO. With this agreement in place, we founded Omega Ophthalmics, LLC .
A PLAN WAS DEVISED
Once we formed our company, the next step was to formulate a project plan. We knew going in that access to capital was a critical component to the success of any startup, so we placed fundraising at the top of the agenda. To successfully raise funds, however, we needed a rock-solid business plan. Fortunately, my partner is a seasoned entrepreneur and well versed in both business development and fundraising. To bolster our idea and business plan, we really needed to do three things. First, we needed to further secure the patent. Second, we needed a prototype. Third, we needed to thoroughly understand the process required to take a lens implant from concept to development and through the regulatory process.
THE SEARCH WAS EXPANDED
In order to properly secure patent protection, we expanded our search internationally and are in the process of securing worldwide protection. To produce a prototype, we contracted with an engineer who specializes in IOL design, and who had the capabilities to be an outsourced R&D department for our company. Waiting for the first prototype to arrive in the mail was intense. Finally holding in my hands something that 2 years earlier was merely an idea was a euphoric moment that I will never forget.
REGULATORY HURDLES WERE STUDIED
Trying to figure out the regulatory process was the counterbalance to this exhilarating experience. If ISO-11979 means nothing to you, count yourself as fortunate. If you are interested in developing an IOL, I’d suggest getting familiar with it. This set of documents is essentially the playbook for the FDA’s approval process. Once we felt comfortable with the regulatory process and had a budget in place, we were ready to build the business plan and start fundraising in earnest.
THE LLC IS READY!
At this time, Omega Ophthalmics, LLC is ready to launch. We have a fully developed business plan and a corporate website with information for investors. In addition, we have begun to assemble a medical advisory board. The last 2 years has been an exercise in patience and diligence as we prepared for each new phase. It has been a wonderful learning experience so far, and I am looking forward to the challenges and lesson I will learn along the way. I have been blessed by the undeserved goodwill of many foundational ophthalmologists who have paid forward a model of mentorship and encouragement that I will never forget. Regardless of the outcome, I am thankful that I decided to take a step and pursue my dreams. If you are thinking of doing the same, I would encourage you to seriously weigh the costs, and if you are ready, go for it.
Do You Have an Idea? Follow These 8 Steps
Perform a patent search to see if your idea is new or simply new to you.
File a provisional patent while considering your options. This gives you 12 months to file a full patent application with protection dating back to the original provisional filing date.
Use a nondisclosure form if you speak to anyone about your idea.
Assess the available market: Honestly assess the problem you are solving, and consider the market available for utilizing your solution.
Utilize your contacts, and be willing to make new ones to broaden your sphere of influence.
Form a team to plug gaps in experience or skill.
Develop a business plan: Study the success and failures of other startup companies to learn from their experiences. Also, study the pathway you’ll need to traverse to take your device from concept to development.
Plan your work and work your plan.