The Long Road from Conception to Consumer

Therese Stewart

So many people say, “I have a great idea, I wonder if I should patent it?” However, there are many questions you need to ask yourself before determining if you should apply for a patent. No matter which type of patent you need/want, it will be a long, and probably expensive process to attain it. Also, and most importantly, your financial stability can dictate your timeline. Large companies with a lot of cash to support the patents typically get approved quicker than solo applicants. Turning ideas into sellable, FDA Products is not an easy endeavor. It takes time, talent, and significant capital along with a methodology to design and develop the product of the future. A positive, “don’t give up” attitude is imperative! This is my journey of evolving an idea from concept to consumer…

It was during the beginning of the Coronavirus Pandemic when I thought about the sheer number of items that required safe, efficient, and quick sterilization. I then realized the sterilization sector had grown exponentially, not only at the consumer level, but also for both commercial and environmental applications. Having a background in Dentistry and knowing about sterilization techniques, and the time it takes to sterilize equipment, I thought there must be a better way. I wanted to come up with an idea that was not only a quick way to sterilize dental instruments and dental supplies, but also one that was environmentally safe. I thought there must be a way to sterilize things that we cannot sterilize through traditional sterilization methods, such as our dental sensors, plastic impression trays, and other plastic and glass objects.

I reached out to a good friend, Ralph, about an idea I had. Ralph and I have worked together in the past on a different sterilization patent. In fact, our technology is used by the government to disable biological weapons. Ralph saw this opportunity and asked if we could invite Brad to join us in this process. Brad and Ralph have worked together at Fallbrook Engineering and Baxter Pharmaceuticals.

I will start with a footnote… just to be clear, this is not an individual endeavor. I have two amazing partners Ralph and Brad, who provide a vast amount of knowledge and expertise in the sterilization and medical device sectors. They both have created very successful private medical device companies. After selling their respective companies they were both waiting for the next big thing. It is important to partner with talented people. Ralph, a Physicist and Chemist with several patents, is the former VP of R&D for Baxter Pharmaceuticals. Ralph recommended Brad, an Engineer and Medical Device Product Designer.

After just a few conversations, it was clear Brad was going to be an integral part of the team. Between the three of us, we have close to one hundred patents. My point here is getting our stateof-the-art product into the hands of consumers takes a lot more than just an idea. Partnerships and strategic vendor relationships are critical to success. I also have had the support of friends and family. One friend, also a successful entrepreneur, was the first to see our vision and invested in our business with both capital and business development assistance.

For the first six months, the three of us took the idea and added several layers to it. We went back and forth on how to design this product. We set weekly meetings with action plans and moved forward with our ideas. We also filed for a C Corp, hired a Business Attorney, and a Patent Attorney, and went to work applying for our preliminary patent.

Note that there are three different types of patents: 1) provisional, 2) design, and 3) utility. Provisional patents are “placeholders” several successes during the process. We continually look for improvements to our sterilization device.

In the next few months, while waiting to hear about our patent, we worked and completed our business plan, hired a company to design a webpage for us, and we also reached out to several investors. We went to California to meet up with a manufacturing company to discuss designs. At this stage, you must be very careful with whom you talk to and make sure anybody you talk to has signed a Non-Disclosure Agreement (NDA).

With our device, we need to be granted a 510 K premarket approval with the FDA. Johnson and Johnson have a similar product which makes it possible to get 510 K FDA approval. This is referred to as “substantial equivalence”. We hired a PhD degreed consultant who has worked with many medical device products on 510 K FDA approval. She has been a godsend. The writing is very technical and takes a substantial amount of time for drawings and thorough writing. We meet with her regularly to discuss changes and adjustments.

Our initial premeeting with the FDA needs to be on point. You never want to leave any open questions that cannot be answered. We must show our risks and how we plan to mitigate those risks. The software to run each cycle must be validated. All the digital readings from each cycle must be accurate and reliable. All the marketing claims must be validated. We must pass high cyber security testing to prevent breaching by hackers. All these factors require significant testing and evaluation both “in-house” and by “independent laboratories”.

At this point, you’re probably wondering about the type of device we developed. Our company is Sterile Solutions International (SSI), a revolutionary heatless sterilization technology that will outperform every current sterilization method used throughout the world. This is less expensive, exponentially faster, and environmentally safe and its potential is limitless. Our sterilizer can sterilize sensitive electronic instruments, paper, plastic, and other heat-sensitive equipment. This heatless method sterilizes in 5 minutes – not the usual 45 minutes plus -- for a fraction of the cost. Best news of all? We have no competition. To claim this, one must do extensive international patent searches. There is NO other device out that uses what we have developed.

One of the hardest obstacles is to find the right investors. We have been solicited by a couple Venture Capitalists who make capital investments in companies in exchange for an equity stake. This can be a great way to accelerate the process. However, there is a fine balance between selling yourself out and making a good financial decision. When Ralph and I had our last business together, we lost our patent rights. I highly advise investing in a great business attorney to help cover your risks! One thing I did not know until recently is that an investor must be a qualifying investor. This means if the investor is single, he/she must make an annual income of 200K and have 1 million dollars of equity not including their primary residence. If it is a married couple the rule is 300K annually and 1 million of equity not including their primary residence. This becomes difficult.

What are our next steps in this process? We are looking to bring on board an experienced CEO. We would like to build a prototype that is office-ready, get feedback from that prototype, and then build 5 to 7 units to be distributed strategically in different sectors. We would like to have our devices in dental, medical, and veterinary practices for our initial launch. We also will have a white paper written on our product and plan to attend professional trade shows to display and educate the attendees on our new state-of-the-art device. The long-term goal is to grow the company and sell it to a large sterilization or medical device and biotechnology company.

Persistence is the key. You will have setbacks, they are inevitable, but be sure to put them down as stepping stones to your goal.

To be continued….

Therese Stewart, CRDH MS has 42 years of dental experience. Including clinical practice, education, research, sales, coaching, KOL, author, speaker, entrepreneur and inventor. She has worked at Solutionreach, Waterpik, American Eagle Instruments, Doxa, Dexis, Hilltop Research, and Office and Practices Solutions. She is as adjunct instructor at Palm Beach State College, where she has taught both didactic and clinical. Therese also is a national Dental Hygiene Examiner for CDCA-WREB-CITA. Therese lives in Florida with her husband Jeff, they have two married sons, one grandson and a granddaughter on the way.