The Long Road from Conception to Consumer

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” to reserve a priority date. They are simply a description of the invention and do not have a particular format or itemized claims. Provisional patents are often written by the inventor and filed directly with the United States Patent and Trademark Office, USPTO. Design patents cover the way an article looks. These are usually written by a patent attorney who submits it to the USPTO. A utility patent protects the way an invention is used and how it works. These are the most common types of patents used by inventors to protect their technology. The term “process patent” is often used as if it were a separate type of patent but it is actually a utility patent that focuses on the process claimed by the inventor.

The next year, Brad and Ralph designed, re-designed, and constructed our prototype. We purchased a lot of equipment to test. We have a laboratory with a hood and have conducted several tedious tests on our product. We tested electronics, paper, plastic, glass, all types of metals, and of course, several dental surgical instruments. We had some failures but followed with 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 Partnerships and strategic vendor relationships are critical to success.

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….