Alphabet Soup

A manufacturer tells what it took to move her product from invention to production and international distribution.

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Number one on the list of entrepreneurs' complaints is bureaucratic agencies and their red tape and regulations. Not so for this CEO

When I first started my business I had no idea that I would be facing a maze of regulatory commissions, agencies, and organizations that were originally designed to benefit small business or the general public but in essence have become the nightmare of the entrepreneur. The walls of that maze are constructed of small groups of capital letters, like IRS, FDA, and SBA (Internal Revenue Service, Food and Drug Administration, and Small Business Administration). Mention any of those dreaded alphabet-soup agencies to most entrepreneurs, and they break out in a rash. Perhaps I was lucky because I was so unlettered in business. Whatever the reason, as it turned out, it was only through the tutoring and assistance of those agencies that I was able to launch my company, which is now about a year and a half old.

At the age of 16 I started working after school as a designer in a small flower shop. My dream was always to own my own shop someday. Then in December 1982 while delivering flowers, I slipped on the ice and fractured my ankle in several places. I had no idea at the time how that accident would change my life. While I continued working at the flower shop and even became the assistant manager, my ankle deteriorated. By the late 1980s I had had surgery three times. Eventually the extended use of crutches caused nerve compression in my hands. In my efforts to avoid the crutches, I would sometimes hop on one leg or scoot around the house on the seat of my pants. One day I got the idea of putting my knee on a chair with wheels and propelling the chair with my standing leg. It was awkward, but it worked.

When my doctor told me that my ankle needed to be fused and I might be on crutches for three to six months, I was determined to find an alternative. After several months of fruitless searching, I decided to make my own scooter. My prototype was quite a sight: an office chair and a narrow bench, with a curtain rod for a handlebar.

While in the hospital I mentioned the scooter to my physical therapist, and she asked me to bring it in for her to evaluate. Next thing I knew, the therapist and an orthopedic surgeon recommended that I apply for a patent and put the scooter on the market. They said it could be used not only by patients with fractures but also by those with ruptured Achilles tendons, amputations, foot ulcers, and many other conditions.

My original plan was to make some improvements, patent the invention, sell the patent to a medical-equipment manufacturer, and open my flower shop with the proceeds. Simple enough. But it didn't work that way.

My first encounter with alphabet soup was the CDRH (Center for Devices and Radiological Health) of the FDA. I wanted a few patients at the local hospital to try out the scooters and evaluate them. After some checking I learned that the scooters were considered medical devices by the FDA and therefore fell under its rules. Because testing a medical device on humans is regulated, I had to check for restrictions on that level of testing. My encounter with the FDA was pretty painless. However, the hospital said I had to have liability insurance before it could do the testing.

I contacted several insurance agents. All of them gave me the same response: they needed to know my first and second years' projected gross income in order to establish a premium. Even after I explained that I had no intention of selling the scooters, they insisted that only by knowing the projected gross could they determine the premiums. I had run into a brick wall.

Luckily, around the corner was the WSU (Washington State University) Spokane SBDC (Small Business Development Center). I had read an article somewhere about the SBDC and thought it might be able to help me. If nothing else, maybe I would end up with some information about starting my flower shop. I will always remember the first meeting, in August 1992, with my SBDC counselor, Mary Alice Brown. After explaining my situation, I asked if she knew of any way I could obtain the insurance. She smiled, folded her hands on the desk, and said, "Give them what they want. Become a business, work up some rough projections, and let them take it from there." I took her advice and became a business, with no intention of really being "in the business." I also decided to sign up for a few SBDC classes -- to help with my future flower shop.

While recuperating from more ankle surgery, I attended classes and worked on improving my scooter's design. Somewhere in the process I came to understand that my ankle couldn't take the abuse I had been putting it through. (As a florist I was sometimes on my feet for up to 18 hours at a time.) I realized that I wasn't meant to own a flower shop -- and that the scooter business, which I had named StoneHeart Inc., was perfect for me.

Even though I was still employed full-time at the flower shop, I spent all my spare time working on my business plan and absorbing any information I could get my hands on. I was determined to go ahead with the scooter business but was still very cautious. My husband and I had put a good deal of our savings into the project, and we didn't really know if there was a market for the scooters. I felt as if I were standing in an airplane with one foot inside the plane and the other hanging out. At any time I was ready to bail out if a light came on to indicate that the plane wouldn't fly. I needed to do a feasibility study and once again turned to the SBDC. It told me about the IAC (Innovation Assessment Center) and SCORE (Service Corps of Retired Executives).

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