Interview with a Nurse Entrepreneur
by Mary Darbey, RN
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Urology Nurses Online: Interview with a Nurse Entrepreneur by Mary Darbey, RN |
November 1997
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Linda Asta, BSN, RN is a urology nurse-entrepreneur, who has created the Asta-Cath®, a device which aids female patients with self-catheterization, and the Feminal®, a female urinal. In 1994 Linda created A+ Medical Products, to develop and market these and other urological products. In this interview Linda answers our questions on a range of topics including product design, FDA regulations for medical devices, and the experience of running her own company. |
Q. How has your nursing background prepared you for the role of entrepreneur?
A. I trained in Brooklyn, New York. We didn't always have what we needed, so we learned to improvise. That's one thing. Nurses have to solve problems all the time. I think we're trained in problem solving. I think, too, that certain types of people become nurses, and one of the qualities nurses have is that they know how to solve problems.
Q. Are there any other skills that you've gained from your experience as a nurse that you are finding useful or helpful now?
A. My nursing background in general gives A+ Medical and myself a lot of credibility, which is very important given the medical nature of the products. I've had the opportunity to speak nationally at nursing conferences about my experiences as a nurse entrepreneur. If I didn't have clinical credibility I don't know if I'd have the kind of impact that I do. Another part of my credibility is that I'm a woman designing products for other women. Most products in the marketplace are designed by men. Who better to design for women than a woman?
Q. Do you now consider yourself a nurse, a designer, or an entrepreneur?
A. I do all three. However, once a nurse always a nurse. I speak with customers for feedback on the Asta-Cath® on a regular basis. I am also available to help clinicians and customers if they are having difficulty using either product.
Q. Are there other skills that are needed to be an entrepreneur?
A. Yes, a broad range of skills are needed. I had healthcare marketing experience, and I think that was invaluable. I had experience creating and developing a specialized rehabilitation division and programs, which was very helpful. I used some of those skills to bring my company into existence, and develop it. Looking back, even experiences such as developing informational brochures were good practice in creating something that didn't previously exist.
Q. How do you create your designs? Where do the ideas come from?
A. The idea for the Asta-Cath® came to me back in 1978 out of a failure to teach a female patient to self-catheterize. The woman had a visual impairment and diminished motor function. Her only other options were an indwelling catheter or a surgical procedure. On the way home from work the idea just came to me.
Q. You got the idea whole and complete?
A. Well, I knew there just had to be something. I kept thinking about it and the idea just came. I conceptualized what it would need to look like, then I looked around to see what was out there already. I took a plastic vaginal speculum apart, and drilled some holes in it. Then I turned it upside down. It sounds simple now, but it went through many stages.
Q. How did the female urinal come about?
A. I was sitting in a meeting with Diane Newman, who is a well-known and highly-respected urology nurse practitioner. She said that someone should design a female urinal that works, and I thought that sounded like a valuable thing for me to do as a second product.
Q. Can you comment on the design process?
A. A lot of thought and time went into the design and development of the Feminal®. First I looked at what was out there, and why they are not ideal for a female patient lying flat in bed. This lead to the key design features of the Feminal® - a flat base and a lip that is pressed up against the vulva so that a seal is created to contain the urine. The patient can use the female urinal while lying flat, seated, or standing.
Q. The urinal seems to have a very smooth, ergonomic shape. Is that an important part of the design?
A. Yes. The sleekness of the neck is because of the need to press the urinal against the body to create a seal, and so that it can be used by women with limited hand mobility. There is no handle because that would encourage holding the urinal away from the body.
Q. Was that your original design?
A. Not exactly. Originally I envisioned a soft, cushioned base, but that was not feasible for a variety of reasons. It caused creasing, which lead to leaking because of decreased suction. It was also very difficult to manufacture. I now have two molds - very expensive doorstops - which remind me that sometimes you have to "let go" of the original idea, even if a lot of time and money have been invested in it.
Q. Why did you depart from the more traditional colors for medical devices?
A. Well, I think its important to make the product look attractive, and feminine. Purple is my signature color.
Q. Do you agree that the business and financial side of developing a company is a lot of responsibility to take on?
A. Yes. First, its very hard for a woman to get capital. That's something that I didn't know before I started. Part of the puzzle was that I had to get to the point where I felt comfortable asking people to invest in me and my company. Initially the company raised money in a private stock offering. The Small Business Association (SBA) later initiated a pilot program for women with small businesses. I qualified for a $250, 000 loan. Under the conditions of the loan the SBA provided an 85% guarantee, however none of the many banks I went to would lend me money. Finally I found an investment company with funds set aside for the SBA women's loan program. Since then additional capital of more than $150,000 has been raised from private investments.
Q. Is it always necessary to raise such large sums of money?
A. It depends. If you don't want to develop and market your product you could take your idea to an existing company, however, the less you have accomplished by yourself, the less profit you'll make. A large company will offer you a very small percentage of the product earnings, and you may have to assume some expenses, e.g. maintenance fees on the patent, and any legal expenses involved if the patent is challenged in a court of law.
Q. Would you advise hiring a financial planner?
A. You need to do a business plan and a marketing plan. They are for your own guidance, to move the company forward. Financial institutions will look at these when you request funding. They will also be required at other times, for example, by your attorney if you plan to do a stock offering. The business plan takes at least 200 hours of work, and that's after all the information is compiled. I would advise hiring a financial planner for at least some of the financial components necessary for the development of the business plan.
Q. What other challenges have you faced as a nurse-entrepreneur?
A. Balance...making sure that I'm getting what I need to function at my maximum potential. As you can imagine, it can be very stressful to have so much at stake. I'm constantly getting rid of my stress, managing it so that it doesn't interfere with my ability to be effective. I like to bring a positive influence and inspiration to everything I'm doing, and an enjoyment. I always see the possibility in everything, and I think that's a vital characteristic in an entrepreneur.
Q. So, as well as needing certain skills, you think that an entrepreneur needs to be the type of person who can deal with stress and even enjoy it?
A. Yes, definitely.
Q. What are the positive aspects?
A. I'm my own boss. I'm never bored. Every day looks different. I do a variety of things. I'm a person who thrives on responsibility, so I don't have a problem accepting my failures or my successes. I'm getting better at accepting the successes. I listen to what other people say about me, not what I say about me. I think women can be very critical of themselves.
Q. Would you consider that you've gone from a "novice" to an "expert" as an entrepreneur?
A. I would consider that I'm still a novice. Every day I learn something that I didn't know. I know that I bring a lot to the table, however, when you take on what I've taken on I don't know if you ever become an expert. Maybe you just get to the next level. Its not 'till the task is over that you can look back and say whether you've been successful.
Q. Do you think that many nurses have the skills needed to be an entrepreneur?
A. If a nurse has an idea and is committed to getting it to the marketplace...I don't know too many nurses who couldn't do it.
Q. Do you help other nurses develop their products?
A. Yes, we offer free counseling to nurses with a product or idea. I am currently in "non-disclosure" confidentiality agreements with several nurses, and am working with them to decide if A+ will take the products to market.
Q. What advice would you give to a nurse interested in developing a product or idea? What do you know now that you didn't know then?
A. It always takes longer than you think it will. You have to be very clear about the result you want in everything. You have to drive it all. You might have several projects, and you need to delegate as much as you can, but ultimately you are responsible for moving everything forward. The other thing to know is that it always costs more than you think.
Q. What gives you professional satisfaction in this role?
A. Well, I spoke recently at a conference in Nashville, and people told me how inspirational it was. I felt great. That's one piece. The other reason - why I do this - is that I get phone calls from patients with multiple sclerosis basically saying "God bless you Linda, and thank you for making this device, because for sixteen years my husband's been catheterizing me and now I can catheterize myself." My company's mission statement is dedicated to developing medical products that honor women and make a difference in the quality of their lives. When I get these calls I know that I'm doing what I say I want to do.
Q. Can you comment on the relationship between catheterization and sexuality?
A. One of the key aspects I've found from women who have had either a husband or a care-giver catheterize them, is that it really affects their being perceived as a sexually desirable woman. Catheterization is not a normal function for a spouse to perform, either in the short or the long term. When the woman can catheterize herself it improves her sexual relationship with her husband. Some women have told me that where it had been non-existent for a long time a sexual relationship had begun again once the woman started to catheterize herself.
Q. How does the Asta-Cath® help these particular patients?
A. The Asta-Cath® is useful for women who have difficulty locating the urethral meatus due to decreased fine motor skills, or poor vision, or difficulties with positioning. The device is designed with a handle which will lock onto the hand, so that even with a tremor the vaginal insert can be positioned. The curves of the device are designed to spread the labia. There are three holes in the Asta-Cath®, one of which will align with the patient's urethral meatus. The catheter can then be pushed easily through the aligned opening.
Q. Can you tell the readers about FDA regulations for medical devices?
A. Yes. There are three classifications for devices submitted for FDA approval. The Feminal® female urinal, for example, is a Class I device, which means that it does not need to be FDA approved, although it must adhere to good manufacturing practices. Class II devices, in addition to following these general practices, must also adhere to certain specific regulations. Clinical trials must be carried out, and the results filed with the FDA. Approval must be obtained from both the FDA and the internal review board of the institution where the trials will be carried out. For example, the Asta-Cath® is a prescription item, and this must be stated on the box. Class III devices are devices such as drugs, or catheters used for cardiac catheterization. Such devices are highly regulated and require extensive testing.
Q. Were you responsible for conducting the clinical trials?
A. Yes. The safety and effectiveness of the Asta-Cath® had to be demonstrated. As it is a device which is inserted intra-vaginally, extensive animal testing was carried out on the material and dye. The cost of testing was approximately $15,000. Drugs and more invasive devices such as cardiac catheters require human trials, which are even more time-consuming and costly.
Q. So, after completion of the clinical trials the products were then FDA approved and could be made available to patients?
A. The FDA doesn't approve a device. In fact, its illegal for a company to state "FDA approved" on a product. The FDA clears the device so it can be offered in this country. It may be wise for a company to also obtain clearance from the International Standards Organization (ISO). This is optional, but I highly recommend it so that the product may be offered outside the US.
Q. Can you explain about patents and how they work?
A. A patent protects your idea. If you take your idea to market without a patent there is nothing to stop someone else using it, and you would have no legal recourse. There are two kinds. One is a design patent which will protect your idea to some extent, but a design patent can be easily altered. The other kind of patent is a mechanical patent which is much more specific about the product and how it works.
Q. Would you recommend filing a patent early?
A. Yes, definitely. I would also recommend sending yourself a certified copy of your design through the mail. Include a simple drawing of your design, a description of the product and a description of its potential end-users. Do not open the envelope. If your ownership of the idea is ever challenged the envelope can be opened in a court of law. The postmark will show the date of inception of the idea. This is an inexpensive but protective first step.
Q. What is the procedure for filing a patent?
A. I would recommend hiring a reputable patent attorney. It may cost more but you1ll have a better patent in the end. One of the steps involves doing a patent search, which is something you can do yourself to save money. Records can be researched at the public library which show the "prior art". You can see what other products already exist. Decide what, if any, aspects of your product idea are patentable. Then go to a patent attorney and explain how your idea works. The patent attorney will draw up claims, which are the basis of a patent. They are what make your patent unique. Not all of your claims may be accepted.
Q. Does the process of patenting take a long time?
A. It takes approximately 2-3 months to do the research and write up the paperwork, then approximately nine months to 3 years from filing to issue of the patent. It may be a longer process, depending on the category of your product.
Q. Can you explain briefly why a company becomes incorporated?
A. There are various legal reasons for becoming a corporation. There are different categories of incorporation, which determine the tax category of the company.
Q. What services do you contract out and what do you do yourself?
A. Legal counsel is necessary for certain parts of the FDA approval process. An FDA consultant is another option. A+ has contracted with plastics engineers and design engineers. Quality control is extremely important. The manufacturing process is subcontracted, and there are specific controls for medical devices.
Q. How do you find subcontractors?
A. Talk to people in the business. Talk to everyone you know.
Q. How do you measure success?
A. Its not about money, but that's one way to determine your success as a company. A+ is not yet making money-it always takes longer and costs more. It is quite customary for a start-up company not to show a profit in the first 3 to 5 years. What's important is what people say about the products. Its also important that the people around me are thriving.
Q. Where do you see yourself in 5-10 years?
A. Spending a lot of time in Italy. I know I'll be very creative there. I see A+ having a full line of innovative medical products for women, and also helping a lot of women bring their products to market.
For Further Information:
You can reach A+ Medical at http://www.aplusmedical.com
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