Nurses making a difference: the process of technology transfer.
Innovation is not a new phenomenon to nurses. Russ Metler, from the Technology Transfer Office of the Centers for Disease Control and Prevention, addressed the American Public Health Association regarding inventions by nurses and their impact on heathcare. According to Metler (2004), although the United States Patent and Trademark Office does not maintain records of inventors by occupation, 42 nurse inventors were identified as "potential" patent-holders for 94 patents issued between 1865 and 2003 (Metler).
The history of nursing includes a rich tradition of nurse inventors. As far back as the 19th century, Florence Nightingale, an avid mathematician, invented a polar-area diagram using colored sections to illustrate medical data about the deaths occurring within the British Army during 1854 and 1855 (Lipsey, 1993; Nightingale, 1858). Nurse Nightingale's invention, the pie chart, is still in use today.
Alice Dicks worked as a blood collection nurse for the Canadian Red Cross Society in Grand Falls, Newfoundland. Nurse Dicks found that it was difficult and dangerous to inject blood into the rubber tops of vacutainers. After sticking herself with a 16-gauge needle during a procedure, she searched for a solution to the problem. Her search yielded no results, so she developed a protective device using the bottom of a bleach bottle with holes cut out to hold the vacutainers. A local company helped Nurse Dicks refine the device and their combined efforts produced the Med Search Hand Guard (hemoshield). The Med Search Hand Guard is currently available in Canada and the United States (Inventive Woman, 2003).
Sharon Ragone was a neonatal intensive care unit nurse who worked with premature babies undergoing treatment for jaundice. She noticed that the bilirubin masks used to protect the infants from ultraviolet light tended to slip from the babies' eyes, placing them at risk of exposure. Nurse Ragone developed a device called the Bili-Bonnet, which is a latex-free compression net bonnet used to hold the eye-guards in place, thereby reducing risk of ultraviolet light exposure (Paolucci, 2000).
Suzi Burns, an associate professor of nursing at the University of Virginia, invented the Burns Wean Assessment Protocol/Program (BWAP). Nurse Burns' invention is a bedside assessment tool and accompanying software program that tracks patients' progress as they are weaned from ventilators. The program also teaches users about weaning assessment factors (Patient Care, 2003).
Dan Tribastone, registered nurse, invented the Puddle Guppy in 1999, a device used to aspirate fluid from floors. In 2000, Nurse Tribastone invented the Aqua-Box (Elghanayan, 2000). The Aqua-Box is a wall-mounted canister unit that allows contaminated fluids to be treated with an FDA-approved disinfectant and disposed of through the sewer system (Elghanayan).
Words of Wisdom
Consider the following bit of sage advice from individuals who have either gone through the process of inventing or have assisted nurses with the process of technology transfer. One thing that might be good to keep in mind--if it were easy, everyone would be doing it! Alice Dicks, inventor of the Med Search Hand Guard (hemoshield), incurred $60,000 in expenses to develop the device (Inventive Women, n.d.). Nurse Dicks' invention has resulted in a safer blood transfer technique for blood collection, but her potential return on the monetary investment has suffered because the reusability of her device limits the number that need to be produced.
Sharon Ragone, inventor of the Bili-Bonnet, advises that one of the initial things a nurse inventor should do is "protect the idea" (Paolucci, 2000). Ragone makes an excellent suggestion to document the idea completely and to include a "detailed description and sketch" (Paolucci). "Send it by certified letter to yourself, but do not open it." This can prove that it was an original idea in a court of law, suggests Ragone (Paolucci). Prior to discussing the ideas with anyone, inventors should obtain a signed confidentiality agreement from other involved parties so that information that is not generally known to the public is safeguarded.
If there are plans to file a patent on the invention, it is very important to know the rules regarding disclosure. An invention "is not patentable in the United States if it was patented or described in a printed publication in the United States or a foreign country ... more than 1 year prior to the date of the application for patent in the United States" (Malilay, Mueting, & Viksnins, 1997; U.S. Consolidated Patent Law). There are a variety of situations that might constitute public disclosure of the invention. Publication of the invention in an article, presentation of the material at a conference, or use of the invention within the market-place prior to filing the patent application would be examples of public disclosure. The take-home message is this--know the rules about the process and avoid the risks.
You Have an Idea-Now What?
Put it in writing, in pen or typed, not pencil! Write down everything about the idea--the date you thought of the concept, the time (if possible), and what circumstances brought about the idea. If you have developed a prototype (i.e., a crude beginning model), sketch a picture of it, time and date the document, and sign the document with your legal signature. Make several copies and put the original in a safe place, such as a safety deposit box.
An invention disclosure document (IDD) will need to be completed to legally document your idea. This document is typically filed with the Technology Transfer Agency. If you plan to file a patent, the first step would be to conduct a comprehensive search of existing patents to make sure that your invention is not an infringement (i.e., does not violate) the claims of another patent. If you are not working with a university technology transfer foundation, it is recommended that the services of a patent attorney be retained.
The purpose of a patent is not to give the inventor permission to manufacture and sell the product. The purpose of a patent is to prevent someone else from manufacturing and selling the product by giving legal sanction to the inventor's claim of invention and ownership. In general, the first step is to file a provisional patent application. The provisional patent application (1) establishes a priority date, (2) costs less than a full utility patent application, and (3) has a 1-year life-time, allowing time for studies to be completed. If the patent process is to continue, the provisional filing must be upgraded to a full utility patent application prior to the provisional patent's expiration (Mueller, 1995).
There are currently three types of patents. A utility patent is a "new, useful, nonobvious machine, manufactures, compositions of matter, processes, or any new or useful improvements of these mentioned items" (Mueller, 1995, p. 5). A plant patent is issued for discoveries of asexually reproduced new varieties of plants that are distinct (Mueller, 1995). A design patent is issued on new, original ornamental designs for articles of manufacture (Mueller). Utility and plant patents have 20-year terms, while the design patent term is 14 years from the date it is issued (Mueller).
Patent filing costs can be very expensive. Provisional filing costs can range from $2000 to $4000 or more. Utility filing fees for United States patents can range from $10,000-$25,000 or more, depending on the complexity and effort to prosecute. A patent filing includes these components:
* title and inventor(s), intellectual property holder
* patent search details (fields and references) used by the examiner
* background of the invention (field and related art)
* summary of the invention
* description of drawings
* detailed description of the invention (embodiments starting with preferred implementation, references to figures)
The claims of a patent describe what has been invented. The claims are used to define the rights of the patent that is issued by the government. Some claims may be allowed, others may be rejected. The claims should be as broad as possible to cover variations in design and field of use, yet specific enough to close loop-holes that allow infringement. A successful patent filing gives a detailed description of all possible embodiments (aspects) of using the device. Detailed drawings of the invention (device) are required, referencing the drawings in the required fashion according to the United States Patent and Trademark Office standards for figures. Everything in the patent application is there to support the claims. The claims are what you have determined makes the device unique (www.uspto.gov).
The Bayh-Dole Act, cosponsored by Senators Birch Bayh and Robert Dole in 1980, enabled universities, nonprofit research institutions, and small businesses to own and patent inventions developed under federally funded research programs (Patent Trademark and Protection Act Amendments, 1980). The act provides an incentive for universities to market their innovations and for industry to make high-risk investments.
Technology transfer is a formal process of taking ideas, discoveries, or inventions to the market-place. Many times this occurs as the result of research conducted at universities. Many of the major universities have not-for-profit entities in place to facilitate technology transfer. Fig 1 shows the process of technology transfer from idea conception through market launch. This is a very complex and risky path. Finding capital to develop, test, and market an idea can be challenging. Individuals (venture capitalists) willing to invest in innovative, yet unproven, ideas are also, understandably, entitled to a lion's share of the profits because they are risking their money. The investor(s) share varies depending on the value of the product, developmental stage of the product, and the current market analysis. There is no one contract that is universally applicable. It would not be unusual for the inventor to realize only a fraction of the profits following distribution to investors and patent attorneys. There are several other avenues for funding:
* federal grants (www.nih.gov)
* Small Business Innovation Research Program (SBIR)
* Small Business Technology Transfer Program (STTR) (www.sba. gov/sbir/indexsbir-sttr.html#sttr)
* foundations such as Robert Wood Johnson and other well-known entities with monies available to appropriate
* industry-sponsored grants
* sponsored research agreements
* startup companies-venture capital.
[FIGURE 1 OMITTED]
Technologies not yet ready for licensure maybe candidates for sponsored research. In some instances, investors may accept stock options instead of cash.
Whereas technology transfer is, in itself, a risk, there are some risks that can be avoided. Following is a brief list of considerations to make:
Protect your data. The information documented in the development of your invention, and the findings recorded in testing the device, or process, are the footprints of your discovery.
Select your research partners carefully. The choice should be based on
* what expertise they bring to the project
* reputation as a scientist/clinician
* how much time they can give to the project, and
* whether this person is easy to work with.
Protect your intellectual property. Intellectual property (IP) may be a new process, a new device, an improvement on a device that already exists, software, or an analytical tool, but it might also include the following items:
* documentation of discussions
* initial brainstorming documentation
* research plans
* research notes
* research data
* patent applications
Intellectual property rights are the rights, or ownership, of individuals over their intellectual innovations or creations (International Council of Nursing, 2004). The best advice anyone can give you is to "know the rules." If you have an idea, do not discuss it with anyone without obtaining a confidentiality agreement first. Go to the United States Patent and Trademark Office Web site (www.uspto. gov). Do not rely on other individuals to interpret the rules for you.
Respect research deadlines. Meeting deadlines for institutional review board review, grant reviews, or other deadlines is important because it is a potential risk to delay funding potential.
Assess your reputation as a scientist. The ability to obtain funding, publish research, and garner the respect of the clinical and scientific community is dependent on your reputation as a scientist.
Require detailed explanation of offers, plans, and contracts. Just because you need money and they have it, does not mean they are right and you are wrong. Don't be foolish. Trust your "gut instinct." It takes many, many presentations to sell your idea. Do not get discouraged. Remember, if it were easy, everyone would be doing it!
Barbara Haberman, Section Editor
Elghanayan, S. G. (2000). Kiss the kick bucket goodbye. American Journal of Nursing, 100(10), 75.
International Council of Nurses. (2004, December 5). Nursing matters. Trade related aspects of intellectual property rights (TRIPS). Retrieved July 12, 2005, from www.icn.ch/matters_TRIPS.htm.
Inventive Women. (n.d.) Inventive women biographies. Retrieved June 13, 2005, from www.inventivewomen.com/library/ library_alice_dicks_nfld.shtml.
Lipsey, S. (1993, July-August). Mathematical education in the life of Florence Nightingale. Newsletter of the Association for Women in Mathematics, 23(4), 11-12. Retrieved from www.agnesscott.edu/lrid dle/women/night_educ.htm.
Maililay, G. P., Mueting, A. M., & Viksnins A. S. (1997). Association of University Technology Managers (AUTM) educational series.. No. 2, "Prior art: Silent time bombs that can blow away your licensing deals." Norwalk, CT: Association of University Technology Managers, Inc.
Metler, R. (November 10, 2004). Patented technologies of nurse-inventors. Abstract 77202, Proceedings of the American Public Health Association Meeting, Washington, DC. Retrieved July 12, 2005, from http://apha. confex.com/apha/132am/techprogram/ paper_77202.htm.
Mueller, L.V.B. (1995). Association of University Technology Managers (AUTM) educational series.. No. 1, "An inventor's guide to patents and patenting. "Norwalk, CT: Association of University Technology Managers, Inc.
Nightingale, F. (1858). Notes on matters affecting the health, efficiency and hospital administration of the British Army: Founded chiefly on the experience of the late war London, England: Harrison and Sons.
Paolucci, M. (August 2, 2000). Mothers of invention: To improve patient care, nurses devise innovative products. NurseWeek. Retrieved December 5, 2004, from www.nurseweek. com/news/features/004)8/invent.html.
Patient care + creativity = nurse inventors: Suzie Burns. (2003, May 19) Virginia Legacy. [Electronic version]. Retrieved June 13, 2005, from www.virginia.edu/ topnews/nurse_inventors.html.
U.S. Consolidated Patent Law, 35 U.S.C. Section 10209).
Patent and Trademark Act Amendments of 1980, 35 U.S.C. Section 102(b).
Questions or comments about this article may be directed to Vicki Y. Johnson, PhD RN CUCNS, 1530 3rd Avenue South-NB439, Birmingham, AL, 35294-1210, or via e-mail to firstname.lastname@example.org. She is an assistant professor at The University of Alabama School of Nursing, and assistant professor at The University of Alabama School of Engineering, Department of Biomedical Engineering.
Edward G. Walsh, PhD, is a research assistant professor at The University of Alabama School of Engineering, Department of Biomedical Engineering, and has a secondary appointment as an assistant professor at The University of Alabama School of Nursing.
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|Title Annotation:||Research Corner|
|Author:||Johnson, Vicki Y.; Walsh, Edward G.|
|Publication:||Journal of Neuroscience Nursing|
|Date:||Oct 1, 2005|
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