THE NURSE: LINDSEY RODDY
Lindsey Roddy has worked as a critical care nurse for over nine years. In 2016, she enrolled in a PhD in nursing program at the University of Wisconsin-Madison (UW-Madison), with the goal of conducting research to improve patient care. Roddy focused on the significant harm associated with inadvertent dislodgment of medical tubes and lines-an issue she was acutely aware of because of her own experience as a nurse. Some years earlier, while assisting an ICU patient out of bed, the line providing critical medication had snagged and become dislodged from the patient's neck. While the patient survived, the incident created a lasting impression on Roddy, leaving her wondering what could be done to prevent this from happening to other patients and nurses.
THE PROBLEM: CRITICAL PATIENT LINE DISLODGMENT
Peripheral IV line insertion is the most common invasive hospital procedure.1 An estimated 70% to 90% of acute care patients require IV access during hospitalization.2 In addition to IV lines, patients often require medical tubing, cords, and physiological monitoring equipment. Disorganization of these lines, cords, and tubes is a safety hazard, as it increases the risk of medical errors and is a time burden for caregivers.3 Furthermore, lines, cords, and tubes that are connected to patients hang down on contaminated floors, increasing the risk of infection or of trips and falls when patients move or when they are transported. They can also become dislodged.3
An estimated 19 million IV lines are inadvertently dislodged every year, leading to increased risk of bleeding, infection, infiltration, air embolism, phlebitis, and extravasation.2 In addition to medical complications, tube and line dislodgment are associated with increased medical cost, pain, patient dissatisfaction, prolongation of patient care, treatment interruption, and additional time required from staff.1, 2
While Roddy did not originally intend to pursue product development, her personal experience with critical line dislodgment inspired her to participate in the University of Wisconsin-Milwaukee (UW-Milwaukee) Startup Challenge-a program that encourages participants to research ideas while providing them with the opportunity to gain entrepreneurial experience. Roddy found herself the only nurse in the program.
Because an essential aspect of product development is gaining a deep understanding of the problem to be addressed, Roddy interviewed over 150 nurses, physicians, physical therapists, and paramedics from several health care systems to learn more about the most significant challenges in managing and preventing adverse outcomes from line dislodgment. Through this process, she came to understand that the fundamental problem in line management was both organization and securement. Unable to find any existing products that could fully address this issue, she sought out the help of an engineer.
INITIATION OF THE NURSE-ENGINEER PARTNERSHIP
Roddy met Kyle Jansson in 2017, when they both participated in the National Science Foundation Innovation Corps (I-Corps), a program that supports engineering research with the goal of bringing innovative technologies from the laboratory to the marketplace.4 I-Corps also helps connect experts and critical team members.4 Jansson, who had encountered ideas from hundreds of entrepreneurs, saw great potential in Roddy's product and recognized the value of her clinical experience.
Jansson says his passion for engineering began with a love for Legos and tinkering with equipment at home. Later, an undergraduate education in mechanical engineering at UW-Madison gave him an understanding of materials, fluid dynamics, and heat transfer-knowledge that would become critical to his work in product design.
Following a long career developing medical devices, including drug delivery systems, anesthesia machines, and surgical tools, Jansson became director of the UW-Madison Prototyping Center, where he works with entrepreneurs to form start-up companies. His experience with both successful and unsuccessful ventures has given him an appreciation of all aspects of product development, including sales, marketing, shipping logistics, and financial planning.
PRODUCT DEVELOPMENT
After receiving permission from UW-Milwaukee, Jansson and Roddy began their collaboration. Roddy brought Jansson to the hospital for observation because, as she put it, "I knew his engineering brain would light up in ways that mine may not." Jansson echoes the importance of this visit, recalling that the ability to see exactly how nurses work, what their environment looks like, and the variety of patient needs they must address helped him understand the features that the product would require in order to perform optimally in a busy clinical environment.
Roddy and Jansson also spent time in the nursing laboratory at UW-Madison, observing how patients moved with lines. They simulated falls and took note of how patients transferred from a chair to a wheelchair. Their collaboration allowed them to exchange ideas quickly and to adjust their product design as needed. The pair credits this process with their ability to cycle through nearly 40 versions of the device in just two years. Each version, they say, enabled them to improve on their design-based on both performance and clinician satisfaction-before they settled on the final design.
Roddy and Jansson agree that although the device seems simple at first glance, it was challenging to create. The current design now includes a versatile tension feature for IV lines, cords, and tubes that provides securement and allows for patient mobility. A series of grip channels can hold up to eight lines, including monitoring cords, oxygen, suction, nasogastric tubing, or IV tubing. Most importantly, when a line is pulled, the force is absorbed by the device, saving the patient from a potentially life-threatening dislodgment. The product has been manufactured without the use of adhesives, and nurses can easily attach it to a patient's arm, a bed rail, or an IV pole. Intended for a single patient, the product can be used from admission to discharge.
Roddy's experience as a bedside nurse allowed her to prioritize features that would be required to facilitate nursing workflow-for example, the ability to keep the transducers at the right atrium level so accurate hemodynamic monitoring can be maintained. The time Jansson invested in understanding the clinical environment was fundamental to choosing the materials and design that would allow the device to withstand the demands of the clinical setting. The combination of nursing and engineering expertise facilitated the development of the best solution in the least amount of time.
NEXT STEPS
In 2019, Roddy and Jansson formed Roddy Medical and became equal partners. They received additional funding through the Wisconsin Economic Development Corporation for ongoing product development. As their prototypes improved, they continued their clinical interviews to further improve their design. They also created a business plan, which included the goal of receiving Food and Drug Administration (FDA) clearance for marketing their product.
In 2020, a mentor introduced Roddy and Jansson to Pat Deno, whose 30 years of experience working at sizable medical device companies provided her with the expertise needed to get the product through FDA quality systems, and assist with marketing, production, commercialization, and launch.
Now, after five years of hard and collaborative work, Roddy is the chief executive officer and Jansson is the director of engineering of their start-up company. SecureMove-TLC is Roddy Medical's first product. Roddy, Jansson, and Deno have partnered with two venture capital funds, a collaboration that will allow them to launch and market their patented SecureMove-TLC.
REFLECTIONS ON THE NURSE-ENGINEER PARTNERSHIP
When asked to reflect on her experience, Roddy credits teamwork and collaboration for her success. Her own clinical experience and nursing perspective, she says, combined with the expertise of her engineer and business development partners, were essential to the creation and launch of the product.
Jansson, who singles out patience and the prioritization of patient safety as the team's core values, emphasizes the importance of not cutting corners and refraining from rushing to market.
Both agree that a real-time collaborative model, based on an interdisciplinary nurse-engineer partnership, facilitates the accurate translation of clinical needs into product development and reduces the time required for the product to be made available on the market.
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