Abstract:

Introduction: In 2018 the presenter was approached by our Extracorporeal Membrane Oxygenation (ECMO) team to assist with the development of a simulation curriculum for the cannulating physicians, ECMO specialist and perfusionist that composed our typical response teams. A needs assessment quickly revealed the need for a simulator that allowed for activation, ultrasound assessment, cannulation and flow to incorporate all members of the team….at the time, such simulator did not exist. The presenter was able to obtain support from the University of Wisconsin’s, Wisconsin Alumni Research Foundation (WARF) in order to proceed with design, patenting and licensing efforts. Five years later, the presenter now has a patented device, licensed to my LLC, that is about to hit the market. The presenter will share the things that he has learned along the way in hopes that this will make the process more streamlined, and less stressful for others in the industry.

Methods: The key steps along the way that the presenter would like to discuss include: forming a LLC, submitting a patent application, design, prototype manufacturing, product evaluation, revisions, legal consultation, manufacturing, and sales.

Results: Along the way, there have been some very gratifying patient outcomes which is ultimately the goal of a project like this. Shortly after an in-situ simulation with our colleagues in the emergency department, our activation process for extracorporeal cardiopulmonary resuscitation (eCPR) was adjusted and activated within our county. Within 72 hours, our team received their first activation. A young man in our area had experienced a cold water immersion injury leading to cardiac arrest in the field. After life-saving efforts were performed in the field, the patient was brought to our center and placed on ECMO within 20 minutes of arrival (thanks to our update process). This patient went home in less than 2 weeks with no neurological deficits. This was exactly the “big win” that we needed to build momentum. We have since performed dozens of activations in the adult population, and have now expanded to pediatric patients down to the age of 13. In addition, after working with our critical care transport teams, UW Med Flight is one of the only programs in the country to respond to outside facilities and place patients on ECMO prior to transport back to our center, thanks to partnerships with our cardiothoracic surgery and perfusion specialists.

Conclusion: Medical and healthcare simulation innovation is continuously developed within institutions, and these products have a much larger potential impact than is sometimes realized. Our goal should be to create an open source location to store and share our innovations in order to provide the greatest good!

Learning Objectives:

1. Describe the necessary steps to determine intellectual property ownership prior to beginning the healthcare simulator process.
2. Identify market, need, and profit margins to validate financial and opportunity costs to develop a new medical simulator.
3. Demonstrate validation tools which can be incorporated into clinical simulators.