Gary Meller MD, MBA

MedSim USA, Inc

The design of the simulator must first of all take into consideration the needs and requirements of the future user. The stimulus for developing a simulator often arises when physicians and scientists have developed a comprehensive and complex understanding of a medical problem or procedure. The end user, however, is usually a student, who may understand the process very differently. Developers should take the opportunity to talk with and observe potential users at every stage in the development process. It is hard to drag yourself away from the laboratory, or the programmer from the workstation, but time spent with future users is always valuable, and will avoid many wasted hours.

Remember, just because it’s neat doesn’t mean you need it. As we develop ever more sophisticated tools, it is easy to get carried away by marvelous technical capabilities. A simple solution may solve the customer’s problems more elegantly. A natural desire to keep ahead of technical developments in the field can make it difficult to stop developing the product long enough to get it into the market.

Programmers need to be programmed. And inventors sometimes need to stop inventing. A company should create a structured a program to assess the requirements and demand for the simulator. This assessment includes an analysis of what activities the simulator will replace, what real world functions it must mimic, and what procedures the user will have to perform to use it. This should include a description of what activities the simulator will replace in current practice. For example, the ultrasound simulator developed by MedSim, Inc, takes the place of students scanning each other in the early phase of their education. This practice has traditionally been a students first hands-on experience with scanning. The practice of scanning fellow students can create embarrassing situations, and potential risks. Students can serve as useful examples of normal anatomy, but the simulator offers the student a chance to patiently explore such conditions as pregnancy, congenital abnormalities, tumors, etc, without having a patient present. The simulator substitutes laboratory experience for clinical experience.

The simulator can also improve on reality in some ways. Good simulators create a new set of functions, abilities, and educational opportunities. For example, a simulator offers a standardized, reproducible, and quantifiable encounter with a “patient” which can be used for measuring student progress, assessing student performance, or evaluating the capability of employees. These tasks difficult to achieve using exisiting technology.

How to determine which products which may be successful in the market? A basic measurement is the cost of development compared to potential returns from selling the simulator. This equation can be difficult to assess accurately in advance. Even an approximation may lead to useful information. The cost of development must consider how long the process will take, whether the necessary resources are available, and the motivation and staying power of the developers. Conversely, the revenue from the market may also be difficult to assess. A simple estimate is the number of potential purchasers multiplied times the sales price for each unit.. Some development costs may be indirect or supported by other programs, grants, or overhead. Also some potential benefits may not be measurable in direct dollar amounts. Patient safety and convenience may be very difficult to quantify. Also, reducing the costs of training time, creating a higher level of initial performance in the clinical setting, or lowering error rates in early training are significant benefits from simulator based training which will not necessarilly be figured into the selling price. There is good evidence from research that most errors in medical training occur during the first five procedures performed or attempted by students. If these five procedures can be performed on the simulator, or ten, or twenty, the potential reduction of clinical costs may be significant.

As medical simulation is adopted in training settings, some products may be developed which have very high initial costs which are not recoverable. In this situation, institutions and government funding may be necessary to complete development. In the US, the military has been a leading and consistant supporter of the role of simulation in medicine. This may result from special factors which affect the operational environment and clinical outcomes in the armed forces. The U.S. military has a generally high level of technical knowledge and ability among its workers and managers. Also, the ongoing investment in manpower is very high and the risk of potential injury and death is significant. These factors, plus a familiarity with simulation based training exercises, have created a supportive environment for development of medical simulation.

Be wary of getting trapped in a classic development spiral. Chasing after small increments in performance that may not be necessary for product acceptance in the marketplace. In general, a lower cost of development may equate with lower potential returns from the market. The converse is not true however, and a high or excessive cost of development may never be recouped by investors. Adequate capital funding, or other financial support is essential to sustain the development process. Because the use of simulation in education is relatively new, potential users may not be familiar with this approach. The developer should have sufficient resources to survive the period of educating customers about the availability, use, and necessity of these products.

“We build it, they sell it” is the attitude of many scientists towards the marketing function. Another common misconception is that “everybody is going to want one of these.” Marketing and sales professionals should be involved in the product design process from the absolute begining. Even halfway into the process may be to late; many fateful decisions have been made by that time. Not only must the product be designed for the intended market, but the market must be prepared for the change in behaviour which will be created by using the simulator on a regular basis. Flight simulation for commercial aviation was not adopted on a universal basis until a network of training facilities was established by Flight Safety International. This developed because flight simulators were run on expensive mainframe computers, while pilots could easily be transferred to centralized locations for training. The market at the time of product introduction will not be the same as the market today. Even a two year development cycle, which is quite short, will result in changes in how the market will view the product. In a fwe will look at how to predict and direct the market’s reception of the simulator.

Engineering and scientific teams should listen closely to the marketing and sales people. This is a difficult assignment. Often these groups communicate in different terms, using language and assumptions which may not be easily understood. Specialists may be needed who can help the company to measure and understand market changes as they are taking place. The company should also actively persue competitive intelligence and market monitoring. This is done by attending conferences, meeting with other developers, and interviewing potential customers. Learn to analyze how other groups have solved common problems, recognize when standardized techniques have been adopted, and acknowledge who is doing things better. In a rapidly growing industry, open communication and exchange of ideas should benefit all participants. The challenge is to develop a new way of teaching, training, and learning.