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Enhancing the Medical Device Product Lifecycle Using Medical Simulators

Tue, 11/13/2007 - 6:42am

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Virtual reality simulators are often associated more with entertainment or video game technology than something that would serve a true medical benefit; however, that’s not proving to be the case when it comes to using simulators with medical devices. This technology is proving to be effective when it comes to enhancing or extending the product lifecycle of a medical device. This article explores these benefits.

Medical device companies are starting to realize the benefits that virtual reality simulation can supply throughout the product lifecycle. Computer-based simulation can be used to gain rapid acceptance of new devices and to train physicians on new tools and procedures. Medical and surgical simulation systems can generate increased profits by facilitating an accelerated launch with faster and greater adoption by healthcare professionals.

The LapVR surgical simulator provides a physics-based environment that allows authentic and realistic graphical movement of tissue and organs. Immersion Medical's TouchSense technology supplies realistic forces felt through the trocar arms and handles.


Today surgical simulators that provide physics-based models can be tuned to achieve authentic responses, creating natural (not scripted) interactions between tools, devices, and tissue. Medical and surgical simulation systems designed using a platform approach can be adapted to simulate specific tools and devices. Integrated into the product lifecycle, a highly realistic simulation program that reproduces the look, sound, and feel of a product’s use can easily and powerfully communicate product benefits and supply valuable information to planners and designers.

Many products and procedures can be simulated within realistic environments. For example, Immersion Medical provides a line of custom-designed simulators for the medical device and healthcare industry for applications in bronchoscopy, upper and lower gastroenterology, endovascular, intravenous access, and minimally invasive laparoscopy. The company’s LaparoscopyVR surgical simulator is a multidisciplinary platform capable of simulating general surgery, as well as OB/GYN and colon-rectal surgeries. Within these procedures, specific medical devices can be simulated such as suturing materials, staplers, coronary and carotid stents, mesh and retrieval bags, and ablation and electrosurgical tools.

Medical simulation could be integrated into a typical medical product development lifecycle to enhance it. Development, market introduction, growth, maturity, and re-innovation are all areas in which simulation could prove useful.

Development
Within the development stage, medical device manufacturers can use simulators to generate ideas for product improvements, modifications, and even new products.

The surgical simulator's Administration module sets out a suggested curriculum and also lets training administrators edit skills and procedures, set task parameters, create and assign courses to meet the needs of individuals and groups, and review and report on user performance.




If someone was approaching the development phase and already had a medical product simulation in use, designers would be able to review user performance metrics, obtain feedback directly from users, and use this information as they develop new products. Understanding the needs of the user can help avoid time-consuming redesign efforts, reduce time-to-market, and increase sales.
Market Introduction
Introducing a new product to the market can be a daunting and expensive task. With the relentless pace of medical innovation, an accelerated launch with rapid product sales can dramatically increase early profitability. On the other hand, delay in securing adoption can severely reduce profits. Medical simulation may provide the greatest benefits during the launch and initial sales phase of the product lifecycle.

With a simulation of a product, a long sales presentation is not always necessary and doctors don’t need to wait for a specialized case to come along. They can try a virtual product for themselves and receive a great deal of information, which can be more compelling than pages of material or a sales presentation of any length.

“Lifelike, physics-based simulation can be very much like performing the procedure and can leave a clinician feeling like they have already gained experience with the product,” says Dr. Kevin Kunkler, physician, vice president, and medical director of Immersion Medical. “This advanced training technology provides a sophisticated stage that can make for very powerful new product demonstrations. Simulations on our physics-based systems often help physicians appreciate the product being demonstrated as the emerging state of the art.”

Doctors need the kind of information that would make them feel confident about altering their diagnostic and treatment practices. Medical simulation supplies the kind of training experience that physicians appreciate. It allows them to see and feel how a product works and its therapeutic role and potential. It provides an experience on which a personal account can be based.

Dr. Campbell Rogers, director of the Cardiac Catheterization Laboratory at Brigham & Women’s Hospital has experience training with Immersion Medical’s endovascular simulator, today known as the CathLabVR™ system. “The feel of Immersion Medical’s simulator, the mechanics of it, are really good,” says Rogers. “The tactile feel is pretty reminiscent of what really happens in patients. The link of the technical steps to what you see on the screen is good and quite realistic. A third point would be that the scenarios represent mainstream everyday events. It allows you to dial-in those sorts of complexities or complications, so you can give experience to people in a much more focused way.”

The base laparoscopic surgical simulator includes an Essential Skills module with 15 skill exercises, a Laparoscopic Cholecystectomy (LapChole) module with 18 cases, Ob-Gyn modules with three procedures and nine cases, the Running the Bowel module, and an Administration module. The Essential Skills module includes exercises for developing camera navigation, cutting, clipping, adhesiolysis, eye-hand coordination, and hand transfer skills. The LapChole module provides an environment for simulating the removal of a gall bladder, one of the most common types of laparoscopic surgeries in the U.S.


In order to adopt new technology, physicians and hospitals need information. In addition, physicians tend to be cautious when selecting treatments and care for their patients. Research suggests that access to information, including other surgeons’ opinions, influences physician adoption behavior and that doctors are also more willing to adopt after they receive personal recommendations from their colleagues.1

In terms of hospital adoption of new technology, it is a key strategy for adding new services and increasing business. But the hospital also wants increased cost-effectiveness, increased efficacy, and decreased complication rates. The hospital’s ability to add new services, then, is entirely dependent on the physician customers. Simulation systems can provide the basis for a very credible and engaging training program that is both convenient and efficient for both trainers and trainees. With skilled, well trained physicians using a product, it has a better chance of acceptance.

Growth
As a product enters the growth stage, marketing activities are ongoing to encourage repeat purchases by customers and extend the distribution channel. A simulator can bring a medical device to a larger and geographically diverse audience via a computer.

Working with a simulator to display a medical device enables a company to easily obtain repeat purchases by adding new procedures, devices, or features. One of the benefits of computers is that new software code can be added to the simulator and easily provide a new tool or procedure for a customer.

Simulation, which can be a more efficient, scalable, and repeatable training aid than many other methods, can help encourage continued use of a product. Healthcare professionals find this hands-on training method extremely valuable and for good reason. Simulation-based training not only imparts the value of a product, but also helps teach the skill and the procedure needed to use it. Research shows that medical simulation can improve performance and lead to shorter response time and less deviation from practice standards than non-simulator training.2 Using a surgical simulator has also shown to increase user confidence and competence,3 and helps to enable the ultimate goal of improved patient safety.

In fact, there is a growing sense that the availability of simulators is now creating a paradigmatic shift in how medicine will be taught and practiced in the future. For example, in April 2004, the FDA voted to clear carotid stent placement and allowed simulation-based training that supports its use.4 Additionally, the Society of American Gastrointestinal Endoscopic Surgeons adopted guidelines incorporating medical simulation training in its laparoscopic surgery program.5

The surgical simulator comes with a widely viewable monitor suitable for team training, virtual camera and tools, and modules packaged in an ergonomic, height-adjustable, wheeled cart. It also includes a curriculum that follows industry training standards, providing key material needed to administer effective training programs for both individuals and teams. Institutions can also import their own didactic video content directly into the simulator for customized training.


A simulator can also help bring a medical device to a much larger audience. Translation into other languages is not as large a factor in communicating product benefits and use because the simulation can, in essence, stand in for the sales presentation. Trainings can be held in almost any type of facility virtually anywhere in the world. During several four-and-a-half-day sessions in Shanghai and Beijing in 2004, 12 U.S. physicians trained nearly 150 doctors using Immersion Medical’s CathLabVR system. The trainees gained experience using virtual, but highly realistic, stents, catheters, and balloons.

Maturity
During the maturity stage, the primary goal is to maintain market share and extend the product lifecycle. As the lifecycle evolves, data continues to be extremely valuable. At this stage it is used for determining which new procedures or devices to add.

When analyzing to continue to improve a product, it may be far easier for a clinician to demonstrate in a simulation what they like or want. Feedback from simulation usage can lead to modifications being made and features added to the product to extend its viability.
Re-innovation
The goal of the re-innovation stage is to prevent a product from becoming technologically obsolete. Instead of retiring a product, a company can use the feedback from the simulator to re-new it.
Conclusion

If the simulators are built on physics-based platforms, they are programmable and extensible. As was previously mentioned, one of the benefits of computers and physics-based simulation platforms is that new software code can be simply added to present a product’s new features or illustrate a new use for it. In many situations, simulators may be adapted or extended to suit new medical developments, products, and procedures. Integrating the benefits of a virtual reality simulator into a product’s lifecycle can help in a variety of aspects, not limited to those covered in this presentation. Additional uses and benefits are being realized by medical device manufacturers seeking to get the most out of their products.

References

1 Escarce, Jose J. 1996. Externalities in hospitals and physician adoption of a new surgical technology: An exploratory analysis. Journal of Health Economics. 16: 715–734.

2 Sedlack, Robert E. and Joseph C. Kolars. 2004. Computer Simulator Training Enhances the Competency of Gastroenterology Fellows at Colonoscopy: Results of a Pilot Study. American Journal of Gastroenterology. Jan; 99(1):38–9.

3 Wang, Tom, Ara Darzi, Rodney Foale, and Richard Schilling. 2001. Virtual Reality Permanent Pacing: Validation of a Novel Computerized Permanent Pacemaker Implantation Simulator. Journal of the American College of Cardiology (Supplement). 37(2): 493A–494A.

4 Dawson, David L. 2007. Virtual reality training for carotid intervention, Nature Clinical Practice Neurology, 3:470-471.

5 Peters, J.H., G.M. Fried, L.L. Swanstrom, N.J. Soper, L.F. Sillin, B. Schirmer, K. Hoffman, and the SAGES FLS Committee. 2004. Development and validation of a comprehensive program of education and assessment of the basic fundamentals of laparoscopic surgery. Surgery. 135: 21–27.

Online

For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com and the following websites:

Dave Tumey is the vice president of product development for Immersion Medical Inc. He is responsible for leading the business’ research and development efforts and the product development team. Tumey can be reached at 240-813-6412 or dtumey@immersion.com.

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