Technology Myths – Buying New Just Because It’s New
Advances in healthcare rely heavily on the development of new and innovative medical devices. There is no doubt that truly new and innovative devices sometimes open up new ways to treat patients - and every once in a while, they radically improve procedure outcomes and change the healthcare market forever. But most of the many medical devices that receive clearance from the FDA annually fall under a different category – they are granted clearance and reaching the market on the merits of other previous generations of medical devices.
The 510k clearance pathway allows medical devices that are functionally equivalent to devices that are currently being used to get to market much faster. Despite the rapid clearance process, these devices are often sold to hospitals and physicians at a premium price as the latest and greatest. The process of releasing new devices at ever-increasing prices contributes significantly to the rising costs that plague our healthcare system. It does, however, allow manufacturers to increase their profits, year after year.
The process of releasing new devices at ever-increasing prices contributes significantly to the rising costs that plague our healthcare system.
The me-too 510k clearance process is what makes it possible for manufacturers to constantly launch new, more expensive devices. To ensure the market actually adopts the new devices, manufacturers use forced obsolescence and push new technology even when there seemingly is no added clinical benefit.
Today, the concept of forced obsolescence is very familiar to most of us. Forced obsolescence is what happens to our Apple products when after a planned time period the devices no longer receive updates or function as they should, and consumers are required to buy new generations of the same products.
Medical device manufacturers use a similar model, but one that is often more heavy-handed and expensive. In some cases, the manufacturers just stop manufacturing previous generation devices. As a consequence, hospitals and physicians cannot continue to use their trusted devices and are forced into buying the latest and greatest. This is an obvious and blunt forced obsolescence example, but more subtle practices are used frequently, such as manipulation of device interface software. As the new generation devices become available, the manufacturers limit the features that are accessible on older devices through software upgrades. This is often explained as a limitation of the software or the hardware built into the device - but in practice is the same process used by Apple.
The field of cardiac electrophysiology relies heavily on medical devices and complex 3D electro-anatomic mapping systems to treat cardiac arrythmias. This field is exploding with new and emerging technology year after year. In this rapid process of innovation, physicians and hospital are constantly forced to decide if new technology should be acquired: Does it truly add value to their patients and procedures? This is often a difficult task to accomplish, since hospitals have to understand not just the clinical aspects of a procedure but also technological and financial aspects. To make matters worse, the major device manufacturers have built proprietary reliance into the systems, as they serve as the single manufacturer.
As new technology is developed and released, these same manufacturers then push the previous generation of devices into obsolescence. This process then forces physicians and hospital to adopt the new technology, all in the name of innovation and advancement. But a new device doesn’t automatically add value to the procedure just because it is newer or more expensive.
...a new device doesn’t automatically add value to the procedure just because it is newer or more expensive.
This brings me back to the difference between diagnostic and mapping catheters from my opening paragraph. In EP labs across the country, our data shows a substantial increase in the use of Biosense Webster DecaNav mapping catheters in Carto 3 (Biosense Webster’s mapping system) procedures. Traditional deca catheters are relatively inexpensive and diagnostic in nature without any advanced mapping capabilities. They are usually placed within the coronary sinus to monitor activation across the left and right atrium. In contrast, the very expensive Biosense Webster DecaNav catheter is a sensor-enabled catheter that is generally used for more advanced mapping techniques and integration with the Carto3 system. The sensor allows the catheter to collect 3D anatomy as well as electrical activation data, and this can be particularly useful in specific cases such as certain ablations where the design and shape allow it to fit easily into the space. But the growth of utilization of the Biosense Webster DecaNav catheter is not due to increased use of the catheter for mapping. Our utilization data suggests that these devices are in fact being used alongside other advanced Biosense Webster mapping catheters such as the PentaRay and the LassoNav.
This means the expensive Biosense Webster DecaNav catheters are being used to replace the cheaper diagnostic deca catheters and not in complex mapping of atrial arrythmias. These devices are simply adding cost to procedures without bringing added clinical benefit. EP labs should be cautious about adding costs from new technology just because the technology is new. It doesn’t always mean it is better.