Cardiovascular Devices

In the cardiovascular devices arena, there is a group of large corporate participants (“dominators”) with lines of products for broad cardiovascular applications (including congestive heart failure), and a much smaller number of smaller companies (“upstarts”) with a primary focus on congestive heart failure. The number of smaller companies has not been growing significantly with the realization that congestive heart failure presents a major economic investment to achieve reasonably-timed technology/product development, clinical trials and market marketing in therapeutic niches for which there is presently no adequate participation.

Simply defining the niches is a difficult task. This trend may persist, but failing the addition of unique core technologies, it is not likely to continue too far into the future.

The barriers to entry into this field are high. In the pharmaceutical field, young companies must be prepared to do battle with some very large competitors, such as St. Jude Medical, Medtronic and Thoratec. There are, however, fewer device companies engaged to any extent in the congestive heart failure area than there are pharmaceutical firms addressing cardiovascular disease in any way. Clinical trials do have some longitudinal aspects, but one can usually measure other quality of life factors almost immediately after implantation of a device, renal output, certain biochemical markers of vital organ function and such. On the other hand, the engineering costs and the need for multidisciplinary product development teams for such devices are expensive in themselves. Yet, it may be easier for a new device company to gain a foothold in these markets than in the pharmaceutical markets. The number of competitors is smaller and the redundancy of product types is significantly less.