Note that this list likely does not include all issued patents, as some may be foreign and many of these patents detail prospective future products. For example, in searching the same database mentioned above (at time of print for this book), the key word CARDIAC produces 93,942 issued patents in 2015 since 1976, compared to 49,017 patents issued in 2008 and 37,410 in 2004. This rapid increase includes only US patent applications, yet the same is true for the number of new international patent submissions. There are several other resources to locate information on emerging cardiac devices, such as the Food and Drug Administration website (http://​www.​fda.​gov), the Google™ patent search website (https://​www.​google.​com/​?​tbm=​pts&​hl=​en&​gws_​rd=​ssl), and various other websites. It is important to note that, relative to medical devices, not all countries uphold patent protection to the same international standards; this is a major issue to consider as a corporation looks to expand globally. Discussion of these implications is beyond the scope of this text, but those developing cardiac devices need to be critically aware of this reality. For example, it was recently noted by Shara Aranoff, former Commissioner and Chairman of the US International Trade Commission [1], that “Over the past 20 years, the number of patent infringement disputes filed annually at the U.S. International Trade Commission (ITC) has more than tripled. Although typically associated with smartphones and semiconductor chips, the ITC has also seen quite a few disputes involving medical devices. Important trends are emerging in medical device patent litigation at the ITC.”

Many novel ideas that eventually lead to new products, therapies, and/or training protocols often first occur through “basic” cardiac research or clinical patient management. Hence, in order for emerging technologies to continue to advance at a rapid rate, it is imperative that laboratories performing basic research in cardiac-related technological areas continue to receive necessary support. Furthermore, prototype testing and clinical trials are essential to insure that the best possible technologies are developed and eventually made available for general use. Yet, it is important to note that many critical lessons can be learned from trials that employ misdirected devices or technologies.

When considering the design of a medical device , there are typically a number of key processes or steps involved:

Some devices can be employed as life-saving measures prior to approval for market release, if a Humanitarian Device Exemption is obtained. For more details on the design process, the reader is referred to Chap. 42.

As cardiac devices become more beneficial and help people live longer lives, we foresee that there will be a need to design devices that: (1) have even higher reliability and longevity; (2) can be upgraded, extracted, and/or replaced; and/or (3) allow for easy data retrieval (i.e., “big data” obtained remotely). More specifically, the retrieval of data and/or the reprogramming of implantable cardiac systems (sensor/pacing/defibrillation) should be accomplished with minimal need for patient training or education; they should function as seamlessly and simply as possible (you just implant them!). As these systems evolve, there will be growing interest from healthcare payers as well as the physicians and/or hospitals that monitor patients. Furthermore, data would ultimately and automatically be interfaced with electronic health records which are becoming commonplace in the USA and many global markets. Importantly, the increased use of home monitoring may be perceived as the only possible way to manage the growing amount of “big data” collected from the “baby boomer” patients receiving such therapies. This approach in turn may result in: (1) improved care, (2) greater levels of patient confidence, (3) better understanding of disease-specific therapies, and/or (4) overall cost savings for both the healthcare industry and consumers. It should also be noted that currently there are patient-owned medical records, as mandated in a Presidential order in 2004. Furthermore, with the passing of the Affordable Care Act in the USA, the future of cardiac device coverage will be affected, but at this time it is still not clear how and/or to what degree. To learn more about these policies, the reader is referred to http://​www.​hhs.​gov/​healthcare/​facts/​timeline/​index.​html. The Affordable Care Act was passed by Congress and then signed into law by President Obama on March 23, 2010; on June 28, 2012, the Supreme Court rendered a final decision to uphold the healthcare law. Important features of the Act include the following:

Despite the occurrence of failed devices, all designs were required to pass rigorous bench testing, animal trials, and human clinical trials before approval for market release. It is of interest to note that each company often designs their own bench testing equipment because, in most cases, the device designs are novel or unique. In fact, many times this testing equipment also becomes proprietary. Therefore, it is likely that bench testing of cardiac devices with high sales volumes will become regulated by governments sometime in the near future.

To provide greater perspective on the design and testing challenges facing the cardiac device industry, perhaps an example will suffice. A pacing lead moves approximately 100,000 times every day (or 37,000,000 times annually), and this can occur in multiple locations and with numerous degrees of freedom. Furthermore, when considering failure of the lead insulation alone, we must expect failures due to abrasions, the association with the fibrous device pocket, the potential for lead-to-lead interactions, anatomical considerations (bones, ligaments, etc.), and/or other complications. It is also interesting to note that some features of lead implantation (e.g., design of the anchoring sleeves) have received little attention or study, yet this may greatly influence the potential for lead failures. For a detailed review on the bench testing of cardiac valves, the reader is referred to Kelley et al. [2].