This volume focuses primarily on managing the discovery of new chemically- and biologically-based therapeutics to treat disease. The management of discovery in the life sciences also encompasses therapeutic medical devices, which are rooted in a different set of disciplines: materials science, mechanical engineering, and (increasingly) electrical engineering. Beyond the different sciences, the medical device sector features an entirely different model of innovation to the pharmaceutical sector. Rather than moving from bench to bedside, device innovation more frequently proceeds from bedside to bench and back again to bedside. In this process, clinicians rather than lab researchers are often the innovators. Physicians identify unmet needs in their patients, attempt to address these needs through product prototypes that they themselves often develop, and then engage outsiders with capital and engineering skills to refine the invention.
Thus, the development of novel medical devices involves the engagement of end users and external firms in an open-source and iterative process of innovation. The process is characterized by rapid prototyping, iterative and incremental changes, and close interaction between clinicians and product companies. This chapter examines one set of medical devices (catheters, guidewires, and balloons) and the procedure to insert them into the human body: percutaneous transluminal coronary angioplasty (PTCA), more commonly known as balloon angioplasty (Figure 6.1 – for a more detailed account of PTCA see “Description of Percutaneous Transluminal Coronary Angioplasty (PTCA)” in the Appendix at the end of this chapter).
Balloon angioplasty has been heralded as one of the 10 greatest discoveries in the field of cardiology during the twentieth century, and one of the most successful examples of translational medicine. Building upon research into transluminal angioplasty from the 1960s conducted by Charles Dotter, Andreas Grüntzig in the 1970s developed a procedure that applied Dotter's research to the treatment of patients with coronary artery disease. The procedure successfully treated stenosis of the femoral arteries using a balloon-tipped catheter to open them up, thereby diminishing the need for more invasive procedures such as coronary artery bypass with graft (CABG) surgery. Within two decades, the technique had become not only the treatment of choice for patients with acute myocardial infarction or occluded leg arteries (who could now avoid amputation), but one of the most widely used medical procedures, and it ushered in the era of interventional cardiology.