Angioplasty and other minimally invasive heart procedures have greatly reduced the need for riskier, more expensive heart bypass procedures. Today, coronary stents and radiation therapy help keep arteries open, heart bypass and valve surgery can be performed less-invasively, heart assist devices promise to provide an alternative to transplant, and highly advanced defibrillators and pacemakers can be implanted through simple, minimally invasive procedures to treat many heart rhythm problems. History of coronary angioplasty illustrates important aspects of medical technology innovation for health care decision-makers. Pioneers of new technology like Dr. Gruentzig often meet initial skepticism and resistance from the medical and insurance community. Small medical technology companies are not equipped to withstand delays or excessive, unclear requirements at FDA or Medicare.
Medical innovation is an incremental process with technologies and procedures evolving over time.
Product life-cycles are very short, on average 18 months but often much less. Thus, the artery reclosure rate after angioplasty has been cut in half over the past two decades as technology and surgical technique have improved. Health care policymakers must keep these points in mind as they seek to weigh the costs and benefits of new technologies. Medicare, for example, is working on a regulation that for the first time will establish the data requirements needed for a medical technology to gain coverage. By demanding cost data or excessive clinical data up-front in the coverage process before a technology has entered widespread use, this regulation could create a significant barrier to patient access and discourage further innovation.