Misconceptions about the role of medical device regulations and their resultant impact on the effectiveness on medical devices

Abstract

This publication will attempt to describe one of the most vibrant manufacturing sectors in the entire US economy and evaluate the present and future potential impact of government oversight and excessive domestic litigation on this industry. The first section of the report includes an overview of the medical device industry which has grown from its infancy in the latter half of the twentieth century. This is an industry characterized by an innovative and entrepreneurial personality that has brought many marvelous new devices to patients around the world which contribute not only to extending life, but more importantly, to improving the quality of life. I remember as a child reading a science fiction story about a futuristic doctor's bag which contained a series of instruments which, when applied against the skin, provide an accurate diagnosis and then, by simply pushing a button, administers a bloodless, non-invasive surgical treatment of the disease or injury. If we step back and look at today's treatments for heart disease, where an EMG can detect irregular heartbeats through patches placed on one's chest and where high blood pressure is treated through a patch placed on one's arm, we are obviously at the threshold of this fictitious miracle treatment only imagined in science fiction in the mid-half of this century. The use of balloon catheters for treatment of occluded coronary arteries, laproscopes for gall bladder removal and arthroscopes for meniscus tears in the knee are further examples of bloodless surgeries that resemble science fiction of the fifties. Who would have imagined in 1950 that before the end of the century, we would be able to replace successfully almost any mechanical structure or function of the human body? Who would have imagined that we could operate on microscopic regions of the brain to correct tumors or other maladies of this complex organ? During the first half of the century, most surgery of the brain was limited to converting a raving lunatic to a benign vegetable through a frontal lobotomy. Much of this miraculous new medical care is a result of a dynamic research and development philosophy within the medical device industry. There are many people today, including this author, who fear that the achievements of the last fifty years would be impossible in today's regulatory and litigious environments. Later sections of this paper will present statistics and deal with concerns about the constraints to innovation if the current legal and regulatory trends, aimed at seemingly zero-risk decision making, continue into the next century.