3 Medical Technology vs Pharmaceuticals A common misconception is that medical technology is the same as pharmaceuticals (drugs). This has led some countries to regulate medical technologies as drugs. However, as the table below highlights, the two are very different. The indiscriminate and arbitrary application of regulations for drugs to medical technologies threatens the development and quality of, and access to, medical technology. Moreover, the ambiguity of the regulatory framework can stunt the growth of the medical technology industry, thereby restricting patient access. Increasingly, countries are appreciating that medical technologies and pharmaceuticals are distinct and, therefore, require distinct regulatory frameworks. DIVERSITY Extremely diverse group of products with very diverse components. Wide variety of applications. Single-molecule or specific compounds typically in the form of pills, solutions, aerosols, or ointments. SCIENTIFIC DISCIPLINES Active components based on mechanical, electrical, materials engineering. Some incorporate and/or are driven by software. Based on pharmacology and chemistry, and increasingly encompass biotechnology and genetic engineering PRODUCT DEVELOPMENT Designed to perform specific functions and approved on basis of safety and efficacy. Developed by discovery, trial, and approved on basis of safety and efficacy. PATENT STRUCTURES Due to the wide variety of structures and components embodied, many different patents cover a single medical technology. Thus, patents are not the basis for competition and do not confer market exclusivity. Short life cycle and investment recovery period with intense competition. There are typically very few patents for individual pharmaceutical products. Therefore, patents form the basis of competition. Typically have a long commercial life-cycle of many years, during which they do not undergo significant changes ROLE OF HEALTH CARE PROFESSIONALS Training of health care professionals is critical so medical technologies are installed and/or used safely and properly. Many products are developed by doctors or nurses. Health care professionals play a different and sometimes limited role. Many products are developed in laboratories by chemists and pharmacologists. SUPPORT PROVIDED In most cases, large investment in manufacturing, distribution, and training/education with need to provide ongoing services and maintenance. In most cases, low manufacturing and distribution cost, little or no training, service or maintenance costs. PHARMACEUTICALS (DRUGS) MEDICAL TECHNOLOGY