Difference between medical devices and pharmaceuticals
| Medical Devices | Drugs | ||
Industry Composition
| Over 80% small and medium-sized companies | Very large multinationals dominate | ||
Active Components
| Generally based on mechanical, electrical and materials engineering | Based on pharmacology and chemistry; now encompassing biotechnology, genetiengineering etc Pharmacologic properties and action of active ingredients are known, based on pre-clinical and clinical studies Standardised batch sizes, manufacturing processes and starting materials Products stable/generally stored at room temperature with a long shelf life | ||
Product Development
| Wide variety of products and applications – from thermometers to x-rays Designed to perform specific functions and approved on the basis of safety and performance Often developed by health professionals | Products are usually in the form of pills, solutions, aerosols, or ointments Product development by discovery, trial, and approved on basis of safety and efficacy Products developed in laboratories by chemists and pharmacologists | ||
How Products work
| Most act through physical interaction with the body or body part | Products are administered by mouth, skin, eyes, inhalation, or injection and are biologically active; effective when absorbed into the human body. Often act systemically on the entire body | ||
Intellectual Property Concerns
| Continuous innovation and iterative improvements based on new science, new technology, and new materials | Extensive research and development of a specific compound or molecule; takes several years for a new drug to enter the product pipeline | ||
Product Life Cycle
| Short product life cycle and investment recovery period (~18 months on market) | Little patent linkage possible. Data exclusivity is important Intensive patent protection, including data exclusivity and patent linkage, needed due to extensive product life cycle and long investment recovery period | ||
Innovation
| Majority of new products bring added functions and clinical value based on incremental improvements | Usually large step innovation | ||
Support Provided
| Large investment in manufacturing, distribution, and training/education; plus need to provide service and maintenance (for many high tech devices) | Low manufacturing and distribution cost, and, in most cases, no training, service or maintenance costs | ||
