What is a medical device?

 A ‘medical device’ is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related material:

  1. a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support, of the anatomy or of a physiological process,
  • support or sustaining life,
  • control of conception,
  • disinfection of medical devices,
  • providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;

and

  1. b) which does not achieve its primary intended action in or on the human body by pharmaceutical, immunological or metabolic means, but which may be assisted in its intended function by such means.

Comparing Medical Devices and Pharmaceuticals

Medical Devices Drugs
Industry Composition
Over 80% small and medium-sized companies
Very large national & multinationals dominated
Active Components
Generally based on mechanical, electrical, and materials engineering
Based on pharmacology and chemistry; now encompassing biotechnology, genetic engineering 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-raysDesigned to perform specific functions and approved on the basis of safety and performanceOften 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