Differences between medical devices and drugs
Medical Devices

In Vitro Diagnostic Medical Devices

Drugs

In vivo and/or ex vivo use
Diagnostic or therapeutic intended uses
Outcomes of use often depend directly on skill orexperience of user
Industry Composition
Over 80% small and medium-sized companies

In vitro use
Diagnostic intended use
Outcomes generally not dependent on
skill or experience of user

In vivo use
Therapeutic intended use
Outcomes generally not dependent on skill orexperience of user

Active Components
Generally based on mechanical, electrical, andmaterials engineering. Many medical devices
incorporate and are driven by software.

Very large multinationals dominate

IVD components have no therapeutic
effect – only used for diagnosis. Key
components are those essential for
detection of the analyte of interest.
Biological core reagents (e.g. antibodies)
Performance of tests (e.g. sensitivity,specificity) depends on design of test,
geographic variations of the infective
agent, populations, and the setting of use

Based on pharmacology and chemistry; now
encompassing biotechnology, genetic
engineering, etc.

Pharmacologic properties and action of active
ingredients are known, based on pre-clinical andclinical studies

Variable batch sizes for a given reagent,individual batches of the same reagent
may use different starting materials.

Standardized batch sizes, manufacturing
processes and starting materials.

Stability varies between products and mayvary between batches.
Generally stored at 4°-8°C
Generally short shelf lives (< 12 months)

Products stable.
Generally stored at room temperature
Generally long shelf lives

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Differences between medical devices and drugs
Some IVDMD incorporate and are driven
by software.

Software is not incorporated

Product Development
Wide variety of products and applications – fromthermometers and bandages to pacemakers to xrays
Designed to perform specific functions andapproved on the basis of safety and performance
Many products developed by doctors or nurses

Most act through physical interaction with the bodyor body part.

Intellectual Property Concerns
Continuous innovation and iterative improvements
based on new science, new technology, and newmaterials
Short product life cycle and investment recovery
period (typically 18 months on market).
Little patent linkage possible. Data exclusivity isimportant.

Products are usually in the form ofreagents (solutions, coated microwells,strips). Wide variety of IVDs designed fordifferent indications (e.g. screening,confirmation, monitoring of treatment)
Product development by discovery,evaluation, and approved on basis ofperformance
Products developed in laboratories bychemists and biologists.
Tests performed on samples (e.g. blood,tissues, saliva, faeces or urine) taken fromthe body
No direct contact with human body - No
need for “clinical trials” with patients=> “performance evaluations” of IVDs withsamples

Products are usually in the form of pills,
solutions, aerosols, or ointments
Product development by discovery, trial, andapproved on basis of safety and efficacy
Products developed in laboratories by chemists
and pharmacologists.
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.

Continuous innovation and iterative
Extensive research and development of aimprovements based on new science, new specific compound or molecule; takes several
technology, and new materials
years for a new drug to enter the product pipeline
Rapid innovation, short product life cycle(3-5 years) and investment recovery
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Intensive patent protection, including data
exclusivity and patent linkage, needed due toextensive product life cycle and long investment
recovery period.
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Differences between medical devices and drugs
Majority of new products bring added functions andclinical value based on incremental improvements;
often results in range of related “models” for user tochoose among based on patient needs.
Support Provided
Large investment in manufacturing, distribution, andtraining/education (and retraining); plus need toprovide service and maintenance (for many hightech devices)

Majority of new products bring added
clinical value based on improvements ofperformance

Usually large step innovation

Large investment in manufacturing,distribution, and training/education (andretraining); plus need to provide service
and maintenance (for many high techdevices)

Low manufacturing and distribution cost, and, inmost cases, little or no training, service ormaintenance costs.

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