Medical Devices
A medical device is an instrument, appliance or software used to diagnose, prevent, monitor or treat disease. Medical devices are categorized in three classes, based on risk. The device classification defines the regulatory requirements controlled in the US by the Food and Drug Administration (FDA), and similar agencies around the globe.
| Class | Risk | Examples | US Distribution of Medical Devices |
|---|---|---|---|
| Class I | Present minimal potential harm to the user | Elastic bandages, hand held surgical instruments | 55% |
| Class II | More complex, higher risk that are not life-sustaining | Monitoring devices, infusion pumps, powered wheelchairs | 44% |
| Class III | Support or sustain human life | Angioplasty catheters, pacemakers, defibrillators, heart valves, neurostimulators for use in the brain | 1% |
Medical device innovators must be intimately aware of the specific requirements to achieve regulatory approval, a process which can take 90 days to more than 5 years based on device complexity. Regulatory processes involve robust verification of safety and efficacy and in recent years also cost effective clinical outcomes. Fees are paid to the US government Food and Drug Association for regulatory submission ranging from approximately $3,000 for devices of minimal risk to nearly $200,000 for the more complex devices. The FDA does offer a substantially reduced fee for first time submission of a small business.
The US market for medical devices is the largest worldwide, with an estimated $86 billion in revenues in 2006, or close to 40% of the global market of $220 billion (Advamed, 2006). Throughout the past years the US market has exhibited growth of approximately 10%, a trend that is expected to continue in the coming years. Cardiovascular, orthopedic and surgical devices make up a major part of the market, with almost 50% of total revenues.
Over two thirds of the 5000 US medical device companies have fewer than 20 employees.
