When people think of medical devices they usually picture the machines that doctors and hospitals use to detect, diagnose, and treat disease. While those items definitely fit the definition, the truth is that many of us use medical devices in our daily lives. The thermometer, you use to take your temperature, is a medical device, as are the glucose meter and the syringes that a diabetic uses to manage his disease. Eyeglasses, ACE bandages, and even your bathroom scale are also all considered medical devices.
In fact, according to The Institute of Clinical Research a medical device is defined as any object or material that is used to diagnose, treat, monitor, prevent, or alleviate a disease, injury, condition, or handicap in human beings. This includes things that replace or modify parts of the anatomy, or a physical process, and control of conception. So, by that definition, a majority of the things in the average medicine cabinet are medical devices.
How Medical Devices are Created
Medical devices always start as an idea. Someone somewhere recognizes a need for a device to treat or diagnose something and finds a way to make it happen. For example, prior to the blood glucose test, the only way to determine if blood sugar was high was to taste the diabetic’s urine; sweet urine meant high blood sugar. The thing is, urine tasting can tell you that sugar is present, but not how much. Also, a lot of patients weren’t too keen on having to taste urine every day – sometimes multiple times a day. There was a need for a more accurate, and less disgusting, way to test blood sugar.
In 1945 a company called Ames fulfilled that need by designing a blood glucose test called Clinitest that used a copper tablets to test blood sugar. Patients would drop a tablet into a test-tube of their urine, and it would change color to indicate the presence of sugar. Clinitest also gave an approximate idea of how much.
Introducing a device is just the tip of the iceberg. Once a design hits the market, it can go through multiple design changes.
Evolution and Design Change
The biggest reason that designs change is that somebody realizes that there could be a better way to get the same job done. Going back to the blood glucose testing above, the Clinitest system was much better than urine tasting, but it still wasn’t the best. Urine glucose testing wasn’t the most accurate measure of blood sugar, and the process was still fairly messy and inconvenient because of the test tubes.
Over the years different companies introduced new and improved glucose-reading devices such as:
• Disposable urine glucose strips, which meant patients didn’t have to maintain and clean test tubes, and that they could test their glucose away from home;
• Disposable blood glucose strips;
• Blood glucose monitors that could accurately measure the amount of sugar in the blood, which made it easier for people to determine the correct insulin dose;
• Smaller glucose monitor, which were more portable;
• Glucose monitors that can take samples from the arm instead of the finger-tips, reducing the need pain and discomfort of frequent needle-sticks in the fingers; and
• Continuous glucose monitors that patients wear for long periods of time.
Today’s & Tomorrow’s Medical Devices
As we learn more about diseases and conditions that affect the human body, we are also exploring new devices to keep people healthy. A lot of devices are designed by companies, like Becton Dickenson, that specialize in making medical equipment. These companies might have in-house design teams, or they might work with an outside design company like DeviceLab, to create a prototype and working model. However, there are also everyday people creating medical devices because they recognized a need for them.
There are also people in the medical community looking at new ways to improve on an old theme. For example, in the realm of diabetes a group from Boston University is working on an artificial pancreas that will continuously monitor blood sugar and automatically administer insulin.
Medical devices also have to go through a fairly rigorous approval process. The FDA oversees medical devices and has a five-step process that every device inventor must go through to get approval for use and sale in the United States. This process is necessary to ensure that the device does what it is designed to do, and that it is safe for human use.
What spectacular technology leaps do you anticipate in the near future, that could significantly improve your lifestyle? Which device would you like to see improved or dramatically enhanced? Share your thoughts, provide some details and we might forward your idea to the elite research groups of the top medical equipment manufacturers!