The medical industry is one that is constantly growing and changing, and new innovations are hitting the market every single day. Have you ever wondered how these new innovations are made?
The medical industry is one that is constantly growing and changing, and new innovations are hitting the market every single day. Have you ever wondered how these new innovations are made?
Keep reading to find out all the steps a new medical technique or technological item have to go through, from inception to distribution, before they appear in your local doctor’s office or hospital.
Step 1 – An Idea Is Born
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Every new innovation starts with an idea, or in the case of innovations in the medical industry, with a need. This need may be noticed by a researcher striving to create new medical technologies. More likely, though, it will be noticed by a doctor or nurse on the front lines of the medical industry — who better to really determine what new things are needed than the people who help heal patients every single day?
The most amazing example that has been recently in the news is a trend toward ‘knifeless’ surgeries, which would have been considered science fiction only five years ago. Using concentrated ultrasound waves as a ‘knife,’ surgeons have been able to complete a variety of procedures without leaving scars or other evidence of normally invasive surgeries.
This amazing innovation wouldn’t have been possible without this first step. Someone looked at these procedures and thought, “There’s a way to do this without invasive surgery,” and with that, an idea was born.
Step 2 – Research
Step 2 almost always involves copious amounts of research. Using the example of the knifeless surgeries again, an inventor would have to consider countless questions before even thinking about jumping to the next step. A few of these questions might look like this:
· Is it possible to complete surgical procedures without using invasive methods?
· What tools could we use to complete these surgical procedures?
· Could ultrasound technology be used to replace scalpels for these surgeries?
· Can ultrasound waves be controlled in such a way that they only affect the targeted tissues?
· What are the possible side effects of using ultrasound technology as a surgical tool?
· Are there any other techniques that could be used to complete these same surgical procedures without the use of a knife?
· Is this device/technique/procedure marketable? Is it something that can positively benefit the medical community?
This is just a small sampling of what might go through a researcher’s head while they’re creating a new medical tool or innovation. These researchers and their teams have to consider every possible option and every possible contingency before proceeding to step 3.
Step 3 – Prototyping
Step three is arguably the most expensive step in creating a new medical innovation. Creating a prototype, especially for a new technique or device that is totally unique, will require finding a company willing to work with you to create the needed casts, molds and other components required to assemble your new device.
Once you’ve determined the manufacturing requirements, most companies will ask for a sizeable initial investment. This is simply because, at this point in the creation process, there is no guarantee that your product will be marketable or profitable, so manufacturing companies stand to lose a great deal of money if they invest in your prototype and it doesn’t succeed.
Once your prototype is assembled, though, it’s time to proceed to the most important step — testing!
Step 4 – Testing
Step 4 is by far one of the most important steps in getting your new device on the market where it can help people.
Testing in a laboratory setting does not usually require any special permitting or information unless your device utilizes radiation or other controlled substances.
Moving on to testing on human subjects will require registering your device with the FDA and applying for approval.
Depending on the type of device you’re trying to create, this step can take anywhere from a few months to a few years. It is important, however, simply because it allows you to make sure your device is as safe as possible while still performing all of the necessary tasks.
Step 5 – Manufacturing
Once testing is complete, its time to move on to the manufacturing of your device on a large scale and marketing it to the medical community. This is where establishing a good relationship with your prototyping company can really pay off — they already have all the dies and casts needed to manufacture your device on a large scale.
Once the device is manufactured and ready to ship, all that remains is getting it into the hands of the doctors and nurses who really need it.
And that, from beginning to end, is the life cycle of a medical innovation. 100 years ago, organ transplants were what knifeless surgeries are today — something we once relegated to the realm of fantasy but are now able to see becoming reality. Only our boundless imagination will limit where we are able to advance in the next year or the next decade.