Coming up with an idea for a medical device is relatively easy, especially when the idea is one of those that suddenly pops up while you’re taking a shower or having a conversation over dinner.
However, the process of actually turning the device from a concept into reality is what really takes the most time and effort. And, in most cases, you may even have to spend a lot of money to turn it into reality. Moreover, if you want to create a medical device and distribute it around the market, you must first get the approval of the Food and Drug Administration, which can be difficult.
But, as difficult as it may be, getting that approval should only be a matter of time once you get started. On that note, here are three pointers to help you out:
- Build Your Team To Cover All Your Bases
Before anything else, you must remember that the development of a medical device isn’t done overnight. It consists of several steps, and with each step, you’ll need the help of individuals with different skillsets. For that reason, it’s advisable that you first build a team to cover all your bases for this project. This team should consist of the following professionals:
You can assume the role of one of these if you want to directly involve yourself in the project. But, of course, you’ll mostly rely on your team of experts to complete the medical device development.
Experts also suggest that you contract medical device manufacturing. It may cost you quite a bit of money, but it’s most likely to speed up the process considerably.
- Decide On Its Classification Before Development
It’s important to know that there are three classes of medical devices. They differ in specifications and functionalities, although their main difference lies in the risks these devices may pose to users. Naturally, the complexity of developing the device may differ according to the classification. Here’s a closer look at these three classes:
- Class I
Class I medical devices are those that pose little to no risk to their users. Most devices nowadays fall under this category, mainly because they’re exempt from device review, which takes up most of your time in the project. Examples of class I medical devices include bandages, hospital beds, electric toothbrushes, examination gloves, and more.
- Class II
As you may have guessed, class II medical devices are riskier to use than the earlier ones. But, apart from that, it’s also worth noting that these devices have stricter requirements. For one, class II devices must pass the 510(k) review. But, just like class I devices, these devices must still comply with quality control and manufacturing standards. Examples of class II medical devices include pregnancy test kits, catheters, blood transfusion kits, and such.
- Class III
Class III medical devices have the highest risks among the three classifications. As such, clinical trials are conducted to test these devices. Moreover, apart from getting the approval of the FDA, manufacturers of class III devices must also submit a premarket approval application, also known as PMA, to sell the device. Examples of class III medical devices include cochlear implants, high-frequency ventilators, and the likes.
Once you have your team, it’d be best to promptly decide on the classification of your planned medical device as it’ll play a massive part in determining the project’s complexity.
- Follow The Five Stages Set Out By The FDA
While it is admirable to have your own set of guidelines to follow to turn your idea into a prominent medical device, it might also help if you follow the stages set out by the FDA.
The following are the five stages of medical device development according to FDA:
- Design And Development
- Final Validation
- Product Launch
By following these stages, you can at least ensure that you’re meeting the minimum standards enforced by the FDA, which would increase your chances of getting their approval to market the device. Moreover, since these stages cover the entire product development cycle, it allows you to have a guide from the conception of the idea to the device’s launch.
It may be difficult, but making a medical device from its conception up to its launch can be fulfilling. Not only are you making a potentially profitable product, but you’re also creating a device that’d help a lot of people. Alas, not many people are familiar with the process, and it’s not often touched upon by experts either. However, with this guide, you should at least be able to get started with the project.