Do you have an idea for a new healthcare product? It can be a drug to treat a common disease or a futuristic medical device. The product development process–from the initial to the licensing stage–is quite complex and, sometimes, frustrating. You need to follow all the necessary steps for your product to be accepted and put in the market.
Of course, there are several key steps to follow before you can be authorized to sell your service or product to the people. All these procedures, however, are governed by a few main factors. But, once you get the hang of the whole process of pharmaceutical product development, you will be well-equipped with the necessary knowledge needed to avoid any potential pitfalls.
Here are the four main factors to consider when creating a new healthcare product:
- Classification Of Your Product
In which category does it fall? Is it a biological or medical device, a drug, or a combination of both? Does it meet the current trends in the healthcare industry? It is very important to correctly classify your product to avoid any issues with the relevant authorities and rule of law. It also gives you an idea of which regulatory path you’ll need to take for a successful concept approval and licensing.
But, how do you classify a product?
Well, a drug has a simple definition and that is quite easy to determine. Problem comes in when trying to decide whether the product you are creating is a medical device or not. The best way to tackle this issue is to follow the definition provided by the governing body within whose jurisdiction you are planning to launch the product. Considering this factor will save you a lot of time and resources when proposing your idea.
- Establishing A Development Plan
After classifying your product, the next thing to do is to determine which path you are planning to take. A development plan is a great way of transforming your ideas into actions. In this section, you should identify four main things. One is the market you’d wish to target. This will give you all the information you need to know about your potential consumers.
Another thing to consider here is the development of a regulatory strategy. This will ensure that you follow all the laws of the land, and avoid any possible barriers along the way. The third factor here is the personnel. How many people will you need to accomplish your project? The answer to this question will lead to the fourth part, which is all about the cost. Make sure to include an estimated cost of every material, as well as the labor. Once everything is in place, you can go on and execute the development plan. For the best results, make sure that the experts of all subject matters are the ones in charge of the execution phase.
- Clinical Plan Execution
As with every medical-related product, a clinical strategy must be developed and implemented accordingly. This mainly includes the practical phase where products are tested to determine their effectiveness. Of course, every country has its own regulatory requirements that must be met. As such, you need to follow all the necessary guidelines and ethics approvals when conducting these clinical trials. It is recommended that you have a meeting with the regulatory body to determine any issues before you can commence the trial phase. This will save you time and resources.
- Regulatory Submission And Post-Marketing Plan
The final parts of the healthcare product development include the collation of the regulatory submission. Ensure you have included all the necessary information in the presentation and arm yourself with any other resources that might be required during its review. Like the clinical plan, it is important to meet with the regulatory authority before submitting your innovation for review.
If everything goes to plan, you will be licensed to produce and distribute your product. This is when you can launch your marketing strategy. But, before that, make sure your plan fulfils all post-marketing obligations. Afterward, it is now upon you to sell the idea to your potential clients.
Healthcare products may have their own regulatory paths, but they all follow these general guidelines. Each of the steps mentioned above is important and should be put into consideration when planning to put any innovative idea into action. Apart from the type of product, the location will also determine the regulations to follow. Furthermore, every country has its own laws by which you are required to abide.