The process of developing healthcare products is complex and time-consuming. It involves the various steps of the development cycle, such as the proof-of-concept stage, the licensing stage, and the clinical trials. Having the proper knowledge about the general development lifecycle can help speed up the time to market. These are the steps of the process.
Determine Correct Classification
Before you start the development of a new healthcare product, make sure that you have the proper classification. This will help you identify the regulatory path that will allow you to market your product.
Develop a Thorough Claim
Before starting the development of your product, you must have the necessary studies to support the claim. Doing so will help prevent potential issues with the regulatory process. For instance, if you change the classification of your medical device, it can affect the requirements for submission to the FDA.
Research Target Market
Before developing a healthcare product, it'll also be essential to identify the requirements for each jurisdiction. This will allow you to create a comprehensive strategy for addressing these requirements.
Develop a Regulatory Strategy
Before you start working on a regulatory strategy, it's also vital that you identify the specific requirements for each jurisdiction. Doing so will allow you to start planning on the path that will enable you to bring your product to market.
Create a Development Plan
A healthcare product development strategy should involve translating the requirements into actions that can be performed. This should be done by working with various functional groups and incorporating key milestones, periodic reviews, and critical paths. The plan should also be regularly updated.
Execute a Clinical Plan
The necessary studies to support the licensing application should be performed according to country-specific regulations and good clinical practices. Before you submit a clinical trial application, it's often a good idea to have a premarket meeting with the FDA to discuss the details of the study.
Collect Data
Once the data related to the product design and the various studies that have been performed are available, you should start collecting these reports and data for submission.
Compile Submission
Before starting working on the regulatory submission, you must identify the applicable requirements for each type of submission. Having the necessary documents will allow you to complete the submission and address any questions the agency might have during the review.
