Criador Labs | Medical Device Development Firm | USA & India
The medical device development process necessitates the completion of specific stages to ensure design control and the creation of a product that is both safe and effective for use. As a result, the complete product development cycle is covered, from medical device prototype to clinical testing, risk assessment to manufacturing. The development of medical devices follows a well-defined path.
Generally, the development process starts when an unmet clinical need is detected. To address this need, an idea or concept for an innovative device is conceived. Then, a "proof of a theory" - a report that highlights the steps required to ascertain whether the idea is viable - is created. Many times, ideas are impractical. The ideas that exhibit promise advance to the next stage of development.
The FDA establishes five steps for accessing medical devices before they are placed on the market. These stages comprise their quality system regulation (QSR), which guides the methods and facilities used in, and the control activities used for: the prototype, production, packaging, branding, backup, setup, and maintenance of all finished devices designed for human needs.
The FDA stages are as follows:
Step 1: Initiation, Chance, And Risk Examination
Plan your device's development, and don't forget to document it!
Consider all the tasks that will be required and accept that you will not be capable of moving the whole path alone.
Consider your financing strategies, as well as the markets where individuals would like to register — where and why, and in what way? This is absolutely essential because each business does have its own set of regulations and difficulties. If you are creating a new product that no one has ever made before, take steps to protect it by having to file for IP (intellectual property) and patenting your concept.
Your market knowledge is essential because it will reveal the following: are there comparable products on the market that you can assert? Do you require medical testing for your device? Due to the expense involved, the difference between the two can make your project viable or impracticable. Do not even forget to take documents upon it.
Setup a QMS (Quality Management System). Your QMS is the basis of your organization, and once it is solid, it will provide a solid foundation on which to build everything else. ISO 13485 is the guideline that most medical device industries use and is recognized internationally, so implement it. The QMS will include your processes, formation, and frameworks for how you might lockdown and regulate all operations in your organization, so take these things seriously.
Step 2: Conceptualization, Theory, and Applicability
In some ways, the idea and feasibility phase are essential because it is the initial stage in which you will get a working device that proves your concept.
Set the ball in motion only after you are assured that your medical device has a position in the market, is feasible, and is financially beneficial. You will require financing to implement your proposed design and test your device, but kudos! If you've reached the prototyping stage, you've completed Phase I, and your journey has begun.
Think deeply about threats and client expectations early on; in this phase, you must understand the customer's voice and gather feedback through surveys, market positioning, competitive analysis, and so on, and incorporate this into the prototype of your device. And make sure to document each phase along the way!
You will be creating the idea and attempting to prove that it performs during Phase II, so be equipped to go back and analyze the prototype as required, and don't forget to document the modifications! At this moment, you can put ownership in the ground and perform with it until you reach layout freeze.
Step 3: Development And Implementation – Validation & Verification
A proper way to do this is to create a design trace matrix that will make sure you don't lose track of the customer's needs. You'll have to translate this into technical specifications, such as how you'll meet the client's expectations, what medium of testing you'll need to validate and verify, what procedures you'll need, and what testing equipment you'll require. Have you begun to consider a production and reliability plan? Or are you going to export this?
Make sure you understand the product's legislative requirements as well as the legislative prerequisites of the country or region in which you intend to sell it. The specifications in the United States differ from those in Europe, and while there is some overlap, the uploading process is dissimilar. Based on your market analysis, focus on the region where you want to initially release your product.
If you had previously determined that clinical studies were required for your device, you must start your diagnostic plan and then use the product for the tests from the layout freeze until real use in a clinical setting. Consider what external authorizations you will require, such as from an Ethics Board.
Step 4: FDA Device Assessment
We're almost there; you should try thinking about branding and marketing right now. Strongly advise! - Be cautious what you put in the branding publications; it must be supported by data. The numerous times my toes fold when marketing professionals make unsubstantiated claims about products is worrisome. NO Proof = NO Assertion is the statement.
We must be collecting all of our information right now. All of our product's verification and validation should've been successful! So, where applicable, we should gather all of our testing evidence - improved bioavailability, safety procedures, etc.
Nice scaling up... We're getting there if we're upgrading. Perhaps we can replicate what we've done with a few effective products in manufacturing.
Perform all consistency testing and trials. It is very common for organizations to reach this stage only to discover that they did not complete all the tests. Why is this? They didn't understand the product's regulatory standards, started taking shortcuts, or didn't see the actual reason for the test. The industry has kept these tests in place to ensure safety, so don't merely throw the baby out with the bathwater.
You must be finishing up your technical documentation right now. Putting together a file containing all the supporting evidence to present to an appropriate authority such as FDA, who will review or audit your document for comprehensiveness in comparison to their anticipations.
Step 5: Launch of the Product and Post-Launch Evaluation
Perform a final review of your technical paperwork; you may have to make changes.
Ensure you have the framework in order for "Post Market"; you'll require a system to collect complaints and feedback, as well as a plan for how this information will be used. How will it be integrated into your risk management program?
Post-Market: Would you need to keep updating your design documents and re-testing? Would you need to contact the appropriate authorities again to notify them of a substantial change? Is it necessary to recall a product from the sector?
Well, guess what? We are ready now. Your regulatory approval and technical document review are complete, and if you ended up getting the auditor on a fine day, you are ready to deploy your product. You can put your device on the market once you have your permit or license.
If you are not based in the EU and want to sell products in Europe, you will need to appoint an "Authorized Representative" to represent your company in Europe.
Criador Labs can help with several aspects of medical device development. You can learn more about our medical device consulting services here.