The process of developing a balloon and taking it all the way to commercialization can be long and difficult depending on the number of designs and various testing procedures. This process includes the development of the balloon through extensive market research, multiple design concepts, prototypes, and successful transfer of the device to be tested, manufactured and prepared for commercial launch. Both the product development and technology transfer process require multiple steps which we have broken down below:
Balloon Catheter Product Development Process
1. Device Design Inputs
Medical Balloon Design inputs serve as the foundation of any balloon development project as they make up the functional, performance, safety and regulatory requirements of the device. They should be clear and objective and based upon user needs and intended use. When developing design inputs, it is important to consider details such as industry standards and regulations, previous projects, competitor products, prototypes and of course the end user. It is also important to consider how you will prove that these inputs have been met during the verification process which requires careful documentation and objectivity.
2. Concept Generation
The concept generation and ideation phase of balloon development usually go hand in hand with the device design inputs as this is where a balloon’s functional and performance requirements can be defined. During this phase, each functionality should be driven by the end user or buyer persona. This requires extensive market and competitor research to make sure you produce a successful product. It is important to consider how each concept detail will be carried over to the initial prototyping.
3. Prototype Feasibility
Once you have defined the balloon design inputs and have generated the product concept or idea that includes the basic functionality of the device, you may now move on to creating a prototype. Creating device prototypes gives you an opportunity to analyze the product feasibility and potential success. During this phase, multiple prototypes are usually created in order to carefully review and analyze the design concepts to select the design that best fulfills the previously defined requirements.
4. Human Factors Engineering
When creating multiple variations of a balloon prototype, it is important to consider human factors as engineering and how this will inform and add to the overall design of the device. The FDA defines human factors engineering as “The application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users to the design of medical devices including mechanical and interfaces, systems, tasks, user documentation and user training to enhance and demonstrate safe and effective use.“ This is an essential part of the user experience, and the main objectives are to increase the safety, reduce errors, enhance usability and ensure that the balloons are compliant with federal regulations. This process similar to prototyping may be ongoing and require multiple attempts as each concept is created and tested to identify any design flaws.
5. Design Documentation
Documenting the design process can be the most crucial part to the balloon development process as this will ultimately determine the success of the verification and validation testing. After defining the design of the balloon and creating multiple prototypes, it is important that you carefully document each design input and how it will be tested to ensure the quality of the balloon and that it will meet regulatory safety standards.
6. Clinical Validation Builds
Once we have created the desired concept of the balloon, we can then test the prototype to make sure that it meets all the previously defined device outputs as well as regulatory standards. Medical balloon testing is crucial in order to prove that the device can meet the needs of the end user and is ultimately ready for regulatory submission.
7. Regulatory Submission
The regulatory submission will be tailored to the submission standards and requirements of the target regulatory agency. The submission includes the preclinical test results and the desired clinical use indications for the new product. In the case of a submission to FDA, whether a 510(k), PMA or IDE, often the formal submission is preceded by interactions with the FDA device review staff to clarify testing uncertainties; this also ensures a compliant submission and an uneventful review with the goal of a timely approval or clearance.
Balloon Catheter Technology Transfer Process
1. Design Transfer Plan
After the design of the balloon has been finalized and tested, we can then prepare for the transfer of the design to manufacturing. Successful design transfer requires an extensive review of the design documentation and regulatory standards. It also requires a strong and open relationship between the R&D and engineering team. The balloon design transfer process includes a detailed design for manufacturing plan to prevent regulatory issues, and save on time, money and resources
2. Validation Plan
Writing a detailed validation plan is a critical step when it comes to obtaining regulatory approval, as this encompasses an overview of the proposed system, identification of responsibilities and description of the overall quality management system. The validation plan will include the design inputs and outputs of each balloon development stage, the identified acceptance criteria as well as the methods of traceability and design review.
3. Regulatory Approval
Regulatory approvals based on the submission and acceptance of preclinical and clinical testing determine the approved clinical indications and instructions for use. In most cases, regulatory approval carries post-approval responsibilities and follow up requirements whether in the form of complaint and complication reporting, or in the form of post approval studies, annual reports, or ongoing design or manufacturing refinements based on accrued clinical performance data.
4. Commercial Launch
After receiving final regulatory approval, we can then transfer our balloon to manufacturing and prepare for commercial launch. This stage also requires discussion on how you will prepare to market your new device to your desired customers. Launching does not signal the end of the balloon development cycle as it requires careful evaluation of the device in the selected market to see how it performs outside the test environment. Gathered market data may initiate a new cycle about concept and ideas for improvements.