One of the most important components of the medical industry is research and development. It is not surprising that R&D expenditures in the medical sector are rising given the world's current level of innovation. Starting a business in this sector might be challenging, especially with all the rules and regulations as well as the expensive R&D costs.
The first step in commencing your R&D project is to properly prepare all the required guidelines. The following points can assist you in this process. It requires advanced technology resources, design knowledge, rigorous testing capabilities, and a deep grasp of both the market and the end user.
One must perform fundamental research to learn more about the markets we want to enter, including where, why, and how. This is crucial because every market is different and has its own set of constraints. When you define your market scope, you will have a better idea of what needs to be done, and the boundaries of your implementation.
When developing a medical device, it is important to identify the following basic questions:
What problem will your device solve?
Who is your intended end user?
In which settings will your device be found?
In what area of medicine can you market your medical device?
Initiation and discovery stage
A product idea will be a fresh approach to a problem for which there are currently existing products on the market. The R&D team will therefore assess these alternative solutions throughout the discovery phase to ascertain how competitive they are.
It also matters how much users appreciate their present solution, how easy the product is to use, and how much it costs. Based on the competitive analysis, market research, and basic financial analysis, the data will determine whether the cost of creating the product is likely to be worth it.
We must begin by evaluating the current technologies used in existing solutions. Many view this as Reverse Engineering. The process is often thought of as copying but most global R&D teams understand that all inventions are based on core principles and solutions that have been previously determined. Improvements are also innovations, and this step is essential to determine the functionality and design objectives of the device. Understanding how different technologies work are assembled and function is also important for long-term product viability in manufacturing.
Each member of the R&D department such as the product designers, engineers, clinicians, and subject matter experts (SMEs), goes through a complete design process from conception to creation.
Product designers work with the users and/or clinicians to establish unmet market and customer needs. When the intended use has been established, the R&D engineer is also looped in so as to have a complete picture to determine the needs of future users. A requirement traceability matrix is a common method to record the user’s demands, which must be done. The user’s needs allow the designers to translate them into design input (technical requirements) which will ensure whether the final product will satisfy the user’s needs or not.
Formulation, Concept, and feasibility stage
At every stage, we need to hear the voice of the customer and gather feedback via surveys, competitive analysis, market research, etc. and incorporate this into the design process of our product. Start thinking about risks and customer requirements early. To develop the concept and ensure it works, we must be prepared to iterate the changes in the design often.
The next step in the process is idea generation. In The R&D department of medical devices determine the needs or the issues that a new medical device could solve in this step. This step could entail patient focus groups, professional interviews, or market research.
The second stage of the medical device development process is concept development. The concept phase is where market research and technological advancements interact to determine whether the desired product is technically possible. Through experimentation, a proof of concept can be achieved.
Design and Development – Verification & Validation
In this step, manufacturers of medical devices develop concepts for unique medical devices that might address the demands or problems mentioned in the design input. After the concept is determined to be sound, more testing must be done to ensure that the proposed medical device is safe and effective, also known as verification and validation (V&V).
While your new medical device concept is approaching the early stages of design development, there are other factors that will determine success. These include securing intellectual property protections and establishing which class the new product will fall into. Medical devices are classified by the US FDA into three different classes, depending on the level of risk they pose to patients: Class I medical devices, Class II medical devices, and Class III medical devices.
Class, I medical devices are low-risk medical devices.
Class II medical devices are medium-risk medical devices.
Class III medical devices are high-risk medical devices.
IDE (Investigational Device Exemption)/510k/Clinical Trials
Once a company has developed its product to the point at which they believe it can safely be used by/for/on people, it must apply to IDE. When the IDE application is submitted, the FDA may either approve, disapprove, or approve with conditions. After receiving the go-ahead from the FDA and selling the device to customers, the job of product development is not yet finished. Product development continues for the entire life of the product.
This is just a brief introduction; we will continue this line of articles with more information on the process.
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