By Paweł Zieliński – Marketing Manager Consonance
The whole process of prototype, manufacture, and market implementation for medical device development is regulated and necessitates a multitude of tests and analysis to assure safety and accuracy. The five stages of the development process for medical devices should help you succeed.
What is design and development for medical devices?
The first thing we need to define is what this means. From my perspective this happens when a creative idea turns into a secure and useful medical device through a certain process. The result can aid in patient diagnosis and treatment, extending and increasing patients’ quality of life by enabling them to avoid, treat, and manage illnesses or ailments. Medical devices such as mini C-arms, for example, have made a huge impact on medical imaging. Companies specializing in mini c-arms have been providing affordable mini c-arm solutions: whether you’re buying, renting, or financing, minicarm.com offers cost-effective options for Orthoscan, OEC, and Hologic Mini C-Arms.
As a medical device development company we can provide one key piece of advice: glue your product and your company with the five stages of medical device development. Missing any one of them might cause you troubles.
Medical regulations and certification pathways, which every new medical device should pass or at least resemble reference items that are currently on the market, are inevitable part of this process.
5 phases of medical device development
Why is it better to stick with them? Well, to avoid mistakes which in the case of medical devices, can get quite expensive. Keep below track created by professionals based on experience from projects which entered the market with a success and those which haven’t got there.
Phase 1: Device Discovery and Risk Analysis
Defining your needs takes some time. It’s essential to create and record a strategy for the development of your medical innovation. I believe the answers to the following queries might assist you in determining the scope of your next project:
- What ought my medical invention to accomplish?
- Does my concept require a hardware component, and are there any rivals?
- Do I have the means necessary to develop my concept?
- Who will join me as a partner in technology (hardware and/or software)?
- Do I have any knowledge of medical certificates and rules?
- Is the business potential of my concept somehow confirmed by data?
Phase 2: Formulation, Concept, and Feasibility
We’re probably getting close to the point where you have to choose whether to continue with the development of the medical device on your own or with the help of industry professionals. The concept and technical feasibility stage (report) is crucial since at the end of this point you will have a functioning prototype that will demonstrate the viability of your idea. You won’t move the process further unless you’re certain the product has a position in the market, is practical, and financially reasonable. Phase II ought to provide a notion and evidence that your concept is credible. Therefore, you must be ready to review the design several times, and if you make any modifications, be sure to record them.
Phase 3: Design and Development – Verification and Validation
To demonstrate that the prototype can actually endure all pressures, validate and test it in the real world. Make sure you and your tech partner are aware of the acceptance standards for each test. Customers’ requirements should be converted into technical specifications, which is a difficult operation if you are not tech savvy. Call out all the possible problems that might occur owing to poor design, shoddy production, or user error from foreseen usage. Less issues will arise during certification and clinical trials the faster you identify design and technological flaws.
Phase 4: Final Validation and Product Launch Preparation
Apply the following straightforward guideline to your project: No evidence, no marketing pitch.
As soon as possible, gather information and documentation of tests for electrical safety, biocompatibility, etc.. Carry out all stability and shipping trials. Some businesses reach this point only to discover they didn’t conduct all the testing. Why? because they took shortcuts, didn’t understand the true purpose of the test, or weren’t aware of the regulatory standards for the product.
By now, technical documentation ought to be completed with all the necessary documentation to provide to a notified authority (MDR EU/ FDA) that will review/audit your file for completeness according to their standards.
Phase 5: Production, Market Introduction, and Post-Market Follow-Up
The final stage is not necessarily the easiest. You must address crucial issues including the production and transportation of medical devices, the verification of marketing strategy prior to product launch, and the implementation of procedures for gathering customer complaints and comments as well as the handling of such information. How does it integrate with your risk management process?
I’m sure you’re curious now, how much time do you need to introduce a new medical device? You must be aware of product risk classification according to MDR or in the US – FDA. If you plan to launch a product in a higher class, the time can be respectively longer.
How MDR’s risk classification looks like:
- Class I – Non-sterile or no measuring function (low risk)
- Class I – Sterile and a measuring function (low/medium risk)
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
The project timeline is determined by the class and how inventive a device is. Due to their complexity and the lengthy process of analyzing treatment outcomes, some medical innovations take from a year to develop to several years to pass clinical trials and get certified.
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