AMPIR-01, AMPIRmini - Blood and infusion warmer. Fast and effective heating of liquids and solutions, blood and blood substitutes with infusion therapy, prevention and treatment of hypothermia and pre-, intra- and postoperative negative aftereffects:
MAMMO-SCREEN - Electro-impedance Mammograf for express diagnostics of mammary glands without X-rays. Innovative solution for the breast diagnosis / screening, preventive examinations, effectiveness of ongoing treatment monitoring:
What can be more important than human life? The answer may be the life of a person who saves millions of lives. Do you think that it concerns only doctors? Think once again, and mention the fact that nowadays all the complex examinations, treatment, and surgeries are performed only with the help of high-tech medical equipment. So what is the medical design and how the process of creating these appliances is held?
The base of every project is to outline it, then, gradually, it will obtain more and more necessary details.
So there is no exception with medical device design. By the way, the idea of any product is usually based on the need that applied specialists encounter throughout their experience. So once the doctors face a problem that a particular examination or a way of treatment can’t be properly performed without an auxiliary instrument, it pushes authors to medical design development and then embedding this technology to the healthcare services.
In fact, this stage requires not only one specialist but a group or even a collaboration of doctors and engineering specialists who can define the need for such device, then bring together all the requirements that this device should perform at the end. Besides, it’s not necessarily that the appliance is an innovation since it’s quite often when the future device may consist of already created appliances or they can be even improved, and, as a result, their efficiency increase greatly. In a consequence, the time of medical device development can be significantly shortened. However, these investigations should be made prior to the stage of making up the plan with the precise requirements.
The next step is not straightforward medical product development, but, again, believe it or not, the preparation stage. To be more certain, it concerns rather the sticking to the rules of the commission that strictly check whether this device is valid for further utilization. And yes, it should be done before the medical device product design will be launched in order to avoid any circumstances that can delay the release date.
In the USA, there are a few commissions that medical equipment has to pass. The first one and the main is FDA, also known as the U.S. Food and Drug Administration that regulates all the medical devices. However, none of the companies can receive an approvement or even permit access for testing without the International Organization of Standardization also known as ISO, and International Electronical Commission or IEO. Unfortunately, this is not the end of the list.
The above-mentioned commissions are under influence the other ones. So the great impact is from the International Medical Device Regulators Forum (IMDRF). Despite the fact that this board was established by voluntary groups, all of them do their work professionally in order to harmonize the standards of medical equipment design. The downside of this group is that it works within one country. As a result, there may be significant differences from equipment from other countries.
Once all the stages are passed, it’s time to proceed with the higher regulatory administration - World Health Organization (WHO). And this should be the last council that checks and releases the product to the market. Thus, from the time when the product was applied for the first commission to the date of release, it may take months or even years depending on the device itself.
Once the project is clear, there begins a stage of the almost magical process of medical device product development. And this is not something that involves casting a plastic form for a future device, but quality controls and numerous testing. All of the points are already listed in the Quality System Regulations (QSR). QSR doesn’t involve such statements as recommended steps of manufacturing, but advice on how the development process should be held, how the documents should be arranged, etc. Besides, it allows creators to track the properties at each stage, which makes the final product of the highest quality.
Once the previous step is accomplished, it is still not allowed to be on the market since testing procedures are the next stage - it is done only for safety reasons. That is why the medical product design and its results are subject to multiple and durable tests until all the issues are fixed and it works correctly. Besides, the software is considered to be a part of the device, so there is no exception for it, too.
Avoiding risks is another important stage that is also regulated by ISO standards. Thus, the medical instrument design lifecycle is always accompanied by procedures that don’t allow the device to trap into a risk zone and to become dangerous for its users. Besides, since these standards can be changed once for five years, the company has to update them and the working flow regularly.
Now, there is a fair question, do you really need to be familiar with this information or can you skip it and have this device made for you by someone who specializes in this field?
Yes, sure you can. Indeed, the health industry is too sensitive to all mistakes that may cost you not only the budget but reputation. So appealing to the company that an expert and has lots of successful cases you are killing two birds with one stone. The first is that you don’t deal with hiring new people and arranging the development process, the second is that the expenses are well defined and transparent. Thus, your task is to monitor what’s going on and provide your recommendations. The perfect fit for you is Axonim company.
Axonim is a company that has all the necessary expertise and manpower who can deal with any level of difficulty of medical equipment design abiding by the ISO standards throughout the whole process. Moreover, the range of services is not limited at all. It means that the idea you have will be fully embodied with no exception but to the last detail. That’s what we have previously released:
And this is not a limit to a variety of things that we have dealt with and glad to apply our expertise to the product that you want to come true.
Axonim is a full-cycle medical device development company that serves as a liaison between the customer’s idea and bringing it into a life. Having already released the surgical appliances, drug supplying systems, portable medical devices, monitoring medical equipment, etc, Axonim stands for the individual approach of medical equipment design.
In particular, we bring together the researchers, creative engineering team, medical specialists and managerial support in order to design and create a high-quality medical product with no risks of utilizing it. Moreover, the complexity of the task is something that will be doubly rewarded at the end proving our professionalism in solving any task.
From the very beginning, once the idea is in our hands for further work, we thoroughly prepare each step from designing to releasing the final product to the home and world market. We put lots of effort into delivering the ideal product that can be more than beneficial for patients but a profitable device for your business.
Besides, since we are trying to establish healthy relationships with our customers, we constantly apply the communicating approach. It means that every customer is always reported about the current stage of development, what complications we have faced during the development process and what we did in order to resolve those issues. Moreover, every customer’s feedback is valuable for us, so we collect and try to implement each of them into the product immediately.
Axonim is a leading device designing company with a proven track record from 2011. Our expertise spreads over the various industries including the medical, oil and gas, drone, video and optical device development, etc. All the projects were fully customized according to the customer’s requirements so we’ve received lots of positive feedback. They are all available on this website - you can click here.
A professional Axonim team of specialists is ready for the extraordinary ideas to live them out and no matter how complex they are. Our expertise can cover all aspects of the development process even those that are not related to the particular industry. That is why, if you are looking for a reliable and capable partner who can create any medical product then there is no better than Axonim company.
We are looking forward to sharing your ideas with us - we’ll take care of it, raise it and make you believe that everything is possible with Axonim.
Read in Russian: разработка и изготовление электронных устройств