Basic Concepts about Medical Device or Equipment Engineering
Medical devices or equipments are required to operate the process diagnosis, prevention, mitigation, medication, treatment of disease and imbalanced health conditions. The modern technology has invented numerous effective and essential equipments applying the knowledge and expertise of medical device engineering.
These medical devices might range from simple structured device that are used and maneuvered by the patients in the home to high level professional use by the surgeons in the operation theater. Some of the most popular and essential inventions of contemporary medical device engineering include: dental implants, pacemakers, somato prosthetics, infusion pumps, facial prosthetics, heart-lung machine, ocular prosthetics, dialysis machines, cochlear implants, artificial organs, corrective lenses, artificial limbs and organ implants, etc.
Medical device engineering is a branch of Bio-medical Engineering study. This branch of Bio-medical engineering not only deals with modeling human-organs, but also carries research and development applying the modern techniques and knowledge of engineering to invent efficient medical devices for providing innovative and effective therapies, medical treatments, 24/7 patient monitoring, quick diagnosis of diseases, etc to save human lives from the life threatening diseases and injuries.
Regulation and classification of the medical devices or equipments vary from country to country. In the following the Medical device engineering products are classified into three categories depending on their structural design and use. They are described below:
- Class I category medical devices represent medication for the primary level health-threat. Devices under this category check minimum vulnerability to human body. Usually, these devices are built with simpler designs with lighter weight in comparison with the devices of Class II and Class III. Medical devices of this category include elastic bandages, hand-operated surgical instruments, tongue depressors, examination gloves, bedpans, etc.
- Class II category medical devices represent medication for the medium level health-threat. Devices under this category check vulnerabilities to human body at a significant level. These devices undergo special monitoring besides the broad-spectrum controls. Special controls might include particular labeling requirements, obligatory performance standards, post market observation, etc. Though medical devices under this category possess complex design, they are usually non-invasive. Medical devices of this category include powered wheelchairs, surgical drapes, x-ray machines, PACS, infusion pumps, etc.
- Class I category medical devices represent medication for the primary level health-threat. Devices under this category check minimum vulnerability to human body. Class III devices generally require premarket approval (PMA) or premarket notification, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I. Medical devices of this category include replacement heart valves, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators, endosseous (intra-bone) implants, etc.
Get the right help to design your medical device.
Medical Device Engineering is an extremely important field in the design industry. Today with the discovery of newer illnesses, doctors and scientists are rushing to build and design devices that can help detect and treat people faster. At Glober design, we are extremely glad to be able to offer them a helping hand.
Glober design has a team of experts who are well versed in all aspects of design. Be it medical or industrial products, we know that the basic design philosophy behind them is that they should be simple to use. With this in mind, when it comes to designing devices for medical use, we provide support on the following parameters.
- Consultation- The designer of a medical device is often from the medical or scientific community. They have an idea of a device but not the mechanical Know-how. At Glover Design, we ensure that we provide the best mechanical brains to the designer during the consultation phase. This helps us understand the concept and thought behind the device.
- Make a virtual model – The next step is the most important one. The information garnered during consultation is passed on to the mechanical engineering team. The team uses the information to make a virtual working model of the device. This model is important because we can see how the device actually looks and if all the components are in the right place.
- Making a POP model- Next our team transfers the virtual model into Plaster of Paris. This is the first time when the device actually comes to life. Making this model is extremely important as we can show the client the device and he or she can check if the device is exactly as per how they want it.
- Making the working prototype – The prototype is one of the most important aspects of any design process. When it comes to medical devices, the doctor or scientist gets to use it in a live situation and check if it fulfils the purpose it was intended for. This is why it is important to have the proper expertise in each of the above steps. Any mis-calculation could cause the device to misbehave.
So, as you can see, engineering a device for medical purposes needs an expert touch. So , come to Glober design and we will guide you on the entire process of Medical Device Engineering.