A medical device is an instrument used to diagnose, prevent, or treat diseases and injuries. Whilst pharmaceutical products use chemical or metabolic actions to achieve this goal, a device tends to act through physical intervention.
The medical device design and development life cycle consists of three main stages: conception, design and development, and mass production.
Conception
As early as the device conception stage, factors relating to economic and production feasibility must be taken into account. Most medical devices will require mass manufacturing and this must be balanced against the implementation of innovative and cutting-edge product features. The planning and conception stage is therefore vital for the long-term sustainability of a project, and benefits greatly from industry knowledge and experience.
Design and Development
Once a project has been deemed feasible, it’s time to develop a prototype. It can be a good idea to approach this stage with a risk-management mentality. Identifying the ways in which your device might fail or function incorrectly will allow you to design a product with patient care at the forefront of your mind. Ensure, too, that you are aware of industry regulatory requirements and the approval process you will need to submit your final product to.
Mass Manufacturing
After having designed your medical device, conducted clinical trials and gained regulatory approval, manufacturing can begin. If, at the beginning of the process, you spent time developing a plan, budget and identifying the mass manufacturing viability of your device, this stage should not pose too many problems.
Standard Medical Devices
There are many different types of devices that clinicians rely upon on a day-to-day basis to diagnose and treat patients. Whilst these devices may have been around for many years, all would have gone through the same design and development process described above.
Thermometer
Thermometers are used across all sectors and at all stages of treatment, from routine physical tests to emergency treatment. Electronic thermometers are a more recent development and minimise the time required to calculate the temperature of a patient. Electronic thermometers may be designed for a particular part of the body, such as the mouth, the armpit, the rectal, or the ear.
Electrocardiographs
Electrocardiographs assess the electrical activity of the heart. During this assessment, heart rate and beat frequency can be recorded, these being the main two determinants of any cardiac issues. Physicians can also read an electrocardiograph to measure the size and location of each chamber of the heart. Electrocardiographs are used when assessing cardiac injury, and the effect and efficacy of drug therapy or structural implants.
MRI Machine
Magnetic Resonance Imaging (MRI) is a modern medical scanning and diagnostic device. This particular device generates a low-level magnetic field that induces a reaction in the body's atoms. The atoms within body tissues respond and the computer — connected to a scanner — measures these responses, transforming detections into a visual image of the internal functioning of the body.
Medical devices allow health care providers to diagnose and treat patients, assisting individuals to overcome illness and disease. The design and development of a medical device — including thermometers, electrocardiographs and MRI machines — is a stringent process, reducing the risk of defects and playing a valuable role in improving patient quality of life.
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