What Is Medical Device Development

Medical device development involves all stages from the conception of a product to releasing it in the market. The product may be an advanced x-ray machine, CT-Scan or MRI.  Launching a medical device is not an easy job. It involves the formation of an optimally operating instrument followed by layers of regulations to be considered.

Need Of A New Medical Device

The need or demand of a new medical device may be for an entirely new way of diagnosing diseases or examining patients that are not available before. It may also be due to the up-gradation of the present equipment to get better and more reliable results or make things easier for health care providers.

Stages Of Medical Device Development

The exact procedure differs from place to place according to the regulatory law applied there.It also depends upon what type of device is under consideration. Generally, the whole process can be divided into five stages for design control and obtaining an effective and safe device for use.

  1. Initiation and risk analysis
  2. Concept formulation and feasibility
  3. Design development and validation
  4. Product launch
  5. Post-launch assessment

There is strict regulation for the approval of medical devices to be launched in the market for public use to ensure the user is at no risk while under examination of these devices.


Duration Of Medical Device Development

The time required in the complete development of a medical device depends on the type of device. According to the FDA, there are three classes of devices.

Class 1

These are the devices that are quickest to get into the market. Electric toothbrushes and oxygen masks are included in this class. The approval procedure completes as soon as one week.

Class 2     

This class comprises 43% of the devices and have a moderate risk factor. These devices have an average time of three to six month to get approved. The anesthesiology devices take the longest time while the toxicology devices are approved more quickly.

Class 3

Almost 10% of the devices belong to this class and are of the high-risk level. These devices include defibrillators, implanted prostheses and cochlear implants. It can take eight months to a year to approve this equipment as there is a more strict system of checking and evaluation for these devices.

Medical Device Development Services

Many companies offer services if you want to launch or develop any medical device. You can get guidance and professional help in all the stages of device development.

Medical Devices Regulation

The medical device regulation is a mechanism to evaluate the significant risk factors involved in using medical devices. These regulation aim to identify problems timely and correct them appropriately. Every region of the world has its regulatory authorities like the  European Union has the law of its medical devices, which is very large. This regulation is something that you cannot quickly and easily come up to speed on. It’s something that takes some time to learn, analyze and prepare for.

Its upgraded text has parts involving more scrutiny of technical documentation and product safety and performance assessment. It has brought stricter checking of clinical evaluation and post-market clinical follow-up procedures. This regulation also ensures better traceability of devices through the supply chain system and distribution. So before diving in the device development, it is vital to fully understand and clear the regulation implemented on the product to work in the right direction legally.




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