NBOT INC

What is a Medical Device?

 

A medical device is any appliance, apparatus, software, material or other article that is intended by the manufacturer for the use with humans with the specific purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of a disease;

• Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;

• Investigation, replacement, or modification of the anatomy or of a physiological process;

• Control of conception; and which does not achieve it's principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in it's function by such means.

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Because medical devices can vary according to their indications and intended use, examples can be as simple as gloves or a thermometer to something as complex as computers which assist in implants and prosthesis. 

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What is Medtech?

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Medtech most often refers to medical technology or alternatively digital health or health technology. The World Health Organization (WHO) defines it as the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve health problems and improve the quality of lives. This includes, but is not limited to, pharmaceuticals, medical devices, some biotech, information technology, procedures and organizational systems used in health care.

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Due to the rapid infusion of electronics and robotics into the medical fields and smartphones in our daily lives, medtech has now overtaken the medical devices industry to encompass those appliances previously defined as medical devices as well as the technologies that are used to treat diseases or medical conditions affecting humans. 

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As a rapidly growing sector, this industry is not only receiving a lot of publicity and economic success, but also great rates of increased venture capital funding to help new devices and companies enter and expand into the marketplace.

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All medical devices, and increasingly most if not all medtech, are subject to local, national and international laws and regulations that govern the testing, safety, efficacy, patenting and marketing of such devices and technologies.

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In general governments will regulate what medtech can be marketed, how they can be marketed. Due to the complex and expensive path from discovery, to development and eventually marketing, it is essential to have strong industry partnerships to help bring companies and their devices and medtech through the development cycle.

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While similar in many ways to the drug development life cycle of a pharmaceutical, medical device development also introduces it's own difficulties and challenges. Depending on the device's classification, the steps involved in the development process can vary, however the general description of the approval process for new medical devices and studies is as follows:

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Device Discovery and Concept - There is a well established path for the development of medtech, however the initial invention is the starting point for all medical devices and technologies. This is followed by device classification, which can differ significantly from one region to another.

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Pre-Clinical Research - This phase is where the prototype device or technology is created and then tested in controlled laboratory settings. Safety and efficacy of the medtech is gathered while also evaluating the biocompatibility of the device or technology.

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Clinical Research - After the preclinical stage, human trial testing begins. The phases of a medical technology or device differs from drug trials as follows:

 

Pilot or Exploratory Studies - This testing is done on 10-30 patients and is designed to evaluate preliminary safety and performance.

 

Pivotal Studies - This phase determines the clinical efficacy in approximately 150-300 participants, while evaluating adverse events.

FDA Review - After the pivotal studies are complete the FDA, or other local governing body, will thoroughly examine all data related to the medical device or technology and the completed clinical research to determine whether to approve or reject the medtech and requested use.

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Commercialization - At this stage medical devices and technologies have received their regulatory (FDA or other) approval and are ready to be brought to market and commercialized for general sale and use.

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Post-Approval Studies - After a device has been released to the public these studies continue to evaluate long term safety and efficacy of the medtech. Sometimes these studies may last for decades with implanted devices in human subjects.

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Please contact us and let us know how we can help make your medical technology or device an international success story!

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