The World Health Organization (WHO), considers a medical device to be defined as “an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.” Therefore, medical devices include an incomprehensively vast range of products from a simple orthopaedic shoe insert to complex trauma-related spinal implants, to complex robotics systems like the Da Vinci surgical robot.
Medical devices are classified into various groups, that can differ from country to country. Within the EU, they are classified as:
Considered to be at the lowest level of risk of all medical devices and as a result their compliance level is the lowest level of regulatory control. Products at this level will include elastic bandages, dental floss and enemas.
Class IIa / Class IIb
Although this refers to a relatively simple device, they are more complicated than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Typical Class II devices include: condoms, pregnancy testing kits and powered wheelchairs.
These medical devices the most complex devices and as such they carry the highest patient risk require the most stringent regulatory controls. Examples of Class III devices include: implantable spinal supports, pacemakers and breast implants.
The medical device industry is one of the largest and moist regulated industries in healthcare, driven by innovation and new technologies. According to The Market Realist,
“The last decade has seen an unprecedented growth in innovative and improved technologies, which has led to the development of state-of-the-art medical devices and catalysed growth and advancement in the healthcare industry”.
Currently, around 40% of the Global Market is owned by US based organisations, with the industry as a whole carrying a value of around £300 billion. The major players in this industry include; Johnson & Johnson, Boston Scientific, Globus Medical, BrainLab, Intuitive, Medtronic (MDT), Thermo Fisher Scientific and Stryker.
Thanks to many recent advancements in medical technologies, people are living longer than ever and in this modern-day people are expecting to get much more out of those extra years. As a result, the demand for innovative health care products has grown exponentially.
The field of medical devices is a place where creative people are encouraged to invent, develop and deliver life-improving and often life-saving technologies aimed to benefit the population and get the best out of our lives; who wouldn’t want to be a part of that!
So what careers could you expect to see in this booming sector? Well, as you can imagine, a sector of this size requires a lot of disciplines in order to deliver such a broad range of innovations. From inception to Research and Development, prototype design to full manufacture, from technical and regulatory affairs, QA compliance to sales people in the field; this sector has it all.