The Medical Device Directive in Europe defines medical devices as:
"any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, or alleviation of 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 its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
There are four classifications and the directive applies different administrative requirements to the devices taking into account the risk that they pose to the user.
Class I devices are generally regarded as low risk, Class IIa and IIb as medium risk and Class III as high risk devices.
Medical device product design and production is a complex process and depends far more on the user than most design areas. The traditional device industry is driven mainly by consumer demand in the beginning and later by technology.
Any new medical device product that is being developed will have to answer the pertinent question of whether it caters to existing demand, or if it answers a yet unrecognized need. The solving of problems or the need factor is the key to a successful device. It has been observed by industry experts that an innovation that satisfies an unrecognized need in the market can account for anything up to two thirds of the profits from new product launches while accounting only for less than two tenths of total product launches.
Two factors involved in the design and conceptualization of a product are: 1) the purpose or objective it serves and 2) the team that makes the product. The process of device design will have to first take into account the data collected by processes that asses consumer specifications and needs. Then all the stakeholders in the project will ideally be involved from the inception of the design and prototype production process. Senior management, designers, engineers, surgeons and visionaries who can visualize the end product and help in adjustments as it evolves are just some of the required people of a design team.
Another factor that is often not taken into account is the need for comprehensive socio- economic research and population profiling. The human factor has to be penciled into the process. The main challenge is to account for consumer need, the efficient and innovative use of technology and conception of a product that is launched at the most opportune time and positioned such that the customer is willing to pay for it. This is the rationale of customer value. A really good design often takes the realistic approach over the idealistic one and early considerations of regulatory requirements of medical device design often help in satisfactory establishment of compliance.
The medical device industry has been quite successful in many cases in this respect. Very good materials, a good industry-user interface, involvement of caregivers and rigorous medical standards have all helped produce a number of winning combinations.
Prototype testing is essential as there is a need to have a fundamental device that gives shape to the vision. This device is tested in controlled processes and feedback is collected to further help in the evolution of the device. The product will then go into the stage of preclinical and clinical studies.
The concept for medical devices often comes from visionaries, surgeons, scientists, creative individuals and is driven by the concept basis. This is carried by the design team into the development process. As the company grows, it often adds new products into its portfolio, either through in-house research and design or by incorporating independent consultants. Another successful way in which many medical device companies have grown is by acquiring small companies and start-ups with great products.
The design and production of medical devices is not only made complex by the fact that it requires a high level of quality and stringent controls but also by the fact that often the device sees unplanned uses and are also used by various levels of caregivers with little specific training. A medical device is not a stand-alone product; it is used in conjunction with many other devices and products in a highly critical area. It thus needs to be harmonious with its environment and other products.
The medical device industry is one in which there has been good growth. It is expected that this will continue in the future. However, development time is expected to become shorter and support services are likely to take on a larger role. The demands of cost reduction and minimization of wastage will drive the industry to increase efficacy and applications. The new challenge in the European medical device market is to keep up to date with the changing regulations of clinical investigations - both at national levels and at the European level.
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