The development of medical devices is one of the most active areas of technology and finance. Our interest here is the large growing segment of medical devices that consists of medical devices that are, in principle, analytical instruments. This segment includes what is known as in vitro diagnostic (IVD) medical devices. These devices provide quantitative results for physiologically important analytes. The best known examples of these devices are the glucose meters used to monitor blood glucose levels at home by diabetics or in clinics and hospitals. The development of IVD medical devices will continue to grow because of the pressing need to bring diagnostic tools closer to where they are needed most…near the patient.
Like other analytical instruments that provide quantitative results, IVD and similar medical devices need to be calibrated. Their accuracy/bias and precision must be quantified and proven to be fit for the intended use. Innovations in IVD medical devices are driven by unfulfilled clinical needs, competition to replace existing devices with better devices and the desire to replace the central laboratory. In addition to patient safety, there are several important design and performance criteria that determine whether a quantitative medical device is likely to become successful or not. These criteria include (1) the specificity of the detection scheme, (2) the clinical agreement between the results of the new device and the results of an existing device (or a reference or traceable method) and (3) the analytical performance (the analytical figures of merit) of the new device itself. These topics will be covered in the following sections.