Bringing a device to market takes an average of 3-7 years, compared to an average of 12 years for drugs. However, there are concerns that the Food and Drug Administration (FDA) processes are not sufficient to meet the expected safety and efficacy guarantees. According to researchers, innovation and time-to-market are the two main competitive drivers in the medical device sector. For medical devices, the sequence is quite similar, with some devices going through a clinical trial phase process; however, most medical devices go through clinical trial "stages" rather than phases.
Clinical trials of medical devices differ from drug trials in that they involve only patients with the disease for which the device is designed. Medical devices are classified according to their intended use, their invasiveness, the duration of their use, and the potential risks and harms associated with their use. The most effective way to predict speed to market is to assess the level of risk associated with your medical device and determine whether it is a class 1, 2 or 3 device. The device class and approval pathway have a major impact on the average waiting time for the FDA medical device approval process to be completed.
Being familiar with the specifications and format of drug and medical device clinical trials can help all participants (including medical professionals, clinical staff and patients) to ensure that trials run as smoothly and efficiently as possible. By definition, a medical device is any "article, instrument, apparatus, appliance or machine used in the prevention, diagnosis or treatment of disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for any health purpose (World Health Organisation). Doctors require these novel medical devices to save and improve the lives of patients, provided the products are safe and effective. John Lehmann is the director of business development at IMARC Research, a clinical research organisation (CRO) specialising in medical device trials.
The table below compares the phases of pharmaceutical trials with those of medical device trials. You can't completely control the FDA's response time to your application, but you can engineer speed and quality throughout your organisation with Qualio, a cloud-based enterprise quality management system (eQMS) built specifically for start-up and scale-up medical device manufacturers. He has also spoken at local and national conferences, including the Association of Clinical Research Professionals (ACRP) Global Conference, the MAGI Clinical Research Conference and the Medical Device Clinical Trials Conference.