Drug development follows an extensive process of Phase I, II, III and IV clinical trials to test safety, efficacy and toxicity, while medical devices have feasibility, pilot and pivotal study models. These phases vary significantly and this is where CROs without experience in medical device trials may have some difficulties. Private industry, such as biotech and pharmaceutical companies, as well as medical centres, foundations and universities, also fund studies. While Phase I drug trials start with a small group of healthy volunteers and patients and gradually expand as they move to Phase II and III, medical device trials are smaller groups of only patients.
In other words, researchers want to know whether drugs or treatments work as intended, whether a drug becomes toxic and at what level, and how a drug specifically reacts in the body. One of the main challenges for CROs that have worked in drug trials and want to approach the growing medical device sector is their own lack of experience with similar devices. However, in the case of medical devices - especially those that require surgical implantation - it may not be appropriate to insert the device into healthy subjects. Volunteers are treated in a clinic, so they can be closely observed and provided with medical care until the half-life of the drug has passed.
Regulators, payers and physicians are asking for more data and even patients are asking to see clinical trials, so medical device companies and CROs are starting to have to match biopharmaceutical companies in the number of trials being conducted. In the case of medical devices, researchers are requesting an investigational device exemption (IDE) for their application, as an IND is not mandatory. These factors have a major impact on the development cycle of medical devices, which can be divided into five main stages. In general, it is important to remember that clinical trials are for research, not for delivering effective and proven medical care to the individual.
Just as pharmaceuticals can be divided into Phase I-III and Phase IV trials, medical devices can be divided into non-CE-marked and CE-marked trials. Inclusion and exclusion criteria are usually related to age, gender, previous or current medication, other existing medical conditions, and recent participation in another clinical trial. In the United States, drugs and medical devices cannot reach patients without being approved by the Food and Drug Administration (FDA). Pharmaceutical companies fund most clinical trials of new drugs, even if the study is conducted in collaboration with or led by a medical institution or university.