In Medical device life-cycle, pre-clinical research bench-top analysis for mechanical and design tests; are the major determination criteria for acceptance of that device. It can be considered as Phase 0 studies for medical devices. Unlike the drugs, feasibility of medical devices practically is done in a combination of engineering tests and Animal studies. The pre-clinical research become more important in medical device compared to drug because the evaluation of Medical Devices (Both performance and safely) depends upon its adverse event occurrence.
From clinical research perspective, medical devices can be classified into four main categories-Therapeutic (Whether active or inactive), Non-therapeutic-non-diagnostic (Accessory), Diagnostic and Contraceptive medical devices.
The clinical trials for diagnostic devices are wider and diagnostic test outcome oriented. The clinical trials are required only to introduce new techniques. Same is the case with contraceptive devices. Contraceptive devices studies are mainly failure oriented single arm trials and accessories do not require clinical trial for regulatory or clinical evaluation.
The therapeutic medical devices, which mainly require clinical evaluation, have mainly two types, Implantable and external. The implantable devices includes Pacemaker, stents, arterio-venous fistulae, dental implants, orthopedic implants etc. and the non-implantable group include Cardio-Pulmonary Resuscitation (CPR) Devices , Heart and Lung Machine, Dialysis unit, Defibrillator (External) etc. Clinical trials in these Medical Devices are major concentrated on its performance and safety analysis. Most devices in this group need repeated confirmation of utility by clinical trials. Highly dynamic devices like stents hence require recurrent validation. Similar but relatively less severe is the case with a pace makers etc.
Genelife Clinical Research has experience in conducting Medical device and drug device combination clinical trials.
The Clinical Trials of medical device’s are complex in comparison to drug. So, one has to design the study to overcome the constrains in medical device clinical research, especially pertaining to comparability and establishment of universal outcomes. There is no perfect control in a medical devices study. Moreover, as there is no “Absolute safety and efficacy” available from experimentation in healthy human subjects, the outcomes of studies remain majorly study specific. Applicability of the trial outcomes to real world is grossly limited.
One of the major problems in Medical Device clinical trials as discussed is lack of a perfect control. Even if some control is selected, the control may have different indications. For example, Stent implant angioplasty and coronary artery bypass graft are the common comparable entities. Both of these treatments and thereby the device “Stent” is studied against a control of CABG.
This makes the point that innovative clinical research study designs can overcome some major constrains in Medical Device Clinical trials and can yield reliable and more accurate clinical data which can be used as a standard reference in day to day clinical practice.
Medical device clinical trials can have several design options. The first is variation of the hypothesis. In many Medical Device Clinical Trials, the study hypothesis is developed in a way that specific outcomes are tested. For example, in many studies, the hypothesis is designed to register an “Event Free Survival” or “proportion of population free from events in a defined period”.
The second important postulate of an innovative study design for Medical Device is inclusion of subsets. In many conditions it is seen that the study design exclude many subsets of the populations, which make the results differ from “real world” scenario. Instead, the predetermined subsets inclusion can give a study a wider acceptance and better power. In fact, based upon this one postulate, the clinical trials can be an union matrix study, a multi-arm study, overlapping matrix study etc. These designs are uncommon to use but Genelife Clinical Research statistician will take efforts to make these ambitious designs. These types of designs may have several expressions such as compartmental design (Tight Subset matrix), blocks design (Loose Subsets Matrix) , clusters design(Loose subsets with stratified or multiple overlapping) ; and the study cohort can be stratified to establish relative betterment.
Use of Standard or Specifically developed scores can be one of the important tools in design for Medical Device Clinical Trials. The Standard Scores Such as Comorbidity Index, Medina Score for Cardiology bifurcation lesion or Study specific scores such as SYNTAX Scores can be highly useful in designing a study and meet specific comparability needs.
Genelife Clinical Research has capability and experience to submit IDE and 510K. We have assisted clients with integrating the various medical device regulatory requirements into their quality management system such as ISO 13485, 21CFR820, Canadian Medical Devices Conformity Assessment (CMDCAS) and Medical Device Directive (MDD). This approach ensures that the quality management system is scalable and can serve the global needs for medical device market approval and distribution.