Medical devices can significantly affect the health and wellbeing of the public. Most medical devices start out as a single great idea. But how does that great idea become a marketed device? This brief video will provide a basic overview of medical device clinical trials or studies under the investigational device exemption – more commonly referred to as an IDE. It’s one way an idea or medical device can be developed and make its way to the US Medical Device Market.
What is a medical device?
The Federal Food, Drug, and Cosmetic Act defines a medical device as “…a product intended for the diagnosis, cure, mitigation, treatment or prevention of disease that does not achieve its primary intended purpose through chemical interaction, and which is not dependent upon being metabolized.” Formal development of a medical device begins in concept and design by establishing mechanical, physical, and performance requirements.
Think of an architect who starts with the idea of the design of a structure in their mind. The architect may go through several different designs trying to optimize different features of each version. The architect’s formal development process only begins once the requirements are captured and translated into specifications for the final blueprints for building construction.
Similar to an architect’s design of a structure, the development of a medical device goes through a formal development process. The prototype for a medical device is typically done in a laboratory setting where access to the proper tools and equipment can be provided. Medical device development should follow the traditional quality engineering development models, which have been adopted across many industries. Once mechanical, stress, and other bench testing has been completed on the prototype many devices will be ready for human usage.
Devices with novel materials, groundbreaking technology or novel mechanisms may require additional biocompatibility testing prior to human usage. Standards available on the FDA website should be consulted when planning a medical device.
Before the medical device is tested in people, the degree of risk of how the device is used in the study must be determined. The sponsor is a person or entity that initiates a study and they are responsible for making the determination of which category the study falls into. For device clinical research there are three categories of study each with specific regulations: Significant Risk (SR), Non-Significant Risk (NSR), and Exempt.
An SR device is defined as an investigational device that presents a potential for serious risk to health, safety or welfare of a subject. For example, the device may be an implant or device used to support or sustain human life. Or the device might be of significant value in diagnosing, curing, or mitigating or treating an illness. If a device is labeled as SR it must follow all IDE regulations in 21 CFR Part 812. If it does not meet the standard of SR it may be NSR. If it is NSR it only has to meet the abbreviated requirements in 21 CFR 812.2(b). An investigative device that involves the lowest risk level is considered exempt from 21 CFR Part 812.
The Institutional Review Board (IRB) is the ethical body which is required to oversee the clinical trials. The job of the IRB is to ensure conformance to the ethical standards of the FDA regulations as well as subject protection requirements. Remember sponsors are responsible for making the initial risk determination and presenting it to the IRB. The IRB when presented with a study must review the sponsor’s risk determination and change it if the IRB disagrees with it.
The FDA is available to help the board with the determination of risk. An addition to this initial review it also provides continuing reviews and studies. The IRB and FDA approval must be given before any enrollment in any SR study.
During the development of the device the FDA is available to meet with sponsors. At these meetings sponsors have the opportunity to at no cost discuss aspects of their submission, such as study design, safety and effectiveness endpoints, timelines on so on.
Early interaction with the agency should help sponsors better understand FDA requirements, regulations, and guidance documents. And it will allow FDA personnel to familiar themselves with new technology. Increased interaction between FDA and sponsors should streamline the process and prevent the holdup of novel devices from the public. Sponsors need to present a pre-IDE submission to the FDA to request a meeting.
Sponsors should select an investigator site qualified to perform the procedure if one is involved, are qualified to conduct FDA-regulated research, and who have the ability to recruit eligible subjects. For example in an orthopedic surgery study, a sponsor would normally target an orthopedic surgery as a site as opposed to a general practice.
Comprehensive clinical site training is critical prior the subject enrollment to insure that all staff are aware of responsibilities associated with the study.
The role and responsibility of a physician is different from that of a clinical investigator. For a physician the primary focus is patient care. On the other hand the objective of a clinical investigator is to protect human subjects while following protocol. This allows information to be obtained that may advance medical care in the future.
Prior to enrolling a subject it is critical to insure that the subject meets the eligibility criteria and has properly consented. This means the subject has signed an IRB approved consent form prior to any study-related procedures being conducted. The consent document outlines the risks, benefits, and other critical information to the subject.
Tracking a subject’s information is an important part of any study. Under 21 CFR Part 812 sponsors are required to properly monitor their device study. Through monitoring which may be conducted onsite or remotely accessing data offline sponsors can insure that information is being collected correctly and the clinical investigator is following protocol. If errors are identified it is important that swift action is taken to correct them and prevent any similar problems.
Once the study has been completed it is important that the sponsor properly close out the study by completing the following steps. Insure that all subjects have completed their follow-up exams. Submit a final report to the FDA. Insure all that documentation is maintained at all sites after the study. And make sure the site is made ready for FDA inspection.
Once all the data from the study is collected it’s important that it be suitable for statistical analysis. After the sponsor believes that all safety and effectiveness points have been met and are statistically valid; the sponsor can begin the process of filing their marketing application by discussing their submission with the FDA. After the sponsor submits his marketing application they should expect visitation from the FDA. These inspections can occur at manufacturing sites or wherever the records are stored as well as at investigation sites where the research actually occurred.
This all started out as a great idea and became an IDE making its way to the medical device market. The FDA get involved early in this process making it possible to meet their mission to “protect and promote public health”. It also helps to promote medical innovation and the development of products that satisfy unmet public health needs.