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Idea to IDE: A Medical Device in the Making

Most medical device inventions start out as a single great idea, but how does that idea become a marketed medical device? This video provides a brief overview of how a medical device, which can range from a contact lens to a knee implant to an MRI machine, begins with an idea and ends with its submission to FDA. The video highlights aspects of the Investigational Device Exemption (or IDE) process, and provides general information on medical device clinical trials.

Topics:
Diagnostics FDA Compliance/Regulatory Affairs Implants & Prosthetics Manufacturing & Prototyping Materials Mechanical Components Medical

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    Transcript

    00:00:19 Medical devices can significantly improve the health and well-being of the public. Most medical device inventions start out as a single great idea, but how does that great idea become a marketed medical device? This brief video will provide a basic overview of medical device clinical trials or studies under an Investigational Device Exemption, more commonly referred to as an IDE. It's one way an idea or a medical device invention

    00:00:46 can be developed and make its way to the U.S. 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

    00:01:14 during concept and design by establishing mechanical, physical, and performance requirements. We're gonna have to think about how this joins in. Think of an architect who starts with a vision of the design of a structure in their mind. The architect may go through several different designs trying to optimize different features with each version. The architect's formal development process only begins once the requirements are captured and translated into the specifications for the final blueprint

    00:01:44 of the 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 developed in a laboratory setting where access to the proper tools and equipment can be provided. Medical device design and development should follow the traditional quality engineering development models which have been adopted across many industries.

    00:02:12 Once mechanical, stress, and other bench testing has been completed on the prototype, many devices will be ready for human studies. Devices with new materials, ground-breaking technology, or novel mechanisms may require additional biocompatibility testing prior to human use. Standards, available on the FDA website, should be consulted when developing a medical device. Before the medical device is tested in people, the degree of risk of how the device

    00:02:48 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 initial determination of which category the study falls into. For device clinical research, there are three categories of studies, each with specific regulations: Significant Risk, or SR, Non-Significant Risk, or NSR, and Exempt. An SR device is defined as an investigational device that presents a potential for serious risk to the health,

    00:03:22 safety, or welfare of a subject. For example, the device may be an implant or used to support or sustain human life, or the device may be of substantial importance in diagnosing, curing, mitigating, or treating disease. If a study is deemed SR, it must follow all the IDE regulations in 21 CFR Part 812. Otherwise, if it does not meet the definition of SR, it may be NSR. If it is NSR, then it would only have to comply with

    00:03:54 the abbreviated IDE requirements in 21 CFR 812.2(b). An investigational device study involving the lowest level of risk may be considered exempt from 21 CFR Part 812. The Institutional Review Board, or IRB, is the ethical body which is required to oversee the conduct of clinical trials. The job of the IRB is to ensure conformance to the ethical principles of clinical research, FDA regulations, as well as other subject protection requirements. Does this project qualify as exempt research since

    00:04:36 the research will not involve interaction with subjects? Remember, sponsors are responsible for making the initial risk determination and presenting it to the IRB. The subject should be contacted to seek informed consent. The IRB, when presented with an NSR study, must review the sponsor's risk determination and change the determination if the IRB disagrees with the sponsor. FDA is available to help the IRB when making its risk determination.

    00:05:04 In addition to this initial review, the IRB also provides continuing review of studies. Both IRB and FDA approval must be obtained before anyone can be enrolled as a subject in any SR study. During the development of the device, FDA is available to meet with sponsors. At this meeting, sponsors have the opportunity, at no cost, to discuss aspects of their submission, such as study design, safety and effectiveness end-points, timelines, et cetera.

    00:05:38 Early interaction with the agency should help to increase the sponsor's understanding of FDA requirements, regulations, and guidance documents, and will allow FDA personnel to familiarize themselves with new technologies. Increased interaction between FDA and sponsors should help to speed the regulatory process and minimize delays in the development of novel devices intended for human use. Sponsors need to submit a pre-IDE submission

    00:06:08 to FDA to request a meeting. Sponsors should carefully select clinical sites with investigators who are qualified to perform the procedure, if one is involved, who are qualified to conduct FDA regulated research and who have the ability to recruit eligible subjects. For example, in an orthopedic implant study, a sponsor would likely target orthopedic surgical sites, as opposed to a general practice facility. Comprehensive clinical site training is also critical prior

    00:06:43 to subject enrollment to ensure that all site staff are aware of the responsibilities associated with the study. Can you breathe in? The role and responsibility of a physician is different from that of a clinical investigator. For a physician, the primary objective is optimal patient care. On the other hand, the objective of a clinical investigator is to protect human subjects while following the protocol.

    00:07:14 This allows information to be obtained that may improve healthcare in the future. Prior to enrolling a subject into a device study, it is important that the clinical site staff verify that the subject meets the eligibility criteria and is properly consented. Sign on the dotted line. This means the subject has signed an IRB-approved informed-consent document prior to any study-related procedures being conducted.

    00:07:45 This document outlines the potential risks, benefits, and other critical information for the subject. Tracking subject consent and enrollment is often an important part of measuring a study's progress. Under 21 CFR Part 812, sponsors are required to adequately monitor their device study. Through monitoring, which may be done as part of an on-site review or through remotely accessing the clinical data in real time, sponsors can ensure that the right data

    00:08:22 is being collected and the clinical investigator is following the protocol. If errors are identified as part of the monitoring effort, it is important that the sponsor take swift action to correct them and prevent any similar problems. Once the study has been completed, it's important that the sponsor properly close out the study by completing the following steps: Ensure that all subjects have completed their follow-up medical procedures;

    00:08:53 submit a final report to FDA, ensure that all documentation is maintained at all sites after the study has been completed, and make certain that the site is ready for an FDA inspection. Once all of the data from the clinical study have been collected, it's important to make sure it's suitable for statistical analysis. After the sponsor believes their safety and effectiveness end-points have been met and are statistically valid, the sponsor can begin the process

    00:09:24 of filing their marketing application by discussing their submission with FDA. After the sponsor submits their marketing application, they should anticipate inspections by FDA. These inspections can occur at manufacturing sites and wherever the study records are stored, as well as at clinical investigator sites where the research was actually conducted. What started out as a great idea became an IDE making its way towards the medical device market.

    00:09:55 The FDA likes to get involved early in this process, which helps us fulfill our mission to protect and promote public health. It also helps us support medical device innovation and the development of medical products that satisfy unmet public health needs.