New opportunities for medical equipment to grasp six major opportunities

Changes in policies and regulations affect all aspects of the industry. In clinical trials of medical devices, pre-marketing clinical trials received the highest level of attention, and trial data was used for the registration and listing of new products, which is also a large proportion of current device trials. Post-marketing clinical studies are mostly non-interventional or observational studies following market launches, as well as epidemiological investigations, health economics studies, and clinical studies initiated by some researchers.

This article will analyze the problems and opportunities faced by clinical research after the listing of medical devices in the new environment.

Why should A pay attention?

RCT has limitations

At present, most medical device tests are pre-marketing clinical trials, especially RCT (random controlled clinical trials). Because randomized and controlled, eliminating intergroup bias and other interfering factors, there is a clear causal relationship between the efficacy of the product and the prognosis of the patient, which is why RCT can be at the most advanced clinical evidence in evidence-based medicine. One reason.

However, in recent years, the RCT began to gradually become a questioning voice. The RCT has undergone a rigorous trial design. The patient's medication and follow-up are under the close supervision of the researcher or research nurse. The compliance is very high, which is completely different from the actual life situation. Whether the results of the RCT test can be extrapolated into real life is a new question.

In addition, pre-market clinical trials, the follow-up time will not be too long, and the sample size will not be too large, because the time to market is considered. If the sample size is not large enough, the test results may be biased; if the follow-up time is not long enough, some adverse events with long incubation periods cannot be observed, which will affect the judgment of product safety and effectiveness. If you want to make large samples and long-term observations, it is only possible in post-marketing trials. This is a source of real-world data. Because pre-marketing trials are risky, a small number of tertiary hospitals can be carried out in a few third-grade hospitals, which are difficult for other hospitals and doctors to access.

Surgical resources are not real value

In addition, the development of post-marketing clinical research is a way for doctors to access scientific research, which will allow more hospitals to join the clinical research and create an atmosphere of scientific research. Clinical trials of medical devices are often dominated by surgeons. In China, a widely existing concept is to judge whether a surgeon is a good doctor, mainly to see the performance in the operating room, whether the surgery is done neatly, the suture is not fast, and the bleeding is controlled to a minimum. For this reason, most surgeons put most of their time into the operating room, ignoring research.

The amount of surgery in China is not small in the world, and many types of surgery in China are also rich in experience and cases. For a long time, these valuable cases and data have not received attention and have not really valued. Now some surgeons are beginning to realize that by doing some clinical research, or even some retrospective research, many medically meaningful information can be translated into papers to inform more doctors and benefit more patients. It is more meaningful to complete a single operation and treat a patient.

But how do you start? Many doctors do not have a clear idea. Post-marketing clinical trials are an entry point to help doctors understand how to do research, make data and cases truly valuable, and promote further academic communication and communication.

B six major opportunities

1 Regulation

From a regulatory perspective, for some three types of high-risk medical devices, the review center has requested data for post-marketing follow-up for registration renewal. Three types of devices, especially implantable devices, are often associated with a patient for life once implanted in a patient. Such products are difficult to recall if there are quality problems or safety hazards. Therefore, post-marketing follow-up data is an important basis for demonstrating product safety and effectiveness.

When the regulatory authorities require post-marketing follow-up data for high-risk devices, it is obviously unrealistic for the device company to conduct patient follow-up. It is not possible to directly contact each patient for regular follow-up, nor to provide the site and equipment for patient follow-up. The only viable option is patient follow-up through the hospital. Taking into account the requirements of current regulations and policies, the requirements of the evaluation center for data analysis reports, comprehensively weighing various compliance risks, and completing patient follow-up through post-marketing clinical research is an ideal way to meet regulatory follow-up requirements.

As regulations become more sophisticated, regulators are also considering how to more effectively monitor riskier medical devices. Perhaps in the near future, post-marketing clinical trials will play an increasingly important role in this field.

2 product replacement

The development process of medical devices is not exactly the same as drugs. After the drug has completed the pre-clinical research and development work, the product is transferred to the clinic and there is a clear handover process. For medical devices, product development is an ongoing process. The various feedbacks or improvements received by the product during clinical use will be passed on to preclinical engineers and become the basis for the next generation of product replacement. Medical devices are often updated very quickly. Two or three years are a new generation of products. In clinical practice, the feedback from doctors and patients from the front line plays a key role and has important value.

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