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The Importance of Clinical Trials in Medical Device Development

An Interview with Mr. Tass Adorján, MedRes Business Development Director

The importance of clinical trials may seem obvious, even for outsiders. This is the final test to reveal if the product is safe and delivers the intended benefits planned before the development started long time ago. But for designers these trials also hold additional significance: this is the final stage of a project they probably started several years ago; this is where they can see real patients treated with the device they worked so much with. For some, this can be an enlightening moment of understanding the huge responsibility of their work.

Mr. Tass Adorján, Director of Business Development at MedRes, shared with us some of his vast experience on this topic taken from the 20 years he has spent at MedRes.


What is the importance of Clinical Trials?

Though clinical trials are not tests – we do not do tests on human patients – but they serve to confirm the results obtained from pre-clinical trials, including bench tests and cadaver models. There is information we cannot get from these models, for example a cadaver will not bleed or react to irritation. During clinical trials we get confirmation that the product is safe to use and it can provide the targeted features in real clinical environment as demonstrated throughout the preclinical trial phases.


What are the requirements of a Clinical Trial?

First, the developed product should be in appropriate state for clinical trials, set by international standards. It needs to comply all required pre-clinical trials, comparative studies, sterility, and biocompatibility and other requirements which are set by international directives, such as MDR. By the time everything is completed it can be a quite huge pile of documents, which is then submitted by the sponsor to the Ethical Committee and following to the Competent Authority. The sponsor of the trial is the one who actually orders the approval of the trial – it can be the same entity as the developer but can be a separate one. The Committee must be convinced by the submitted documents that the product is as safe as or safer than already approved and commercially available products and provides additional benefits for the patient.


How Clinical Trials are conducted?

The population of the study is to be selected carefully. Of course, people who fall significantly outside the median age range or have other comorbidities are generally not enrolled in clinical trials.

At MedRes we usually have a patient cohort of less than hundred people. This is normally enough for clinical trials of devices classified I, II, or IIb. We strive to conduct these trials as efficiently as possible. Obtaining approvals from the Ethical Committee and from the Competent Authority typically takes about 4-5 months once the product and documentation are completed and submitted. These types of clinical trials can be completed in about 6 months if everything proceeds smoothly.

Multicentered studies can be more complicated. At MedRes we have done both single- and multicentered trials, for example we had cooperations with the University Clinics of Debrecen, Szeged, Budapest, and Vienna. The need for multicentered trials arises when we need bigger patient numbers or a more specific patient cohort. For example, a trial of a laryngeal mask can be used on a wide patient group, but when we target a rare medical condition, we might need a multicentered cooperation.


Could you please share with us a personal experience that was really important for you?

During clinical trials, a lucky developer may have the chance to see that their work has really made a difference and helped people. I still remember very well the story of a nice old lady, a relative of my business partner. She was 80 and she needed immediate spine surgery. Of course, we wanted her the best, and luckily, she met the criteria of our ongoing study, so she was included in the trial. After the operation the doctor told her to get out of the bed and walk towards us. First, there was disbelief in her face, but she did as the doctor told her. When she started to walk without the crippling pain, she broke out in tears of joy. These are the moments that keep you walking on despite all the difficulties and struggling of a long and hard development process of medical devices.

In conclusion, clinical trials represent the critical nexus between innovation and real-world impact in the realm of medical device development. They not only validate the safety and efficacy of these devices but also offer developers a profound connection to the lives they aim to improve. The transformative potential of medical devices becomes palpable during these trials, motivating us to persevere through the challenges of long development projects and continue pushing the boundaries of healthcare innovation.