Clinical Trials for Medical Devices: A Few Considerations

Clinical trials for medical devices are fundamental to developing life-changing solutions for society’s most significant health problems.

In the healthcare industry, medical devices are ubiquitous, from humble medical devices such as scalpels going all the way to sophisticated imaging devices for brain scans.

We live in a world where medical devices live almost silently, not only in hospitals and doctor’s offices but in every corner of our homes. Blood pressure and glucose meter, or even a scale to check our progress on a sports regimen, can be considered medical devices since we use them to keep tabs on our health and be alert to potential risks or imbalances.

While medical devices and pharmaceuticals treat diseases and improve people’s health, their clinical trials are very different. Besides having large budgets, the pharmaceutical industry also has a robust infrastructure of suppliers, information, and processes to design and run clinical trials.

Meanwhile, the medical devices industry, predicted to reach $500 billion in 2024, consists of many small and large companies. Many need more funding to conduct device trials like those undertaken by the pharmaceutical industry daily.

Let’s take a closer look at what makes clinical trials in the medical devices segment unique. 

CROs: MedTech Clinical Trial Allies

The way medical device companies conduct clinical trials differs. To a large extent, these differences are due to the complexity of the device or the unique organization of each MedTech company.

Depending on their backgrounds, some founders focus only on one aspect of medical device development, such as clinical research, scientific component, or financial element. As a result, many MedTech companies outsource a significant portion of all processes involved in conducting clinical trials.

Medical technology companies often acquire these services from contract research organizations (CROs), which specialize in providing clinical management services to biopharmaceutical and MedTech companies.

In 2022, CROs are expected to have a market worth $73.38 billion, providing their research expertise in almost all current medical developments since biopharmaceutical and Medtech companies prefer to concentrate on their core competencies and outsource the operations to minimize costs.

In the particular case of MedTech startups, a study sponsor that provides capital to bring new products and services to the market often requires CROs to participate in the clinical trials of new medical devices. These companies lend their credibility to some extent to ensuring that high-quality standards and proven processes are implemented to develop successful products and adhere to FDA regulations.

Because many medical device companies are founded by innovators without prior clinical trial experience, the contribution of CROs in designing and executing clinical trials is crucial. 

Let’s learn how clinical trials for medical devices work.

Clinica Trials Rely on Data to Succeed

In 2021, 3,347 clinical trials were conducted for medical devices. To demonstrate the efficacy or not of a medical device, information and data are essential to the process of conducting clinical trials. Clinical trials are designed to prove that a device positively affects people’s health. What evidence supports this positive effect? Using questionnaires, health professionals and patients report whether specific parameters improve or deteriorate with the medical device.

Undoubtedly, how these questionnaires are handled often determines the fate of a clinical trial for a medical device. Statistical significance can only be achieved, for example, if the questionnaire is well-designed and standardized. Relying on standard questionnaires is critical to measure the same thing and prove a medical device works or not.

Additionally, the complexity of the healthcare industry’s IT systems makes it challenging to conduct clinical trials for medical devices. 

A clinical trial may use four or five software packages to collect and manage data. This situation adds complexity to healthcare professionals and patients. It could even confuse clinical investigators, resulting in unreliable trial data quality that delivers inconclusive results that invalidate the clinical investigation.

In the health care industry, managing clinical data is complex because the systems often do not talk to each other. In device clinical trials, the quality and the ease with which information is collected and analyzed are crucial as they determine whether a medical device clinical trial succeeds or fails.

The COVID-19 pandemic and the remote life that followed made clinical trials in the MedTech industry even more challenging.

Medical devises Clinical Trials After The Pandemic

It is an open secret for those of us who make up parts of the healthcare industry that while the pandemic was disastrous on a human and social level, it served as an accelerator for implementing changes necessary to optimize the healthcare system.

Decentralized clinical trials have become necessary to deal with the difficulty in recruiting patients willing to travel to hospitals. Health equity concerns also have been a driver for clinical researchers during trial design for widening the selection criteria of participants in clinical studies.

Our new remote culture is detrimental to the medical device industry, as it is more challenging to test the effectiveness of scanners and imaging devices in a non-face-to-face setting since many devices must be handled by experts in the hospital environment with human subjects present.

The difficulty of conducting clinical trials of medical devices has forced researchers to rely on digital health technologies to recruit and engage participants. Various apps have been deployed to create open communication channels, reminders, and in some instances, coach the participants so that their engagement can be helpful for researchers to collect enough clinical evidence to prove the efficacy of the devices being tested.

Besides the scientific complexity involved in innovating to improve people’s health, the medical device industry has to cope with socio-cultural changes that make conducting clinical trials more challenging.

What Succesful MedTech Clinical Trials Look Like

This article aims to provide a 10.000-foot overview of what founders of MedTech companies must consider before embarking on a clinical trial.

This is not an exhaustive guide, just a reminder that some areas, particularly finding the right partners, such as experienced CROs, managing data intelligently, and taking into account the social barriers that make patient recruitment difficult, must be considered when designing a clinical study with a high chance of FDA approval.

Please get in touch if you need help creating content for your MedTech company. I‘d love to talk.

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Serg Valencia

Serg Valencia is a Longevity Ghostwriter and Master in Neuroscience empowering longevity pioneers to communicate their life-extending vision.

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