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The medical device industry is evolving rapidly, driven by digital innovation, increasingly complex regulatory requirements, and increasing demand for real-world data. Yet many CROs continue to rely on outdated protocols built for pharmaceutical trials, not today’s intricate device studies.
The potential consequences? Challenges in obtaining regulatory approval, additional research to collect more data, delayed timelines, and increased costs.
To avoid these pitfalls, CROs must stay up-to-date with medical device industry trends, including:
From AI-powered diagnostics to Bluetooth-enabled sensors, connected and software-driven devices are now at the center of medical devices. But these technologies bring unique challenges:
Many CROs lack the infrastructure or experience to support iterative development cycles or software-specific endpoints. Without deep expertise in digital health, they risk overlooking critical elements, such as human factors testing or real-time data capture.
How to Stay Ahead:
CROs must evolve into partners who understand the technology development lifecycle and the regulatory nuances associated with software as a medical device (SaMD).
Today’s medical device sponsors must prove more than just safety and efficacy—they need to demonstrate ease of use, workflow compatibility, and the feasibility of training. If integrating a new technology into clinical practice disrupts day-to-day operations or requires steep learning curves, adoption can stall regardless of how promising the data may be.
Traditional clinical trial designs—which require participants to visit physical sites for study activities—often fall short in capturing how treatments are actually used in real-world settings. As a result, CROs may treat onboarding, training validation, and clinician or patient usability as afterthoughts rather than essential outcomes that shape the success of a trial.
How to Stay Ahead:
CROs need to design trials that reflect real-world use. This means capturing feedback from users, integrating training support, and generating operational data that supports both approval and commercial success.
Medical device companies, especially startups, are pushing for faster, more agile clinical programs. Device trials often require a broader mix of data types, covering performance, usability, human factors, and real-world integration.
In addition, these trials are often plagued with the overly complex protocols seen in drug trials, capturing extraneous data and limiting participation with rigid eligibility criteria. This results in recruitment bottlenecks that ultimately slow the pace of innovation.
How to Stay Ahead:
To ensure more efficient device studies, your protocol should incorporate the following elements from the outset:
From custom packaging and calibration to onsite setup and post-study returns, logistics can make or break a device trial. Medical devices may require special handling, multi-part kits, or specialized storage conditions. For many devices, site staff need hands-on demonstrations, clear handling instructions, and ongoing tech support to ensure proper use.
Missteps in setup or training can delay enrollment, frustrate sites, and ultimately compromise data quality. That’s why device companies need a partner that understands these operational realities—not a CRO bound by the traditional pharma-first mindset.
How to Stay Ahead:
Device-savvy CROs plan logistics from day one. This includes utilizing site readiness assessments, patient-friendly packaging, comprehensive training workflows, and tech support as needed.
Medical devices, especially wearables, offer unique opportunities to leverage decentralized or hybrid study models. These settings not only enhance evidence generation through assessing a product’s performance in real-world environments, but they lend way to more patient-centric research. Yet many CROs lack the infrastructure and digital tools to operate decentralized workflows effectively.
How to Stay Ahead:
Embrace tech-forward solutions for virtual trial execution, including:
As the medical device landscape continues to advance, traditional clinical trial approaches are no longer sufficient. Sponsors need partners who understand the nuances of, usability, iterative development, and operational complexity. From wearable sensors and smart dosing technologies to neurostimulation interventions and implantables, today’s devices require trials that are lean, flexible, and grounded in real-world use.
CROs that continue to rely on pharma-centric models risk falling behind—missing key insights, delaying regulatory approvals, and increasing costs. To stay competitive and support innovation, trial design must evolve alongside the technologies it seeks to evaluate.
Join us on June 24 for our live webinar, “What CROs Get Wrong About Medical Device Trials,” where industry leaders from Lindus Health, Glucotrack, and Motif Neurotech will explore why device trials require a fundamentally different approach than drug trials. You’ll learn how an integrated, expert-led team across clinical design, regulatory strategy, operations, and more can streamline development, accelerate approval, and improve market success.
