Introduction

Selecting the right CRO is one of the most important decisions a MedTech company can make. With increasing regulatory demands, tighter timelines and growing competition, many innovators are rethinking the traditional reliance on large, global CROs. More and more, they are turning to smaller, specialised partners who offer the agility, expertise and personalised support needed to successfully navigate medical device and diagnostics clinical studies.

Innovation and Agility in MedTech Clinical Research

In the fast-evolving world of medical technology (MedTech), innovation and flexibility is key. Whether you’re developing a novel diagnostic tool, wearable device, companion diagnostic, software as a medical device (SaMD), or implantable system, getting your product to market quickly and safely is critical.

However, navigating the complex landscape of clinical research for medical devices and diagnostics requires more than just technical expertise — it demands the right Contract Research Organisation (CRO) partner.

While large, global CROs have long been the default choice for clinical study outsourcing, a growing number of MedTech companies are turning to smaller, specialised CROs for their medical device or diagnostics clinical studies. Boutique CROs like Franklyn Health combine deep domain expertise with agility, offering a modern approach to clinical research, one that aligns perfectly with the needs of innovative MedTech developers.

Here’s why partnering with a small CRO could be the smartest decision you make for your next clinical study.

Tailored Expertise in Medical Device Clinical Studies

Unlike pharmaceutical trials, medical device or diagnostic studies come with their own unique challenges, from device classification and usability testing to post-market surveillance.

Franklyn Health was founded by a team with substantial experience in medical device and diagnostics regulatory pathways, including EU MDR, EU IVDR, FDA 510(k), and IDE (Investigational Device Exemption) submissions.

We understand the nuances of clinical research across different device classes, even helping you understand whether your product qualifies as a medical or in vitro diagnostic device, and we can provide you with customised strategies that align with your product’s risk profile and regulatory requirements.

Agility and Speed to Market

Time is a critical factor in the MedTech space. Whether you’re racing to meet investor milestones or responding to competitive pressures, delays in clinical study execution can have a significant impact to your company, especially in regard to increasing risks to costs and delays in release and respective profit.

Franklyn Health is built for speed. With our lean teams and streamlined processes, we can accelerate study start-up, site activation, and data collection. Using our proprietary regulatory tool, we ensure rapid alignment with current regulatory study submission requirements, reducing the risk of costly delays and compliance issues.

This agility is especially valuable for early-stage MedTech companies and digital health innovators, where rapid iteration and feedback are essential.

Personalized Service and Senior-Level Engagement

One of the biggest advantages of working with a small CRO is the level of personalised attention you receive. Large CROs typically operate a business model based on volume of studies, prioritising the largest contracts and the sponsors with the deepest pockets. Small CROs often take a different approach, prioritising quality and long-term partnerships over chasing every-larger sponsors and studies. Franklyn Health has built this ethos into our DNA: we exclusively work with small to midsize medtech companies, and we treat every study as if it were our own.  You’ll work directly with senior clinical professionals, including founders and directors, who bring decades of experience to your project.

This hands-on approach ensures strategic alignment, faster decision-making, and real-time problem-solving, which is critical for navigating the complexities of MedTech clinical research.

Cost-Effective Clinical Study Management

Budget constraints are a reality for many MedTech startups and scale-ups. Large CROs often come with high overheads and rigid pricing models. In contrast, smaller CROs can offer cost-effective clinical study solutions without compromising on quality or compliance.

Franklyn Health’s lean operations and pricing structures mean we can provide value-driven clinical research services. Whether you’re conducting a pilot study, feasibility study, or post-market clinical follow-up (PMCF), we can help you maximize your budget without compromising quality.

Innovation and Technology Integration

MedTech companies are often at the forefront of innovation, and your CRO partner should share that mindset. As a small, agile organisation, we embrace digital tools to enhance efficiency, data quality and patient engagement.

Small CROs can integrate seamlessly with your preferred platforms, whether it’s an electronic data capture (EDC) system, electronic patient reported outcome measures (ePRO), or device telemetry outputs.

We also leverage our proprietary regulatory tool to keep our team continuously aligned with the latest regulatory requirements for clinical studies. This ensures compliance in an evolving landscape, without losing the expert oversight that drives sound decision-making.

Our tech-enabled, human-centric approach ensures your study runs smoothly and generates high-quality data.

Strong Sponsor-CRO Relationships

The team at Franklyn Health thrive on building long-term partnerships, and that is the relationship a Sponsor and CRO should have. While many big organisations work in a transactional capacity, we believe that true partnering drives greater efficiencies and better outcomes.

Our growth depends on your success, and we are committed to delivering exceptional service. You’ll benefit from transparent communication, shared accountability, and a team that’s genuinely invested in your product’s journey.

This collaborative culture fosters trust and ensures your clinical study is not just a transaction, but a strategic partnership.

Passion and Purpose

Franklyn Health was founded by professionals who are passionate about improving healthcare through innovation. We’re not just executing protocols, we want to help bring life-changing technologies to patients.

This sense of purpose translates into dedication, attention to detail, and a proactive mindset. Sponsors often find that our energy and commitment make a real difference in the quality and pace of their clinical programs.

Rethinking Your CRO Strategy for MedTech Success

In today’s competitive MedTech landscape, choosing the right CRO is not only a logistical decision, but a strategic one. Franklyn Health offers a compelling alternative to traditional CRO models, combining expertise, agility and personalized service to help you navigate the complexities of medical device and diagnostic studies.

Whether you’re preparing for a regulatory submission, launching a first-in-human study, or conducting post-market follow-up, a small CRO partnership can provide the flexible, cost-effective, and innovative support you need to succeed.

Ready to explore a new kind of CRO partnership?

Are you a MedTech company looking for a CRO that understands your product, your pace, and your purpose?

Partner with Franklyn Health, where expertise meets agility, and your innovation becomes our mission.

Contact us to discuss your next medical device or diagnostic clinical study.