Introduction
Bringing a new medical device to market is an exciting but daunting journey—especially for small and mid-sized manufacturers. While innovative devices often start with a strong concept and prototype, the pathway from idea to regulatory approval is paved with rigorous clinical research requirements. For many smaller companies, clinical studies represent the single biggest hurdle: they’re costly, complex, and full of potential pitfalls.
Yet with the right strategy and support, these challenges can be managed. At Franklyn Health we specialise in helping small and mid-sized device companies navigate the clinical landscape with efficiency and confidence. In this article, we break down the top five challenges small device companies face in clinical studies—and share practical tips to overcome them.
1. Recruiting and Retaining the Right Patients
Why it’s a challenge
Recruitment consistently ranks as one of the toughest aspects of clinical trials. For medical device companies, the challenge is amplified: eligible patient populations are often smaller and more specific than those for pharmaceutical trials. Devices may target a narrow indication or require patients willing to undergo procedures or implants, which adds another layer of complexity.
Retention is just as critical. Patients who drop out of a study can compromise data quality, delay timelines, and increase costs.
How to overcome it
- Engage early with investigators and sites to understand patient demographics and likely recruitment rates.
- Simplify study protocols to minimise patient burden (e.g., fewer site visits, flexible scheduling).
- Use digital tools like patient registries, outreach platforms, or even decentralised trial elements to widen reach.
- Prioritise patient experience by providing clear communication, support, and follow-up throughout the study.
- Patient advocacy groups can help improve both recruitment and long-term engagement – get them involved early.
2. Managing Costs Without Compromising Quality
Why it’s a challenge
Clinical studies are expensive, and for small and mid-sized companies, budgets are often tight. Even modest trials can run into the millions of pounds once you account for investigator fees, monitoring, data management, and regulatory requirements. Many device startups underestimate costs or struggle to balance quality with financial limitations.
How to overcome it
- Plan early: Build a realistic budget during the development phase, not after device design is finalised.
- Prioritise critical data: Focus on endpoints that truly support regulatory approval and reimbursement, avoiding unnecessary “nice-to-have” measures.
- Choose the right CRO partner: A CRO experienced with small and midsize device companies can tailor transparent solutions to fit budget constraints without cutting corners.
- Leverage adaptive trial designs: These can help adjust enrolment numbers or endpoints based on interim results, saving time and money.
- Build a contingency fund of 10-15% for unexpected delays or additional requirements.
3. Navigating Regulatory Complexity
Why it’s a challenge
The regulatory landscape for medical devices is evolving rapidly. In the EU, MDR has raised the bar for clinical evidence, while in the U.S., FDA is increasing its focus on real-world evidence, human factors, and post-market surveillance. For small companies without in-house regulatory expertise, interpreting guidance documents and aligning study design with requirements can feel overwhelming.
How to overcome it
- Engage regulators early: Pre-submission meetings with FDA or consultations with notified bodies in the EU can clarify expectations.
- Seek specialised expertise: Partnering with a CRO or consultant who tracks evolving regulations can save costly mistakes.
- Document everything: Clear, well-organised clinical and technical documentation reduces the risk of regulatory delays.
- Plan for post-market evidence: Build surveillance into your strategy from the start rather than treating it as an afterthought.
4. Finding and Managing Clinical Sites
Why it’s a challenge
Choosing the wrong sites can derail a trial. Smaller manufacturers often struggle to attract high-performing sites that prefer partnering with larger sponsors. At the same time, many underestimate the complexity of site management—leading to missed deadlines, inconsistent data, or compliance issues.
How to overcome it
- Prioritise investigator experience: Seek sites with proven expertise in your device’s therapeutic area, a track record of high research compliance and consistent enrolment.
- Assess patient access realistically: A prestigious site isn’t always the best if it lacks access to your target patient population, plus they are often the most expensive.
- Invest in site relationships: Regular communication, training, and support ensure sites remain engaged and motivated.
- Use centralised monitoring tools: Technology can help oversee multiple sites efficiently without inflating travel costs.
- Start small with fewer, higher-quality sites rather than spreading this across many average ones.
- Work with a CRO with an extensive site network who can help you conduct feasibility and select the best sites for your clinical studies.
5. Ensuring Data Quality and Compliance
Why it’s a challenge
In clinical research, data is everything. Poorly collected, inconsistent, or incomplete data can invalidate a study. For smaller companies with limited resources, maintaining robust data management systems and ensuring compliance with Good Clinical Practice (GCP) can be daunting.
How to overcome it
- Invest in electronic data capture (EDC) systems best suited for your type of study.
- Train site staff thoroughly on study protocols, reporting requirements, and GCP standards.
- Monitor proactively: Regular checks (on-site or remote) catch issues before they spiral.
- Standardise procedures to ensure data is collected consistently across all sites.
- Treat data as a regulatory submission asset from day one, not just a byproduct of the study.
Final Thoughts: Turning Challenges into Opportunities
Clinical studies are never simple, but for small and mid-sized medical device companies, they don’t have to be insurmountable. With careful planning, the right partners, and a patient-centred approach, these five common challenges can be turned into opportunities for stronger evidence generation and faster market access.
The most successful companies are those that view clinical studies not as a regulatory box to tick, but as a strategic investment in their device’s long-term success. Partnering with an experienced CRO can help ensure studies are designed and executed efficiently, while balancing cost, quality, and speed.
At Franklyn Health, we’re passionate about helping innovative device companies bring their ideas to life through well-executed clinical research.
If you’re preparing for your next study, get in touch to discuss how we can help you navigate your clinical journey with confidence.
