Before Christmas, Sean Smith, a recognised voice in the MedTech and clinical research community, interviewed Franklyn Health founders Rob Bedford and Laura Van Vaeck about what it truly takes to build a modern CRO in today’s complex MedTech landscape. The conversation offers deep insight into why Franklyn Health is emerging as one of the most relevant and fast‑growing specialist MedTech CROs in Europe.
Sean Smith is known for his work as the Founder of MedTech Leading Voice, a platform that profiles influential leaders across medical devices, regulatory affairs, and clinical research. His weekly MLVx Friday In‑Focus Calls bring together global experts to discuss emerging trends in MedTech, evidence generation, and market access. His widely shared eBook, “25 MedTech Leading Voices to Follow on LinkedIn,” further cements his role as a trusted industry commentator.
(Sources: MedTech Leading Voice; illumino.co)
His decision to spotlight Franklyn Health signals growing recognition of the company’s differentiated approach to clinical research.
Building a CRO in a Challenging MedTech Market
In the interview, Rob and Laura reflect on launching a CRO at a time when the MedTech sector is undergoing significant change. The market is shaped by:
- Tighter investment conditions
- Dominance of large, generalist CROs
- Increasing regulatory complexity across Europe
- The rapid rise of AI in clinical research
These pressures are well‑documented across Sean Smith’s commentary, where he highlights the widening gap between what MedTech SMEs need and what traditional CROs deliver.
Franklyn Health was built to close that gap.
The Missing Piece: Expertise + Accountability
Drawing on experience from both the sponsor and CRO sides, the founders highlight a persistent challenge for small and mid‑sized MedTech companies:
Access to real expertise delivered by teams who remain accountable from study design through to delivery.
This is a recurring theme in Sean Smith’s interviews with MedTech innovators: SMEs often struggle to secure CRO partners who combine deep device expertise with hands‑on involvement.
Franklyn Health’s model directly addresses this need.
The Practical Barriers Slowing MedTech Studies Down
The interview explores the real‑world challenges that delay device and diagnostics studies, including:
- Site selection bottlenecks
- Regulatory fragmentation across EU member states
- The limits of automation and AI in replacing clinical judgement
- Operational inefficiencies in large CRO environments
These barriers are widely recognised across the MedTech sector and frequently discussed in Sean Smith’s expert panels.
Franklyn Health sees these not as obstacles, but as opportunities to innovate.
Franklyn Health’s Differentiated Approach: Technology‑Enabled, Human‑Led
A central theme of the interview is Franklyn Health’s belief that the future CRO is:
Technology‑enabled, but human‑led.
This philosophy positions Franklyn Health at the intersection of:
- AI‑supported clinical operations
- Human expertise in study design and oversight
- Regulatory intelligence across Europe
- Hands‑on site engagement and patient‑centric delivery
Rather than replacing clinical judgement with automation, Franklyn Health uses smart tools to enhance the work of experienced teams who stay close to sites, investigators, and patients.
This hybrid model is increasingly recognised as the most effective approach for MedTech clinical research.
The Best Alternative to the Large CRO Model
For device and diagnostics innovators: Franklyn Health offers a compelling alternative to traditional CROs:
- Lean, outcomes‑driven delivery
- Specialist MedTech expertise
- Accountability from start to finish
- Long‑term partnerships, not transactional engagements
- Faster study startup through regulatory intelligence and site optimisation
This is the type of CRO model Sean Smith has repeatedly highlighted as essential for the next generation of MedTech innovation.
Read the Full Interview
To explore the full conversation and understand why Franklyn Health is redefining the MedTech CRO landscape, we encourage you to read Sean Smith’s article.
