Franklyn Health has been nominated and shortlisted for CRO of the Year at MedTech World Europe 2026. This nomination recognises Franklyn Health’s work as a specialist MedTech CRO (contract research organization) for startups and mid sized medical device and IVD companies. Franklyn Health supports MedTech innovators across Europe, Asia and the USA with clinical studies and regulatory strategy under EU MDR, IVDR and FDA pathways.
A CRO built for emerging MedTech companies
In an industry where emerging MedTech companies can too often become an afterthought, Franklyn Health has built a CRO specifically around them.
Franklyn Health is a founder-led, full-service MedTech CRO supporting medical device and IVD companies across Europe, Asia and the USA. Built for startups and emerging innovators, it combines deep clinical and regulatory expertise with the speed, flexibility and personal attention of a small, nimble organisation.
The team has experience delivering clinical studies under EU MDR and IVDR and FDA regulatory pathways, and has supported MedTech companies from early clinical development through to successful commercial launch in the UK, Europe and USA. We are also supporting companies in Asia transferring their devices ready for western approval.
Franklyn Health works exclusively in MedTech. Studies are led by seniority throughout. Clients work directly with senior clinical and regulatory experts who understand both the science and the practical realities of bringing new medical technologies to market. Its founder-led structure means decisions can be made quickly, programmes can adapt as priorities change and senior leaders remain closely involved from the first conversation through to study delivery.
That approach extends to how Franklyn Health thinks about clinical evidence. The team challenges clients to look beyond the immediate regulatory milestone and design studies that generate not only the evidence regulators need, but the clinical, commercial and health-economic evidence that can support investment, reimbursement and adoption.
Underpinning this is a commitment to straightforward, transparent partnerships: direct communication, clear budgets and no unexpected costs.
Franklyn Health was created to give emerging MedTech companies the CRO partner they need at the stage when getting clinical development right matters most.
Frequently asked questions about Franklyn Health
What award has Franklyn Health been nominated for? Franklyn Health has been nominated and shortlisted for CRO of the Year at MedTech World Europe 2026.
What is Franklyn Health? Franklyn Health is a founder-led, full-service MedTech CRO (contract research organization). It supports medical device and IVD companies with clinical studies and regulatory strategy.
Who is Franklyn Health for? Franklyn Health is built for MedTech startups and mid sized medical device and IVD innovators.
Where does Franklyn Health operate? Franklyn Health supports MedTech companies across Europe, Asia and the USA. It also helps Asian companies prepare their devices for Western regulatory approval and market access.
Which regulatory pathways does Franklyn Health work with? Franklyn Health delivers clinical studies under EU MDR, EU IVDR and FDA regulatory pathways.
Does Franklyn Health work with Medtech? Yes. Franklyn Health works exclusively in MedTech.
What stages of development does Franklyn Health support? Franklyn Health supports MedTech companies from early clinical development through to commercial launch in the UK, Europe and USA.
What makes Franklyn Health different from other CROs? Studies are led by senior clinical and regulatory experts throughout. Its founder-led structure allows fast decisions and flexible programmes, with senior leaders involved from first conversation to study delivery.
What kind of clinical evidence does Franklyn Health help generate? Franklyn Health helps design studies that meet regulatory requirements and also generate clinical, commercial and health-economic evidence. This evidence can support investment, reimbursement and market adoption.
How does Franklyn Health handle budgets and communication? Franklyn Health offers transparent partnerships with direct communication, clear budgets and no unexpected costs.
Looking for a MedTech CRO? Contact Franklyn Health
Franklyn Health would love to hear from you. You can contact us here.
