Why Clinical Trial Design Should Begin at the Earliest Stages of Medical Device Development

A man sitting whilst a nurse prepares his arm for an injection.

A Franklyn Health × Mantra Systems Perspective.

This article was written by Rob Bedford, Head of Clinical Operations at Franklyn Health. Franklyn Health is a medical device contract research organisation (CRO) that works with small and midsize medtech manufacturers to design and lead outcome-driven, pragmatic clinical trials. Franklyn Health generates clinical evidence to support regulatory objectives in UK, EU and USA.

The most successful medical device clinical investigations rarely start with a protocol. They start months, sometimes years earlier, during concept development. Under both the EU MDR (2017/745) and the UK Medical Devices Regulations (UK MDR 2002, as amended), clinical evidence is not simply a box-ticking exercise before market approval. It is a continuous thread running through the entire lifecycle of a device, from initial design to post-market follow-up.

This means that the earliest decisions in device development often shape the feasibility, efficiency and impact of the clinical investigation later on. Teams that integrate clinical strategy and communicate with their target users early are consistently better positioned for regulatory approval, clinician adoption and commercial success.

Why early classification shapes the entire programme

Determining the correct device classification is one of the earliest and most critical steps in development. Classification directly influences:

the clinical evidence required
whether a clinical investigation is mandatory
the type of post-market obligations
the regulatory pathway and approval timelines
the claims that can ultimately appear in marketing materials

Many start-ups inadvertently make early assumptions about classification based on perceived risk, competitor products or intended use. However, classification hinges on the specific intended purpose: the exact wording that defines how the device is meant to be used. Even subtle phrasing changes can move a device between classes, fundamentally altering what evidence is required.

Misclassification discovered late can lead to additional studies, redesigns or major delays at a point when funding and timelines are tight. Identifying the correct classification early provides a stable foundation for the entire clinical and regulatory strategy.

The value of early SOTA work: setting the frame before design begins

A State of the Art (SOTA) review is often conducted when preparing the Clinical Evaluation Plan (CEP). But its real power lies when it is done early, even before design controls formally begin. An early SOTA review helps teams understand:

what technologies exist
how clinicians currently treat the condition
what outcomes matter most to clinicians and patients
what performance thresholds competitors have already achieved
which imaging modalities, scoring scales or patient-reported outcomes are considered meaningful
where genuine gaps in treatment outcomes exist

This knowledge informs every downstream decision. When you know the benchmark clinical outcomes and what surgeons or users value, the initial design inputs, risk controls and endpoint selection all become much clearer.

It also prevents a common pitfall: building a technically impressive device that ultimately solves the wrong problem or solves a problem that doesn’t exist.

Validate the need before designing the solution

A fundamental question for all MedTech teams (especially at early-stage) is whether the device solves a meaningful problem and whether the problem is commercially viable. Procurement teams, clinicians and hospital administrators increasingly expect devices to demonstrate clinical benefit or economic benefit, not simply performance improvements.

Under MDR, “clinical benefit” is defined as a measurable positive impact on the health of an individual. If a device cannot show this, adoption will be slow and reimbursement difficult. Technical excellence alone does not guarantee success.

Validating the problem early helps teams:

confirm that a worthwhile unmet need exists
understand the commercial landscape
map where the device fits within treatment pathways
identify the outcomes that will matter to end users and payers

Once this foundation is in place, the team can begin shaping a clinical and regulatory strategy that answers the most important questions, not just the easiest (or even most obvious) ones to study. A thorough evaluation of the SOTA can give MedTech teams the early problem validation they need to move forward with the next stages of development.

A real example of early alignment that delivered results

Members of the Franklyn Health team previously worked on a global clinical investigation for a rotator cuff repair device in sports medicine. Before the clinical evaluation plan had been drafted, the team had already mapped out:

the specific clinical need they aimed to address
the demographics and characteristics of the ideal study population
which literature publications formed the true benchmark
what surgeons needed to justify switching from their existing devices
which endpoints would demonstrate meaningful clinical benefit
the appropriate follow-up schedule to capture healing and functional outcomes
how the data would feed into positioning, marketing and procurement discussions

Because this thinking occurred early (i.e. years before protocol development) the entire programme was cohesive. Regulatory requirements, clinical design, commercial strategy and user needs all aligned. The result was a highly efficient study that generated compelling data, supporting global adoption and strong clinical confidence.

This level of early clarity is not limited to large organisations. Start-ups and scale-ups can follow the same approach by ensuring that design, regulatory planning, market knowledge and clinical strategy develop together. Engaging clinicians early is essential.

How early clinical planning strengthens the whole development pathway

When early planning is done well, it supports critical regulatory and quality system activities:

1. Risk Management (ISO 14971)

Early understanding of clinical risk informs hazard identification, risk control measures and safety-related endpoints. This strengthens both the risk management file and the protocol.

2. Design Controls

Intended purpose, user needs and clinical claims provide the foundation for design inputs. When these are aligned from the start, verification and validation become more efficient.

3. Clinical Evaluation (MDR Annex XIV)

A strong early SOTA and early understanding of clinical claims make CEP development smoother, reducing gaps later on.

4. Human Factors and Usability

Knowing the intended use scenario, and the outcomes that matter, helps structure meaningful usability testing, rather than superficial exercises.

5. Post-Market Planning

A clear early understanding of risk, claims and clinical needs helps define appropriate post-market clinical follow-up (PMCF) activities.

Avoiding late-stage surprises

Companies that begin clinical planning too late often face:

delays due to incomplete or misaligned evidence
protocols that require redesign after regulatory feedback
endpoints that don’t map to clinical claims
unintended gaps in clinical evaluation
the need for additional clinical investigations
issues with investigator recruitment due to poorly chosen endpoints

Early planning prevents these missteps and ensures that evidence collection is deliberate, focused and defensible.

Benefits for smaller companies and investors

For start-ups and scale-ups, early planning builds confidence among investors and stakeholders. A team that understands its: device classification, evidence pathway, benchmarks, likely endpoints and trial structure appears far more credible than a team that “will figure that out later”.

This helps secure funding, attract partners and maintain momentum through development.

Working with an experienced CRO and regulatory consultancy early in the journey can accelerate this alignment, ensuring that the evidence strategy, regulatory planning and commercial pathway reinforce one another from the very beginning.

Conclusion

Clinical trial design should not begin when the protocol template is opened; it should begin during the earliest moments of device conception. Early classification, early SOTA work, early understanding of clinical benefit and early alignment between engineering, regulatory strategy and market expectations create a development pathway that is efficient, credible and coherent.

This approach results in stronger evidence, clearer claims, smoother regulatory review and better adoption by clinicians and healthcare systems. Whether you’re a global manufacturer or a two-person start-up, planning your clinical strategy from day one remains one of the most powerful ways to set your device up for success.