Bringing a medical device to market is rarely as simple as build it, submit it, sell it. For many startups and emerging MedTech companies, clinical trials are essential not only to reach the market, but also to support adoption and sales. However, clinical trials introduce new operational demands, regulatory exposure, financial pressure, and execution risk.
For first-time founders especially, approaching a clinical study or trial can feel overwhelming. These efforts are complex, resource-intensive undertakings that are often intimidating for MedTech teams navigating them for the first time.
The key question most teams eventually face is not just whether they need a clinical study, but how they should run it. Should they partner with a Contract Research Organization (CRO), or build out the system and manage the trial internally?
The right answer depends on your regulatory pathway, study type, internal infrastructure, long-term strategy, and prior experience. This guide walks through each of those variables so you can make a confident, informed decision that sets you up for a successful clinical trial.
When Clinical Data Is Required and When It Is Strategic
In the US, many medical devices are cleared through the 510(k) pathway, under which manufacturers must demonstrate substantial equivalence to a predicate device. In many cases, clinical data is not required to achieve 510(k) clearance.
FDA explains in its guidance on clinical data in 510(k) submissions that non-clinical testing is often sufficient to support clearance when substantial equivalence can be demonstrated through pre-clinical data.
However, while clearance does not always require human / clinical data, commercial adoption often does. While you may achieve FDA clearance without clinical data, you often still need strong clinical evidence to move into true commercialization.
Hospitals, health systems, insurance companies, and other payers frequently ask for evidence beyond safety and basic performance. They want to see outcome improvements, reduced complication rates, shorter procedure times, and/or cost savings. For these reasons, FDA clearance or CE marking alone may not be sufficient to unlock purchasing decisions.
In Europe, the regulatory landscape is much different. Under the EU Medical Device Regulation (EU 2017/745), clinical evaluation is mandatory for devices placed on the market, including legacy products. The regulation requires manufacturers to demonstrate sufficient clinical evidence to support safety and performance.
In summary, clinical strategy is not only a regulatory decision, it is a commercial one.
Understanding Clinical Study Types
Before deciding between a CRO or in-house management of a trial, you must first understand what type of study you are planning.
Early Feasibility Studies
Early Feasibility Studies (EFS), often involving a single investigator and fewer than 10 subjects, are used as part of the development of a medical device, and are designed to gather early human data and refine the design. These studies are intended to gather safety data, and are closely tied to design controls and risk management.
Flexibility is higher in this phase, and changes to the study protocol or device design are more common.
Traditional or Pilot Studies
Traditional or pilot studies expand subject numbers and reduce flexibility. Under this type of study, device design is closer to final and protocol rigor increases. For many Class II medical devices, these study types are generally sufficient to support clearance or approval. They also help validate methods and prepare for larger trials, which are required for Class III medical devices.
Pivotal Studies
Pivotal trials are larger and more rigid than EFS and traditional studies. These trials typically involve several hundred subjects or more and include multiple study sites and clinical investigators. As such, any protocol deviations have a major impact and can also compromise regulatory acceptance. Operational precision is critical at this stage.
Post-Market Studies
After regulatory clearance or approval, manufacturers often conduct post-market studies to gather real-world evidence to support marketing claims, reimbursement strategy, or long-term safety monitoring. Post-market studies are, however, typically done under the cleared or approved indications for use, which makes these studies easier to conduct.
Each of these four study phases carry different operational demands, which directly influence whether in-house management is realistic.
Factoring in Significant Risk vs Non-Significant Risk
Another major factor to consider is whether your study is classified as Significant Risk or Non-Significant Risk.
Under FDA regulations, Significant Risk studies require an Investigational Device Exemption (IDE) application and FDA approval before enrolling subjects. Non-Significant Risk studies may proceed with Institutional Review Board (IRB) approval alone. The FDA provides a clear overview of IDE requirements here.
Risk classification depends not only on the device, but on how the study is designed and which subject population is enrolled. The same device could be considered higher risk in one population and lower risk in another.
Therefore, particularly during an Early Feasibility Study, sponsors should consider whether their endpoints can be achieved in a lower-risk patient population rather than beginning with higher-risk groups, such as elderly patients with significant comorbidities. Thoughtful study design at this stage can influence risk classification and overall regulatory burden.
Risk classification directly impacts monitoring requirements, documentation burden, and oversight intensity. That in turn affects timeline, level of effort, and whether internal teams can realistically manage the trial execution.
CRO vs In-House: Defining the Two Models
A Contract Research Organization, or CRO, is an external partner that provides clinical trial management services under contract. This can include site recruitment, monitoring, data management, regulatory submissions, and overall trial execution.
In the in-house model, the sponsor builds and manages all clinical operations internally. This includes staffing, systems, monitoring, collaboration with study sites, and compliance oversight.
Regardless of model, the sponsor retains ultimate responsibility for the study. In fact, FDA guidance on sponsor responsibilities emphasizes that accountability cannot be delegated away.
A Practical Decision Framework for Choosing CRO vs In-House
When evaluating CRO versus in-house management of a clinical trial, consider these core questions:
- Do we have internal clinical and regulatory expertise?
- Do we have the proper resources besides knowledge (time and budget)?
- Do we have the infrastructure to manage data, monitoring, and documentation?
- What is our timeline pressure?
- Do we have strong investigator and site networks?
- Are we prepared to manage regulatory oversight and reporting risk?
Companies must honestly assess whether they truly have the knowledge, experience, resources, and network required to pull off in-house management of a clinical trial.
If your answer is no to more than one of these, a CRO may significantly reduce risk and accelerate timelines.
Advantages and Risks of Working with a CRO
Benefits
CROs bring established processes, trained staff, and existing site relationships. This can shorten project timelines, de-risk the overall study, and improve study enrollment rates. For MedTech companies without prior trial experience, this can significantly reduce operational uncertainty and resource strain.
CROs can also provide geographic reach, which is especially valuable for multinational studies.
Risks and Mitigation
Sponsors often worry about losing visibility and control by partnering with a CRO. However, communication structures, shared dashboards, and clearly defined governance models can help mitigate this.
Change orders can increase costs if protocols evolve. For this reason, strong contract language defining scope, staffing qualifications, and change management processes is essential.
CRO staff variability is another concern for sponsors. Contractual clarity around personnel assignments and turnover procedures is a great way to reduce disruption and ensure alignment from the outset.
Sponsors should also clarify Trial Master File ownership, data access, and confidentiality terms upfront to avoid downstream conflict.
When In-House Makes Sense for Managing Clinical Trials
Managing a clinical trial internally offers direct control, stronger long-term knowledge retention, and closer site and investigator relationships. In-house management allows companies to retain institutional knowledge that can be leveraged for future studies and initial sales.
This approach can work well for early feasibility studies or when internal clinical operations expertise already exists.
However, companies frequently underestimate infrastructure costs. Clinical trial management systems, electronic data capture systems, monitoring capabilities, and trained staff require significant investment and support. Enrollment can also become a bottleneck without established site networks.
The key is to be realistic. Internal capability must match study complexity.
Clinical Trial Readiness Before First Patient Enrollment
Before launching any study, certain elements must be complete:
- A robust Quality Management System (QMS) aligned with applicable regulations
- Design and development documentation, including design controls under QMSR and EU MDR
- Risk management files
- Preclinical testing data demonstrating safety for intended clinical use
- Clinical protocol and informed consent documentation
- IRB approval and IDE submission, if required
- Data collection and monitoring plans
- Prior discussions with regulatory authorities, such as an FDA pre-submission or discussions with a Notified Body, to confirm study expectations
Without strong documentation and systems, even a well-designed study can stall.
For teams choosing to manage trials internally, having structured systems in place to support documentation, design controls, quality processes, and clinical oversight becomes critical.
Designing Studies for Both Regulatory and Commercial Success
A common mistake is designing studies only for regulatory clearance. Regulators focus on safety and effectiveness within intended use, while payers and providers focus on value, cost, and workflow impact.
Clinical endpoints should be defined early with commercialization in mind. Doing so may prevent the need for costly follow-up studies later.
When done correctly, a single well-designed study can support regulatory submission, reimbursement discussions, peer-reviewed publication, and sales enablement.
Support for Every Clinical Trial Path
Choosing between a CRO and in-house execution is not about which model is better. It is about alignment between your study complexity, internal infrastructure, funding, and long-term strategy.
Companies must truly understand what both options require and be realistic about their own capabilities before committing.
For companies building internal capabilities, QuickVault’s eQMS provides a structured, all-in-one solution to support documentation, clinical readiness, and compliant execution.
For MedTech teams planning a clinical trial, whether through a CRO or in-house, Veeva Systems brings extensive experience across both models and provides end-to-end clinical trial management solutions. To learn more about how Veeva can support your clinical strategy, contact us by clicking here.
Whether you outsource, build internally, or adopt a hybrid approach, the goal is the same: execute with clarity, protect patient safety, generate credible data, and design your clinical strategy to support both regulatory approval and commercial success.
Article Contributors
Tamar Cohen
Associate Account Partner, North America Clinical Data, Veeva Systems
Tamar began her career in healthcare as an Occupational Therapist after earning her Master of Science, a role that provided her with a deep appreciation for patient care and the complexities of healthcare systems. Her clinical foundation instilled strong analytical and problem-solving skills that continue to shape how she approaches challenges in clinical research and operations today.
Before joining Veeva, Tamar navigated the fast-paced worlds of early-stage startups and the expert network world, helping clients solve complex challenges in evolving environments. These experiences strengthened her passion for healthcare innovation and highlighted how data, research, and technology can converge to drive better outcomes. Her background gives her a practical, first-hand understanding of both patient and provider needs within the life sciences space.
Bridging healthcare and technology today, Tamar focuses on Sales and Clinical Operations at Veeva, with an emphasis on advancing research through modern technology. She partners with MedTech sponsors and CROs to guide the adoption of solutions that make clinical trials more efficient and impactful. By combining her clinical perspective with a consultative strategy, Tamar bridges the gap between healthcare and technology to deliver meaningful results for the industry.
Axel Strombergsson
VP of QuickVault, Veeva Systems
Axel brings over 20 years of diverse experience in the MedTech industry, spanning R&D leadership, operations, regulatory strategy, and medical device commercialization. Before joining Veeva, Axel led R&D efforts for a surgical device company and later transitioned to roles focused on scaling operations and bringing medical devices to market. He also worked at Vanderbilt University’s Tech Transfer Office, where he collaborated with research teams on cutting-edge medical device innovation.
As an integral part of multiple MedTech startups, Axel has gained firsthand experience in navigating the challenges and opportunities of the entire device lifecycle. Beyond his professional roles, Axel is a passionate mentor and thought leader within the MedTech ecosystems in both the US and EU. He frequently delivers lectures and provides mentorship to startups and smaller companies, helping them navigate regulatory landscapes and accelerate business growth.
With his extensive expertise and practical insights, Axel is uniquely positioned to guide companies in achieving success across R&D, regulatory compliance, commercialization, and long-term business development.
